BO CH HC

Chng I:

i cng
v mn hc bo ch

Mc tiu hc tp:
1- Trnh by c v tr, i tng ca mn hc.
2- Tm tt c mt s giai on chnh v lch s pht trin
mn hc.
3- Nu c cc kh nim: dng thuc, dc cht, t dc, ch
phm v bit dc.

1- Khi nim v bo ch:

- T thi ng thy con ng bit dng cy c,
khong vt quanh mnh cha bnh. Ban u
dng cc ng liu lm thuc trng thi t nhin,
dn dn bit ch bin, bo ch thnh cc dng
thuc n gin tin dng v bo qun.
- Cng vi s pht trin ca cc ngnh KH khc,
vic BC ngy cng c ng cu hon thin
thnh mt trong nhng mn hc chnh ca ngnh
dc.

BC hc l mn hc ng cu c s l lun v
KT thc hnh v pha ch, sn xut cc
dng thuc, v TCCL, cch ng gi v b
qun cc ch phm thuc nhm pht huy
cao nht hiu lc tr ca thuc, bo an
ton, thun tin cho ng dng v p ng
c h qu kinh t.

2- Vi nt v lch s ph trin
L s ph trin ca BC hc gn lin vi s ph
trin ca Ngnh dc.
Trong ti liu c cch y 3000 nm c
nhng sch ghi chp v KT BC cc dng
thuc. V d: Trong kinh Vedas ca n
, trong Bn tho cng mc ca TQ
m t cc dng thuc bt, vin trn, cao
thuc.

Vo th k th V trc cng nguyn, cc

nh trit hc kim thy thuc ni ting ca
La m, Hy lp nh Platon; Socrat; Aristot
i su ng cu cc PP cha bnh v
BC thuc. Nm 400 trc cng nguyn
Hypocrat a KH vo thc hnh Y
Dc hc da trn c s thc nghim v
bin son nhiu sch Y Dc hc c gi
tr.

Tuy nhin Bc hc ch c coi l bt u

vi s cng hin ca Caludius Galenus
(131 210 trc cng nguyn) ng l
ngi gc Trung ng sinh ti La m lm
thuc cho Hong gia, ng li trn 500
tc phm v y hc trong c tp sch v
phn loi thuc c ghi chi tit cch pha ch
mt s loi thuc. T ng c coi l
ngi sng lp ra mn BC hc. Tn ng t
cho mn hc Pharmacie Galenique

T th k XIX, do s ph trin cc ngnh

KH lin quan nh vt l, ha hc, sinh hc
ngnh dc ni chung v KT BC ni
ring c s ph trin mnh m. Mt lot
cc dng thuc mi ra i: Thuc vin nn,
thuc tim, nang mm l thuyt v BC
c xd trn c s KH do vn dng
thnh tu ca cc mn KH c bn v c s,
t ngnh cng nghip Dp ra i.

Sau i chin The World ln th 2, do s

tc ng ca cuc cm KHKT trn phm vi
ton th gii, ngnh BC t c nh
cao. Hng lot bit dc c sx quy m
cng nghip ra i, vi my mc hin i
c nng sut cao (my dp vin quay trn,
my ng nang, my ng, hn ng tim t
ng ) c hnh thc tr by p, hp dn
thay th dn cc thnh phm pha ch
theo n hoc BC qui m nh.

Tuy nhin,cng bt u t nhng nm 60,

ng ta nhn thy rng mt dng thuc c
hnh thc p cha chc c td tt.
Nhng NC bt u t M cho thy mt lot
Bd tuy cng mt dng thuc, c hm lng
dc cht nh nhau (tng ng v BC)
nhng p ng sinh hc khng ging nhau
(khng tng ng v SH) . i su NC ng
nhn ca nhng h tng khng tng
ng ny hnh thnh nn mn Sinh
dc hc (Biopharmacy) .

Sinh dc hc BC nhn mnh vai tr

ca t dc, ca KTBC, ca bao gi i
vi SKD (Bioavailability) ca thuc. T
thc y s ph trin ca CN t dc v
CN bao b. Hng lot nhng t dc mi v
bao gi mi ra i nng cao cht
lng ca cc ch phm BC.
Vic ra i ca SDH nh du mt g
on chuyn tip t BC qui c sang BC
hc hin i.

Trong BC hc hin i, ch lng ca dng

thuc khng ch c nh gi v mt l,
ha hc m cn c nh gi v phng
din gii phng v hp thu dc cht (sinh
kh dng) . Nhiu dng thuc c SKD ci
tin ra i: Thuc td ko di, thuc gii
phng c kim sot, thuc gii phng theo
chng trnh. y l nhng h iu tr c
kh nng duy tr nng thuc trong mu
mt khon th gian kh di nhm nng cao
SKD ca thuc.

Trong nhng nm gn y, BC hin i ang c

xu hng i vo th gii siu nh (cng ngh
nang), ch ra cc Nanocapsule, nanosphere,
liposome, niosome, c kch thc c nanomet
l nhng c gng nhm a thuc ti ch.
Hin nay, bn cnh cc bd c sx hng lat
qui m CN, hnh thc pha ch theo n c duy
tr b p cho s thiu ht ca sx ln v
gup cho vic iu chnh thuc ph hp vi c th
ng bnh trong dc lm sng.

 nc ta, t lu nn Y, dc hc c
truyn ra i v pht trin. Nhiu dng
thuc cao, n, hon, tn c dng kh
ph bin trong nhn dn.
Cc danh y ln nh Tu Tnh (th k XIV),
Hi Thng Ln ng (th k XVII) c
nhiu pho sch ln m t cc v thuc v
cc PP ch bin, BC cc dng thuc c
truyn.

Di thi php thuc, trng HYD ng

dng c thnh lp (1902) trong c
b mn BC (1935). Nhiu bd c a vo
nc ta, mt s ca hng pha ch theo n
ra i cc thnh ph ln, pha ch cc
dng thuc thng thng: thuc bt, thuc
nc, thuc m

T nhng ngy u cuc kc chng Php

Vin kho cu v ch to Dp thuc Cc
qun Y c thnh lp NC v sx thuc
bng nguyn liu trong nc. Ngnh BC
c nhng ng gp ng k trong vic pha
ch thuc cung cp cho b i v nh dn.
Sau ha bnh lp li, nhiu XNDP TW
c thnh lp. Cc KD BV cng pha ch
nhiu loi thuc, ch yu l DC.

Trong nhng nm kc chng M cu nc,

hng lot cc XNDP a phng ra i, to
thnh mt mng li pha ch, sx thuc
rng khp, m bo c vic t tc nhu
cu thuc phc v cho chin u v bv sk
nhn dn.
Sau khi thng nht t nc, nht l t
ngy c chnh sch i mi, nhiu XNDP
tch cc i mi TTB v qui trnh cng
ngh. Nhiu TB v KT mi c a vo
nc ta: My dp vin

nng sut cao, my ng nang, my p v,

my bao mng mng t ng, my to ht,
bao tng si. H thng pha ch - ng
thuc tim t ng, h thng ng kh,
my ch to pellet Do vy, dng BC tht
s c i mi v hnh thc. V mt sx
c nhiu Cty, XN dp trin khai p dng
theo h dn Thc hnh tt sx thuc
GMP ca Hip hi cc nc Asean v
WHO. Do , cht lng thuc sx trong
nc ngy cng m bo.

Tuy nhin, ngnh BC nc ta vn ch l BC

quy c. Thuc ch mi c nh gi v
mt c, l ha hc ch cha c ch tiu
v sinh dc hc. Cc dng thuc c SKD
bin i cha c NC a vo sx. Vic
pha ch theo n hu nh b b qun.
3. V tr ca mn BC
BC l mn hc KT, ng dng thnh tu ca
nhiu mn hc c bn, c s NV ca
ngnh. V d:

- Ton c ng dng thit k, thm

ng cng thc v qui trnh BC cc dng
thuc, thm nh qui trnh phn tch dc
cht trong BC.
- Vt l hc, ha hc c vn dng
nh gi tiu chun ng liu v ch phm
BC, NC n nh, tui th ca thuc,
nh gi sKD, tng ng SH ca
thuc, la chn bao gi v iu kin bo
qun.

Dc liu, dc hc c truyn c vn
dng trong vic ch bin, nh gi cht
lng cc ch phm BC i t dc liu.
Sinh l, gii phu, dc ng hc c v
dng NC cc g on sinh dc hc ca
dng thuc (4 giai on hp thu, phn b,
chuyn ha, thi tr ca dc cht t
dng BC)

Dc lc, dc lm sng ng dng p

hp dc cht trong dng BC, h dn cho
bx s dng ch phm BC hp l, an ton v
hiu qu.
Cc qui ch, ch v hot ng h mn,
ngh nghip c v dng trong thit k, xin
php sx v lu hnh ch phm BC.

4. Mt s k nim hay dng trong BC

4.1 Dng thuc (Dng BC)
D thuc l h thc tr by ca dc cht
a d cht vo c th vi m ch tin
dng, d bq v pht huy ti a t dng iu
tr ca dc cht.
V d:
+ Dng thuc lng: DD ung (DD tht, dd
keo, siro thuc, elixir, potio ) dd dng
ngoi, thuc tim, thuc nh mt, nh mi

+ Dng thc rn: vin nn, vin nang cng,

bt, cm
+ Dng thuc bn rn: m, kem, gel bi,
xoa ngoi da, h iu tr qua da (dn ngoi
da), thuc t (trc trng hay m o)
+ Mt s dng thc c bit: thuc phun m
(kh dung), xng, ht

Thnh phn ca mt dng BC gm:

+ Cht c hot tnh (dc cht). Bao gm cc
cht c ng gc v c, hu c, sinh hc,
thc vt, ng vt.
+ Cht khng c hot tnh (t dc): ng vai
tr hnh thnh dng thuc v gp phn lm
n nh, lm tng SKD ca dc cht.
+ Bao b ng gi trc tip nh: chai, l, ng,
tup ch to bng thy tinh, kim loi hay
polyme: mng nhm, mng polyvinyl
clorid, polyethylen, v nang.

Dng thuc c th c phn loi theo

nhiu cch:
4.1.1 Theo th cht:
- Cc dng thuc lng: dd thuc, siro thuc,
potio, cao lng, hn dch
- Cc dng thuc bn rn: Cao mm, th m,
thuc n, thuc trng
- Cc dng thuc rn: Th bt, vin nn, nang
cng, cm thuc

4.1.2 Theo ng dng v cch dng

- Dng thuc ung: lng (dd thuc, potio
), rn (bt, vin )
- Dng thuc dng ngoi:
+ Bi, xoa ln da, nim mc (th bt, thuc
m, th lng )
+ Dn vo da hoc nim mc ( h tr liu
qua da, h iu tr dng cho mt, mi,
ming)
+ Nh ln nim mc: th nh mt, nh tai.

+ t vo hc t nhin ca c th:
thuc n (t trc trng), thuc trng (t
m o)
- Thuc tim: Tim dd, tim bp (IM), tim
hoc tim truyn tnh mch (IV)
4.1.3 Theo ng gc cng thc
- Thuc pha ch theo cng thc trong D,
Dc th

V d:
DD Lugol
(D V N)
Iod
1g
Kali iodid
2g
Nc ct tinh khit va 100ml

DD tim truyn tnh mch

DD Ringer Lactat
Natri clorid
0,6g
Kali clorid
0,04g
Calci clorid 6H2O
0,04g
Natri lactat 60% 0,516g
Nc ct pha tim v 100ml

- Thuc pha ch theo n: l nhng ch

phm pha ch theo n ca thy thuc
Ni dung ca mt n thuc thng
c vit bng ch latin, gm: Mnh lnh
pha ch, cng thc pha ch (thnh phn, s
lng), dng BC cn phi pha, s lng
cn pha, hng dn cch dng.

 Bng 1.1 Nhng ch vit tt bng ting

latin trong n thuc
Ch vit
tt
Aq.

Ch vit y
Aqua

Ngha ting Vit

Nc

Aq. Destill. Aqua destillata

Nc ct

Cap.

Vin nang

Capsula

Collut.

Collutorium

Collyr.

Collyrium

Thuc r
ming
Thuc nh mt

Comp.

Compositus

Kp

Cream
D.In p.aeq
D.t.d

Kem
Divide in
partes
aequales
Detur tales
doses

Chia thnh
nhng phn
bng nhau
Cho nhng liu
nh th

Dil.

Dilue, Dilutus

Pha long

Emplas.

Emplastra

Thuc cao dn

Emuls.

Emulsio

Nh dch

Extr.

Extractum

Cao thuc

F.

Fiat

Lm thnh

Garg.

Gargarisma

Thuc sc
ming

Gutt. , Gutts.

Gutta, Guttae Git

Inj.

Injection

Thuc tim

M.

Misce

Thuc bi xoa
ngoi da
Trn ln

Mixt.

Mixtura

Hn hp

Lotio

N0

Nummero

Ovul.

Ovula

Thuc trng

Pil.

Pilula

Vin trn

Pulv.

Pulvis

Thuc nc
ngt
Thuc bt

q.s.

Quantum
satis

Potio

Lng va

R/ , Rp

Recipe

Ly, hy ly

Sig. , S

Signa

Sirup.

Sirupi

Ch dn, cch
dng
Si r

Sol.

Solusio

Dung dch

Supp.

Supositorium

Thuc n

Susp.

Suspensiones

Hn dch

Tab.

Tablet

Vin nn

Tinc.

Tincturae

Cn thuc

Ung.

Unguentum

Thuc m

Sta.

Statim

Ngay tc khc

t.i.d.

Ter in die

Ngy 3 ln

b.i.d

Bis in die

Ngy 2 ln

a.c.

ante cibos

Trc ba n

4.1.4 Theo cu trc h phn tn

- Cc dng thuc thuc h phn tn ng th:
Dung dch thuc
- Cc dng thuc thuc h phn tn d th:
Hn dch, nh tng thuc
- Cc dng thuc thuc h phn tn c hc:
Thuc bt, thuc vin

4.2 Ch phm
L sn phm BC ni chung ca mt dc
cht
V d:
- Aspirin c nhiu ch phm vin nn: Vin
bao tan rut 500mg v 100mg, vin si
bt, cm si bt
- Vitamin C c BC di dng thuc vin
nn khng bao, vin bao, vin si bt, vin
ngm, vin nang cng, thuc tim

4.3 Bit dc
l ch phm BC lu hnh trn th trng
di mt tn thng mi do nh sn xut
t ra
V d:
- Vin nn Paracetamol c nhiu bit dc
nh Pamol, panadol, Dafalgan, Pacemol,
Valadol
- Vin nang cng cha Amoxycilin c cc bd
nh: Amolin, Amopen, Moxalin
Danoxillin

CHNG II
MT S K THUT CHUNG
Mc tiu hc tp
Nu c 09 KT chnh sd trong BC thuc:
Cn; ong; Ha tan; Lc; Nghin, tn;
Ry; Trn; Lm kh v tit khun.

1. Cn
L mt trong nhng KT c bn, quan trng
trong pha ch, sx thuc.
Cc dc cht c dng vi cc liu
lng xc nh, phi hp theo nhng t l
nht nh vi t dc trong thnh phn
dng thuc.
Nu cn khng ng s dn n hu qu
nghim trng.

- Khng hnh thnh dng thuc mong mun

- Khng m bo cht lng ca ch phm
- Khng liu gy km hiu qu hoc qu
liu gy khng an ton hay ng c
1.1 Cc loi cn dng trong pha ch, sx
thuc

a/ Cn a (Cn Roberval)
Gm 2 a cn ta trn mt n cn.
Thng dng loi c sc cn (trng lng cn
c) t 0,2 200 g vi nhy hng
Centigam.
C khi sc cn n 5kg.
Thng dng loi cn ny cn nhng dc
cht khng c.

b/ Cn k thut (cn quang)

Cu to ch yu bi 2 quang cn treo 02
n cn.
Thng dng loi c sc cn t 0,01
200g, nhy t 5 10mg, chnh xc
ti 1mg.
Cn KT c th dng cn cc dc cht c,
dc cht c khi lng nh, cn c
chnh xc cao.

Cc qu cn trong hp cn KT thng b
tr nh sau:
1 qu 100g ; 1 qu lc gic 500mg
1 qu 50g; 2 qu vung
200mg
2 qu 20g; 1 qu tam gic 100mg
1 qu 10g; 1 qu lc gic 50mg
1 qu 5g; 2 qu vung
20mg
2 qu 2g; 1 qu tam gic 10mg

c/ Cn phn tch (cn chnh xc)

Thng dng cn cc loi dc cht
c, mnh. Cc mu nh lng vi khi
lng nh, cn chnh xc cao.
nhy ca cn thng l 1/10mg.
d/ Cn in t hin s
Dng trong NC, SX v kim nghim ty
theo thng s KT.
Cn bq cn in t trong k x nh v nhit
, m.

1.2 Cc pp cn
Nu s dng cn c hc, thng dng 2 pp.
Cn n v cn kp. (Cn kp c 2 PP. Kp
Borda v kp Menlep)
Trong thc t hin nay, ch yu sd cn in
t. V vy cn tun theo cc quy trnh thao
tc chun (SOP).
Mt s thao tc sau:
- K tra, chun ha cn bng q cn chun
- Khng cn vt qu sc cn
- Ghi li kq bng kt ni my in (nu c)

1.3 Mt s ng tc cn ch khi cn dc
cht
Khi cn, cn tun th mt s ng tc:
- La chn cn v pp cn thch hp, ty
thuc vo s lng, loi dc cht, tnh
trng cn
- K tra tin cy v nhy ca cn
- B tr qu cn, vt cn cho thun tay, d
quan st

- Khi cn, khng d cht trc tip ln a cn,cn

la chn dng c ng dc cn cn cho thch hp
(cn c vo th cht v tnh cht ca dc) chng
hn
+ Dc l cht oxy ha mnh: khng dng giy
thng thng cn sd vt liu bng polyme hoc
thy tinh ng cht oxy ha
+ Dc c th cht lng, snh, mm, do, dnh
nn sd dng c thch hp nh mt knh ng h,
bt s thun li khi cn.

- Dc c phi cn bng cn KT hay cn phn

tch
- Khi cn, thao tc phi nh nhng, gi cn
sch s trong v sau khi cn
1.4 Thm nh v chun ha cn
Cn mi a vo sd cn phi thm nh v mt
lp t, tnh nng sd. Trc mi ln cn, cn ktra
cn bng qu cn chun. Sau tng thi gian sd (1
hoc 6 thng) cn thm nh li v chun ha li
theo qui nh.

2. ong (o) th tch cht lng

2.1 Dng c dng ong (ht) cht lng
-ng ong: dng ong dc cht, dung mi th lng trong khi pha ch.
Trong cc n thuc hoc cng thc, c khi ghi nguyn liu lng theo khi
lng, nhng cn cc cht lng tng i phin phc v chm, v vy thng
quy i ra th tch, ri ong bng ng ong. Tuy nhin, mc chnh xc khi
ong cht lng c th khng tht chnh xc nh php cn.
-Trong bo ch hay dng cc loi ng ong c dung tch 5. 10, 25. 50, 100,
250, 500 v 1000 ml ng vi nhit ghi trn ng (thng l 20C). Mt s
ng ong c nt mi dng ong cc dc cht d bay hi. Khi ong dc
cht lng nn dng ng ong c dung tch thch hp bo m chnh xc,
nht l vi cc cht c nht cao, d dnh dng c nh siro, du thc vt,
glycerin, propylen glycol.... Khng nn ong cht lng lc cn nng hn
ch sai s.

- Cc c chn: dng ong cht lng, thng c dung tch 100, 500, 1000 ml.
Cch s dng ging nh ng ong nhng khng chnh xc bng. Trong pha ch
nh, thng dng cc chn ho tan dc cht.
-Bnh cu: khi cn ong mt lng cht lng chnh xc, nht khng cao v khi
cn iu chnh th tch chnh xc mt dung dch, ngi ta ng cc bnh cu c vch
vi dung tch thch hp : 50, 100, 250, 500, 1000 ml...
Pipet: gm 4 loi:
+ Pipet khng c vch: dng ly mt lng nh cht lng m khng cn chnh

xc iu chnh th tch, iu chnh pH ca dung dch v.v...

+ Pipet chnh xc c chia vch: chia ti 1/10, 1/20 hay 1/100 ml, dng ht cht
lng tng i chnh xc.
+ Pipet chnh xc c bu: thng dng ht mt lng cht lng nht nh mt
cch chnh xc: 1, 2, 5, 10. ml,... Hay dng trong phn tch nh lng.
+ Pipet chnh xc ht t ng: c th ly t ng hng lot lng cht lng chnh
xc.

-Buret: cc loi buret dung tch 5. 10, 20, 25 ml... c dng ly cht lng hoc nh
lng bng phng php th tch.
-ng m git hp thc: l ng m git c kch thc u ng nh sau: ng knh trong
0,6 mm; ng knh ngoi 3 mm, dng ly:
+ Dc cht lng c khi lng nh (di 3 g) m bo chnh xc, trnh hao ht.

+ Mt s dc cht lng hay dung dch dc cht c.

+ Mt s cht lm thm c k trong n bng s git.
Khi m git phi cm ng thng ng, cho cht lng ri t do tng git mt. Khi
lng ca mt git cht lng ph thuc vo sc cng b mt v nhit ca cht lng. V
d:
20C: 1 gam nc ct tng ng vi XX git,
1 gam dung dch nc tmg ng vi khong XX git,
1 gam ethanol tng ng khong LX git,

1 gam du tng ng khong L git.

Ngoi ra, i khi ngi ta cn dng cc dng c o lng n gin

phn liu thuc lng nh tha v cc.
Dng c

Nc

Tha cafe (5ml),

tng ng vi

5,0g

Tha canh (15ml)

Cc con (150ml)

Siro

Du

6,5g

4,5g

15,0g

19,5g

13,5g

150,0g

195g

135,0g

2.2. Mt vi im ch khi s dng dng c v tin hnh ong rt cht

lng
-Trc khi rt cn lau k ming chai, l bng mt khn sch trnh bi bn
ri vo thuc.
-Cm chai quay pha nhn ln trn trnh dc cht rt bn ra nhn v tin
kim tra tn cht cn ly.
-Nn dng mt a thu tinh k vo ming chai hng dng cht lng chy
gn vo dng c ng.
-Trc khi ngng rt, quay chai thuc khong 1/2 vng, dng a thu tinh
gt qua ming chai trnh cht lng gy bn ra ngoi chai. -Dng khn lau
sch ming chai ri mi y nt.
-Cn chun ho dng c o th tch theo quy nh m bo tnh ng, tnh
chnh xc ca dng c v php o.
-Khng sy nhng dng c o th tch chnh xc sau khi ra (bnh nh mc,
pipet chnh xc...), nn kh t nhin.

3. HO TAN
Ho tan l mt k thut c bn nht khi b ch cc dung dch thuc.
Tu theo bn cht ca dc cht v dung mi m chn nhit ha tan thch hp
ho tan nhanh dc cht trong dung mi:

+ Ha tan nhit phng (18c - 30C).

+ Ha tan nng (50 c - 80 C).
+ Ha cch thu (98 c - 100C).
+ Ha tan cch ct hay cch du (> 100C).
a s cc trng hp, tan ca mt cht rn (hay mt cht lng) trong mt cht lng
tng theo nhit , nhng cng c ngoi l nh calci citrat, calci glycerophophat,
methyl cellulose,... tan gim khi nhit ho tan tng. Vi cc cht d bay hi (cc
tinh du...) hoc cht tan khng bn vi nhit (natri hydrocarbonat) cn ho tan nhit

phng.

 lm tng tc ho tan, ngi ta s dng bin php khuy trn:

Khi la chn my khuy ho tan dc cht trong dung mi nn
tham kho mt s thuc tnh nh:
-Lng cht tan v dung mi.
-Kch thc tiu phn ca cht tan.
- nht ca cht tan v mi trng ho tan.
-Chnh lch v t trng gia cht tan v dung mi.

Thit b s dng ho tan:

Trong phng th nghim, thng s dng cc c m, cc c chn v a thu tinh d
khuy trn. Cng c th dng my khuy t hoc khuy trc vi cc loi que khuy
lm bng vt liu khc nhau: thp khng g, polyme (hnh 2.3).
Trong sn xut cng nghip, thng dng h thng pha ch kn, dung tch t hng
trm n hng chc nghn lt, bao gm cc b phn:
+ Ni hai v bng thp khng g iu chnh nhit khi cn thit trong qu trnh

ha tan.
+ My khuy c mt hoc nhiu tng cnh khuy.
+ My nn kh khng du ( y hay lc dung dch).
+ ng h o p lc & nhit .
4. LC
Lc l mt thao tc c hc tch ring cc pha trong mt h d th khi bo ch
dung dch thuc. Mc ch ca qu trnh lc l lm trong hoc v khun dung mi,
dung dch, kh

4.1Vt liu dng lc

Bng 2.1: Mt s loi vt liu lc thng dng trong bo
ch
Loi vt liu

c tnh v s dng

-Bng thm nc, vi.

-Giy lc

Lc dch chit v dung dch keo

-Mng cellulose acetat/nitrat

-Mng cellulose ti t hp (RC),

Lc dung dch nc

polytetrafluoroethylen (PTFE)...

Tit khun

Lc dung dch

Lc dung dch nc hoc dung mi hu c.

- Thu tinh xp
G-l (100-120 im)
G-2 (40-50 m)
G-3 (20-30 |im)

Lc th

G-4 (5-10 im)

Lc dung dch tim

G-5 (1-1,5 um)

Lc v khun

Nhit m

Lc dung dch
Lc dung dch nh mt

Nhit kh, nhit m

4.2 Phng php v thit b lc

Lc do chnh lch p sut thu tnh. p dng vi vt liu lc l
bng, i, giy lc vi gi l phu thu tinh
Lc p sut gim (lc ht chn khng)
Lc p sut cao (lc nn)
Thng s dng a lc vi mng lc hoc ng lc, c kch thc
l xp thch hp, ph hp vi mc ch lm trong hoc loi vi
khun ca dung mi, dung dch. ' to p lc nn, c th dng
my nn kh khng du hoc kh nn nh kh nit, kh carbonic.

4.3. Mt s im cn ch trc v trong khi lc

-Bng, giy lc cn c t vo phu mt cch cn thn.
-Khi rt dch cn lc vo phu cn gn, rt t t, tt nht l qua mt
a thy tinh vo thnh phu.
-Khi lc cc cht lng bay hi cn y kn phu.
-Thng gn hay lc s b kt ta trc khi cho vo phu lc trong
hoc v khun.
-Vi mng lc: cn kim tra tnh trng nguyn vn ca mng, thm t
mng lc bng dung mi trc khi lc.
5. NGHIN, TN CHT RN
Nghin, tn dc cht v t dc rn l mt trong nhng giai on c
bn u tin bo ch cc dng thuc, nht l cc dng thuc rn v
bn rn nh thuc bt, thuc vin, thuc m, hn dch,...

 c th chn la cc thit b nghin tn ph hp cn cn c vo mt s

thuc tnh ca cht rn:
- cng, n hi, b, m, tnh nhy cm vi nhit.
- Kch thc ca tiu phn cht rn trc v sau khi nghin tn.
-Hnh dng ca tiu phn cht rn.
-S lng cht rn cn nghin tn.
C th chia cc thit b nghin tn ra lm hai nhm: Dng cho phng th
nghim v dng trong sn xut.

5.1 Thit b dng cho phng th nghim

-Ci: c dng nghin, tn, trn nhng khi lng nh cht rn.
C nhiu loi ci vi hnh dng khc nhau, c np hay khng, ch to
bng vt liu khc nhau nh: s, thu tinh, st, ng, thp khng g,
m no...
Trong phng th nghim thng s dng ci c dung tch 100, 250,
500, 1000 ml. Ngoi tc dng nghin, tn, trn cht rn, i khi
ngi ta cn dng ci nghin, ho tan mt s dc cht kh tan.
Khi s dng nn ch la chn b ci chy c dung tch thch hp vi
lng ghi trong n hoc cng thc v c bn cht ph hp vi tnh
cht ca dc cht. Khi nghin trn cc dc cht c tnh kch ng
phi dng ci c np.

-Thuyn tn: c c bng gang, thng dng trong y hc c truyn

nghin mn cc dc liu c ngun gc tho mc hay khong vt. Nghin bng
thuyn tn kt hp c nhiu c ch phn chia nguyn liu nh nn p,
nghin mi, ct ch, va p, nhng khng tht hp v sinh v nng sut khng
cao. Hin nay thng dng thuvn tn ci tin ko bng tay hay chy bng
ng c in.
5.2 -Thit b dng trong cng nghip
Dng cc loi my xay, nghin khc nhau:
My xay dao:
Cu to ca my gm cc dao quay v cc dao c nh, c lp ry y.
My xay dao l loi my xay lin tc. c ch phn chia nguyn liu chnh l
ct x kt hp c xay v ry, thch hp xay dc liu.
-My xay ba:
Nguyn liu c phn chia do s va p kh mnh ca cc ba kim loi.

Thit b ny c th xay gin on hay lin tc, t bay bi khi xay.

-My nghin bi
Nguyn liu c phn chia bng lc va p l chnh. y l loi
my xay gin on, khng kt hp c nghin v ry, nhng kn,
trong qu trnh xay khng bay bi ra ngoi v sau khi nghin, b
mt tiu phn cht rn thng nhn, thch hp dng nghin cc
dc cht rn dng bo ch thuc m tra mt.
-My nghin bt siu mn (micropulverizer): phn chia dc cht
rn ti kch thc micromet bng p lc cao, dng lm nguyn liu
bo ch thuc m v hn dch tra mt, hn dch tim...

6. RY

Ry nhm mc ch tch ring v phn loi bt c kch thc

tiu phn khc nhau sau khi nghin, tn.

6.1C ry
Dc in Vit Nam 3 quy nh s ry v kch thc mt ry nh
ghi bng 2.2.
6.2 Phng tin ry
Trong phng th nghim v trong sn xut cng nghip, s dng
nhiu thit b ry khc nhau:
Li ry lp vo khung bng g hoc kim loi.
My ry hot ng theo nguyn l lc theo chiu ngang hoc chiu
dc, cng c th va lc, va rung.
7. TRN
Trn l mt k thut c bn nhm lm cho nhiu cht rn, nho, lng
phi hp vi nhau tht ng nht. c th trn c cc hn hp
mt cch tt nht, cn ch : mn, t trng v t l ca cc thnh
phn.

Trong phng th nghim thng s dng ci, chy trn cc thnh phn dc cht,
t dc vi khi lng nh. Cng c khi dng mt s thit b trn theo nguyn l trc

xon hoc nguyn l ri t do.

Trong sn xut cng nghip, s dng cc loi thit b nh:
Thit b trn theo nquvn l ri t do: l cc thng bng thp hoc polyme c np kn,
trong cha cc thnh phn cn trn n. Thng t quay trn bt, vi cc kiu
dng khc nhau: hnh tr, hnh hp ch nht hay hnh lp phng, hnh ch V hay
ch Y. Trong sn xut thuc vin, thng dng thit b ny trn t dc trn vi
ht trc khi dp vin hoc ng nang cng.
My trn cao tc (High speed mixer):
S dng 2 tng cnh khuy. Tng th nht dng trn bt kh. Tng th hai trn bt
t v to ht. Ngy nay. thit b trn cao tc c s dng trong hu ht cc dy
chuyn sn xut thuc ht. cm. vin nn, vin nang cng, bi u im nho trn
nhanh, ng u.
Mv nho trn trc xon:
Loi ny dng nho trn bt kh v bt t trong cng ngh sn xut thuc vin,
cm. V nguyn tc, cc thnh phn c nho trn nh nhng cnh xon b tr

trong thng trn.

8. K THUT LM KH
Lm kh hoc sy kh l k thut loi mt cht lng d bay hi cha
trong mt cht khc khng bay hi. Trong ngnh dc, cht lng d
bay hi thng l nc hoc dung mi v cht cn lm kh thng
l cht rn.
Ty thuc vo cu trc, tnh cht ca cht cn lm kh, ty theo
bn ca dc cht vi nhit v oxy ca khng kh, tu theo mc
kh cn t c m la chn phng php cng nh phng tin
lm kh thch hp.
8.1 Sy bng khng kh nng
Thit b sy khng lin tc:
+ T sy tnh: Ngun nhit c th l than, in, kh t, du hay hi
nc.

+ Thit b sy tng si:

Thi gian sy nhanh, hn ch s tip xc ca nguyn liu vi nhit
v oxy khng kh. Ngy nay. thit b sy tng si c s dung nhiu
trong cng ngh sn xut cc dng thuc rn. Mt s my sy tng
si c thm chc nng to ht v bao ht, bao vin.
+Thit b sy lin tc (my sy ngc dng):
Hot ng theo nguyn tc: cht cn sy c a vo my lin tc
mt u v thot ra u kia trng thi kh. Khng kh nng c
a vo theo chiu ngc li. Loi ny c u im l nng sut, sy
cao. kh u.

8.2 Sy kh di p lc gim
Cc cht d hng do nhit cao hay do tip xc vi khng kh
thng c sy kh trong chn khng. Di p sut gim. Qu
trnh lm kh xy ra nhit thp hn, thi gian sy ngn hn.
Cc my lm kh di p lc gim hot ng khng lin tc. c th
trng thi tnh hay quay c. V d:

T sy chn khng c:
H thng t nng bng in tr hoc tia hng ngoi.
My ht chn khng lm gim p sut trong bung sy.

8.3 Lm kh trn tr
Thng dng lm kh trc tip cht lng dn n trng thi kh.
Cc my lm kh trn tr c cu to bng mt hay nhiu tr, c
o
dun nng pha trong bng hi nc p sut cao ( 140 150 C).
trc quay vi tc thch hp. Cht lng cn lm kh c tri trn
din tch b mt ca trc quay. Nc bc hi v li mt mng
mong, cht kh s c tch ri bng ml li dao, sau nghin
thnh bt Thit b ny thch hp iu ch cao kh.
Ngoi ra, cn c loi my sy kh trn tr di p lc gim sy
kh cc ch phm cha hot cht km bn vi nhit nh enzym hay
ni tit t.

Lm kh bng phng php sy phun

Nguyn tc: dch cn lm kh c phun thnh nhng tia rt nh trong mt dng
kh nng. Nh , dung mi bc hi nhanh, li cht kh di dng bt mn.
Do thi gian tip xc vi nhit xy ra rt ngn (khong 1 phn giy) nn phng
php sy phun c p dng lm kh cc cht khng bn bi nhit, d b oxy
ho. Trong mt s trng hp c bit, trnh mi h hng do oxy ho, qu
trnh sy phun c th thc hin trong mt dng kh tr.
V nguyn tc, my sy phun gm cc b phn:
Bnh cha dch & bm dch n u phun.
u phun ni vi my nn kh.
Bung lm kh vi dng kh nng.
Bnh cha sn phm kh.
Trong cng nghip dc, phng php sy phun dng lm kh cc loi t
dc, cao kh, mt vi loi bt ph tng, enzym, bt dng trong vin nn dp
thng bt pha tim, xng ht...

8.5 ng kh
ng kh l k thut lm kh do s thng hoa nc ca cc dung
dch, hn dch, m ng vt hay thc vt... iu kin nhit thp,
p sut gim.
Mc ch ng kh:
-Tng n nh ca dc cht.
-Tng tc ho tan ca dc cht hoc ch phm.
-Phn chia liu nh chnh xc.
-iu ch bt thuc v khun.
-iu ch thuc tim khng c cht bo qun.
Phng php ng kh p dng sn xut thuc tim, thuc nhn
khoa, thuc xng ht, vin nn r nhanh...

8.5.1- Qu trnh ng kh
Qu trnh ng kh qua 3 giai on: ng lnh, lm kh s cp v
lm kh th cp.
Giai on ng lnh: l giai on u tin ca qu trnh ng kh.
giai on ny phn ln nc c tch ra khi dc cht v t
dc, h tch thnh nhiu pha.
Qu trnh ng lnh phi lm nhanh, sn phm phi c ng cng
tc th, nu ng lnh chm va lm hu hoi cc m, va lm bin
cht protein trong cc sn phm sinh hc.

lm ng lnh nhanh, c th s dng tuyt carbonic (- 80C)

hoc nit ng (- 196C).

Giai on lm kh s cp: nhit c duy tr di nhit

ph v cu trc ca sn phm cn lm kh. Ni chung, nhit trong
giai on ny khng nn vt qu -15c, ap sut bung duy tr t 0,05
mm Hg n 0,2 mm Hg.
- Giai on lm kh th cp: nhm loi b lng nc khng ng
lnh, hp ph trong khun bng cch kh hp ph, lm gim hm m
cn li ti mc thp nht c th, thng khong 2-5%, m bo
n nh ca ch phm trong qu trnh bo qun.

8.5.2. Thit b ng kh
C nhiu loi dng trong phng th nghim hoc trong cng nghip.
8.6. Lm kh bng cht ht m

K thut lm kh bng cht ht m c thc hin nhit phng.

im khc bit vi cc phng php lm kh ni trn l hi nc
c gi li bng mt ho cht ho nc gi l cht ht m (bng
2.3)

Thc hin trong mt dng c kn (bnh ht m hay thng kn), cht ht

m c cho vo phn di, ngn cch bng vt liu thch hp, ri cho
cht cn lm kh ln trn.

9. K THUT TIT KHUN

Tit khun l k thut c s dng dit hoc loi cc vi sinh vt sng
nhim trong nguyn liu, bn thnh phm, thnh phm, dng c, thit b
hay khng kh... Trong ngnh dc, tit khun c p dng vi: thuc
tim, thuc tim truyn, thuc nh mt, bng bng, ch khu, dng c phu
thut, dng c pha ch, bao b dng cho thuc v khun v cc yu cu
khc. Tu theo tnh cht ca cht cn tit khun, mc tiu v iu kin sn
xut m p dng cc phng php tit khun khc nhau.
9.1 Tit khun bng nhit
9.1.1Tit khun bng nhit kh
Thch hp i vi nhng sn phm lng khng phi l nc hoc bt kh,
dng c pha ch bng thp khng g, thu tinh, t dc dng cho thuc m

khng sinh hoc thuc m tra mt. Quy trnh tit khun

c s dng phi m bo s lu chuyn ca khng kh v duy tr

p sut dng trong bung tit khun ngn cn lung khng kh
khng v khun vo t sy. Khng kh cp cho t sy vi mc ch
tit khun cn phi lc (v d mng lc HEPA).

Ngun nhit dng cho cc thit b tit khun bng sc nng kh

thng l than, ci, in, du. cho nhit phn phi u khp
trong bung sy, hu ht thit b u p thm qut gi.
Trong sn xut cng nghip, s dng hm sy hai ca va lm kh,
va tit khun ng, l thy tinh dng ng thuc tim.

 kim tra quy trnh tit khun bng nhit kh, c th dng ch th
sinh hc (v d: bo t Bacillus subtilis ATCC 9372). Trong trng
hp tit khun loi ch nhit t, p dng i vi dng c thu tinh
phi a nhit ti 220c v cn s dng ni c t khng nhit
thay th cho ch th sinh hc

9.1.2. Tit khun bng nhit m

Phng php Tyndal thng p dng cho dung dch thuc tim
khng bn nhit cao. Tin hnh tit khun 3 ln nhit
trongkhong 70 - 80 c, thi gian 1 gi, mi ln cch nhau 24 gi.
Ln th tht dit cc vi c sng, ln th hai dit cc vi c pht trin
li t nha bo, ln ba dit cc vi c cn st li t nha bo. Phng
php tit khun ny rt tn thi gian v c nguy c gy ch nhit t
v vy thng kt hp tit khun bng phng php Tyndal vi dng
thm cht st khun v khng p ng phng php ny tit
khun cc dung dch tim truyn tnh mch.

Tit khun bng nhit m 100C: luc si trc tip vi nc hoc

tit khun bng hi nc p sut thng (p sut kh quyn).
lm tng nhit ln vi , c th ho tan natri borat hoc natri
carbonat vi nng t 2-5%.
Tit khun bng nhit m nhit trn 100 C: phng php ny
p dng tit khun dung mi, dung dch thuc tim bn vng
nhit cao. tit khun bng nhit m trn 100c, ngi ta dng
ni hp (autoclave).

Cu to ca ni hp gm nhng b phn ch yu sau:

+ V ngoi thng c dng hnh tr ch to bng thp khng g, c dy
xc nh, dung tch t vi chc n hng nghn lt.
+ Np y c cc vt d dng thao tc. Trn np thng b tr: mt van
an ton t ng x khi p sut qu cao gy nguy him, mt vi thot hi
nc v mt p k. Gia ni v np c ging cao su Silicon.
+ Nu l ni hp xch tay kiu c in th bn trong c mt gi bng kim
loi ng vt cn hp, nu l ni hp ln dng trong cng nghip th v
trong bng thp khng g gn lin v ngoi.
+ Nhit cung cp cho ni hp thng l kh t, in hay hi nc vi p
sut cao.

p sut hi, nhit v thi gian tit khun cn thit c ghi bng 2.5.

 kim tra nhit trong ni hp c ng nht hay

khng, thng dng cc cht ch th nhit c chy
xc nh, ng vo cc ng hn kn v t ri rc cc
v tr khc nhau trong ni

Cc cht ch th nhit ho hc thng dng : exalgin (101 - 102 C), I

benzonaphtol (110 C), antipyrin (114 C), acid benzoic (121 C),
phenacein (135 C) v.v... Ngoi ra, cn s dng ch th sinh hc
kim tra quy trnh tit khun. Chng hn nh: bo t Bacillus
stearothermoliphilus NCTC 10007...
kim tra thi gian tit khun, c th dng mt loi bng dnh
dnh vo cc vt cn tit khun, mu ca bng ny thay i theo nhit
v thi gian un nng.
Trong cng nghip, dng nhiu loi ni hp khc nhau, c cc c cu
ci tin nhm t an ton cao trong thao tc v hiu qu cao trong tit
khun. Mt s ni hp hin i c trang b my tnh m bo cc
thao tc c lin tc v t ng, c h thng o, bo nhit cc
khu vc trong bung hp v hin th trn mn hnh theo di v kim
tra qu trnh tit khun.

Khi s dng ni hp cn ch :
+ Kim tra cn thn np c y kn, kht vo ming ni hay khng, giong m

cn tt hay khng.
+ Kim tra p k, cc kho, van an ton c hot ng tt hay
khng.
+ Trc khi xp cc vt cn tit khun vo ni hp, cn kim tra mc nc trong
ni c hay khng. Nc s dng l nc ct hay nc kh khong.
+ Phi m van x ui ht khng kh ra khi ni hp, ri mi kho van nng p
sut hi trong ni n p sut v nhit tit khun cn thit, m bo mc
bo ho hi nc v nhit ng u trong ni hp.
+ Tun theo quy trnh thao tc chun s dng ni hp v an ton lao ng.
+ nh k thm nh li ni hp v chun ho cc ng h o p lc gn trn ni
hp.

9 2. Tit khun bng phng php lc

L phng php loi khun c th p dng cho cc cht lng, kh v dung dch
thuc, c bit l dung dch thuc c dc cht khng bn vi nhit.
lc tit khun, thng s dng:
Mng lc: c kch thc l lc 0,22 micromet (hoc nh hn), c hp tit
khun 120c trc khi s dng. Mng lc khng c c tng tc vi dc
cht c trong dung dch hoc nh hng ti tinh khit ca sn phm. Khng
s dng mng lc hp ph dc cht v mng lc ch to bng amian.
ng lc (cartridge), s dng vt liu lc polyme thch hp, c kch thc l lc
0,22 micromet (hoc nh hn). u im ca lc ng l hiu sut cao, p dng c
trong trng hp dung dch c nht tng i ln.
Cc loi lc ny c th loi b c vi khun v nm, nhng khng loi b c
tt c cc virus v micoplasma.

Ch khi lc tit khun:

iu kin tin hnh lc tit khun phi m bo trnh nhim vi
sinh vt t mi trng, con ngi, bao b, dng c - thit b thi gian
bo qun dung dch trc khi lc.
Tt nht nn s dng lc hai lp hoc lc ln hai ngay trc khi
ng ng hoc l.
Cn kim tra tnh trng nguyn vn ca mng lc trc v sau khi
lc bng cc phng php thch hp nh im si bt, dng khuch
gin hoc o chnh lch p sut.
Khng s dng mt thit b lc trong thi gian qu 1 ngy, tr
trng hp c thm nh v hiu qu sau khi lc.

9.3. Tit khun bng bc x

p dng ch yu vi nguyn liu v sn phm khng bn vi nhit.
Mt s loi bc x s dng tit khun:
-Tia t ngoi (bc x in t):
Loi bc x ny c kh nng dit vi khun rt cao. Trong ngnh
Dc, tia t ngoi dng dit vi khun trong khng kh ca cc bung
sch v duy tr v khun ca nc ct ng trong cc bn cha. Tia t
ngoi ch tc dng khi chiu thng, ngha l khng c c vt cn gia
n v vt tit khun. Mt khc n c th gy nguy him cho mt, v vy
cn c knh bo h khi lm vic. Tia t ngoi khng c dng tit
khun sn phm cui cng trong quy trnh sn xut v khng p dng cho
cc ch phm ng trong ng tim hoc chai l thu tinh. di sng ti

u ca tia t ngoi khong 290 nm.

Bc x v Y
Cc nguyn t phng x pht ra tia Y(bc x in t): thng dng
coban 60. Cht ny hu nh ch pht ra tia c tc dng dit khun rt
mnh, c nng lng trung bnh l 1,27 MeV v m xuyn rt su, kh
nguy him khi s dng. Coban 60 c t trong mt hp ch ch m np
khi ng, hp chuyn ng trn mt ng ray, t trn trn ca bung
tit khun. Bung tit khun phi c tng b tng dy tia khng
tn x ra khu vc xung quanh.
Cc my gia tc in t pht tia (bc x ht) c cng bc x rt
mnh, do , qu trnh tit khun c thc hin trong mt phn giy.
Tuy nhin, tia ny t xuyn thu hn tia Y. Cu to ca my gm mt thit
b c bit, c kh nng hot ho cc in t t di tc dng ca mt
trng gia tc v gii phng ra tia . Vt cn tit khun c di chuyn
bng mt h thng t ng n trc chm in t pht ra t my gia
tc.

Phng php dng tia ni chung khng s dng tit khun cc loi
thuc v cc bc x gy ra nhiu phn ng ho hc, do lm hng c
dc cht ln t dc. Thng ch dng tit khun cc dng c
ngoi khoa, bng bng, ch khu... Vic tit khun phi c tin hnh
trong bao b kn hon ton.
kim tra quy trnh tit khun bng bc x, c th dng ch th sinh
hc. V d: bo t Bacillus pumilus NCTC 10327.
Ch khi s dng phng php tit khun bng bc x:
- Tit khun bng bc x ch c php s dng khi bit r l bc x
khng nh hng n n nh v tui th ca sn phm.
- Trong qu trnh tit khun, phi o liu bc x. Thit b o bc x
phi c a vo bung tit khun. Nu s dng thit b o bc x
bng nha, ch c dng trong mt thi gian nht nh trc khi
chun ha li. Ch th sinh hc ch nn dng kim tra b sung. Cc
a mu nhy cm

Ch khi s dng phng php tit khun bng bc x:

Tit khun bng bc x ch c php s dng khi bit r l bc xa khng nh
hng n n nh v tui th ca sn phm.
Trong qu trnh tit khun, phi o liu bc x. Thit b o bc xa phi c
a vo bung tit khun. Nu s dng thit b o bc x bng nha, ch c
dng trong mt thi gian nht nh trc khi chun ho li. Ch th sinh hc
ch nn dng kim tra b sung. Cc a mu nhy cm vi bc x ch c
dng phn bit gia bao b chiu x v bao b cha chiu x, khng cho
php dng kim tra kt qu ca qu trnh tit khun.
Cn xc nh tng liu bc x s dng trong mt khong thi gian nh
trong quy trnh chiu x nguyn liu hoc sn phm.
Ngi s dng phi c hun luyn y v phi chp hnh nghim ngt
quy trnh thao tc chun v quy nh v an ton lao ng khi s dng bc x.

9.4. Tit khun bng kh v xng hi

Phng php tit khun bng kh v xng hi ch c s dng i vi cc sn
phm khng c phng php thay th thch hp. p dng tit khun cc
dng c v mt s thuc bt trong nhng iu kin nht nh v nhit , thi
gian, m v nng . Cc kh dng tit khun phi t cc yu cu: tc
ng nhanh, mnh trn vi khun, bo t, virus, nm mc, tr hon ton, c h
s khuch tn cao; khng c hi vi ngi, khng chy; d bo qun v d s

dng, c tc dng mi trng kh, gi r...

Formol: Tc dng tt mi trng m nhng gy ra nhiu phn ng ho hc
vi dc cht, v vy ch dng tit khun dng c v cc bung v khun.
Khi dng, un paraformaldehyt 56c chuyn thnh formol trong cc
3
phng cha dng c cn tit khun. Liu lng: 1-3g/lm khng kh m,
tip xc trong mt thi gian di.

Ozon: chuyn dng tit khun dng c phu thut, bng bng

trong mi trng m. Do tnh oxy ho rt mnh, v vy t dng tit

khun cc ho dc.
Ethylen oxyd: c nhiu u im hn so vi cc loi kh trn. Dng tit
khun cc dng c phu thut khng dng c ni hp (v d bao bng
polyvinyl clorid, polyethylen, mt vi loi cao su...). Tc dng tit khun
ca ethylen oxyd ph thuc vo nhiu yu t nh bn cht v s' lng
cc mm cn dit, nng kh, loi bao b. Hot tnh tit khun ca
ethylen oxyd tng theo nhit (hot tnh tng 2,7 ln khi nhit tng
ln 10C); thng tin hnh 35 - 55C. Mt khc, hot tnh cng tng
theo nng khi s dng, nng ethylen oxyd thng dng t 450-1200
mg/lt. Hot tnh gim khi m ca khng kh tng, thng tin! hnh
tit khun m tng i 25 - 50%.

 kim tra quy trnh tit khun bng ethylen oxyd, c th dng ch th sinh
hc nh Bacillus subtilis var. niger ATCC 9372. Khi th, cn ch to nh
tng bo t gc ca vi khun theo mt quy trnh tht chnh xc v nghim
ngt. Nh tng gc phi cha phn ln bo t cha ny mm c bo
qun trong mi trng lng khng c cht dinh dng.

Mt s im cn chu khi s dng phng php tit khun bng kh, xng hi:
Ethylen oxyd rt d chy v c th gy n. v vy ngi s dng phi c hun
luyn y v quy trinh tit khun v bin php an ton lao ng.
Trc khi tip xc vi kh, vt liu phi c cn bng v m v nhit
theo yu cu ca quy trnh tit khun.
Mi chu k tit khun phi c theo di bng ch th sinh hc. thch hp. Cc
a th cn phn b khp bung tit khun.
i vi mi chu k tit khun, phi c h s ghi li thi gian, p sut, nhit ,
m trong bung tit khun, nng kh s dng. p sut v nhit phi
c ghi thnh biu trong sut chu k tit khun.
Sau khi tit khun, khi sn phm v khun phi c bo qun trong iu kin
thng thong, kim sot nng kh tn d trong sn phm.
Quy trnh tit khun bng kh v xng hi phi c thm nh trc khi ban
hnh v ti thm nh sau mt thi gian thc hin.

Chng 3
DUNG MI V VT LIU CH TO BAO B
DNG TRONG K THUT BO CH THUC
Mc tiu hc tp
1. Nu c nguyn tc iu ch v phm vi s clng nc ct, nc kh
khong, nc thm thu ngc v nc siu lc tronq k thut bo ch thuc.
2. Nu c ngun gc v phm vi s dng ca mt s alcol, polyol, du thc
vt & dung mi thn du trong k thut bo ch thuc.
3. K tn, thnh phn chnh v tnh cht ca mt s vt liu ch to bao b dng
trong k thut bo ch thuc.

I. DUNG MI
Dung mi thng dng trong k thut bo ch thuc bao gm:
Nc, alcol (ethanol, isopropanol), polyol (glycerin. propylen glycol,
polyethylen glycol)... l nhng dung mi phn cc mnh, ho tan vi
nhau nn c th dng ring hay phi hp vi nhau thnh cc hn hp
dung mi.
- Du thc vt, du parain l nhng dung mi khng phn cc.
- Mt dung mi tt cn phi t c nhng yu cu sau:
- C kh nng ho tan cao nhng phi c tc dng ho tan chn lc
- Khng c c tc dng dc l ring
- Khng mu, khng mi, trung tnh

- Phi bn vng, khng phn ng vi cht tan hoc vi vt liu ch

to dng c, thit b dng pha ch v bao b ng thuc.
- Khng c, khng d chy, n
- Khng gy d ng
- C th thu hi hay bc hi d dng, nht l khi dng iu ch dch
chit.
- R tin, d kim.
1. Nc tinh khit
Nc tinh khit l nc c iu ch t nc sinh hot bng
phng php ct, trao i ion, thm thu ngc hay siu lc, t cc
ch tiu cht lng ghi trong Dc in.

1.1.Nc ct
L nc tinh khit c iu ch bng phng php ct.
1.1.1. K thut iu ch nc ct
X l ngun nc trc khi ct:
+ Loi b tp cht c hc bng cch lng, gn hoc lc.
+ Cc tp cht hu c c ph hu bng kali permanganat.
Lng kali pevmanganat dng ph thuc vo hm lng cc cht hu c trong
nc. Thng ngi ta thm kali permanganat vo nc cho n khi c mu
hng bn vng. Khuy u yn nc trong 6-12 gi. Sau lc v em ct.
+ C th loi tr cc tp cht bay hi (amoniac) bng cch un si nc trong
nhng dng c khng c np hoc cho nc tc dng vi nhng ho cht c kh
nng c nh amoniac nh phn chua. Lng phn chua dng x l nc ph
thuc vo lng amoniac v nng thng dng l 0,5%.
+ Ngoi cc tp cht c hc v tp cht bay hi, nc thin nhin cn cha cc
tp cht v c. Thng hay gp nht l calcid hydrocarbonat v magnesi
hydrocarbonat. Nc cha mt lng ln mui calci v magnesi gi l nc cng.
Tri li th gi l nc mm. cng ca nc ph thuc vo s miligam ng
lng ca cc ion calci, magnesi c trong mt lt nc.

Nu iu ch nc ct t nc cng, trong qu trnh un nng, di

tc dng ca nhit, calci hydrocarbonat v magnesi hydrocarbonat s
cho mui carbonat tng ng. Cc mui carbonat ny ng thnh
cn y ni un lm cho nc rt lu si, lm lng nhin liu
phi dng tng ln t 15 n 40%.
Trc khi ch nc vo ni un phi s b lm mm nc nu nc
c cng cao. lm mm nc ngi ta thm vo nc mt
lng calci hydroxyd v natri carbonat c tnh sn tu theo
cng ca nc. Sau khi thm ho cht, khuy k v yn nc
trong mt thi gian ta vn li. Sau s gn hoc lc ly phn
nc trong ct.
Cng c th dng nha trao i ion lm mm nc. C ch ca
phng php ny s c trnh by trong phn iu ch nc kh
khong.
Thit b iu ch nc ct l ni ct nc hay my ct nc. Ni
ct thng gm 3 b phn:

+ Ni bc hi (ni un), trong nc c un si v ho thnh hi

nc. B phn ny thng lm bng ng trng thic, thp khng
g... v thng c hnh tr.
+ Np ni v b phn dn hi cng bng cc kim loi trn.
+ B phn ngng t c ng sinh hn, lm theo nhiu kiu khc nhau:
ng xon rut g, ng di hoc hnh a. C khi ngi ta phi hp cc
kiu trn tng din tch lm lnh.
+ Bnh hng bng thu tinh hoc thp khng g.
Ngi ta ch to ni ct nc theo nhiu kiu khc nhau v c th l
nhng ni ct nc hot ng c chu k hoc lin tc. Tu theo v tr
ca b phn ngng t i vi v tr ca b phn bc hi, ngi ta chia
ra 3 loi ni ct nc:

Kiu ni c b phn ngng t cnh b phn bc hi (hnh 3.1).

Kiu ni c b phn ngng t pha trn b phn bc hi (hnh 3.2).
Kiu ni c b phn ngng t pha di b phn bc hi (hnh 3.3
).

Vi loi ni ct hot ng c chu k thng thu c nc ct t nhng phn

nc ring bit. Mun nc vo b phn bc hi. phi tam ngng qu trnh
ct. i vi loi ni ct ny, thng ch c nc n 2/3 dung tch ca
ni khi si, nc khng bn sang b phn ngng t. lm sch ng dn
hi nc v ng sinh hn trc khi hng nc ct phi cho hi nc nng
i qua trong 5-10 pht khng lm lnh. Sau cho nc lnh vo b phn
ngng t v hng nc ct. Phn nc ct u thng cha nhng tp cht bay
hi nn b i vi lt. Kt thc qu trnh ct khi nc cn li trong ni cn
khong 1/4 so vi lng nc ban u.
Vi ni ct lin tc, nc lm lnh b phn ngng t sau khi nng ln do
tip xc vi hi nc nng trong ng sinh hn, c t ng tip sang b phn
bc hi. Phng php ct lin tc cho hiu sut cao hn v tn t nhit lng
hn. Nhng do nc b phn ngng t (nc lm lnh) c t ng tip
thng vo b phn bc hi nn nc lm lnh cng phi c x l trc.
Ngoi cc loi ni ct trn, cn c cc kiu ni ct nc hin i hn nh ni
ct kp, my ct nhit nn.

My ct nhit nn vn hnh theo nguyn tc khc vi cc my ct thng thng:

+ Ct p sut hi thp hn p sut thng.
+ Sau khi b nn, s ngng t ca hi nc xy ra cng nhit nhng p sut hi
cao hn p sut bnh thng, do khng cn nc lm lnh.
+ My c un nng bng in v c cch nhit hon ton trnh hao ht nhit
lng. Hiu sut nhit ca my ny rt cao (khong 30W cho 1 lt nc ct i vi
my cng sut 150 lt/gi).
-Cn tin hnh ct nc trong mt phng ring, sch. Hin nay, cc c s sn xut
thuc tim thng b tr phng ct nc gn vi phng pha ch v dng ng dn nc
ct vo binh hng hoc trc tip vo bnh pha ch thuc. Binh hng nc ct c
bo n nhit 80c v y kn trnh hin tng ho tan kh carbonic trong
khng kh vo nc nh hng n tan ca mt s dc cht.
Ngy nay, hu ht cc c s sn xut thuc v khun nh: thuc tim, tim truyn,
thuc nh mt, vaccin... iu ch nc ct qua cc giai on sau:
+ X l tp cht c hc
+ Trao i ion
+ Thm thu ngc (Reverse Osmosis)
+ Ct 1 ln hoc ct 2 ln bng ni ct thch hp.

1.1.2. Tiu chun cht lng nc ct

Nc ct phi c kim nghim v phi t cc ch tiu cht lng c quy nh
trong Dc in.
Theo DVN 3, nc ct pha thuc tim phi t cc ch tiu cht lng nh sau:
Tnh cht cm quan: cht lng trong, khng mu, khng mi, khng v.
pH: 5,0-7,0
Amoni: khng qu 0,2 phn triu
Nitrat: khng qu 0,2 phn triu
Kim loi nng: khng qu 0,001%
Clorid: t theo phng php th
Sulat: t theo phng php th
Calci v magnesi: t theo phng php th
Cht oxy ho: t theo phng php th
Nhm: t theo phng php th
nhim khun: tng lng vi khun hiu kh sng li c khng ln hn 102 vi
khun/ml, th theo phng php lc qua mng lc
Ni c t vi khun: khng c nhiu hn 0,25 E.u ni c t/ml
Cht gy st: khng c c.

l.2. Nc kh khong
Nc kh khong c th thay nc ct iu ch mt s dng thuc
(thuc nc dng ngoi, thuc ung,...) v s dng ra bao b ng
thuc.
Nc kh khong khc vi nc sinh hot ch khng cha cc mui
khong. thu c nc kh khong ngi ta dng phng php trao
i ion, bng cch cho nc i qua cc ct cha nha trao i ion.
V mt cu trc ho hc, cc nha trao i ion l nhng cht cao phn
t thin nhin hoc tng hp, khng tan trong nc, cha nhng nhm
hot ng c cc ion linh ng c th trao i d dng vi nhng ion c
cng in tch trong dung dch. C th vit cng thc ca cc nha trao
i ion nh sau:
- R+ - OH' anionit (cht trao i anion).
- R' - H+ cationit (cht trao i cation).
Trong R+ v R' l cc gc cao phn t.

Do c cu trc phn t ln, cc cht trao i ion khng tan trong nc v

trong dung mi hu c. C hai loi cht trao i ion l cation v anion.
v phng din cu trc ho hc, cc cht trao i ion chia thnh hai loi
ln: cc cht hu c v cc cht v c. Trong mi oi, c th l nhng
cht t nhin hoc tng hp.
Qu trnh c bn ca vic iu ch nc kh khong l qu trnh trao i
ion xy ra b mt ca cht trao i ion do hp ph cc ion trong nc
thin nhin ln b mt.
S trao i ion ca cc cht trao i ion khc vi phn ng trao i ho
hc ch, cc cht ny trc v sau qu trnh trao i u dng khng
ho tan. Hin tng trao i xy ra b mt tip xc rn - lng, gia b
mt cht trao i v dung dch bao bc quanh n. Nh cu trc xp ca
cc cht trao i ion, b mt tip xc vi dung dch rt ln. Qu trnh trao
i ion thng din ra qua hai giai on, giai on th nht, cc ion
trong dung dch hng v b mt cht trao i ion v do lc ht phn cc,
s xy ra qu trnh tp trung mt s ln ion ln b mt. Tip sau s xy ra
qu trnh trao i cc ion.

Nguyn tc ca phng php iu ch nc kh khong l cho

nc i qua nhng ct cha cationit gi li cc cation v sau
qua ct cha anionit gi li cc anion.
Khi nc i qua ct cationit, xy ra qu trnh:
R+H+ + Na+ R Na+ + H+
2R-H+ + Ca+ (R-)2 Ca+ + 2H+
Khi nc i qua ct anionit, xy ra qu trnh:
R+OH- + Cl- R+ Cl- + OH2 R+OH- + SO4-2 (R+)2 SO4-2 + 2H+
Khi cationit v anionit khng cn kh nng trao i ion, c th ti
sinh bng cch ra nha cationit vi dung dch acid hydrocloric 3 6% v ra nha anionit vi dung dch natri hydroxyd 3 - 4%.

R-Na+ + H+ + Cl- R-H+ + Na+ + ClR+Cl- + Na+ + OH- R+ OH- + Na+ + Cl-

Sau ra cc cht trao i ion ti sinh vi nc ct cho n

khi ht cc vt cc ion.
Qu trnh iu ch nc tinh khit bng cht trao i ion c u
im l khng cn ngun nhit, thun tin v d thc hin. Nc
kh khong c th t c tinh khit ho hc cao. Nhng v
mt vi sinh hc, khng th coi l t yu cu v cc cht trao i
ion khng c kh nng hp ph cc cht gy st (ch nhit t) v
cn khng gi li c cc vi khun. Nc kh khong i khi
cha tht tinh khit do nc ho tan mt phn rt nh cht tra
i ion nht l nha tng hp. V vy, khng dng nc kh
khong pha thuc v khun nh: thuc tim, thuc tim truyn,
thuc nh mt...

1.3 Nc iu ch bng phng php thm thu ngc

Nguyn tc: mng bn thm ch cho nc i qua t dung dch c
nng cht tan thp sang dung dch c nng cao. Khi tc ng
mt p sut mnh ln ngn cha dng dch m c nht s lm
o ngc li: nc i qua mng bn thm t dung dch c nng
cao sang dung dch c nng thp.
Mng bn thm dng l mng cellulose acetat hoc cc si nilon
rng. T l khong trong nc c loi trung bnh khong 95%,
c th t 88% vi cc ion c kch thc nh n 98% vi cc ion
c kch thc ln.
Nc thm thu ngc dng ra ng tim, l dng cho thuc
nh mt; pha thuc ung, thuc dng ngoi v dng iu ch

nc ct.

1.4 Nc iu ch bng phng php siu lc

Cc mng siu lc gi li cc cht hu c vi kch thc nht nh (v
d nh ch nhit t), cc tiu phn khng ho tan, vi sinh vt v virus,
nhng khng loi b c mui khong.

2. Mt s ung mi ha tan vi nc
2.1. Alcol
Cc alcol ni chung l nhng dung mi phn cc do s c mt ca cc
nhm hydroxyl trong phn t ca chng. Alcol bc nht tan tt trong nc
v l dung mi tt cho cc cht phn cc mnh.
Mch hydrocarbon trong dy ng ng cng tng, tnh phn cc v kh
nng trn ln vi nc ca alcol cng gim. Cc alcol bc cao c nhiu
nhm hydroxyl c tnh phn cc mnh hn cc alcol tng ng ch c mt
nhm hydroxyl.
Ethanol (alcol ethylic): l alcol c s dng rng ri nht trong ngnh
dc. N c th ho tan cc acid, cc kim hu c, cc alcaloid v mui
ca chng, mt s glycosid, nha, tinh du, mt s lipid, phm mu,...
ethanol khng ho tan pectin, gm, protit, enzym...
Ethanol ha tan vi nc v glycerin bt c t l no.
Khi trn ln ethanol vi nc s c hin tng to nhit v th tch hn bp
thu c nh hn tng th tch ca ethanol v nc tham gia vo hn hp.

i vi mt s dc cht, dung mi ethanol - nc c kh nng ho tan cao

hn so vi cc thnh phn ethanol v nc ring r.
Ethanol c tc dng st khun, do dng bo qun v lm tng n
nh ca ch phm. Mt s dc cht vng bn trong
ethanol hn l trong nc o hn ch phn ng thu phn. Tuy nhin,
ethanol cng c nhc im l khng hon ton tr v mt dc l, d bay
hi, d chy, lm ng vn albumin, cc enzym v d b oxy ho.
Trong ngnh c, ethanol c phi hp vi nc v cc dung mi phn
cc tan trong nc khc d lm dung mi cho cc dng thuc ung, thuc
tim v thuc dng ngoi, lm dung mi chit xut dc liu iu ch
cn thuc, cao thuc. Ethanol cng c s dng trong thnh phn thuc
vin nn, vin nang cng v vin bao mng mng nh mt dung mi ho
tan t c dnh, t dc bao mng v cc cht lm thm.
- Alcol isopropylic: cht lng trong, linh ng, d bay hi, d chy,mi c
bit.

Trong ngnh dc, alcol isopropylic ch yu c dng lm dung

mi cho cc dng thuc dng ngoi, khng dng cho thuc ung,
thuc tim. Tng t nh ethanol, alcol isopropylic c s dng
nh mt dung mi ho tan t dc dnh, t dc bao mng mng
trong sn xut thuc vin. Mt khc, do c kh nng dit vi khun
tt, alcol isopropylic 70% cn c dng lm cht st khun trong
qu trnh chun b phng pha ch cc thuc v khun.
22. Polyol
Glycerin (glycerol): sn phm thu c khi x phng ho cht bo.
Glycerin l mt cht lng khng mu, snh nh siro, v ngt, nng,
c phn ng trung tnh. Glycerin ha ln vi ethanol v nc bt
c t l no, khng trn ln vi clorofonn, ether, du m.
Glycerin ho tan mt s mui, cc acid hu c v v c, ho tan.
alcaloid v mui ca chng, cc tanin, ng,...

Glycerin khan rt d ht m v thng gy kch ng da, nim mc,

V vy, trong bo ch ch dng glycerin c dng c t trng 1,225
1 1,235 cha 3% nc, khng gy kch ng nng 25%.
Trong bo ch, glycerin c dng trong cc dng thuc dng ngoi;
hn hp dung mi lm tng tan ca dc cht t tan trong dng
thuc ung, thuc tim. Ngoi ra, glycerin cn c ng trong
thnh phn c v nang mm, cht gi m trong cc ch phm m
phm.
Propylen glycol (propan-l,2-diol): cht lng khng mu, nht, khng
mi, v ngt nng.
Trong cng ngh dc phm, propylen glycol c s dng rng ri
lm ung mi, lm tng tan ca dc cht t tan trong nc, c|
thin tnh thm qua mng sinh hc ca dc cht ngho tnh thn,
lm cht ho do trong thnh phn t dc bao mng mng...

Do c tc dng st khun nn propylen glycol cn c dng nhf mt

cht bo qun trong thnh phn mt s ch phm thuc.
c bit, propylen glycol phi hp vi nc, ethanol, alcoi benzylic
lm dung mi cho mt s thuc tim cha dc cht t ta hoc d b
thu phn nh khng sinh, ni tit t, glycosid, barbiturat...
Cng nh glycerin, propylen glycol c s dng trong dng thuc
dng ngoi v m phm nh mt cht gi m.

Polyethylen glycol (Carbowax, Macrogol, PEG): l sn phm trng

hip cao phn t ca ethylen oxy, c cng thc chung:
OHCH2- CH2OCH2)-CH2OH
Tu theo mc trng hip (n), c cc PEG vi phn t lng khc
nhau, tnh cht l hc khc nhau. lm dung mi hoc hn hp
dung mi cho mt s dng thuc (dung dch ung, elixir, thuc
tim), thng ng PEG 200, 300,400 v 600.

Trong cng ngh dc phm, polyethylen glycol c s dng rng

ri lm dung mi, cht m tng tan ca dc cht t tan trong
nc v lm cht ho do trong thnh phn t dc bao mng mng.

Tng t nh propylen glycol, PEG c dng ring hoc a s

trng hp phi hp vi nc, ethanol, alcol benzylic lm dung mi
cho mt s thuc tim cha dc cht t tan hoc d b thu phn
nh khng sinh, ni tit t, glycosid, barbiturat...
Nhng cn ch rng, PEG c th b phn hu to ra fomlaldehyd
trong qu trnh tit khun thuc tim nhit cao, lm tng c
tnh ca ch phm.
3.1 Du thc vt
Du thc vt l hn hp cc glycerid ca acid bo bc cao no (acid
myristic, palmitic, stearic, arachidic...) v khng no (acid oleic
linoleic, linolenic, arachidonic...). Du thc vt c iu ch bng
phng php p hoc chit t ht, qu, v qu ca mt s loi thc
v nh: olive, hnh nhn, lc, vng, u tng, thu du, thuc
phin! bng, da...

Cc u thc vt ngoi tc dng lm dung mi ch cc dung dch cha

dc cht khng tan trong nc nh: alcaloid base, ni tit t, vitamin A,
D, E, tinh du, mt s dc cht tan tt trong u nh artemether,
arteether... cn l cht n, t dc cho mt s loi dng thuc khc nh
hn dch, nh tng.
Du thc vt c nhc im l d b i kht. V vy, cn thm cc| cht
chng oxy ho nh butyl hydroxytoluen (BHT), butyl hydroxyanisol
(BHA), tocoferol,... bo qun du khi s ng lm dung mi.
c u lm dung mi cho thnc tim (quy nh cht ch v ch s
acid: < 0,2, ch s peroxid: < 5 v t l nc < 0,05%), ngi tap phi
trung tnh du.
Phng php: c th dng ethanol hoc natri carbonat. Nu dnp
Na2CO310OH2O, tin hnh nh sau:
Trc ht, phi xc nh lng acid bo t do c trong du bangj cch:
cn p gam du, ho tan vo hn hp dung mi (ng lng cloroform v
o
ethanon 95 thm vi git dung dch phenolphtalein trn u.

Nh n tng git dung dch KOH 0,1N cho ti khi c mu hng. Gi X

l lng acid bo t do (quy ra acid oleic) c trong 100 g du, ta c:
X=

0,0285.n.100
P

Trong :
n l s ml dung dch KOH 0,1N dng ht
1 ml dung dch KOH 0,1N ng vi 0,0285 g acid oleic
Thc t, lng Na2CO310OH2Ocn dng l 2,5X mi c th trung ho ht
acid bo t do trong du.
Tin hnh: ho tan natri carbonat vo mt lng nc ct va c
dung dch m c. un du nng 45c, thm dn dung dch natri carbonat
vo, khuy u. yn 24 gi, gn ly u, thm natri sulfat khan, khuy
k. Lc qua giy lc kh tit khun 160c trong 1 gi.
Khi pha ch dung dch du, dc cht phi khan hon ton trnh lm
c dung dch v trnh lm bih cht du khi bo qun ch phm.

Mt s loi du thng dng trong ngnh dc:

Du bng: ly t ht cy bng (Gossipium sp, Malvaceae). Du ht
bng th mu vng thm, ng c 2c - 4c Du tinh ch c mu
nht 'hn, ng c 0c. Trong thnh phn du ht bng, ch
nhiu acid bo khng no linoleic v mt t l nh vitamin E. T l
thng dng trong hn hp dung mi thuc tim trong khong 73,6 87,4 %.
Du da: ly t ci trng bn trong qu da (Coconus nucifera, b
Da) bng phng php p ngui hoc p nng. Du da mu trng,
mi thm, ng c 15c -18 c. Cc aci bo c trong du da
ch yu l acid lauric, myristic, palmitic, stearic, capric, caprylic v
caproic. Du da chng ct phn on c im ng c cao hn
c s dng thch hp lm dung mi thuc tim.

Du lc: ch bng phng php p nng hoc p ngui t ht cy

Lc(Arachis hypogea, h Cnh bm). Du lc mu vng nht,
gm phn ln glycerid ca cc acid bo nh arachidic, linoceric,
oleic' linoleic... v mt phn khng x phng ho l phytosterol.
Trong bo ch, du lc c s ng rng ri im ung mi pha
thuc tim, thuc dng ngoi, lm pha u cho nh tng.
Du Olive: p t v qu cy Olea europea, h Oleacae. Du olive
c mu vng nht hoc hi xanh, khng mi, v thm d chu.
Du vng: c p t ht cy vng (Sesamum indicum. h
Pedaliacae). Du vng c mu vng c trng, cha t l ln
glvcerid ca acid bo khng no (linoleic, oleic) v mt phn acid
bo no; (palmitic). Do ng c thp (-5 C), t b oxy ho, v
vy du vng rt thch hp lm dung mi cho thuc ung, thuc
tim.

Du parafin
Du parafin c iu ch bng phng php chng ci du mi
sau tinh ch. Du parafin c th cht lng snh, khng mi, khng; v, bn
vng v mt l hc v ho hc.
Du parafin-hay c dng ho tan cc cht khng phn cj nh cc tinh
du, cht chit t tinh du nh menthol, long no, mt s dc cht tan nong
du nh methyl salicylat... Trong ngnh dc v| m phm, du parafin dng
lm dung mi cho du xoa, hn hp tj dc thuc m, pha du trong nh tng
lng, kem, lotio...
Mt s dung mi thn du khc
Benzyl benzoat: cng thc phn t C14H1202, khi lng phn t 212,24.
Tnh cht: cht lng snh nh u, khng mu, mi thm nh, I im ng c
khong 17 c
Benzyl benzoat c ghi trong Dc in Anh, M. chu u,| Nht. Trong
ngnh dc, benzyl benzoat c dng lm tng J tan ca mt s dc
cht trong du v phi hp lm ung mi cho mt vi loi thuc tim bp, vi
nng thng dng trong khong t 20-44,7%.

Ethyl olea: cng thc phn t C20H38O2, khi lng phn t 310,52.
Tnh cht: cht lng linh ng, nht km hn u, khng mu
O
hoc vng nht, im ng c khong -32 C.
Ethyl oleat c ghi trong Dc in Anh, M v chu u. Trong
ngnh dc, ethyl oleat c dng phi hp lm dung mi cho mt
vi loai thuc tim bp cha dc cht tan trong du nh steroidTriglycerid mch trung bnh (du da phn on, Miglyol 810,
Miglyol 812): c thnh phn l hn hp cc trigycerid mch ngn v
trung bnh ca cc aci bo, ch yu l acid bo khng no (khng
di 95%) gm acid octanoic (caprylic) v decanoic (caprc).
Tnh cht: cht lng trong, khng mu hoc vng nht, khng mi,
khng v. ng rn khong 0 c, nht thp hn du. Do c
nhng c tnh nh trn, Migyol c s dng kh rng ri trong
ngnh dc: dung mi thuc tim, thuc ung v thuc dng ngoi.

II. VT LIU CH' TO BAO B DC PHM

1. Vai tr ca bao b trong bo ch thuc
-Bo v, gi cho thnh phm n nh v m bo tui th.
-Gip cho s dng dng thuc d dng, an ton v hiu qu.
-Hng dn s dng, theo di hn dng, tng tnh thm m.
2. Yu cu chung i vi vt liu ch to bao b c phm
-Vt liu ch to bao b ng thuc phi p ng mt s yu cu sau:
-Bn vng v mt hc, ho hc v vi sinh vt.
-Khng cho thuc thm qua.
-Phi ngn chn c cc yu t tc ng ca mi trng xung quanh
nh khng kh, m, nh sng i vi thuc cha trong bao b.
-Phi tr vi thuc, khng c tc dng dc l ring.
-Tuyt i khng c.

3. Cc loi vt liu thng dng ch to bao b dc phm

3.1 Thu tinh
3.1.1 Thnh phn ca thu tinh
Thu tinh dng lm chai l, ng rng c ch to bng phng
php nung chy silic oxyd nhit cao vi cc cht ph gia khc,
Thnh phn chnh ca thu tinh c ghi trong bng 3.5.

Tu theo t l cc oxyd kim a vo thnh phn ca thu tinh m ta

c thu tinh kim hay thu tinh trung tnh. Thu tinh kim c hm
(lng oxyd kim trn 20%. Thu tinh trung tnh hay cn gi l thu
tinh borosilicat c cha khong 10% bo oxyd (B2O3), t l cc oxyd
kim di 5 %.
c thu tinh mu, nhm hn ch tc ng ca nh sng ti , bn
vng v n nh ca dc cht trong ch phm, thng thm vo
thhh phn ca thu tinh mt s cht ph (bng 3.6).

3.2 c tnh v phm vi s dng ca bao b thu tinh

- c tnh:
+ Trong sut nn d pht hin s bin cht ca thuc.
+ Khng cho m v kh thm qua.
+ Gin, v
+ C th nh kim v cc ion kim loi vo thuc.
- Phm vi s ng:
Dc in Vit Nam chia bao b thu tinh dng trong sn xut dc
phm lm 3 loi:
+ Thu tinh loi I (thu tinh borosilicat hay thu tinh trung tnh): c
bn c hc cao, hu nh khng b thu phn v nh cc cht kim
t b mt bao b vo thuc nn dng thch hp lm bao b cho mi
thuc tim c pH khc nhau.

+ Thu tinh loi II l thu tinh kim c x l b mt bng kh

acid thch hp. Thu tinh loi n ng thch hp cho nhiu thuc tim,,
c bit l cc thuc tim truyn, v cc dung dch tim truyn thng
l cc dung dch trung tnh hay acid.
+ Thu tinh loi III l thu tinh kim: khng dng ng thuc tim
nc, m thng dng ng cc thuc tim du hoc thuc tim
dng bt kh.
hn ch kh nng tng tc c th xy ra giacc thnh phn trong
thu tinh vi cc thnh phn trong ch phm, lm cho thu tinh bn
vng hn v mt ho hc v gim kh nng dnh bm thuc vo l,
mt s hng sn xut bao b trng ln b mt ca thu tinh mt lp
Silicon.

3.13. Kim tra cht lng bao b thu tinh

Tu theo Dc in mi quc gia, yu cu cht lng v phng php
th c th khc nhau, nhng a s u kim tra:
-pH, kim
- lc
-Gii hn arsenic
-Kh nng ngn cn bc x t ngoi.
-Mc chng thm hi nc.
3.2 Cht do (polyme)
32.1. c tnh
So vi thu tinh, cc cht do nh hn, c bn c hc cao hn, t b
tc ng ca nh sng, nhung c nhc im l kh ra sch, d thm
m, tan trong ung mi hu c, chy v mm vi nht < 100c (tr
polytetrafluoroethylen P.T.P.E), t thch hp cho thuc tim khi cn tit
khun bng ni hp.

3.2.2 Mt s cht do s dng lm bao b dc phm

a, Polyolefin
-Polyethylen (P,E): l sn phm trng hip ca ethylen (CH2 = CH2),
c 3 loi: polyethylen t trng thp (LDPE), t trng trung bnh (MDPE)
v t trng cao (HDPE).
Polyethylen l cht do c s dng nhiu nht lm bao b trong ngnh
dc. C th ch to PE thnh nhiu hnh dng bng nhiu cch khc
nhau nh bm, y, nn, cn mng... to thnh chai, l c thnh mm
G rc bt, bm phun m, ng nh git..) nhng bnh cng vi th tch
ln, ng ng thuc vin nn, thuc bt, khun v thuc n, bm
tim... Polyethylen c th hn c bng nhit, in trn b mt sau khi
x l v vy dng lm bao b t hiu qu cao v kinh t, thm m.
-Polypropylen (PP): c tnh ca pp gn ging vi PE nhng kh nng
chu ng du m tt hn, t thm kh v hi nc hn v kh nng ch
nhit tt hn ( chy khong 170C), do c th ch to bao b cho
php tit khun bng nhit m.

b. Polystyren v styren bin tnh

-Polystyren: ch to bng cch trng hip styren (C6H5-CH=CH2)
- u im: khng c, khng mu v rt d nhum mu. B ngo ging
nh thu tinh nhng nh hn rt nhiu, d khun, chu c acid,
base, alcol v dn. Nhc im: khng chu c tinh u, hydrocarbon
v nhiu loi dung mi khc, d v v chu nhit km, ch bn nhit
di 80c, khng th tit khun bng nhit.
-Khc phc: s dng polystyren tc ng (thng dng vi cao su
butadien), styren acrylonitril (SAN), acrylonitril butadien styren
(ABS)...
c. Polyvinyl clorid v cc loi khc
Polyvinyl clorid (PVQ: thng dng lm khun v cho thuc vin.
Polyamid (Rilsan v nilon)

d.Dn cht ca cellulose

Cellulose c x l bng cc bin php ring r cho nhng nha
do thng dng. Nhng mng mng bng cellulose ti sinh thng
gi l celophan hay giy bng knh. Loi ny c th nhum mu v
in hnh, in ch ln b mt mt cch d dng. Hay dng nht l
cellulose acetat (b dy 2/100mm). Ngoi ra, cn s dng aceto
butyrat v cellulose propionat.

Cc dn cht ca cellulose c nhc im l thm m v vy thng

phi hp vi cc vt liu khc lm bao gi.

3.2.3 Kim tra cht lng bao b cht do

Dc in ca mi nc c nhng qui nh c th v yu cu cht lng v
phng php th i vi bao b bng cht do.
Dc in Vit nam 3 c chuyn lun ng v nt bng cht do,
trong chia ra:
Cht do dng cho nhng ch phm khng phi thuc tim, trong quy
nh th cc ch tiu: kn, gp un, trong ca nc chit v cn
khng bay hi.
Cht do dng cho thuc tim, quy nh th cc ch tiu: kn, gp un,
trong ca bao b, thm hi nc, th nghim cht liu bao b (bari, kim
loi nng, thic, km, cn nung), th nghim trn dch chit (th nghim ho
l: trong v mu sc, hp th nh sng, pH, cht khng bay hi, cn
nung, kim loi nng, dung lng m v nhng cht b oxy ho), th nghim
sinh hc: th nghim tim ton thn, cht gy st.
Cht do dng cho thuc nh mt, quy nh th cc ch tiu: kn, gp
un, trong ca dch chit, cn khng bay hi, th nghim ton thn, tim
trong da v kch ng mt

3.3 Cao su
Trong ngnh Dc, cao su c dng nhiu lm bao b v ch to cc vt dng
nh: nt chai, nm v, np bnh sa, cc dy v ng ni ch truyn, ng thm
d...
3.3.1 Mt s loi cao su thng dng
a, Cao su thin nhin
Ch to t m cy cao su. Mun s dng, cn ch ho v thm cc cht ph, chng
hn nh:
Cht lm do: hy dng acid bo v mercaptan.
Cht n lm tng sc bn nh carbon, kaolin, magnesi carbonat; lm tng
rn v khi lng: bari Sulfat, talc...
Cht gia tc lu ho nhm lm gim lng lu hunh v thi gian lu ho nh ch
(II) oxyd, amin, thiazol, mui thioacid...
Cht chng oxy ho nh phenol, amin...
b, Cao su tng hp
Ni chung, cao su tng hp t b lo ho hn, t thm kh v nc hn cao su thin
nhin, chu dung mi tt.

Cao su buthyl (cht trng hip ca isobutylen) lm nt.

Cao su clorobuthyl: n nh v chu dung mi tt hn so vi cao su butyl.
Cao su nitril: chu c du v tinh du
c. Cao su silicon
Gm ch y cc cht trng hip ca imethylsilosan. u im: n nh
i vi nng v lnh, chu c ozon v nc. Nhc im: ' thm kh, hi
nc v km chu ng dung mi.
3.3.2. Kim tra cht ng cao su
Dc in ca mi nc c nhng qui nh c th v yu cu cht lng v
phng php th i vi bao b bng cao su.
Dc in Vit nam 3 c chuyn lun Nt cao su dng cho chai ng dung
dch tim truyn, trong quy nh th mt s ch tiu nh: bn,
kn, mu sc ca dch chit t nt, gii hn acid kim, gii hn kim loi
nng, gii hn cht kh, gii hn cn kh, gii hn amoni, gii hn sulfit d
bay hi, gii hn km ho tan v hp th nh sng.

3.4. Kim loi

3.4.1. Nhm v thic
Nhm tinh khit (> 99,5%) c nhng a im quan trng nh: nh, d dt
mng, bn vng do c mt lp nhm oxyd bo v trn b mt.
Nhc im: do lp nhm oxyd c tnh cht lng tnh nn c th b ho
tan trong c acid v trong kim.
Bin php x l:
-Tng cng lp oxy nhm bng in phn theo phng php oxy ho
cc dng.
-To mui phc ln b mt vi cromat, phosphat, fluoricL.
-Sn hoc trng polyethylen hoc rilsan ln b mt nhm.
-Nhm c dng lm bao b cho cc dng thuc di nhiu hnh dng
nh: ti mng nhm trng polyme, tup, hp, l...
Thic tinh khit (97%) c s ng lm bao gi nh tup ng thuc
m do n bn vng, d dt mng v khng c. Tuy nhin gi thnh cao v
vy ngy nay t c a chung.

3. 4.2. Kim tra cht lng bao bi bng kim loi

Dc in ca mi nc c nhng qui nh c th v yu cu cht lng
v phng php th i vi bao b bng kim loi.
Dc in Vit nam 3 c chuyn lun ng bng kim loi dng thuc
m tra mt" trong quy nh th mt s ch tiu nh: tiu phn kim loi.
Cng ty SANTEN Pharmaceutical Co.Ltd quy nh tiu chun tup ng
thuc m a mt vi cc ch tiu sau:
-Cm quan
-Tnh cht dch chit: cm quan, pH, cht kh, hp th t ngoi v cn
khng bay hi.

Chng 4
K THUT BO CH DUNG DCH THUC
Mc tiu hc tp
1.Nu c nh ngha, u nhc im, phn loi dung dch thuc
2.Trnh by c cc thnh phn ca dung dch thuc
3.M t ng cc trnh t k thut phi thc hin trong pha ch - sn xut
dung dch thuc
4.Nu c yu cu cht lng ca dung dch thuc
5.Nu c cch pha ch mt s dung dch thuc c th

1. I CNG V DUNG DCH THUC

1.1 nh ngha
Dung dch thuc l nhng ch phm lng trong sut, cha mt hoc nhiu dc cht
ho tan trong mt dung mi hoc mt hn hp dung mi.
1.2 u, nhc im
u im:
Dung dch thuc l dng thuc c dng nhiu trong iu tr, l dng thuc thch hp
vi tr em v ngi cao tui do ung dung dch thuc d nut hn khi ung vin nn
hay vin nang cng.
Ung dung dch thuc c tc dng nhanh hn so vi ung cng liu dng thuc vin.
V khi ung dng dch thuc, dc cht c hp thu ngay t dung dch khng phi
qua qu trnh gii phng v ho tan dc cht nh khi ung thuc vin.
- Mt s dc cht (kali clorid, natri bromid, aspirin...) khi ung dng dung dch t
kch ng nim mc hn khi dng di dng thuc rn do thuc c pha long ngay
vo dch tiu ho v d khuch tn trn din rng b mt nim mc.
- Dung dch thuc l mt h ng nht nn vic chia liu chnh xc, hn khi chia liu
hn dch thuc.

Nhc im:
Khi bo ch thnh dung dch, c cht thng km n nh hn khi
bo ch dng thuc rn.
Ni chung, cc dung ch thuc l mi trng thun li cho s pht
trin ca cc vi sinh vt nn dung dch thuc d b nhim khun, gy
hng thuc v khng m bo an ton khi s dng.
Vi dc cht c v kh chu khi pha thnh dung dch thuc, v kh
chu thng mnh hn khi bo ch dng thuc rn.
Khi s dng dung dch thuc, cn phi c thm dng c chia liu
(tha cafe, tha canh, cc ong...) v ngi bnh t chia liu theo hng
dn v th vic chia liu km chnh xc hn so vi cc dng thuc
phn liu.
Cc dung dch thuc thng c ng trong chai, l c th tch cng
knh, d v nn bo qun v vn chuyn kh khn hn so vi cc dng
thuc rn.

3. Phn loi
C nhiu cch phn loi cc ung dch thuc:
3.1. Theo ng dng thuc
- Dung dch dng trong: dung dch thuc ung, dung ch thuc tim.
- Dung dch dng ngoi: dung dch bi, xoa, p trn da hay nim
mc, dung dch sc ming, dung dch nh mt, dung dch nh mi,
dung dch nh tai, dung dch tht, dung dch ra...
Trong chng ny ch trmh by v cc dung dch thuc ung v
dng ngoi- Cc dung dch thuc tim v dung dch nh mt l
nhng ch phm v khun s c trnh by ring trong chng 5 v
chng 6.

3.2 Theo bn cht ung mi dng pha dung dch thuc

C cc loi dung dch:
-Dung dch nc (dung mi l nc).
-Dung dch du (dung mi l du).
-Dung dch cn (dung mi l ethanol).
-Dung dch glycerin (dung mi l glycerin).
3.3 Theo cu trc ha l ca dung dch
-Dung dch tht: cht tan ho tan hon ton trong dung mi di
dng cc phn t hay ion.
-Dung dch keo: l nhng ch phm c iu ch bng cch phn
tn mt cht keo vo nc nh dung dch argyrol, dung dch
protargonr dung dch ichthyol...
-Dung dch cao phn t: cht tan l cc hp cht cao phn t nh
gelatin, methylcellulose... Tu theo nng v nhit m cc
dung dch cao phn t th lng hoc th gel.

3.4 Theo tn gi quy c

Trong bo ch, nhng dung dch thuc c thnh phn c trng
tng t nhau c xp chung thnh tng nhm thuc c tn gi
quy c l potio, elixir, thuc nc chanh v so thuc:
Potio:
Potio l dng thuc nc c v ngt cha mt hay nhiu dc
cht, thng pha ch theo n, dng uhg tng tha.
Potio c hm lng ng thp khong 10 - 15 %, l mi trng
dinh dng thun li cho s xm nhp v pht trin ca cc vi sinh
vt. Do , cc potio thng pha v dng ngay.
-Hin nay, nh s dng cc cht bo qun khc nhau, nhng dung
dch thuc ung c hm lng ung thp cng c sn xut v
lu thng vi hn dng 24 thng hoc lu hn.

Elixir:
Ehxir l nhng ch phm cn thuc ngt, cha mt hay nhiu
dc cht v c hm lng cao cc alcol nh ethanol, propylen
glycol v glycerin.
Khc vi potio do trong thnh phn elixir c t l alcol c tc
dng bo qun nn cc ch phm elixir kh n nh, kh b nhim
vi sinh vt
Thuc nc chanh:
Thuc nc chanh l nhng dung dch c v chua - ngt, c lm
thm v i khi c CO2 ung gii kht hoc cha bnh.
Thuc nc chanh rt d b nhim vi sinh vt v mt CO2 rt
nhanh. V th thuc nc chanh hin c thay th bng cc
ch phm thuc si bt (bt, cm hay vin si bt), khi dng mi
pha trong nc thnh dung dch ung.

Siro thuc:
Siro thuc l dung dch m c ca ng trong nc (hm lng
ng khong 56 - 64%) c cha cc dc cht hoc cc dch chit t
dc liu v cc cht thm dng ung.
V ngt ca ng trong siro thuc c th t c v kh chu ca mt
s dc cht v do hm lng ng rt cao nn hn ch c s
pht trin ca cc vi sinh vt trong qu trnh bo qun siro thuc.
4. tan ca cht tan
tan ca cht tan trong mt dung mi iu kin nhit , p sut
xc nh l t s gia lng cht tan v lng dung mi ca dung
dch bo ho cht tan trong dung mi cho khi qu trnh ho tan
t n trng thi cn bng.
tan ca mt dc cht c biu th bng lng ti thiu s mililit
dung mi cn thit lm tan mt gam ca dc cht . Theo Dc
in Vit Nam 3 (2002), tan c biu th nh sau:

Bng 4.1. Cch gi quy c v tan ca dc cht theo DVN 3

tan ca mt cht tan trong cc dung mi khc nhau rt khc nhau,

ph thuc vo bn cht ca cht tan v ca dung mi.
Trong bo ch dung dch thuc cn phi bit v tan ca dc cht
v cc cht dng pha dung dch c th p dng nhng k thut bo
ch thch hp khi bo ch cc dung dch thuc c dc cht v t dc
t tan trong dung mi.

II. THNH PHN CA DUNG DCH THUC

Cc dung ch thuc thng km bn vng, d b bin cht do nhng bin
i ni ti trong dung dch v do nhng tc ng bt li t mi trng nh
nhit , nh sng, khng kh, vi sinh vt... n thuc trong qu trnh bo
qun. Cc dung dch thuc b bin cht c th do nhng thay i vt l
(ho mui, ng vn, hp ph,...), ho hc (thu phn, oxy ho, quang
ho, to phc...) hay sinh hc (bin cht do thuc b nhim cc vi sinh
vt).
Khi dung dch b bin cht c th nhn bit c qua nhng thay i cm
quan ca dung dch nh vn c, kt ta, bin mu,... Nhng cng c khi
s bin cht ca dung dch thuc khng c biu hin thay i g v cm
quan m ch c th nhn bit bng cc phng php phn tch thch hp.
n nh cc dung dch thuc, nng cao tui th ca ch phm, trong
thnh phn ca dung dch thuc phi c dc cht, t dc (dung mi, cc
cht ph tr khc nhau) v bao b thch hp vi tng ch phm thuc.

1. Dc cht
Dc cht ng pha ch cc dung dch thuc rt a dng v ngun
gc v tc dng c l.
Dc cht dng trong bo ch thuc phi t ch tiu cht lng nh
ghi trong tiu chun ca dc cht (hoc l t tiu chun Dc in
hoc l t tiu chun ca nh sn xut).
Khi pha dung dch thuc, dc cht phi tan hon ton trong dung mi
hoc hn hp dung mi, v vy phi bit c tan ca dc cht. Nu
dc cht t tan trong dung mi th cn p dng cc bin php ho tan
thch hp pha dung dch.
2. T dc
2.1 Dung mi
Dung mi l nhng cht lng thng chim t l ln trong thnh phn
dung dch thuc. Cc dung mi thng dng bo ch cc dung dch
thuc l: nc, ethanol, propylen glycol, glycerin, du thc vt, u
parafin...

2.1.1 Nc
Nc l dung mi thng dng nht pha ch cc dung ch thuc
do nc c kh nng ho tan nhiu cht phn cc.
pha ch cc dung dch thuc ung v dung dch dng ngoi c
th dng nc chn (nc t tiu chun nc sinh hot mi un
si ngui), nc ct hay nc kh khong t tiu chun ca
Dc in Vit Nam 3 (k thut iu ch nc ct v nc kh
khong xem chng 3).
Trong bo ch, cn dng nc thm pha dung dch thuc khi
dc cht c mi kh chu. Nc thm l nc bo ho tinh du
c iu ch bng cch ct ko dc liu hoc bng cch ho tan
tinh du trong nc. Nc thm khng c tc dng dc l, tr
nc thm l o, nc thm hnh nhn ng. Nc thm c
iu ch bng cch:

+ Ct dc liu: cho dc liu chia nh vo ni ct cng vi nc,

hng ly nc ct, gn b phn tinh u tha thu e nc thm.
+ Ho tan tinh du vo nc: c th ho tan tinh du vo nc nh
cc cht trung gian nh bt talc hay kaolin theo cng thc:
Tinh du
lg
Bt talc
10g
Nc ct va
1000g
Trn tinh du vi bt talc ri thm nc vo khuy k, 24 gi,
thnh thong khuy v lc qua giy lc thm nc s thu c
nc thm
C th bo ch nc thm nh cht din hot Tween 20 theo cng
thc: Tinh du
2g
Tween 20
20g
Ethanol
200g
Nc ct
778g

Thc t trong sn xut, lm thm thuc ngi ta khng iu ch

ring nc thm m ho tan cc cht thm (tinh du, menthol, bomeoi,
long no...) trc tip vo dung dch thuc bng cch dng cc dung mi
trung gian nh ethanol, propylen glycol v cht in hot thch hp
(cng thc 4.16).
2.1.2. Ethanol
Ethanol l mt dung mi c dng pha nhiu dung dch thuc.
Ethanol c u im l c tc dng st khun, mt s dc cht vng
bn trong ethanol hn l trong nc, ethanol c th lm tng tc dng
iu tr ca thuc. Nhc im ca ethanol l c tc dng dc l ring,
d bay hi, d chy v b oxy ho.
Hn hp ethanol - nc c hm lng ethanol khc nhau l dung mi
pha ch cc dung dch cn (cng thc 4.1,4.2,4.3).
- Ethanol c th trn ln vi glycerin v nc theo bt k t l no tao
thnh cc hn hp dung mi c kh nng ho tan nhiu dc cht t tan
trong nc (cng thc 4.4,4.5).

2.1.3 Propylen glycol

Propylen glycol l dung mi ho tan c nhiu dc cht t tan
trong nc (cng thc 4.7).
Propylen glycol phi hp vi ethanol, glycerin v nc to hn hp
dung mi pha nhiu dung dch thuc c c cht t tan v d b
thu phn trong nc (cng thc 4.6).
2.1.4. Glycerin
Glycerin c th ho tan cc acid hu c, cc alcaloid, tanin v mt
s mui nn glycerin c dng lm dung mi pha ch cc dung
dch glycerin (cn gi l thuc glycerin) dng ngoi (cng thc
4.8).
Glycerin trn ln vi ethanol v nc bt c t l no thnh cc
hn hp dung mi pha cc dung dch thuc c dc cht t tan
trong nc (cng thc 4.9).

2.1.5. Du thc vt
Du thc vt l ung mi bo ch cc dung dch du. Du
thc vt ho tan c mt s dc cht hu c nh salol, long
no (cng thc 4.10), menthol, tinh du, cc alcaloid base, mt
s vitamin nh A, D, E, du gc...
Trong bo ch thng dng du lc, du hng dng, du oliu,
du thu du, du vng, du hnh nhn...
Khi pha ch dung dch du, dc cht phi kh trnh lm c
dung dch v trnh lm bin cht du khi bo qun ch phm.
2.1.6. Du parafin
Du parafin l mt dung mi khng phn cc, c kh nng ho
tan cc cht khng phn cc nh cc tinh du, cht bo...
Du parafin hay c dng pha cc du xoa (cng thc
4.11).

2.2. Cc cht lm tng tan

pha cc dung dch thuc c c cht t tan trong nc,
c th n s dng hn hp cc dung mi (xem cc cng thc
t 4.1 n 4.9)1 hoc dng cc cht lm tng tan ca dc
cht trong dung mi:
To dn cht d tan nhng khng lm thay i tc dng dc
l ca dc cht ban u (cng thc 4.12).
Dng cht din hot: cc cht in hot khi thm vo dung
dch vi nng cao hn nng micel ti hn ca chng
c tc dng ho tan nhiu c cht kh tan. Thng dng
cc cht in hot khng ion ho nh Tween 80 pha cc
dung dch thuc ung v cc cht din hot x phng pha
dung dch dng ngoi (cng thc 4.13)

2.3. Cc cht iu chnh pH

Trong thnh phn ca cc dung dch thuc c th c cc acid, I
kim, mui acid, mui kim hoc h m c tc dng iu chnh
pH ca ung dch v mt khong gi tr thch hp n nh c
cht (cng thc 4.18), tng tan ca dc cht (cng thc 4.14),
gim kch ng ca thue (cng thc 4.15) hay tng tc dng ca
thuc.
2.4. Cc cht chng oxy ho
Vi cc dung dch nc c th dng acid ascorbic (cng thc
4.17), natri methabisulfit, natri bisulfit, natri sulfit v cc cht c
tc dng kho cc ion kim loi nng nh dinatri edetat, acid citric.
Vi cc dung dch du c th dng cc cht nh a-tocoferol
(vitamin E), butyl hydroxyanisol (BHA), butyl hydroxytoluen
(BHT)... chng oxy ho cho cc dc cht tan trong du v
chnh bn thn dung mi l du thc vt.

2.5. Cc cht bo qun

hn ch n mc thp nht tc hi ca vi sinh vt i vi cc dung
dch thuc, trc ht phi tun th ng cc quy nh v v sinh trong
pha ch - sn xut thuc ni chung. ng thi trong thnh phn ca
dung dch thuc cn c cc cht bo qun c tc dng dit cc vi sinh
vt xm nhp vo thuc trong qu trnh pha ch, bo qun v s dng
thuc.
C th dng cc cht bo qun nh nc cloroform (cng thc 4.14 &
4.17), nipasol phi hp vi nipagin (cng thc 4.18), acid benzoic,
acid salicylic, ethanol nng trn 15 %...
2.6. Cc cht lm ngt
Nhiu dung dch thuc ung c lm ngt bng ng glucose,
saccarose, sorbitol hay ng ho hc nh saccarin, aspaltam. Trong
, saccarose c dng ph bin nht v thng c pha ch trc
thnh siro n.

2.6. Cc cht lm ngt

Nhiu dung dch thuc ung c lm ngt bng ng glucose,
saccarose, sorbitol hay ng ho hc nh saccarin, aspaltam. Trong
, saccarose c dng ph bin nht v thng c pha ch trc I
thnh siro n.
Siro n l dung dch m c ca ng saccarose trong nc dng
pha ch cc so thuc hoc lm ngt trong nhiu ch phm thuc khc
nhau.
+ Siro n ch nng theo cng thc:
-ng saccarose
165 g
-Nc
100 ml
un si nc, cho ng vo khuy n khi tan hon ton, lc qua li
vi (nu cn), lc khi siro cn ang nng. Siro n phi c t trng l
1,26 khi o nhit 105c (nhit si ca siro) v t trng l 1,32 khi
o nhit phng, tng ng vi nng ng l 64 %. Nu kim
tra t trng ca siro khc vi quy nh th phi iu chnh bng cch
thm nc hoc thm ng.

+ Siro n ch ngui theo cng thc:

ng saccarose
180g
Nc
100 ml
Cho ng vo ng c thch hp, khuy cho ti khi ng ho tan ht,
thu c siro n
Trng hp cc bnh nhn b bnh tiu ng, pha thuc dng
Siro, ngi ta phi thay siro n bng mt dung dch c th cht ging
nh siro (cng thc 4.21).
2.7. Cc cht mu, cht thm
Cc dung dch thuc c th c cht mu tng s ch khi s dng
(cng thc 4.11; 4.14) hoc tng s hp dn ca ch phm. Ch c
s dng cc cht mu cho php dng cho thuc v thc phm.
Cc dung dch ung c th c thm cht thm c tc dng che u mi
kh chu ca thuc (cng thc 4.5, 4.6, 4.16) hoc gip cho ngi bnh
cm gic d chu khi ung... Cc dung dch dng ngoi c cht thm
c ngi dng thuc d chp nhn hn.

3. Bao b
Bao b ng cc dung dch thuc c nh hng trc tip n- cht
lng thuc ng trong . Bao b c th l thu tinh hay cht do, c
hnh thc, kiu dng, dung tch, mu sc ph hp vi tng ch phm
v phi t cc yu cu cht lng theo quy nh ca Dc in Vit
Nam 3 hoc tiu chun ca nh sn xut (xem phn! bao b chng 3).
ng cc dung dch thuc c thnh phn d bay hi, d thng hoa hay c
tnh oxy ho mnh (cng thc 4.1, 4.2, 4.3, 4.4, 4.8, 4.12) v cc dung dch
du (cng thc 4.10, 4.11) phi dng chai l bng thu tinh np kn, khng
c dng chai l bng cht do.
Nu thuc c thnh phn khng bn di tc ng ca nh sng th cn dng
bao b cha thuc (bao b trc tip) c mu hoc hp giy (bao b th cp) c
kh nng ngn cn nh sng.
thun tin cho ngi ng, hin c nhiu ch phm l dung dch thuc
c ng gi thnh tng liu, mi liu c ng trong mt ti nh
(sachets) c hn km (ti c lm t mng c 3 lp, lp trong v lp ngoi
bng mng cht do, gia l mng nhm).

III. K THUT PHA CH DUNG DCH THUC

1. Quy trnh chung trong pha ch - sn xut dung dch thuc
Ni chung, quy trnh pha ch - sn xut mt dung ch thuc gm cc
cng on nh m t trong s hnh 4.2,
1.1. Chun b trc khi pha ch
1.1.1. Chun b c s, dng c, thit b pha ch
Phng pha ch, bn pha ch, cc dng c v thit b my mc dng
trong, pha ch phi c lau, ra, v sinh sch trc v sau khi pha ch
theo ng cc quy trnh thao tc chun c quy nh bng vn bn
c th p dng trong tng c s pha ch - sn xut.
1.1.2. Chun b nguyn, ph liu
Tt c cc dung mi, ho cht, bao b, hm, hp, nhn... trc khi a
vo pha ch - sn xut phi c kim nghim theo cc tiu chun p
dng i vi tng nguyn, ph liu v ch c s dng khi c phiu
kim nghim xc nhn t tiu chun cht lng cng b.

1.1.3. Chun b bao b

Bao b dng ng thuc phi
c ra sch trong, ngoi bng
nc x phng, ra sch x
phng bng nc, trng li bng
nc tinh khit, sy kh hoc
lm kh bng phng php
thch hp (tu vt liu lm bao
b l thu tinh hay cht o).
Bao b cn c x l ngay
trc khi ng thuc. Trng
hp, bao b x l nhng
lu cn phi x I l li trc khi
ng thuc.

1.2. Pha ch
1.2.1. Cn, ong ho cht v dung mi
Cn, ong ho cht v dung mi phi ng khi lng hay th tch
ghi trong cng thc. trnh nhm ln, sai st trong pha ch,
khi cn, ong ho cht v ung mi cn c 2 ngi, mt ngi cn
v mt ngi kim tra v s lng v tn ho cht, dung mi.
1.2.2 Ho tan
Trong pha ch dung dch thuc, ho tan l mt cng on quan
trng nh hng trc tip n cht lng thuc. Nguyn tc chung
l phi hn ch n mc thp nht s tc ng ca mi trng n
thuc trong qu trnh pha ch, do vy phi thc hin qu trnh ho
tan cng nhanh cng tt. ho tan nhanh, ho tan hon ton cc
cht tan trong dung mi phi ch p dng cc nguyn tc ho tan
c trnh by di y:

-Lm mn dc cht:
Cn lm mn dc cht bng phng php thch hp (nghin, tn hoc xay)
trc khi ho tanT khi din tch b mt tip xc ca cht tan vi dung mi
s ln hn, do qu trnh ho tan s nhanh hn, nht l i vi cc dc
cht kh tan v tan chm...
-Trnh t ho tan:
+ Khi trong thnh phn ca dung dch thuc c nhiu cht c tan khc
nhau th phi ho tan cc cht theo th t cht t tan ri mi n cc cht d
tan hn.
+ Vi cc dung dch thuc s dng hn hp cc dung .mi ho tan cc cht
kh tan trong nc th trc'ht phi pha hn hp ung mi ri mi ho tan
dc cht vo trong (cng thc 4.6).
+ Vi cc dung dch thuc c s dng cc cht lm tng tan th phi ho
tan cc cht trc ri mi ho tan dc cht kh tan (cng thc 4.12).
+ Vi cc cht kh tan trong nc nh nipagin, nipasol nhng tan trong
dung mi trung gian nh ethanol, th phi ho tan cc cht ny vo dung mi
trung gian thnh ung dch ri mi phi hp vo ung dch thuc (cng thc
4.18).

Vi cc dung dch c cht chng oxy ho (cng thc 4.17), c h m, c

cht bo qun th cn ho tan cc cht ny trc khi ho tan dc cht.
+ Cc cht lm thm, cc cht d bay hi th nn ho tan sau cng (cng thc
4.16,4.18).
-Ho tan nng:
Mun ho tan nhanh cc cht tan trong dung mi khi pha ch dung dch
thuc, trong nhiu trng hp cn phi un nng ung mi n nhit thch
hp ho tan. Khi un nng dung mi, tc ho tan ca cht tan tng ln
do nht ca dung mi gim v qu trnh khuch tn ca cc phn t c
cht trong dung mi tng. Thm vo , khi nhit tng, tan ca a s
cc cht tan tng ln (tr cht kh); v d acid boric,... kh tan trong nc
nhit thng nhng d tan nhit si. Tuy nhin, c mt vi trng
hp tan gim khi nhit tng do chuyn dng kt tinh; v d natri sulfat
s chuyn thnh dng khan rt kh tan nu ho tan nhit trn 33C hay
calci glycerophosphat khng tan trong nc si do chuyn sang dng hydrat
t tan.

Nhit cao gip ho tan nhanh cht tan trong dung mi, song nhit
cao cng c th lm cho dc cht b phn hu ngay trong m qu trnh
pha ch. V vy, phi da bn ca dc cht vi nhit m tin hnh
ho tan nng hay ho tan nhit si ca dung mi
+ un nng dung mi ho tan, p dng vi cc dung mi c M
nht cao nh propylen glycol (cng thc 4.7), glycerin (cng thc 4.15),
du thc vt (cng thc 4.10), siro n (cng thc 4.19).
+ un si dung mi ho tan (cng thc 4.20).
+ Vi cc ung dch thuc trong thnh phn c cc polyme nh
methylcellulose, hydroxymethylpropyl cellulose, alcol polyvinic.
gelatin... th cn phn tn u polyme vo nc nng, ngm trong nhiu
gi, cho polyme ht nc, trng n to thun li cho qu trnh ho
tan cc polyme ny trong nc (cng thc 4.21).

-Khuy trn:
Phi khuy trn khi ho tan. Khuy trn trong qu trnh ho
tan c tc dng ph v lp dung dch bo ho bao quanh cc
tiu phn cht tan lm cho cht tan tip xc c vi dung
mi cha bo ho, gip cho qu trnh ho tan nhanh hn, rt
ngn c thi gian pha ch. Tu quy m pha ch m ng
ng c hay my khuy thch hp (xem chng 2).
Tri li, khi pha ch cc dung ch bc keo nh dung dch
protargon, argyrol... khng nn khuy v s lm bt dc cht
dnh li thnh cc cn tr qu trnh ho tan (cng thc 4.22).

1.2.3. Kim tra bn thnh phm v iu chnh th tch

Vi cc dung ch trong tiu chun cht lng c quy nh v
pH th sau khi ho tan hon ton cc thnh phn c trong ung
dch thuc cn o pH ca dung dch v iu chnh pH v gi tr
quy nh (nu cn) bng dung dch acid hay base thch hp.
Vi cc dung dch thuc trong tiu chun cht lng c quy
nh v t trng nh cc siro thuc th cn xc nh t trng ca
dung dch (bng t trng k hoc cn mt th tch chnh xc
dung dch) v iu chnh (nu cn) v gi tr quy nh bng cch
thm dung mi hoc thm cht tan.
Thm dung mi va n th tch theo cng thc pha ch. Ly
mu nh lng hm lng dc cht trong dung dch thuc
(nh lng bn thnh phm) v iu chnh (nu cn) ung
dch c hm lng dc cht nm trong gii hn quy nh.

1.2.4. Lc dung dch

Sau khi pha, dung dch thuc cn c lm trong bng cch lc dung
dch qua cc vt liu lc thch hp (xem k thut lc chng 2).
Tu theo quy m pha ch v tnh cht ca dung dch m p dng:
-Lc qua bng thu tinh vi gi l phu thu tinh lc cc dung
dch c tnh oxy ho mnh nh dung dch Lugol, dung dch, cn
iod...
-Lc qua bng ht vi gi l phu thu tinh lc cc dung dch
c nht thp khi pha ch nh hay pha ch theo n.
- lc cc dung dch c nht cao nh cc siro thuc, cc dung
dch du... C th lc qua giy lc dy, xp, th to (l lc ln) hay
lc qua ti vi v phi lc khi dung dch ang nng.
-Lc qua mng lc c kch thc l xp t 0,45 micromet n vi
microraet vi cc loi gi mng v thit b lc ph hp vi quy
m sn xut.

2.5. ng thuc
Dung ch sau khi lc v kt qu kim nghim bn thnh phm
t yu cu s c ng vo bao b c x l. Tu theo
quy m pha ch v iu kin v thit b, c th thc hin ng
thuc vo chai (l) bng cch:
+ ng th cng: bnh cha dung dch thuc c t ln mt
gi cao hn so vi mt bn ngi ng thuc, dung ch thuc s
t chy t bnh cha vo chai (l) theo mt ng cht do hoc
ng cao su c ng knh thch hp nh chnh lch v p sut
thu tnh. Khi dch thuc chy vo chai (l) t n th tch yu
cu (so snh c lng vi ngn th tch ca cc chai thuc lm
mu) th kp u ng li v chuyn u ng sang chai (l) khc,
m kp cho dung dch chy vo chai (l). Thuc ng n u
cn y np ngay n hn ch nhim t mi trng vo
thuc.

Th tch thuc ng vo tng chai (l) lm mu so snh c

ong bng ng ong. Cn ng 5 n 10 chai (l) mu t trc
mt i khi ng thuc d so snh.
+ ng bng my bn t ng: Qu trnh ng dung dch thuc
vo chai (l) c thc hin bng mt my bm ch ngt, m
theo chu k hot ng ca my. Th tch hay khi lng thuc
ng vo tng chai (l) c iu chnh theo mun ca ngi
vn hnh my ngay t khi bt u ng thuc. Qu trnh tip
chai (l) v y np vn phi lm th cng.
+ ng thuc bng my t ng: Qu trnh tip chai (l), ng
thuc, y np v c th cc khu dn nhn, in s kim sot c
thc hin t ng bng mt h thng my lin hon

Kim tra gii hn cho php v th tch thuc trong qu trnh

ng chai: D qu trnh ng ung dch thuc vo chai (l)
c lm th cng, bn th cng hay t ng, u phi nh k
(quy nh theo thi gian hoc theo s sn phm ng) kim
tra li th tch thuc ng vo chai (l) c nm trong gii hn
cho php khng. Nu khng t yu cu th phi iu chnh kp
thi.
Dc in Vit Nam 3 (2002) c quy nh gii hn cho php v
th tch p dng i vi tng loi dung dch c th nh ghi
bng 4.2. Vi quy nh ny, th tch dung dch thuc thc ng
trong chai (l) u phi ln hn so vi th tch ghi trn nhn
thuc.

1.2.6. Dn nhn v ng gi
Sau kh ng gi, tng chai (l) thuc u phi c n nhn. Kch
thc nhn thuc dn ttn chai (l) phi cn xng vi chai (l) thuc.
Ni dung thng tin ghi trn nhn thuc phi tun th ng theo quy
nh ca Quy ch nhn thuc (xem Quy ch nhn thuc).
Sau khi dn nhn, mi chai (l) thuc c th c cho vo mt hp
giy km theo mt t hng dn s dng thuc. Ni dung thng tin in
trn hp giy v t hng dn s dng thuc cng phi tun th ng
quy nh ca Quy ch nhn thuc.

Sau , sn phm cn c ng hm thun tin cho vic

vn chuyn v bo qun. Quy cch v s lng thuc ng
trong hm tu theo tng sn phm nhng phi c nhn, mc
y .
Trong qu trnh dn nhn, ng hp, ng hm, phi kim a
s l sn xut, hn dng ghi trn nhn chai thuc, hp thuc
v hm thuc trnh sai st, nhm ln.
Sn phm sau khi ng gi hon chnh phi c ly mu
kim nghim thnh phm. Kim nghim tt c cc ch tiu
c ghi trong tiu chun cht lng ca ch phm. Nu t
yu cu cht lng th cho nhp kho v a vo lu thng.

2. Pha ch theo n
Mc d th trng thuc c rt nhiu ch phm thuc cung ng
cho nhu cu cha bnh c sn xut theo l m vi s lng
ln c quy trnh v tiu chun cht lng c ng k vi
Cc Qun l dc, song vic pha ch theo n ca bc s vn rt
cn thit khng ch nc ta m tt c cc nc, k c cc
nc c nn cng nghip dc phm pht trin. Bi v cc thuc
pha ch theo n ca bc s thng c thnh phn v liu lng
c ch nh da trn thc trng bnh tt ca tng c th (din
bin bnh, tui, gii tnh, cn nng...) nn thng c hiu qu
iu tr tt hn.
thc hin pha ch theo n i hi ngi dc s phi c
kin thc v k thut bo ch cng nh trch nhim ong vic
m bo cht lng thnh phm do mnh pha ch.

Trc khi thc hin pha ch theo n phi kim tra n thuc:
+ n thuc phi ghi r h tn, tui (thng tui vi tr
em), a ch bnh nhn.
+ Tn dc cht, nng hay hm lng.
+ Liu lng ch nh, ng dng, cch dng m bo an
ton, hp l.
+ Thnh phn v ch nh ca n thuc c tng k, tng
tc khng.
+ Chc danh, a ch v ch k ca ngi k n.
+ Ngy k n.
+ Mu n thuc c m bo tnh hp php theo quy ch hin
hnh hay khng.

Khi pha ch:

+ Phi lu on thuc v ghi s pha ch c th theo di, i
chiu v kim tra khi cn.
+ Phi thc hin ng k thut bo ch. Thuc phi c
ng, trong bao b thch hp, c nhn thuc ng quy ch.
+ Khi pha ch theo n, vi nhng ho cht m lng dng
cho mi ln pha ch qu nh, d mc sai s ln khi cn th
nn pha thnh cc dung dch m c c nng nht nh
(gi l dung dch m), khi pha ch s ong mt th tch c
cha lng ho cht tng ng vi khi lng ho cht cn
phi cn nh vy va thun tin va m bo chnh xc hn
trong pha ch.

IV. YU CU CHT LNG CA DUNG DCH THUC

Mi ch phm thuc pha ch - sn xut ra u phi t cc yu
cu nh cng b trong tiu chun cht lng p dng i vi
ch phm . Hin c hai loi tiu chun c p dng cho cc
ch phm thuc ni chung l: tiu chun Dc in (Dc in
Vit Nam 3, Dc in M 26, Dc in Anh 2001...) v tiu
chun ca nh sn xut (cn gi l tiu chun c s) do nh sn
xut t xy dng v c c quan c thm quyn thm nh.
Ni chung, tiu chun cht lng p dng vi dung ch thuc
gm c cc ch tiu:
V cm quan: dung dch thuc l nhng ch phm lng trong
sut, c mu, mi, v c trng ring, c quy nh c th i
vi tng ch phm. Kim tra bng cm quan, ch phm phi t
cc yu cu nu trong tiu chun ca ch phm .

Sai s v th tch thuc: phi t gii hn cho php v th tch p dng

i vi tng loi dung dch nh ghi bng 4.2. Xc inh bng cch ly
5 n v bt k (chai, l...) xc nh th tch tng n v bng ng
ong chun, sch, kh, c chnh xc ph hp. Th tch mi n v
phi nm trong gii hn cho php.
pH: p dng i vi cc dung dch nc. Xc nh bng my o pH.
Ch phm phi c pH nm trong khong gi tr pH cng b trong
tiu chun cht lng ca ch phm .
T trng: l ch tiu cht lng thng c quy nh vi cc siro
thuc. xc nh t trng ca siro thuc c th dng t trng k
o hoc cn xc nh khi lng ca mt th tch thuc nht nh ri
m
tnh t trng theo cng thc
d=

Trong d l t trng, m l khi lng siro (gam), V l th tch siro

ng vi khi lng cn (mililit). Siro thuc thng c t trng t
1,28 n 1,32.

nh tnh: ch phm phi cho phn ng dng tnh ca dc

cht. Th theo phng php ghi trong tiu chun cht lng
ca tng ch phm c th.
Hm lng dc cht: theo Dc in Vit Nam 3, gii hn
cho php v hm lng dc cht p ng i vi cc dung
dch thuc nh ghi bng 4.3.

Tin hnh nh lng dc cht trong dung dch thuc theo

phng php ghi trong tiu chun ca tng ch phm c th.
Hm lng dc cht phi nm trong gii hn cho php.

-Gii hn tp cht: i vi cc dung dch thuc c dc

cht d b phn hu v sn phm phn hu c c tnh cao
th trong tiu chun cht lng ca sn phm ngi ta cn
quy nh phi th gii hn tp cht.
- nhim khun: Nguyn tc th l nui cy mu thuc
trong mi trng nui cy thch hp pht hin xem c vi
khun hay nm men, nm mc pht trin hay khng. Dung
dch thuc ung v thuc dng ngoi c th c khun lc
nhng phi nm trong gii hn cho php v nhim khun
nh quy nh ong Dc in Vit Nam 3, ph lc 10.7
(trang PL 182).

V. MT S CNG THC DUNG DCH THUC

Cng thc 4.1: dung dch cn iod 5 %
Iod
5,0 g, Kali iodid
2,0 g
Ethanol 95 % v nc ng th tch va 100 ml
Ho tan kali iodid trong mt lng dung mi ti thiu, cho iod vo
ho tan hon ton, thm dung mi va theo cng thc, lc qua
bng thu tinh (nu cn), ng vo chai thu tinh mu, np kn. Dung
dch c dng st trng vt thng, vt m...
Cng thc 4.2: dung ch cn long no 10 %
Long no
10,0 g, Ethanol 90 % va 100 ml
Ho tan long no trong ethanol, thm ethanol va th tch, ng
vo chai thu tinh, np kn. Cn long no ng xoa bp cc ch
sng au do chn thng nh.
Cng thc 4.3: dung dch acid benzoic, acid salicylic v iod
Acid benzoic 5,0 g, Acid salicylic 5,0 g , Iod
2,5 g
Ethanol 90% va 100 ml

Ho tan ln lt iod, acid salicylic, acid benzoic trong 2/3

lng ethanol, thm ethanol va th tch, lc qua bng
thy tinh (nu cn), ng thuc vo chai thu tinh mu, np
kn. Dung dch thuc dng bi ngoi da, c tc dng cha
nm da, hc lo.
Cng thc 4.4: dung ch bromoform 10%
Bromoform 10,0 g, Glycerin dc dng 30,0 g
Ethanol 90 % 60,0 g
Cn cc thnh phn, phi hp, lc u, ng thuc vo chai
thu tinh, np kn. Dung dch bromoform tan c trong nc
vi t l nht nh v c dng pha cc n thuc nc
c tc dng du ho, chng co tht.

Cng thc 4.5: elixir phenobarbitan

Phenobarbitan
0,3 g,
Ethanol 90 %
40,0 g
Glycerin
40,0 g
Cn v cam 2,5 ml
Dung dch amaranth
1,0 ml
Nc ct va 100 ml
Ho tan phenobarbitan trong ethanol 90%, thm cn
v cam, glycerin, dung dch amaranth v nc va
th tch, khuy k, ng vo chai mu, np ka
Elixir c tc dng chng co git, cha ng kinh.

Cng thc 4.6: elixir paracetamol

Paracetamol
2,4 g
Ethanol 96 %
10,0ml
Propylen glycol
10,0ml
Cn cloroform
2,0ml
Siro n
27,5 ml
Cht mu, cht lm thm va 100ml.
Phi hp cn cloroform vo ethanol ri phi hp vi
propylen glycol, cho paracetamol vo ho tan, thm
so n, cht mu, cht thm v glycerin va th
tch, khuy u ng chai, np kn. Elixir c tc
dng h nhit, dng cho tr em b st cao.

Cng thc 4.7: dung dch cloramphenicol 5%

Goramphenicol
5,0 g
Propylen glycol va 100 ml
un nng 2/3 lng propylen glycol n khong 5060C, cho cloramphenicol vo ho tan, thm
propylen glycol va th tch, ng thuc vo l
dung tch 5 ml c b phn nh git. Dung dch dng
nh tai khi b vim tai gia. Khng c dng
dung dch ny nh mt, nh mi.

Cng thc 4.8: ung dch glycerin - iod

Iod 2,0 g; Kali iodid Nc bc h Glycerin 4,0g
Nc bc h 90,0 g, Glycerin 90,0g
Ho tan kali iodid trong nc bc h, cho tip iod
vo ho tan hon ton, thm glycerin khuy k, lc
qua bng thu tinh (nu cn), ng thuc vo chai
thu tinh np kn. Dung dch c dng r ming,
r hng khi b vim hng ht, vim li, vim chn
rng.

Cng thc 4.9: dung dch digitalin 0,1%

Digitalin
Mi centigam, Ethanol 90 %40,0 g
Glycerin
40,0 g, Nc ct va
100 ml
Phi hp ethanol vi glycerin, cho digitalin vo ho tan, thm
nc va th tch, khuy u, ng chai, np kn. Thuc
c tc dng tr tim, ung theo git.
Cng thc 4.10: dung ch du long no 1 0%
Long no
10,0 g
Du lc va
100 ml
un nng nh u lc, cho long no vo ho tan, thm du
va th tch, ng thuc vo chai thu tinh, np kn. Du
thuc dng xoa bp ngoi a.

Cng thc 4.1 1: ung dch du xoa

Menthol
14,5 g; Methylsalicylat 30,0 g
Tinh du qu
2,0 g; Tinh du long no 2,0 g
Clorophyl 0,02 g; Du parafin va
100 g
Trn k menthol, raethylsalicylat, tinh du qu, tinh
du long no thnh hn hp lng ng nht ri phi
hp vo du parafin, thm clorophyl vo ho tan,
thm du parafin va th tch, ng thuc vo
chai thu tinh, np kn. n thuc c dng xoa
bp c tc dng gim cc chng au nhc nh au
c, au khp, vt bm tm, cha cm lnh.

Cng thc 4.12: dung ch iod 1% (hay dung ch

Lugol)
Iod 1,0 g; Kali iodid 2,0 g;
Nc ct va 100 ml
Iod rt kh tan trong nc (1/2000). Khi c thm kali
iodid kt hp vi iod to dn cht KI3 tan tt trong
nc. Khi pha dung dch Lugol, trc ht phi ho tan
kali iodid trong lng nc gp i lng kali iodi,
cho tip iod vo ho tan hon ton, ri thm nc va
theo cng thc, lc dung dch qua bng thu tinh
(nu cn), ng thuc vo chai thu tinh mu, np kn.
Dung ch c tc dng cha bu c n thun, ung
theo git sau khi pha long vi nc.

Cng thc 4.13 : dung dch cloroxylenol

Cloroxylenol 5,0 g; Kali hydroxyd 1,36 g; Acid oleic 0,75 ml
Dn thu u 6,3 g; Terpineol 10,0 ml; Ethanol 96 % 20,0 ml
Nc tinh khit va 100 ml.
Cloroxylenol rt kh tan trong nc (1/3000). Nh c x phng kali
ricinoleat to thnh gia du thu du v kali hydroxyd nn
cloroxylenol ho tan c trong nc. pha dung dch ny, ho
tan kali hydroxyd trong mt t nc, thm dung dch du thu du
pha trong ng lng ethanol vo khuy trn k, yn 1 gi, thm
acid oleic vo trung ho kim tha. Ho tan cloroxylenol vo
lng ethanol cn li, thm terpineol vo ho tan ri phi hp vi
dung dch x phng trung ho trn, cui cng thm nc va
, c dung dch trong sut. ng thuc vo chai, np kn. Dung
dch c tc dng st trng cc vt xc, vt ct, vt thng trn da.
Phi pha long dung dch vi nc (pha long 20 ln) trc khi
dng.

Cng thc 4.14: dung dch km sulfat v km clorid

Km sulfat 2,0 g; Km clorid 1,0 g; Dung dch tartazi
10,0 ml; Acid hydrocloric long 10,0 ml; Nc
cloroform 50,0 ml; Nc tinh khit va 100 ml
Km clorid thng c cha OCR lm cho dung dch b
c, thm acid hydrocloric lm cho dung dch trong sut.
Dung dch dng sc ming, phi pha long vi nc m
20 ln trc khi dng.

Cng thc 4.15: dung dch acid boric v tanin trong

glycerin
Acid boric 1,0g; Tanin 2,0g; Natri hydrocarbonat
va ; Glycerin 20,0g
un nng glycerin, cho boric bong v tanin vo ho
tan, thm natri hydrocarbonat n ht si bt, ng
chai, np kn. Khi pha ch dung ch ny acid boric
phn ng vi glycerin, to thnh acid glycero-boric
l mt acid mnh. V th cn trung tnh dung dch
bng natri hydrocarbonat dung dch ny kch
ng nim mc ming khi r ming.

Cng thc 4.16: dung dch oxymethazolin 0,05%

Oxymethazolin 50 mg; Acid citric 0,27 g
Natri hydroxyd 0,1 6 g; Natri clorid 0,60 g; Thimerosal 0,01 g;
Menthol 4 mg; Tinh du bc h
8 mg; Propylen glycol 1,0 g
Tween 80
10 mg; Nc ct va
100 ml
Ho tan ln lt acid citric, natri hydroxyd, natri clorid,
thimerosal, oxymethazolin trong 3/4 lng nc c trong cng
thc (dung dch A). Ho tan Tween 80 vo propylen glycol, tip
tc ho tan menthol v tinh du bc h (dung dch B). Rt t t
dung dch B vo dung dch A, va rt va khuy k. Thm nc
va theo cng thc, lc, ng l c u nh git hoc u xt.
Thuc nh hay xt mi c tc dng co mch chng ngt mi,
chy nc mi.

Cng thc 4.17: dung dch st n sulfat

St II sulfat 1,2 g; Aci ascorbic
0,2 g
So cam
10,0 ml; Nc cloroform 50,0 ml
Nc tinh khit va 100 mi
Acid ascorbic c trong dung dch c tc dng chng
oxy ho st II sulfat. Dung dch c pha theo trnh
t: ho tan acid ascorbic trong nc cloroform, ha
tan tip st n sulfat, siro cam v thm nc va ,
ng thuc trong chai mu, np kn. Thuc ung b
sung st cho tr em.

Cng thc 4.18: Siro extromethorphan

Dextromethorphan hydrobromid
0,300 g
Nipagin
0,045 g; Nipasol 0,029 g; Ethanol 90
%
0,250 g; Siro glucose 60%
100,0 g
Dung dch natri hydroxyd 10% va pH 4,75 Cht
thm va ; Nc tinh khit va 100 ml
Ho tan dextromethorphan hydrobromid trong siro
glucose, kim tra v iu chnh pH bng ung dch
natri hydroxyd. Ho tan nipagin, nipasol trong
ethanol, phi hp vo siro trn, thm cht thm v
nc va , ng chai, np kn. Thuc ung c tc
dng ct cn ho.

Cng thc 4.19: Siro Benzo

Natri benzoat
2,50 g; Kali bromid
2,50 g;
Amoni clorid 2,50g; Cn u 0,65g;
Cn opi n 2,00g; Siro n va 100,00 g
Siro thuc c bo ch bng cch ho tan c cht
trong siro n. V siro n c nht cao v t l
nc thp, do d dng ho tan natri benzoat
vo siro phi un nng siro ri mi cho natri benzoat
vo ho tan, tip tc ho tan kali bromid v amoni
clorid, ngui cho cn u, cn opi vo khuy
u, ng thuc vo chai, np kn. Thuc c tc
dng cha ho, long m.

Cng thc 4.20: Siro cnh kin trng

Cnh kin trng Nc 30g; Nc 500ml
Dung dch amoniac 1 % 700ml; ng trng 1800ml
Siro thuc c bo ch bng cch ho tan ng vo dung dch'
dc cht. Tn nh cnh kin trng cho vo mt dng c hm c
np kn, thm 500 ml nc, un cch thu si trong 2 gi, gn, lc
c dch chit 1. Thm 500 ml dung dch amoniac 1 % vo b,
un cch thu si trong 1 gi, gn, lc c ch chit 2. Tip tc
thm 200 ml % dung ch amoniac 1% vo b, un cch thu si
trong 1 gi, gn, lc : c dch chit 3. Tp trung 3 dch chit v
c n khi tng th tch cn 1000 ml. Thm ng vo dch chit,
un nng v khuy u n khi ng tan hon ton, lc qua nhiu
lp vi khi siro cn ang nng. ng chai, np kn. Siro phi c t
trng 1,30 -1,32. Thuc ung cha ho, long m hoc dng lm
cht dn pha cc so hay potio c tc dng cha ho long m.

Cng thc 4.21: Siro khng c ng saccarose

Natri carboxymethylcellulose (Na CMC): 1,0 g
Nipagin
: 0,2g
Ethanol
: 2,0ml
Saccaril
: 0,2 g
Nc va
: 100 ml
Rc bt Na CMC ln mt nc, cho bt thm u nc,
thnh thong khuy nh cho n khi Na CMC ho tan hon
ton. Ho tan nipagin, saccarin trong ethanol ri phi hp vo
dung dch Na CMC, trn u, thu c cht lng snh khng
mu, v ngt ging siro dng pha cc siro thuc cho cc
bnh nhn tiu ng.

Cng thc 422: dung dch protargon

Protargon
1,0 g
Nc ct va 200 ml
pha dung dch ny, cho nc vo mt cc m c b mt
ln, rc protargon ln b mt nc v yn cho protargon
ht nc, trng n v ho tan hon ton vo nc, thm
nc va theo cng thc, ng thuc vo chai (l) np kn,
trnh nh sng.

Chng 5
K THUT BO CH THUC TIM -

TIM TRUYN
MC TIU HC TP
1, Nu c nh ngha, u nhc im, phn loi thuc tim - tim truyn.
2, Nu c c tnh ring ca thuc tim truyn.
3, Nhn bit c vai tr ng thnh phn c trong cng thc thuc tim - tim truyn g/'
trong ti liu ny.
4, Nu c yu cu v nh xng, thit b dng trong pha ch thuc tim - tim truyn.
5, M t c trnh t k thut phi thc hin trong tng cng on pha ch- sn xut thuc
tim - tim truyn.
6, Nu c yu cu v nguyn tc kim tra cht lng thuc tim - tim truyn.
7, Vit c -nh t pha ch mt s cng thc thuc tim - tim truyn c th.
8, Nu c cng dng ca mt s thuc tim - tim truyn thng dng trong iu tr.

I. I CNG V THUC TIM TIM TRUYN

1. nh ngha
Thuc tim l nhng ch phm v khun, c th l dung dch, hn dch,
nh tng hoc bt kh khi dng mi pha li thnh dung dch hay hn dch
tim vo c th theo nhng ng tim khc nhau.
Thuc tim truyn l dung dch nc hoc nh tng du trong nc, v
khun, khng c cht gy st v ni c t v khun, khng c cht st khun,
thng ng tng vi mu, dng tim nh git tnh mch vi th tch ln.

2. Phn loi
Thuc tim c phn thnh nhiu loi, do mi loi thuc tim c khc
nhau v trnh t pha ch v nhng yu cu ring phi ch khi s dng.
Cc thuc tim c phn loi nh sau:
Theo ng tim thuc c: thuc tim di da, thuc tim bp, thuc tim
tnh mch, thuc tim truyn tnh mch.
Theo h phn tn c: thuc tim dung dch, thuc tim hn dch, thuc tim
nh tng, thuc tim dng bt v khun (c th l bt dc cht v khun
hoc hn hp bt dc cht v t dc v khun c bo ch bn phng
php ng kh hay phun sy cc dung dch thuc v khun).
Theo bn cht dung mi c: thuc tim nc v thuc tim du.

3. u, nhc im
3.1. u im
Tim thuc c tc dng nhanh, nht l khi tim tnh mch, thm ch c tc
dng tc thi nu tim trc tip vo c quan ch nn rt thch hp trong nhng
trng hp cp cu.
Thuc tim l dng thuc thch hp vi dc cht hoc b phn hu hoc
khng hp thu c hoc kch ng mnh ng tiu ho khi dng theo ng
ung.
Tim thuc l ng dng thch hp khi bnh nhn khng ung c
(ngt, phu thut ng tiu ho...), khi bnh nhn khng hp tc vi thy
thuc.
Thuc tim truyn c th b sung nhanh nc, cht in gii, th tch huyt
tng, cht dinh dng... khi c th bnh nhn b mt nc, mt cht in gii,
mt mu hoc khng n, ung c trong mt thi J gian i.

3.2 Nhc im
Thuc c tim trc tip vo cc mi b qua cc hng ro bo v sinh hc
ca c th nh da v nim mc. Do vy, thuc tim phi v khun. Nu thuc
tim khng v khun s gy nhim khun rt nguy him cho bnh nhn.
Khi tim thuc qu liu, tim thuc sai ch nh v ng tim s gy tai
bin nng, thm ch t vong.
Khc vi cc dng thuc ung, bnh nhn khng th t tim thuc. Ch
nhng ngi c chuyn mn nht nh mi c php tim thuc cho
bnh nhn.
Ch c th bo ch c thuc tim t yu cu cht lng khi c c s,
thit b v nhn lc c o to theo ng cc quy nh v thc hnh tt
sn xut thuc v khun.

4. c tnh ca thuc tim truyn

Thuc tim truyn l mt loi thuc tim, v vy cc thuc tim truyn phi
t tt c cc yu cu cht lng quy nh i vi thuc tim. Nhng thuc
tim truyn c truyn trc tip vo mu vi liu hng trm mililit tr ln. Do
, thuc tim truyn c mt s c tnh ring khc vi thuc tim ni chung:
Thuc tim truyn khng cha cc dc cht c hot lc mnh nh thuc
c bng A, B v cc st khun.
Dung mi pha thuc tim truyn l nc ct pha thuc tim. Dc
cht phi ho tan hon ton trong nc thnh dung dch tht hay dung dch keo,
Nu trong thnh phn ca thuc tim truyn c du thc vt, th du phi c
phn tn vo nc di dng nh tng du trong nuc.
Thuc tim truyn thng l dch ng trng vi mu. Trng hp l
dung dch u trng phi truyn vi tc chm.
Thuc tim truyn khng c cht gy st, khng c ni c t; vi khun.
Dung dch thuc tim truyn c yu cu rt cao v trong (xem phn yu
cu cht lng thuc tim). Nh tng tim truyn dng du trong nc phi
c kch thc git phn tn ca pha du nh hn 0,5 ml.

II. THNH PHN THUC TIM - TIM TRUYN

Mt ch phm thuc tim - tim truyn c 3 thnh phn chnh l: dc
cht, t dc v bao b.
1. Dc cht
Cc dc cht c pha thnh dng thuc tim rt a dng, ging nh cc
dng thuc khc, nhng yu cu v cht lng i vi dc cht pha thuc
tim cao hn:
Dc cht phi t tinh khit cao: khng ln tp cht c hc, c hm
lng dc cht v hm lng cc tp cht lin quan trong gii hn cho php,
v khun v khng c cht gy st.
trnh nhim tp t mi trng, dc cht pha thuc tim thng
c ng gi vi nhng lng va cho mt m pha ch - sn xut.
2. T dc
Cc t dc dng bo ch thuc tim phi t tinh khit cao: khng
ln tp cht c hc, hm lng cc tp cht lin quan phi trong gii hn cho
php, v khun v khng c cht gy st.

2.1. Dung mi
Dung mi dng bo ch thuc tim phai khng c tc dng c l
ring, tng hp vi mu v cc dch c th, khng c, khng kch ng m ti
ni tim thuc, khng cn tr tc dng ca thuc, m bo n nh ca
thuc.
Cc dung mi thng dng trong bo ch thuc tim:
2 1,1. Nc ct pha thuc tim
Nc ct pha thuc tim phi t yu cu cht lng nh ghi trong
chuyn lun Nc ci: pha thuc tim ca Dc in Vit Nam 3.
Nc ct pha thuc tim phi v khun v khng c cht gy st. V vy
tt nht l dng nc mi ct trong vng 24 gi hoc nc ct bo qun lin
tc 80c, cha trong bnh thu tinh hay thp khng g, y kn.
Khi pha cc thuc tim c dc cht l mui ca cc acid yu nh natri
barbiturat, natri sulphonamid... khng gy ta dc cht, phi dng nc ct
pha thuc tim loi kh C02 ho tan trong nc bng cch un si hoc sc
kh N2 vo nc.
Khi pha thuc tim c dc cht d b oxy ho nh clopheniramin,
clopromazin, adrenalin, apomorphin, acid ascorbic... phi dng nc ct pha
thuc tim loi kh 02 ho tan trong nc ging nh loi C02.

2.1.2. Dung mi ha tan vi nc

Cc dung mi nh ethanol, glycerin, propylen glycoh polyethylen glycol
300, polyethylen glycol 400 hay c phi hp vi nc, to thnh cc hn
hp dung mi, dng pha thuc tim c c cht t tan trong nc, d b
thu phn trong nc khi tit khun sn phm nhit cao nh digoxin (cng
thc 5.1), phenobarbital (cng thc 5.2), cc khng histamin...
Cc thuc tim bo ch vi hn hp dung mi ha tan vi nc c mt s
nhc im cn ch khi s ng:
+ Kch ng v gy au khi tim, v th trong thnh phn c th cho thm
alcol benzylic c tc dng gim au khi tim.
+ Ethanol c tc dng dc l ring, do vy, hm lng ethanol trong
thuc tim khng nn vt qu 15 %.
+ Thuc tim bo ch vi dung mi polyethylen glycol c th b phn hu
thnh formaldehyd khi tit khun bng nhit, lm tng c tnh ca thuc.

2.2.3. Du thc vt v dung mi tan trong du

Cc du thc vt nh du vng, du lc, du hng dng, du ng, du
ht bng, du ht thuc phin, du thu du v mt vi este ea acid bo nh
ethyloleat, benzyl benzoat c dng lm dung mi bo ch cc thuc tim
c dc cht tan trong du (cc hormon steroid, vitamin A, vitamin D, vitamin
E ..)
Du thc vt dng lm dung mi pha thuc tim l du thu c bng
phng php p ngui, c trung tnh ho (xem chng 3, phn trung tnh
du). Du thc vt rt d b i kht, do cn bo qun du trong cc bnh
cha bng s hay thu tinh, y kn, trnh nh sng v cho thm cc cht chng
oxy nh a-tocopherol, butyl hydroxyanisol hoc butyl hydroxytoluen.
Thuc tim u ch tim bp, khng c tim tnh mch, tr dng thuc
tim nh tng u trong nc (D/N).
Mt s u thc vt c th gy phn ng qu mn khi tim. V th trn
nhn thuc phi ghi r tn u thc vt c trong thuc tim .

2.2. Cc cht lm tng tan ca dc cht

Khi bo ch cc dung dch thuc tim c dc cht t tan., phi lm tng
tan ca dc cht sao cho th tch thuc ca mt ln tim ph hp vi sc dung
np ca ng tim v cha mt liu dc cht c tc dng iu tr.
Trong bo ch thuc tim c th tng tan ca c cht bng cch:
+ Dng hn hp dung mi (cng thc 5.1, 5.2).
+ Thm cht trung gian thn nc nh natri benzoat trong thuc tim
cafein (cng thc 5.3.), ethylendiamin trong thuc tim aminophylin (cng thc
5.4.), niacinamid ho tan prednisolon dng alcol t o (cng thc 5.10).
+ Dng hn hp ung mi kt hp vi iu chnh pH (cng thc 5.5).

2.3. Cc cht iu chnh pH

Khi bo ch thuc tim dung dch hay hn dch nc, pH ca thuc tim
thng c iu chnh n mt khong gi tr thch hp bng acid hoc base
hoc h m thch hp :
Tng tan ca dc cht (cng thc 5.4.).
n nh dc cht do hn ch oxy ho (cng thc 5.6), hn ch thu phn
(cng thc 5.7) hay n nh tan ca c cht l mui alcaloid nh
strychnin sulfat, atropin Sulfat, cocain hyroclorid...
Tng tc dng ca thuc (cng thc 5.8).
n nh pH ca ch phm thuc tim trong qu trnh bo qun thuc.
Trong cc trng hp ny ngi ta dng dung dch m. Trong bo ch thuc
tim c th dng h m acetat, h m citrat, h m phosphat, h m
glutamat nhng khng c ng h m borat v acid boric gy v hng cu
rt mnh.

2.4. Cc cht chng oxy ho.

Nhiu dc cht nh adrenalin, morphin, apomorphin, clopromazin,
diclofenac, vitamin c, vitamin A... l cc cht kh nn b oxy ho.
Tc nhn oxy ho dc cht l oxy ho tan trong dung mi, oxy trong
khng kh u ng thuc v gc t do ln trong dung mi, ho cht ng pha
thuc tim. ng thi qu trnh oxy ho dc cht cng tng nu c vt ion
kim loi nng (Cu++, Fe+++,...), pH khng thch hp, nhit cao khi tit
khun v tc ng ca nh sng.
Nu dc cht b oxy ho, hm lng dc cht s gim, hm lng cc
cht phn hu tng, hiu lc iu tr v an ton ca thuc s gim. V vy,
m bo cht lng ca thuc phi p dng ng thi cc bin php sau:
Dng dc cht, ho cht, dung mi tinh khit, hn ch a vo thuc
cc gc t do v cc ion kim loi nng.
Thm vo thuc cc cht chng oxy ho thch hp. C th ng:
+ Cc mui suifit nh natri Sulfit, natri bisulfit, natri methabisult v natri
ithionit (cng thc 5.6, 5.9).
+ Cc cht kh nh acid ascorbic, cystein, thioure, Rongalit...
+ cc-tocofero, butyl hydroxytoluen (BHT), butyl hydroxyanisol (BHA),
propyl gallat... dng cho cc thuc tim du.

Thm cc cht to phc nh dinatri edetat v mt s acid a chc nh acd

citric, acid tartric kho ion kim loi nng.
iu chnh pH ca thuc tim v gi tr thch hp, m ti khong pH ,
tc phn ng oxy ho dc cht l thp nht.
Loi oxy ho tan trong nc ct ngay trc khi pha thuc bng cch un
si nc hoc sc kh nit.
ng ng (l), hn ng (y np) trong dng kh nit thay th khng kh
c oxy u ng bng kh tr. y l bin php chng oxy ho dc cht rt
hiu qu nn c th gim bt nng cc cht chng oxy ho cn a vo
thuc m vn t c mc ch.
Bo qun thuc trnh nh sng.
Tit khun ng nhit v thi gian tit khun cn thit.

2.5. Cc cht st khun

Vi cc ch phm thuc tim ng nhiu liu ong mt ng hoc l phi
c cht st khun dit cc vi sinh vt nhim vo thuc sau mi ln rt thuc
tim, gi cho cc liu thuc cn li v khun.
Cc ch phm thuc tim ng mt liu, c bo ch trong mi trng v
khun, lc loi khun qua mng c l lc 0.22 m nhng sau khi ng ng (l)
sn phm khng c tit khun bng nhit, phi c cht st khun trong thnh
phn ca thuc (cng thc 5.10).
Cc thuc tim tnh mch vi liu trn 15 ml, thuc tim truyn khng
c cho cht st khun.
Mt s cht st khun thng dng trong thuc tim c ghi bng 5.1.

2.6. Cc cht ng trng thuc tim

Mt dung dch ng trng vi mu khi c p sut thm thu l 7,4 atm, h
bng im l -0,52c ging nh huyt tng v khng m thay i th tch t bo
mu trong nghim php Hematocrit.
Khi tim cc dung dch ng trng, t bo m ti vng tim thuc khng b
thay i th tch, khng gy tai bin.
Tri li, nu tim thuc khng ng trng, t bo m ti vng tim thuc s
phng to hay xp li, gy au, thm ch gy hoi t t bo ni tim. Khi tim
truyn gy ph mu v ri lon bin gii. V th, yu cu thuc tim phi l dch
ng trng i vi mu.
a s cc thuc tim c cha mt lng dc cht rt nh so vi ng dung
mi nn dung dch thu c thng l nhc trng, v vy phi thm cc cht tan
nh natri clorid, natri suat hay glucose... ng trng dung dch.
2.7. Cht gy thm v cht nh ho
pha thuc tim hn dch cn c cht gy thm d dng phn tn cc tiu
phn c cht ng nht trong mi trng phn tn.
Thng dng cht in hot khng ion ho nh polysorbat
Khi pha thuc tim nh tng cn c cht nh ho nh ho pha du vo
pha nc hoc ngc li. Thng dng cht nh ho l cc phospholipid.

3. Bao b ng thuc tim

Cng nh i vi cc dng thuc khc, bao b mt thnh phn ca thuc
c vai tr bo v v duy tr s nguyn vn ca thuc khi bo qun, vn chuyn
v s dng thuc (xem phn bao b chng 3).
Khc vi cc dng thuc khc, thuc tim - thuc tim truyn l nhng ch
phm v khun. Do , a s thuc tim phi tit khun bng nhit sau khi
ng thuc vo bao b. Thuc tip xc vi b mt bao b nhit cao khi tit
khun v trong qu trnh bo qun, nu b mt bao b khng tr s c tng tc
vi thuc, lm gim cht lng thuc. V th phi chn bao b thch hp vi
tng loi thuc tim v thuc tim truyn.
Vi bao b l ng tim, chai, l bng thu tinh cn ch n kim ca
thu tnh chn loi bao b thu tinh thch hp vi thuc tim ng trong
(xem chi tit chng 3 phn bao b thu tinh).

Nt cao su dng y kn chai, l thuc tim phi c n hi thch hp

np kht vi ming chai, l v phi khng b do, dnh khi luc si trong nc
hay hp trong ni hp.
Bao b bng cht do ngy cng c dng ph bin ng cc thuc
tim, nht cc thuc tim truyn. Khi truyn, thuc trong bao b cht do c
th t chy m khng phi i lu khng kh nh i vi chai thu tinh, nn
khng lm nhim vo thuc nht l khi tim truyn trong mi trng khng
m bo v khun. Nhng bao b bng cht o thng khng trong sut nn
rt kh kim tra s bin cht ca thuc bng cm quan, hi m v cc kh (02,
C02) t mi trng c th thm nhp qua bao b vo thuc. Bao b ng the
tim, thuc tim truyn bng cht do phi l loi t tiu chun dng ng
thuc tim (xem DVN 3, trang PL 207).

III. K THUT PHA CH - SN XUT THUC TIM - TIM

TRUYN
1. Nh xng v thit b
1.1 Nh xng
Thuc tim, thuc tim truyn l nhng ch phm thuc v khun. V vy
phi c nh xng t yu cu cho php sn xut cc ch phm v khun.
H thng nh xng phi c b tr xp xp theo mt trt t hp l, ph
hp vi trnh t cc thao tc c yu cu mc sch v v khun khc nhau,
loi tr hoc hn ch n mc thp nht s nhim cho gia cc khu vc.
Trong phng, b mt tng, sn, trn phi c lm bng cc vt liu nhn,
khng thm, khng nt n, khng c cc khe, hc, cc g ni khng gy bi
hay gi bi, d ra sch, chu c cc cht ty ra v st trng.
Phng v khun (c cp sch cao nht) ch nn c din tch v khng
gian ph hp vi quy m sn xut m bo c mc v khun cn thit.
Ra v dng cc cht st khun c th lm sch cc b bn v cc vi sinh
vt trn b mt tng, trn, bn v b mt cc thit b pha ch trong phng. Tit
khun khng kh bng ho cht nh hi formol hay bc x t ngoi cng khng
th duy tr c mc sch ca khng kh trong phng do b ti nhim trong
qu trnh sn xut. Bin php tt nht kim sot mi trng khng kh i
vi cc phng pha ch v khun l cp kh bng h thng lc v iu ho
khng kh.

H thng lc khng kh (laminar airflow

systems): khng kh c thi qua mng tin lc
(cc tiu phn bi c kch thc ln c gi li
bo v mng lc chnh) ri c nn qua mng
lc HEPA (high efflency particulate air) c kch
thc l lc t 0,20 n 0,25 m (c th gi li
99,97% - 99,99 % s tiu phn c kch thc 0,3
m) i vo khu vc pha ch. Ton b th tch
khng kh trong mt din tch bng din tch ca
mng HEPA s chuyn i vi mt tc ng
nht (0,54 m/giy) thnh nhng lp song song dc
theo chiu thi ca ng khng kh, s ti trc tip
cc tiu phn bi ti nhim t ngi pha ch, t
my mc thit b. t nguyn liu ra khi phng,
duy tr v khun ca mi trng khng kh
trong dng thi ca h thng. Tu quy m pha ch
- sn xut m s dng h thng cp, lc khng kh
thch hp.

1.2. ng c, thit b
ong, o cht lng: trong pha ch nh dng ng ong, bnh ong. Trong sn
xut ng my bm qua ng h o th tch.
ho tan: trong pha ch nh dng cc chn, bnh thu tinh v dng c khuy
thch hp. Trong sn xut dng bn pha ch bng thp khng g c np kn, c my
khuy iu chnh c tc khuy.
Thit b lc: lc cc dung dch thuc tim, thuc tim truyn c th dng
phu thu tinh xp G4, G5 hoc mng lc vi thit b lc thch hp (xem k thut lc
chng 2).
+ Cc mng c kch thc l lc 0,45 m dng lc trong dung ch. Cc mng
c kch thc l 0,22 m dng lc v khun dung dch.

My ng thuc tim:
+ ng thuc vo ng tim thu tinh v hn kn u ng phi c my ng - hn ng
tim. My ng - hn ng tim vn hnh theo nguyn l: ng tim c t ng tip vo my
nh khun tip ng, chuyn ch ti v tr kim ng thuc, thuc c bm vo ng nh mt
bm pit tng (iu chnh c th tch thuc cn ng), ng thuc tip tc c dch chuyn
ti u np kh tr (khi cn loi khng kh trong u ng bng kh nit), sau ng thuc
c dch chuyn ti ngn la hn t nng chy thu tinh khong gia u ng, cp u
ng va ko va xoay, u ng tim c hn kn, trn v nhn.
+ ng cc dung ch thuc tim truyn vo chai cn c my ng ch vn hnh
theo nguyn l bm pitton, bm quay trn hay p sut nn nh k.
Thit b tit khun:
+ T sy, my sy, l sy (nhit kh): tit khun bao b v cc dng c pha ch bng
s, thu tinh, kim loi v cc ch phm thuc tim du (thi gian v nhit tit khun xem
chng 2).
+ Ni hp (nhit m): tit khun nt cao su v a s cc thuc tim c thnh phn
bn vi nhit (k thut s dng, iu kin v thi gian tit khun xem chng 2).
Cc thit b khc: nu bo ch thuc tim hn dch hay nh tng phi c cc thit b
phn tn v ng nht ho. Nu bo ch thuc tim ng kh phi c thit b ng kh...

2. Quy trnh pha ch

Vic pha ch - sn xut cc ch phm thuc v khun nu ch da vo bin
php tit khun cu cng th ch phm thu c cha chc m bo v
khun tuyt i do phi ch trng thc hin cc bin php v sinh - v
khun tt c cc cng on c lin quan trong qu trnh pha ch - sn xut,
bao gm: nh xng, mi trng khng kh thit b, ho cht, bao b v con
ngi trc tip sn xut theo nhng quy trnh v sinh, v khun c quy nh
c th trong tng quy trnh thao tc chun c thm inh.
Ni chung, quy trnh pha ch cc thuc tim ung dch c thc hin qua
cc cng on nh m t trong s hnh 5.2.
2.1. Chun b c s, thit b pha ch
Ngay trc khi tin hnh pha ch, cc phng sn xut v cc thit b s s
ng trong qu trnh pha ch - sn xut phi c v sinh, lau ra sch, tit
khun t yu cu v khun.
i vi phng pha ch v khun c th tin hnh x l theo cc bc sau:

Lau ra sch tng, sn, trn nh bng nc. Lau tip bng cc dung dch cht
st khun thch hp nh cloramin B hoc cloramin T 2% hoc dung ch
phenol 0,5%. Tit khun khng kh bng dung dch formaldehyd (un nng
dung dch formaldehyd 50% cho hi formol lan to vo khng kh trong phng,
cn x l trc 1 m) v bng n t ngoi. Cho h thng cp lc kh hot
ng.
2.2 Chun b ha cht
Cc ho cht, dung mi c trong thnh phn ca thuc tim s pha ch sn xut phi c kim nghim 100% v ch c a vo sn xut khi
nguyn liu t tiu chun cht lng nh cng b trong quy trnh sn xut.
2.3 Chun b bao b
Vi cc dy truyn sn xut thuc tim thuc tim truyn, thuc nh mt
hin i, vic ch to bao b c thc hin ng thi vi qu trnh pha ch
thuc theo nhng quy trnh khp kn, khi s khng c quy trnh x l ring
bao b.
i vi bao b c sn xut ring th phi x l theo nhng quy trnh nht
nh v phi t yu cu sch, v khun.

- Bao b thu tinh:

Ra sch bng nc, ra sch bng dung dch x phng, ra sch x
phng bng nc (tt nht l dng nc kh khong), trng li 2 - 3 ln bng
nc ct pha thuc tim (tt nht l dng nc lc qua mng 0,45 im
trng), tit khun bng nhit kh 180c trong t nht 2 gi. Trong nhng
trng hp cn phi loi cht gy st mt cch trit , sau khi ra sch x
phng, c th trng bng dung dch aci hydrocloric 10% hoc dung dch acid
sulfocromic.
- Bao b cht do:
Bao b bng cht do cng c x l tng t nh bao b thu tinh,
nhng cht do b bin dng di tc ng ca nhit do vy phi la chn
phng php tit khun thch hp vi tng loi cht do. Bao b bng
polypropylen hoc polyetylen t trng cao c th tit khun bng nhit m. Bao
b cht o khc thng c tit khun bng kh ethylen oxyd. Nt cao su

Ra sch bng nc, luc si vi nc loi parafin hoc sp trn b mt

nt, ra bng dung dch cht ty ra (dng tetranatri pyrophosphat hoc trinatri
phosphat), ra sch bng nc, trng li bng nc ct pha tim, tit khun
bng nhit m trong ni hp 121C trong 30 pht.
Vic ra bao b ng thuc tim thng c thc hin bng cc my ra
ph hp vi kiu dng v loi bao b. Bao b sau khi ra v tit khun t yu
cu ch c dng trong mt khong thi gian quy nh nu qu thi gian quy
nh phi x l li.
2.4 V sinh con ngi
Nhng ngi tham gia trc tip trong dy truyn sn xut phi c hun
luyn k thut v sinh c nhn v phi tun th cc quy trnh v sinh c nhn
i vi mi ngi c lin quan n cc cng on sn xut nh: Ra tay, thay
qun o chuyn dng k c m, mng, bc giy, gng tay cao su... c x
l v khun. Vic ra vo khu vc sn xut v khun ang hot ng phi tun
th theo nhng quy nh c th.

2.5 Tin hnh pha ch

Trong phng v khun:
Tin hnh cc cng on: cn ho cht, ong dung mi, ho tan cc cht tan (ch
trnh t ho tan), iu chnh pH, iu chnh th tch, kim sot qu trnh, kim nghim
bn thnh phm ging nh khi pha ch ung dch thuc (xem phn trnh t pha ch
dung ch thuc chng 4).
Lc trong dung dch qua mng c l lc 0,45 m. Phi kim tra s nguyn vn ca
mng trc khi lc v trong ca ch lc.
V khun bng cch lc: cc dung dch thuc tim c thnh phn khng bn vi
nhit, khng tit khun c bng nhit th thc hin v khun bng cch lc qua mng
c l lc 0,22 m. Dch lc v khun c ng ng (chai, l), hn kn (y np) ngay
trong iu kin v khun. ng thuc (ng - hn ng vi thuc tim hoc ng chai
ha ti vi thuc tim truyn): phi nh k kim tra th tch thuc ng vo ng
(chai) iu chnh kp thi trong qu trnh ng thuc m bo th tch quy nh.
Tit khun bng nhit: p ng vi cc thuc tim bn vi nhit v phi tit khun
ngay sau khi ng thuc.
o
+ Tit khun dung ch thuc tim du bng nhit khi 18 C/30pht.
Tit khun cc dung dch thuc tim nc bng nhit m nhit v thi gian
c quy nh vi tng ch phm c th.
Cc cng on tip theo l ghi nhn, ng gi, kim nghim thnh phm v nhp
kho (ch nhp kho khi kim nghim t tiu chun cht lng).

IV. YU CU CHT LNG THC TIM - TIM TRUYN

Theo Dc in Vit Nam 3, thuc tim, thuc tim truyn phi t cc
ch tiu cht lng sau y:
1. Cm quan
Thuc tim khng mu hoc c mu ca dc cht.
Thuc tim nh tng khng c du hiu tch lp.
Thuc tim hn dch c th lng cn nhng phi phn tn ng nht khi
lc u v gi c s phn tn ng nht trong thi gian ly thuc vo
bm tim. Tiu phn dc cht trong hn dch tim phi nh hn 15 m.
Thuc tim bt ng l phi kh v nhanh chng chuyn thnh dung dch
trong sut hay hn dch ng nht khi cho dung mi vo lc u.
Thuc tim dung dch (k c ung dch pha li t thuc tim bt) phi t
trong cho php, c bit vi thuc tim tnh mch v thuc tim truyn:

+ Khi quan st bng mt di dng c soi thuc c cng sng 11 t

2000 n 3750 lux (xem DVN 3, trang PL 139) thuc tim v thuc tim
truyn khng c c tiu phn l lng trong dung dch.
+ m s tiu phn dc gi li trn mng lc sau khi lc 25 ml ung
dch cn kim tra qua mng lc c l lc 1 m bng knh hin vi I c lp
thc o kch thc cc ht t 10 m tr ln. Mi thao tc phi c thc
hin trong mi trng khng kh c lc qua mng lc HEPA. Dung ch
tim truyn khng c c qu 20 tiu phn c kch I thc > 10 m /1ml,
khng c c qu 5 tiu phn c kch thc 25 m /1ml, khng c tiu phn
no c kch thc bng 50 m.
+ Dng my m tiu phn t ng: l phng php c ghi trong
Dc in Anh, Dc in M. My hot ng theo nguyn l khi bm dung
dch qua b nhn cm ca my m vi mt tc thch hp, cc tiu phn c
trong dung dch s ngn cn nh sng mi khi chng i qua b nhn cm v
c my ghi li c v kch thc v s lng tiu phn ng vi kch thc
. i chiu kt qu vi quy nh ca Dc in kt lun mu th c t
yu cu hay khng.

2. pH
Xc nh bng my o pH, thuc phi t yu cu v pH theo quy nh
trong tiu chun cht lng ca ch phm.
3. Th tch hoc khi lng
Sai s th tch (vi thuc tim l cc dch lng): th tch thuc phi t 100
n 115 % th tch ghi trn nhn vi thuc tim ng ng di 5 ml v 100 n
110% vi thuc tim ng ng trn 5 ml. Vi thuc tim truyn, th tch thuc
phi t 100% th tch ghi trn nhn. Tin hnh theo Dc in Vit Nam 3.
ng u khi lng (p dng vi thuc tim bt) l 10 % so vi
khi lng trung bnh. Tin hnh theo Dc in Vit Nam 3 (trang PL 132).
4. v khun
Thuc tim phi v khun.
kim tra v khun ca thuc tim, tin hnh nui cy mu thuc cn
kim tra trong cc mi trng nui cy thch hp. Tin hnh theo ph lc 10.8
trong Dc in Vit Nam 3 (trang PL 189).

5. Cht gy st
Cht gy st l sn phm chuyn ho do cc vi sinh vt nh v khun, nm mc,
nm men, virus, sinh ra trong qu trnh sng v xc cht ca cc v sinh vt gy
phn ng st khi tim.
Tu theo lng cht gy st tim vo m c th c phn ng nh rng mnh, rt
run, au nhc chn tay, au u, kh th, tm ti, st cao...
Bn cht ho hc v tnh cht ca cht gy st:
+ Cht gy st l phc hp lipo-polysaccarit c khi lng phn t ln. Ho tan
trong nc nhng khng bay hi nn c loi khi nc khi ct nc.
+ Kh bn vi nhit. V vy, loi cht gy st trn cc dng c thu tinh v
kim loi phi sy 250c trong t nht 45 pht.
+ B ph hu bi cc kim mnh, acid mnh v cc cht oxy ho mnh. loi b
cht gy st trn b mt chai thu tinh ng dung dch tim truyn phi trng hoc
ngm chai trong dung dch acid sulfocromic.
Thuc tim truyn, thuc tim tnh mch vi liu trn 15 ml, thuc tim vo dch
no tu, vo mt, vo ti bao khp khng c c cht gy st.
thuc tim khng c cht gy st cn ch :. S dng dung mi, ho cht
tinh khit, khdng c. thit b, bao b s dng trong pha ch - sn xut thuc tim phi
v khun v loi cht gy st bng cc bin php thch hp khng c cht gy st v
thuc tim phi c tit khun ngay sau khi pha.

Th pht hin cht gy st trong thuc tim: Dc in Vit

Nam 3 cng nh Dc in cc nc u quy nh th cht gy st
trong cc ch phm thuc tim trn th. Da trn s tng thn nhit
ca th sau khi tim tnh mch dung dch mu th vi liu lng t
0,5 - 10 % ml/kg th (theo chuyn lun ring). Tin hnh th theo
ph lc 10.3 trong Dc in Vit Nam 3 (trang PL 180).
6. Ni c t vi khun
Php th pht hin v nh lng ni c t vi khun trong thuc
tim bng dch phn gii t bo dng amip (Amebocyte Lysat) c.
trong mu loi cua b Limilus polyphemus. Khi cho thuc th vo
dung dch c ni c t vi khun s b c, kt ta hoc to gel. Th
theo Dc in Vit Nam 3 (trang PL 175).
7. nh tnh, nh lng
Phi t theo quy nh trong tiu chun cht lng ca ch phm.

V. MT S CNG THC THUC TIM - TIM TRUYN

1. Mt s cng thc thuc tim
Cng thc 5.1: dung dch tim digoxin (BP 1988)

Digoxin
Acid citric dihydrat

25 mg
75 mg

Natri phosphat

0,45 g

Ethanol

12,5 ml

Propylen glycol

40,0 ml

Nc ct pha thuc tim va

100 ml

Thuc tim ng 1 ml/ng. Thuc c tc ng chng lon nhp tim, tr tim khi
b suy tim.

Cng thc 5.2: thuc tim natri phenobarbital (BP 1980)

Natri phenobarbital
20,0 g
Dinatri edetat
0,02 g
Dung mi (c 90 % propylen glycol
v 10 % nc ct pha thuc tim) va
100 ml
Hn hp dung mi hn ch thu phn natri phenobarbital khi tit khun
ch phm 121C trong 20 pht. Thuc tim ng 1 ml/ng. Thuc c tc
ng chng co git, cha ng kinh.
Cng thc 5.3. Thuc tim cafein
Cafein
7,0 g
Natri benzoat
10,0 g
Nc ct pha thuc tim va
100 ml
Cafein rt t tan trong nc, ho tan cafein phi s dng natri benzoat
lm tng tan ca cafein. Thuc tim ng 1 ml/ng. Thuc tim bp c cc
ng tr tim tr h hp.

Cng thc 5.4: thuc tim aminophylin

Aminophylin
2,5g
Ethylendiamin 68,5 %
2,1 m
Alcol benzylic
2,0 ml
Nc ct pha thuc tim va
100 ml
Ethyleniamin to mi trng kim duy tr tan ca aminophylin.
Thuc tim ng 10 ml/ng. Thuc tim tnh mch, dng cp cu trong cn
hen nng hoc cn ngng th tr thiu thng.
Cng thc 5.5: thuc tim natri diclofenac
Natri diclofenac
2,5 g
Natri methabisulfit
0,3 g
Propylen glycol
60,0 g
Alcol benzylic
4,0 g
Natri hydroxyd va n pH
8-9
Nc ct pha thuc tim va
100 ml
Thuc tim ng 3 ml/ng. Thuc gim au, chng vim khng steroid,
ng tim bp hay tim tnh mch gim au sau m, au trong ung th.

Cng thc 5.6: dung dch tim vitamin C

Acid ascorbic
5,00g
Natri hydrocarbonat
2,37g
Natri metabisulfit
0,01g
Dinatri edetat
0,02g
Nc ct pha thuc tim va
100ml
Dung dch c pH 5 - 7. Trong khong pH ny, c thm cc cnt
chng oxy ho l natri methabisulit, dinatri edetat, kt hp vi np
kh nit khi ng v hn ng, natri ascorbat trong thuc tim n nh
hn. Pha ch: ho tan inatri eetat, natri methabisulft trong khong
4/5 lng nc ct, ho tan tip acid ascorbic, natri hydrocarbonat,
thm nc ct va th tch, lc qua mng c l lc 0,45 m soi
kim a trong ca dch lc, ng ng thu tinh 2 ml, kt hp np
kh nit trong qu trnh ng v hn ng, tit khun 121c trong 15
pht. Thuc tim bp trong bnh thiu vitamin C

Cng thc 5.7: dung dch tim vitamin B1

Thiamin hydroclorid
2,5g
Dung dch acid hydrocloric 0,1N va pH 2,5 - 4,0
Nc ct pha thuc tim va
100 ml
pH 2,5 - 4,0, vitamin B1 trong ung dch hu nh
khng b thu phn khi tit khun bng nhit.
Pha ch: ho tan vitamin B1 trong khong 90 ml nc ct
thm dung dch acid hydrocloric 0,1N va pH 3,0 (khong
4 ml), khuy u kim tra pH bng my o pH (iu chnh
nu cn), b sung nc ct va th tch, lc qua mng c
l lc 0,45 m, soi dch lc kim tra trong, ng ng
thu tinh Iml, tit khun 121C trong 20 pht. Thuc tim bp
trong trng hp suy tim cp hoc tru mch cp.

Cng thc 5.8: dung ch tim lidocain hydroclori

Natri hydroxyd va pH
7-8
Nc ct pha thuc tim va
100ml
Prednisolon natri phosphat rt d b thu phn khi tit
khun v th dung dch c pha ch trong mi trng v
khun, sau v khun bng cch lc qua mng lc c l lc
0,22 m. Trong qu trnh bo qun, prednisolon natri
phosphat c th b thu phn to thnh prednisolon t do rt t
tan trong nc nhng nh c niacinamid c tc ung ho tan
prednisolon t do m bo trong ca dung dch tim.
Thuc tim ng 1 ml/ng. Tim bp hay tim tnh mch khi
b d ng nng, chong phn v, vim khp...

2. Mt s cng thc thuc tim truyn

2.1. Mt s dung dch tim truyn cung cp nc
C th ngi bnh thng cha khong 45 - 60% nc. Khi ngi bnh b st cao, nn, tiu
chy ko i s dn ti tnh ng c th b mt nc, lm tng nng cc cht in gii trong
cc dch c th. Khi c th b mt nc cn phi b li cho c th lng nc mt bng cch
truyn dung dch glucose 5%, dung dch sorbitol 5%. Dung dch fructose 10%, dung dch ng
phi hp vi cht in gii nh dung ch glucose 5% v natri clorid 0,26%...
Cng thc 5.11: dung dch glucose 5%
Glucose khan
50,0g
Nc ct pha thuc tim va
1000 ml
Dc in Vit Nam quy nh dng glucose khan. Trong thc t c th dng glucose kt
tinh ngm phn t nc nhng phi tnh b lng nc kt tinh (100g glucose khan tng
ng vi 110g glucose ngm mt phn t nc). Dung dch glucose d bin mu khi tit khun
121C trong thi gian di, v vy cn ly thuc ra ngay sau khi tit khun thi gian (20
pht).
Cng thc 5.12: dung dch glucose v natri clorid
Glucose khan 50 g hoc 100 g hoc 250 g hoc 400 g
Natn clori
0,26g
Dung dch acid hydrocloric 0,1N va pH
3-4
Nc ct pha thuc tim va
1000 ml
Ngi t cho rng natri clorid to phc vi glucose v phc hp ny kh b caramen ho
hn v dung dch mn - ngt ny ph hp hn vi ch sinh l ca c th. Tu theo thnh phn
cng thc dung dch glucose c pH t 3,5 - 6,5.

2.2. Mt s dung dch tim truyn cung cp cht in gii

Cng thc 5.13: dung dch natri clorid 0,9%
Natri clori
9,0 g
Nc ct pha thuc tim va
1000 ml
Dung dch natri clori 0,9% l dung dch ng trng, c pH 4,5 - 7,0,
c tim truyn thit lp li cn bng in gii ca dch ngoi bo khi bnh
nhn b mt in gii do bng, nn v tiu chy.
Bnh nhn b mt cht in gii thng mt ng thi nhiu cht in gii
nn tt nht l truyn cc dung dch a in gii (cng thc 514,5.15)
Cng thc 5.14: dung ch Ringer
Natri clorid
8.6 g
Kali clorid
0,3 g
Calci clorid 0,33 g
Nc ct pha thuc tim va
1000ml
Dung dch Ringer c pH 5,0 -7,5. Tim truyn cung cp nc v cht in
gii khi c th b mt nc v cht in gii.

Cng thc 5.15: dung dch Ringer-iactat (dung dch

Hartmann)
Natri clorid
6.0 g
Kali clorid
0,3 g
Calci clorid
0,2 g
Natri lactat
31g
Nc ct pha thuc tim va
1000 ml
Dung dch Hartmann c pH 6,0 -7,5. Dung dch tim truy
n ny c dng nhiu trong iu tr khi bnh nhn b mt
cht in gii.

23. Mt s dung dch tim truyn lp li cn bng acid - kim

Huyt tng ngi bnh thng c pH 7,35 - 7,45 v c duy tr dn nh
trong khong pH ny nh cc h m sinh l c trong c th. V mt nguyn
nhn no pH ca huyt tng < 7,35 ngha l mu b nhim acid, ngc li
nu pH ca huyt tng > 7.45 ngha l mu b nhim kim. Khi cn phi
truyn cc dung dch c tc dng thit lp li cn bng aci - kim ca mu.
Cng thc 5.16: ung dch natri hydrocarbonat 1,4%
Natri hyrocarbonat
14.0 g
Nc ct pha thuc tim va
1000 ml
Khi pha ung dch ny, natri hydrocarbonat trong dung dch di tc ng
ca nhit cao khi tit khun, b phn hu v mt CO2. n nh dung dch
phi sc kh CO, vo dung dch (sc n khi dung dch c pH < 7,5) trc khi
ng chai. trnh mt CO2 phi dng chai thu tinh, c nt cao su kn, c
chp nhm bn ngoi, lt ngc chai khi hp tit khun, tit khun xong phi
cho thuc ngui mi ly ra, lc mnh chai thuc CO2 ho tan tr liDung dch natri hydrocarbonat 1,4% l dung dch ng trng, c pH t 7,0
n 8.5. Thuc tim truyn khi mu b nhim acid.

Cng thc 5.17: dung dch natri lactat

Acid lactic
14,0 ml
Natri hydroxyd
6,7 g
Acid hydroeloric long
va
Nc ct pha thuc tim va
1000 ml
Ho tan natri hyroxyd trong 400 ml nc, thm acid lactic v hp
115C trong 1 gi, ngui, thm t t acid hydrocloric long cho ti khi 0,15
ml ung dch ny cho mu da cam vi 0.05 ml ch th phenol, thm nc
va 1 lt, lc trong, ng chai v hp tit khun nhit 121C trong 30
pht. Dung dch c hm lng natri Iactat t 1,75 - 1,95% v c pH t 5,0 - 7,0.
Thuc tim truyn trong trng hp mu b nhim acid nng.
Cng thc 518: dung dch amoni clorid
2,14%
Amoni clorid
21,4 g
Nc ct pha thuc tim va
1000 ml
Thuc tim truyn tnh mch chm (500ml trong 3 gi) lp li cn
bng acid-kim khi mu b nhim kim do chuyn ho.

2.4. Mt s dung dich tim truyn cung cp cht dinh dng

Khi bnh nhn khng th n, ung c trong mt thi gian di cn phi
dng cc thuc tim truyn c thnh phn dinh dng cn thit.
cung cp nng lng c th tim truyn cc dung dch glucose u' 10%,
20%, 30% hoc tim truyn nh tng D/N, hoc tim truyn
cc dung dch acid min nh cc bit dc: Trophysan (Php), Alvesine
(c), Monamin v Klinitamin (Nht).
Cng thc 5.19: nh tng tim truyn cung cp nng lng
Du u tng
100.0 g
Phospholipids lng trng
12,0 g
Glycerin.
22,5 g
Nc ct pha thuc tim va
1000 ml
y l mt thuc tim truyn nh tng kiu D/N. Kch thc ca cc git
du phn tn trong nc phi < 0,5 m khng gy tai hin tc mch.

2.5. Dung dch b sung th tch mu

Trong trng hp bnh nhn b mt mu do chn thcmg. o phu thut, do chy
mu ni tng nhng khng c mu truyn, c th tam thi b lai th tch mu mt
bng cch tim truvn cc dung dch nh dung dch extran.
Cng thc 5.20: dung ch tim truyn dextran 40
Dextran 40
100.0 g
Glucose khan
50,0 g
Nc ct pha thuc tim va
1000 ml
Hoc:
Dextran 40
100.0 g
Natri cori
9,0 g
Nc ct pha thuc tim va
1000 ml
Cng thc 5.21 : dung dch tim truyn extran 70
Dextran 70
60.0 g
Glucose khan
50.0 g
Nc ct pha thuc tim va
1000ml
Hoc:
Dextran 70
60,0 g
Natri orid
9,0 g
Nc ct pha thuc tim va
1000 ml

2.6 Dung dch tim truyn li niu thm thu

Dung dch manitol c nng 10, 15, 20 v 25% trong nc ct pha tim,
c tc ng li niu thm thu, dng tim truyn trong iu tr ph no.
nhit di 20C, dung dch manitol c nng t 20% tr ln c th
b kt tinh li. Khi phi lm nng dung dch manitol ho tan tr li trong
dung dch mi c tim truyn cho bnh nhn, nhung m bo an ton vn
phi cho dung dch i qua c mu (c trong b giy truyn mu).
2.7 Dung dch chng ng v bo qun mu
thc hin c vic truyn mu phi c cc dung dch c tc dng
chng ng v bo qun mu.
Cng thc 5.22: dung dch A.C.D
Dung dch A:
Acid citric khan Natri citrat.2H20 Dextrose. 1H20 7,3 g 22,0 g 24.5 g
Nc ct pha thuc tim va
1000 ml
Dung dch B
Acid citric khan Natr citrat.2H20 Dextrose. 1H20 4,4 g 13,2 g 14,7 g
Nc ct pha thuc tim va
1000ml

C th dng acid citric ngm 1 phn t nc, natri citrat khan,

extrose khan pha dung dch A.C.D nhng phi tnh quy i tng
ng vi lng dc cht dng ng ghi trong cng thc trn. Khi
pha ch v kim tra cht lng ca dung dch A.C.D cn lu : nairi
citrat c th gy lc thu tinh trong dung dch, l nguyn nhn gy tai
bin tc mch hoc v mng mch khi truyn cho bnh nhn.
trnh lc thy tinh phi dng bao b thy tinh trung tnh hoc bao b
cht do thch hp v phi soi kim a k trc khi tr mu. C 15
ml dung dch hoc 25 ml dung dch B c cng thm vi 100 ml
mu tu. Mu c chng ng trong dung dch A.C.D c
dng trong vng 21 ngy k t ngy ly mu v phi bo qun mu
o
nhit 4 C

Chng 6

K THUT BO CH THUC NH MT

MC TIU HC TP
1. Nu c u nhc im ca thuc nh mt so vi thuc m tra mt kki dng
ti ch iu tr bnh mt.
2. Trnh by c tc dng ca cc thnh phn c trong thuc nho mt.
3. M t c cc k thut phi thc hin khi pha ch - sn xut thuc nh mt.
4. Nu c yu cu cht liig ca thuc nh mt.
5. M t c trnh t pha ch mt s cng thc thuc nho mt.

I. I CNG
1. Dng thuc trong iu r bnh v mt
Mt c th mc cc bnh khc nhau:
+ Bnh mi mt: nhim khun, lo mt.
+ Bnh vng trc gic mc: kh mt, d ng, vim kt mc do
vi khun hay virus, xut huyt di kt mc. vim ti l.
+ Bnh gic mc: vim gic mc do vi khun hoc virus? ph
v lot vng m, nhim khun gic mc do vi khun, viriLs, nm.
+ Cc bnh thu tinh th - vng mc: vim ni nhn, vim vng
mc, vim vng mc tng sinh, vim vng mc sc t.
+ Cc bnh trong nhn cu: glaucom (tng nhn p), c thu
tinh th...

- Hin c rt nhiu dng bo ch c thnh phn dc cht khc

nhau c s dng trong iu tr cc bnh mt theo nhiu ng
dng thuc khc nhau:
+ Dng thuc ti ch iu tr nhiu chng bnh trn b mt
cng nh trong cc t chc ca mt. y l ng dng thuc
thun tin nht v ngi bnh c th t dng thuc theo ch nh ca
thy thuc, hn na dc cht tp trung ch yu mt nn hn ch
c nhiu tc dng khng mong mun.
+ Tim thuc trc tip vo cc t chc b bnh mt: p dng
khi dc cht khng c hp thu hoc hp thu khng ng k khi
dng ti ch. ng dng thuc ny phi do bc s chuyn khoa mt
thc hin.
+ ng ton thn: cho bnh nhn ung hoc tim thuc, dc
cht t dng thuc s hp thu vo tun hon, ri c phn b n
cc m ca mt.

Mt s dng bo ch dng ti ch trong iu tr bnh mt:

Thuc nh mt: Thuc nh mt l nhng ch phm lng, c th l
dung dch hay hn dch, v khun, c cha mt hay nhiu dc cht, c
nh vo mt chn on hay iu tr bnh mt. Thuc nh mt cn
c bo ch dng bt v khun v c pha vi mt cht lng v
khun thch hp trc khi dng.
Thuc nh mt l dng thuc dng ph bin nht trong iu tr cc bnh
mt (chim trn 70% cc ch phm thuc mt) do d s dng, t gy tc
dng ph nhng hiu qu iu tr thng khng cao do thuc b ra tri v
pha long rt nhanh bi nc mt tit ra t tuyn nc mt, mun c tc dng
iu tr cn phi nh thuc nhiu ln trong ngy.
Dung dch ra mt: l cc dung dch v khun v ng trng, c thnh
phn cht tan ch yu l cc mui nh natri clorid, kali clorid. calci clorid,
magnesi clori, natri acetat, natri citrat... v mt cht si khun thng l
benzalkonium clorid. Cc dung dch ny c dng ra mt, c tc dng loi
cc tiu phn t bi, cc ho cht, cc cht nhim t mi trng nh khi,
kh... xm nhp vo mt.

Thuc m tra mt: l dng thuc mm v khun thng c

iu ch vi hn hp t dc vaselin, lanolin v du khong, tra
vo b mi mt. Dc cht trong thuc m tra mt c th tan trong
hn hp t dc hoc c phn tn trong hn hp t dc vi kch
thc tiu phn di 75 m. So vi thuc nh mt, tc dng ca
thuc m tra mt thng tt hn do thi gian tip xc ca thuc vi
nim mc mt ko di, t b pha long bi nc mt, khng b loi tr
theo ng mt - mi. Nhc im ca thuc m a mt l lm m mt
tm thi nn phi dng thuc khi ng.
Ngoi cc dng thuc thng thng k trn, cn c nhiu dng
bo ch hin i nh dng sol - gel, knh tip xc, h iu tr ci t
mt...
Trong chng ny ch trnh by v k thut bo ch thuc
nh mt.

II. THNH PHN THUC NH MT

Thuc nh mt c 3 thnh phn chnh l c cht, t c v
bao b.
1. Dc cht
Dc cht pha ch thuc nh mt cn t tinh khit cao v
v khun. Trong mt ch phm thuc nh mt c th c mt hoc
nhiu c cht. Cc c cht thng c bo ch di dng
thuc nh mt l:
Thuc iu tr nhim khun:
+ Mui v c hay hu c ca cc kim loi bc, km, thu ngn:
km Sulfat, argyrol, protargol v thimerosal.
+ Sulfamid: natri sulfacetamid v natri sulfamethoxypiridazin.
+ Thuc khng khun: coramphenicol, tetracyclin, gentamicin.
neomycin, polymycin, cipronoxacin, norfloxacin, ofloxacin...
+Thuc chng nm: nystatin, natamycin, ketoconazol.
miconazol.

Thuc chng vim ti ch:

+ Corticosteroid: dexamethason, prednisolon. hydrocortison. C
th phi hp corticosteroid vi khng sinh. Khi dng corticosteroid
cn ch n cc tc dng khng mong mun ca thuc nh: tng
nhn p, gin ng t, vim mng mch, sa mi mt, chm lin vt
thng gic mc, nhim khun th pht.
+Thuc chng vim khng steroid: natri diclofenac,
indomethacin...
Thuc gy t b mt: tetracain hyrooric cocain hydroclorid
c dng khi tin hnh cc th thut chun on hoc cc phu
thut nh mt.
Thuc iu tr bnh glaucom (thuc gim nhn p): pilocarpi
carbachol, betaxolol, timolol v bunolol...
Thuc gin ng t: atropin, homatropin v scopohimin.
Vitamin: vitamin A, vitamin B2, vitamin c...
Thuc dng trong chn on xc, lot gic mc v cc tn
thng vng mc: natri fluorescein.

2. T dc
2.1. Dung mi
Dung mi pha thuc nh mt thng dng nht l nc ct v khun.
Du thc vt cng c dng lm ung mi pha thuc nh mt. Du
dng lm dung mi phi c th cht lng nhit phng v phi khng gy
kch ng i vi mt. Tt nht l dng du thu du do bn thn du c tc
dng lm du nim mc mt.
2.2. Cht st khun
Thuc nh mt l ch phm v khun, c pha ch trong iu kin mi
trng, thit b v khun, c tit khun sau khi pha ch bng mt phng
php tit khun thch hp. Nhng thuc nh mt thng c ng vi th tch
dng nhiu ln mi ht mt n v ng gi. Do cch s dng c bit ny nn
nguy c thuc nh mt b nhim khun t mi trng sau mi ln nh thuc rt
cao. gi cho thuc lun v khun, trong thnh phn ca thuc nh mt bao
gi cng c mt hay nhiu cht st khun. Nhng d c cht st khun th
cng khng nn dng nhng l thuc m np qu mt tun k t ln m np
u tin v lng cht st khun c trong l thuc c hn.
Mt s cht st khun hay dng cho thuc nh mt c ghi bng 6.1.

Bng 6.1. Mt s cht st khun thng dng trong thuc nh mt

Tn cht st khun

Nng thng
dng

Ch khi s
dng

Benzalkonium clorid

0,01 - 0,02

Dng rt ph
bin

Thimerosal
Thu ngn phenyl
acetat
Thu ngn phenyl
nitrat

0,01 - 0,02

Clorobutanol

0,002 - 0,004
0,002 - 0,004
0,50

Thm qua cht

do

Clohexidin acetat
0,01
Methyl
Ch yu l in
0,18
tng tc dng ca cht st khun trong thuc nh mt, ngi
ta cn thm
nm
parahydroxybenzoat
++
dinatri
edetat vo thuc. Dinatri edetat kho ion Ca trnThng
mng t dng
bo viphi
khun
Propyl
0,02
gip parahlydroxybenzoat
cht st khun thm tt hn vo t bo vi khun.
hp

2.3 Cc cht iu chnh pH

Nc mt c pH xp x 7,4 nu thuc nh mt c pH cng gn 7.4 cng t
gy kch ng mt. Nhng tu theo thnh phn dc cht trong thuc m pH ca
thuc cn c iu chnh n mt khong gi tr khc 7,4 .
+ n nh dc cht, ko di tui th ca thuc.
+ Tng tan c dc cht (cng thc 6.1) hoc duy tr tan ca c
cht (cng thc 6.2,6.3).
+ Tng kh nng hp thu ca dc cht qua gic mc.
Cc cht thng dng iu chnh pH ca thuc nh mt:
- Dung dch acid boric 1,9% (kl/tt) l dung dch ng trng vi dung dch
nc mt v c pH xp x 5, dng thch hp pha cc thuc nh mt c dc
cht d tan v n nh pH acid.
+ H m boric - borat c dng kh ph bin iu chnh pH ca
nhiu thuc nh mt do bn thn h m c tc dng st khun.
+ H m phosphat (h m Sorensen) c pH t 5,9 n 8,0 tu t l gia
mui natri dihydrophosphat (NaH2PO4) v dinatri hydrophosphat (Na2HPO4
+ H m citric - citrat ngoi tc ng iu chnh pH cn c tc dng kho
ion kim loi nng nn thch hp vi thuc nh mt c dc cht d b oxy ho.

2.4 Cc cht ng trng thuc nh mt

Hm lng dc cht trong thuc nh mt thng rt thp, dung dch
thu c thng l nhc trng so vi dch nc mt. Nu khng cho
thm cht tan ng trng thuc th khi nh vo mt, mt b kch ng,
gy tng tit nc mt, lm gim tc ng ca thuc. Do phi ng
trng thuc nh mt.
Thng dng natri ciorid, kali clorid, acid boric cc cht trong dung
dch m ng trng thuc nh mt.
2.5 Cc cht chng oxy ho
Nu thuc nh mt c c cht d b oxy ho th trong thnh phn
ca thuc cn c cht chng oxy ho (cng thc 6.2) n nh dc
cht.
Mt s cht chng oxy ho dng trong thuc nh c ghi bng
6.2.
Sc kh nit vo dung dch thuc trc khi ng l c xem l mt
bin php bo v c cht chng li qu trnh oxv ho c hiu qu.

Bng 6.2. Mt s cht chng oxy ho hay dng trong

thuc nh mt

Tn cht chng oxy ho

Nng thng dng

Natri Sulfit

0,1-0,5

Natri bisulfit

0,1-0,5

Natri methabisulfit

0,1-0,5

Natri thiosulfat

0,1-0,2

Dinatri edetat

0,01-0,03

2.6. Cc cht lm tng nht ca thuc nh mt

Nc mt tit ra lin tc ra tri thuc nh vo mt theo ng mt
- mi, lm gim thi gian tip xc ca thuc vi gic mc, t l dc
cht c hp thu qua gic mc rt thp. hn ch s ra tri thuc
ca h thng nc mt, ko di thi gian lu thuc gic mc gip
cho dc cht c hp thu tt hn cn cho thm vo thuc nh mt
cc cht tng nht.
i vi hn dch thuc nh mt, cht tng nht ca mi
trng phn tn cn gip phn tn dc cht ng nht hn v n
nh hn trong cht dn.
Mt s cht tng nht hay dng cho thuc nh mt ghi bng
6.3

Bng 6.3. Mt s cht tng nht dng trong thuc nh mt

Tn cht
Methylcellulose
Hyroxypropylmethyl cellulose
Alcol polyvinic

Nng thng dng (%)

0,25
0,50
1,40

Khi thuc nh mt c cht tng nht s rt kh lc qua mng

nn cn phi c thit b lc thch hp mi lc c. Gy thm, gip
phn tn ng nht cc tiu phn dc cht rn trong mi trng
phn tn khi pha thuc nh mt hn dch.
+ Tng hp thu dc cht qua gic mc.
- Thng dng cc cht in hot khng ion ho nh Tween 20,
Tween 80.

3. Bao b
Bao b ng thuc nh mt c yu cu v cht lng ging nh
bao b ng thuc tim. Bao b ng thuc nh mt phi c b phn
nh git gn vi phn np l thuc. pht huy tc dng ca thuc
gim kch ng v gim tc dng khng mong mun ca thuc, ng
knh trong ca b phn nh git cn tiu chun ho to c git
thuc nh c dung tch khong t 30 n 50 l

Hnh 6.1. Mt s ch phm thuc nh mt ng trong cc

loi bao b khc nhau.

III. K THUT PHA CH - SN XUT THUC NH MT

1. Nh xng v thit b
Thuc nh mt l nhng ch phm v khun. V vy. nh xng
v cc thit b dng trong pha ch - sn xut thuc nh mt phi i
yu cu nh i vi pha ch - sn xut thuc tim (xem chng thuc
tim).
2. Chun b c s, thit b, nguyn liu v bao b
Vic chun b c s, thit b, nguyn liu v bao b pha ch sn xut thuc nh mt cng ging nh i vi pha ch - sn xut
thuc tim.

3. Quy trnh pha ch

3.1 Dung dch thuc nh mt
Quy trnh pha ch - sn xut mt dung dch thuc nh mt tng t
nh quy trnh pha ch - sn xut thuc tim dung ch (xem chng
thuc tim).
C mt s im cn ch :
+ Trnh t ho tan: nu khng c yu cu ho tan c bit th nn
ho tan cht to h m, cht st khun, cht chng oxy ho. cht ng
trng trc ri mi ho tan dc cht. C th ho tan nhit
phng hoc un nng dung mi trc khi ho tan, tu theo c tnh ho
tan v bn ca cc cht vi nhit. Khi pha dung dch thuc nh mt
c cht tng nht cn ngm trc polyme vi mt lng dung mi
nht nh cho polyme trng n v ho tan tt hn.
+ Lc dung dch: lc trong dung dch thuc nh mt cn lc qua
mng lc c l lc 0,45 m. Vi dng ch c nht cao th c?! th
lc qua mng c l lc 0,8 m - 1,2 m. V khun thuc nh mt bng
phng php lc, phi dng mng c l lc 0,22 m.

+ Tit khun thuc nh mt: hu nh cha c p dng trong phaM ch

- sn xut thuc nh mt nc ta. Nhng Dc in nhiu nc quy nh
thuc nh mt phi c tit khun bng phng php titl khun thch hp.
Thng tit khun nhng lng ln dung dch, sau mi ng thuc
o vo l
v khun trong mi trng v khun. Tit khun
o bng nhit m 121 C trong
20 pht nu thuc bn vi nhit v 98-100 C trong 30 pht nu thuc nh
mt c cht st khun v dc cht khng bn nhit cao nh
cloramphenicoL cocain hydroclorid, neomyxin Sulfat, physostigmin Sulfat.
Hn dich thuc nh mt
Pha ch hn dch thuc nh mt c thc hin nh sau:
Pha dung dch cht dn (mi trng phn tn): ho tan tt c cc thnh
phn c trong cng thc vo nc, lc dung ch (nu cn) ging nh khi pha
dung dch thuc nh mt. thu c dung dich cht dn.
Phn tn c cht rn (bt siu mn) vo trong dung dch cht dn thu
c hn dch ng nht, iu chnh th tch (nu cn).
Tin hnh tip cc cng on ng l ghi nhn, ng gi thu c
thnh phm hon chnh.

IV. YU CU CHT LNG THUC NH MT

Thuc nh mt phi t cc ch tiu cht lng sau:
1. Cm quan
Dung ch thuc nh mt phi trong, khng c cc tiu phn quan st
c bng mt thng, khng mu hoc c mu ca dc cht.
Hn dch thuc nh mt c th lng ng nhng phi phn tn ng
nht khi lc l thuc. Hn dch thuc nh mL phi t gii hn v kch
thc tiu phn dc cht rn khi m di knh hin vi: trong 10 ng pha
rn khng c c qu 20 tiu phn > 25 m. 2 tiu phn > 50 m, khng
c tiu phn no c kch thc > 90 mm.
2. v khun
Thuc nh mt phi v khun. Th theo ph lc 10.8 trong Dc in
Vit nam 3 (trang PL 189).
3. Cc ch tiu khc
Cc ch tiu nh pH, nh tnh, nh lng, nht, thm thu, tin
hnh xc nh theo nh ch dn trong tiu chun chi lng ca ch phm.

V. MT S CNG THC THUC NH MT

Cng thc 6.1: dung dch thuc nh mt cloramphenicol 0.4%
Cloramphenicol 0.40 g
Acid boric
1,10g
Natri borat
2.00 g
Natri clori
0.20 g
Thu ngn phenyl nitrat
0.02 g
Nc ct va
100 ml
Cloramphenicol rt t tan trong nc (1/400) nhng tan c v n
nh trong dung dch m boric/borat pH 7,2. V th. khi pha dung dch
ny phi ha tan theo trnh t sau: un si 90 ml nc ct, cho acid boric
vo ho tan, tip tc ho tan natri clorid, thu ngn phenyl nitrat, cho
nhit ca dung dch h xung di 60C mi cho cloramphenicol
kim tra pH v iu chnh (nu cn), thm nc va th tch, lc qua
mng l lc 0,45 m, ng l 5 ml c b phn nh git, dn nhn ng
quy ch. Thuc dng iu tr cc bnh nhim khun mt.

Cng thc 6.2: dung dch thuc nh mt natri sulfacetamid 10%

Natri sulfacetamid
10,00g
Natri thiosulfat
0,10g
Dinatri edetat
0,01g
Methyparaben
0,18g
Propylparaben
0,02g
Acid hydrocloric va pH
8,0-9,0
Nc ct va
100ml
Natri sulfacetamid rt d b oxy ho, v th phi cho thm vo dung dch
cc cht chng oxy ho l natri thiosulfat v dinatri edetat, ng thi sc kh N2
trc khi ng l n nh dc cht v phi bo qun thuc trnh nh sng.
Pha ch: ho tan methylparaberu propylparaben trong 90 ml nc ct un
si, ho tan tip natri thiosulfat, dinatri edetat, ho tan natri sulfacetamid, o
kim tra pH v iu chnh (nu cn), thm nc va th tch, lc qua mng
l lc 0 45 m, sc kh N2 vo ung dch trong 5 pht, ng l 5 ml c b phn
nh git, dn nhn ng quy ch. Thuc nh mt dng iu tr cc bnh nhim
khun mt.

Cng thc 6.3: dung dch thuc nh mt km Sulfat 0,5%

Km Sulfat
0,50 g
Acid boric
1,73 g
Benzalkonium clorid
0,01 %
Nc ct va
100 ml
Acid boric c trong dung dch c tc dng to mi trng acid
n nh km sulfat v ng trng thuc nh mt.
Pha ch: ho tan acid boric trong khong 90 ml nc ct un si,
ngui ri ho tan km Sulfat v benzalkonium clorid, thm nc
va 100 ml lc dung dch qua mng c l lc 0,45 m, soi dch
lc kim a trong, ng l 5 ml c b phn nh git, dn nhn
ng quy ch. Thuc nh mt dng iu tr au mt ht.

Cng thc 6.4: dung dch thuc nh mt timolol 0,1%

Timolol maleat
136,6mg
(tng ng vi 100,0 mg timolol)
Benzalkonium clorid
100 mg
Natri dihydrophosphat dihydrat
24 mg
Dinatri hydrophosphat
100 mg
Dinatri edetat
10 mg
Natri clorid
46,4 mg
-cyclodextrin
40 mg
Propylen glycol
1000mg
Natri hydroxyd hoc acid hydrocloric va pH
6,5 -7,5
Nc ct va
100 mi

Cng thc 6.5: hn dch thuc nh mt prednisolon acetat 1 %

Prednisolon acetat (bt siu mn)
1,00 g
Benzalkonium clorid
0,01 g
Dinatri edetat
0,01 g
Hydroxypropylmethylcellulose
0,50 g
Polysorbat 80
0,01 g
Natri clorid va
Natri hydroxyd hoc acid hydrocloricva pH
Nc ct va

ng trng
6,8 - 7,2
100 ml

Cng thc 6.6: thuc nh mt Maxidrol

(Laboratorie ALACOL SA )
Dexamethason
100 mg
Neomycin sulfat
350.000 UI
Polymycin B sulfat
600.000 UI
Hydroxypropylmethyl cellulose
500 mg
Benzalkonium clorid
10 mg
Natri clorid va
ng trng
Polysorbat 20
va
Nc ct va
100 ml

Cng thc 6.7: thuc nh mt pilocarpin hydroclorid

Pilocarpin hydroclorid
1,00 g
Benzalkonium clorid
0,01 g
Dinatri edetat
0,01 g
Natri clorid va
ng trng
Hydroxypropylmethyl cellulose
0,50 g
Natri hydroxyd hoc acid hydrocloric
va
Nc ct va
100 ml

Cng thc 6.8: thuc nh mt Vita B (Laboratone H.

FAURE)
Thiamin hydrclorid
50 mg
Ribonavin
5 mg
Nicotinamid
400 mg
Cc thnh phn khc: natri laurylsulfat, natri borat, natri
citrat, natri clorid, sorbitol, cystein, methyparaben,
propylparaben.
Nc ct va
100 ml

Cng thc 6.9: dung dch ra mt Eye - Stream (Alcon)

Natri clorid
0.49 %
Calci clorid
0,048 %
Kali clorid
0,075 %
Magnesi clorid
0,03 %
Natri acetat
0,39 %
Natri citrat
0, 1 7 %
Benzalkonium clorid
0,013%,
Natri hydroxyd hoc acid hydrocloric va pH = 7,4
Nc ct va
100 ml

Cng thc 6.10: dung dch nc mt nhn to

(Bausch and Lomb)
Hydroxypropylmethyl cellulose 2960
0,5%
Dextran 70
0,1 %
Glycerin
0,2%
Benzalkonium clorid
0,01 %
Cc thnh phn khc: dinatri edetat, natri clorid. kali
clorid, natri borat, acid boric.
Nc ct va
100 ml

Chng 7
K THUT BO CH CC DNG THUC
BNG PHNG PHP CHIT XUT

MC TIU HC TP
1.Trnh by c nh ngha chit xut, u nhc im ca mt
s dung mi dng chit xut.
2.Trnh by c nguyn tc tin hnh cc phng php chit
xut: ngm lnh, hm, hm, sc, ngm kit, ngm kit ci tin.
3.Trnh by c k thut iu ch v yu cu cht lng chnh
ca cc dng thuc: cn thuc, ru thuc, cao thuc.
4. Trnh by c k thut bo ch mt s cn thuc, ru thuc,
cao thuc c th.

I. I CNG
1. nh ngha
Chit xut l qu trnh dng dung mi thch hp ho tan cc cht
tan c trong dc liu, ch yu l cc cht c tc dng iu Tr. sau
tch chng ra khi phn khng tan ca dc liu.
Phn dung mi ho tan cc cht tan c gi l dch chit.
Cc cht c tc dng iu tr trong dc liu c gi l hot ch
(c th l alcaloid, glycosid, vitamin, tinh u...)
Cc cht khng c tc dng iu tr, cc cht gy kh khn trong
qu trnh bo qun c coi l tp cht (ng, tinh bt, pectin, gm,
cht nhy, nha).
Mc ch ca chit xut khng nhng ch to ra cc ch phm ton
phn (cha hn hp cc hot cht) m cn chit tch ring cc hot
cht tinh khit. K thut bo ch cc dng thuc ch cp n cc
phng php chit xut dng iu ch cc ch phm ton phn nh:
cn thuc, ru thuc, cao thuc, ch thuc.

2. Dc liu v dung mi iu ch dch chit

2.1 Dc liu
Dc liu thc vt l nguyn liu chnh, c th dng l, hoa, r,
ht, v... nhng b phn c cha hot cht. Ngoi ra cn c dc liu
ng vt nh da, xng, sng... l nguyn liu iu ch cao ng
vt.
Dc liu em chit xut phi t cc tiu chun quy nh trong
Dc in hoc cc ti liu chuyn mn khc.
2.2 Dung mi
Dung mi chit xut cn chn sao cho c kh nng ho tan ti
a cc cht c tc dng iu tr v ti thiu cc tp cht trong dc
liu.

2.2.1 Yu cu i vi dung mi chit xut

D thm vo dc liu (thng l ung mi c nht thp, sc
cng b mt nh).
C kh nng ho tan chn lc (ho tan nhiu hot cht, t tp
cht).
Tr v mt ho hc: khng lm bin i hot cht, khng gy kh
khn trong qu trnh bo qun, khng b bin cht bi nhit cao.
Phi bay hoi c khi cn c c ch chit.
Khng lm thnh phm c mi, v c bit.
t c t gy chy n.
R tin, d kim.

2.2.2 Cc dung mi thng dng chit xut

a, Nc:
Nc l dung mi thng dng v c nhng u im:
+ D thm vo dc liu do c nht thp v sc cng b mt nh.
+ C kh nng ho tan mui alcaloid, mt s glycosid, ng, cc
acid, cc mui v c, enzym...
+ R tin, d kim.
Nc c mt s nhc im:
+ C kh nng ho tan rng nn dch chit c nhiu tp cht, to mi
trng cho vi khun, nm mc pht trin, dch chit kh bo qun.
+ C th gy thu phn mt s hot cht (glycosi. alcaioid).
+ C si cao nn khi c c dch chit, nhit lm phn hu mt s
hot cht.
Tu theo mc ch v phng php chit xut c th dng nc ct,
nc-kh khong, nc kim ho, nc aci ho, nc c cht bo qun
lm dung mi chit xut.

b, Ethanol:
Ethanol dng lm dung mi chit xut c nhiu u im:
+ C kh nng ho tan chn lc c cc alcaloid, mt s glycosid,
tinh du, nha, ho tan t cc tp cht.
+ C th pha long vi nc bt c t l no, nn c th pha long
ethanol thnh nhng nng khc nhau theo yu cu chit xut i vi
tng loi dc liu.
+ Ethanol c nng > 20% c kh nng bo qun, ngn cn vi
khun, nm mc pht trin.
+ Nhit si thp nn khi c c dch chit, hot cht t b phn
hu.
+ Ethanol cao lm ng vn cc cht nhy, albumin, gm,
pectin... nn cn dng loi tp cht.
+ L dung mi thch hp vi phng php ngm nh git v khng
lm trng n dc liu nh nc.
+ C th dng ethanol c acid ho bng cc acid v c hoc hu
c lm tng kh nng chit xut.
Nhc im ca ethanol: d chy, c tc dng dc l ring.

c, Glycerin:
C nht cao nn thng dng phi hp "vi nc v ethanol
chit nhng dc liu c tanin.
d, Du thc vt:
Du lc, du vng, du hng dng,... c kh nng ho tan tinh
du, cht bo c trong dc liu, do nht cao nn kh thm vo
dc liu. iu ch du thuc, dc liu cn chia nh v chit
xut bng phng php hm nhit 50 C - 60 C trong thi gian
3 - 6 gi. Du d b thu phn v oxy ho, do acid tng v i
kht sau mt thi gian bo qun.

3. Cc phng php chit xut thng ng

3.1. Phng php ngm
Ngm l phng php cho dc liu c chia nh ti
mn thch hp ngp trong dung mi, trong mt thi gian nht nh,
sau gn, p, lng, lc, thu ly dch chit.
Tu theo nhit chit xut, ngm c chia thnh cc phng
php: ngm lnh, hm, hm, sc. Phng php ngm c tin hnh
mt ln vi ton b lng dung mi hoc ngm phn on.
Ngm phn on: l qu trnh ngm nhiu ln, mi ln dng
mt phn ca ton lng dung mi. Lng cht tan chit c trong
tng th tch cc phn on dch chit s ln hn nhiu so vi chit
mt ln bng ton b lng dung mi.

Trong ngm phn on, lung dung mi cc ln sau dng t hn

cc ln trc s ln ngm v thi gian ngm tu thuc c liu v
dung mi.
Ngm lnh: l ngm dc liu trong dung mi nhit phng,
thng dng hn hp ethanol - nc cc t l thch hp. Trong qu
trnh ngm c th khuy trn tng hiu sut chit, dng c cn y
kn trnh bay hi dung mi, thi gian ngm lnh thng ko di
nhiu ngy. Ngm lnh thng p dng vi cc dc liu c hot
cht d b phn hu do nhit (v cam, gng...) dc liu c cht
nha, cc cht cn chit c c tnh chm ho tan trong dung mi (l
hi, Cnh kin trng...)

Hm: l ngm dc liu chia nh vi dung mi trong mt bnh

kn nhit thp hn nhit si ca dung mi, nhng cao hn
nhit phng v gi nhit trong mt thi gian qui nh,
thnh thong c khuy trn.
Nhit hm thng t 40C - 60C, thi gian ko di hng gi.
Phng php hm thng c dng vi cc dc liu c hot cht t
tan nhit thng, d phn hy nhit cao, cn p ng khi
dung mi c nht cao nh du thc vt.
Dng c hm c th dng ni nhit cch thu hoc cc thit b
nhit c rle m bo nhit hm theo yu cu. Nu dung mi bay
hi cn c b phn ngng t.

Hm: l cho ung mi si vo c liu phn chia nh trong

mt bnh chu nhit, trong mt thi gian xc nh (thng t 15 30 pht) c khuy trn hoc lc, sau gn, p ly, dch chit. u
im ca phng php l n gin, thi gian tip xc vi nhit ngn.
Dng c hm c th c bc cch nhit trnh lm gim
nhanh nhit ca dung mi trong qu trnh chit xut.
Phng php hm c p dng cho dc liu thc vt c cu
to mng manh nh hoa, l..., c hot cht d tan trong thi gian ngn
nhit cao. Dung mi chit thng l nc iu ch thuc
ung, dch chit lm cht dn cho cc dng thuc lng.

Sc: l un si u dc liu vi dung mi trong mt thi gian

quy nh sau gn ly dch chit.
Thi gian sc thng t 30 pht n hng gi. Dung mi thng
dng l nc chit xut cc dc liu rn chc nh v. r. g,
ht... v c hot cht t b phn hu nhit cao, thng p dng
iu ch thuc ung v cao thuc.
Nhiu cng trnh nghin cu ci tin phng php ngm nh
chit vi thit b khuy tc cao, dng siu m tng cng tc
ho tan khuch tn hot cht trong qu trnh chit xut nhm nng
cao hiu sut chit.

2. Phng php ngm nh git

Ngm nh git hay ngm kit l phng php chit xut hot
cht bng cch cho dung mi chy rt chm qua khi dc liu ng
trong bnh ngm kit c hnh dng v kch thc quy nh, ong
qu trnh chit xut khng khuy trn. Nguyn tc ca phng php
ngm kit l dc liu lun c tip xc vi dung mi mi, lun
to s chnh lch nng hot cht cao, do c th chit kit hot
cht.
Bnh ngm kit lm bng thp khng g, thu tinh, s, kim loi
m thic hoc trng men, tu theo hnh dng c cc loi nh sau
(hinh 7.1):

Bnh ngm kit thng c hnh nn ct (hnh 7.la) hoc hnh tr

kt hp vi hnh nn ct (hnh 7.1b), cho php dung mi chy khng
trn ln cc lp dch chit, dung mi chy u qua ton khi dc
liu, np v ly b dc liu ra d dng.

Hnh 7.1. M hnh cc loi binh ngm kit

Khi dng cc dung mi bay hi nh ether, cloroform, c th dng

bnh ngii kit vi h bnh ng dch chit khp kn kiu Guibourt
(hnh7.1c).
Khi cn ngm nh git nhit cao c th dng bnh ngm kit
bo n vi thnh bnh c 2 lp, dng nc nng hoc hi nc lu
thng iu nhit (hnh 7. ld).
K thut ngm nh git bao gm cc giai on:
+ Chun b dc liu:
Dc iiu c m khng qu 5%, c phn chia mc
thch hp, khng nn qu nh v bt dc liu khi thm dung mi d
b nn cht, dung mi kh i qua, ngn cn qu trnh chit xut. Nu
dc liu phn chia qu th th din tch tip xc vi dung mi s
gim, lm gim hiu sut chit.
Bt dc liu thng c kch thc nm gia c ry s 180 - 355
hoc 250 - 710 m.

+ Lm m dc liu:
Dc liu sau khi phn chia cn c lm m bng dung mi,
y kn, yn mt thi gian cho dc liu trng n hon ton, sau
mi cho vo bnh tin hnh ngm kit. Thi gian dc liu
trng n t 2 - 3 gi. Lng dung mi thm m tu theo kh nng
thm m ca dc liu vi dung mi cn dng. Sau ry bt
dc liu thm m qua c ry to bt ti u.
+ Cho dc liu vo bnh ngm kit:
Cn lt mt lp bng thm nc ln trn ng thot dch chit
bt dc liu khng gy tc bnh v khng ln vo dch chit. Sau
t giy lc ct va vn y bnh hoc vi gc hoc tm kim loi
c l ln trn. Cho t t bt dc liu c lm m vo bnh, va
cho va san u v nn nh cc lp dc liu. Cho dc liu n 2/3
th tch ca bnh, t giy lc v cc vt nh cc vin bi thu tinh,
tm s, thp khng g c l,... ln trn trnh xo trn dc liu
khi dung mi.

+ dung mi vo bnh v ngm lnh:

M kho ng thot dch chit, ung mi ln khi dc liu i
khi c v git dch chit chy ra, ng kho li. tip ung mi
ngp trn mt dc liu 3-4 cm. Ngm lnh ong mt thi gian thch
hp (thng l 24 - 48 gi).
+ Rt dich chit:
Ht thi gian ngm lnh, m kho cho dch chit chy tng git
vo bnh hng. Ch thng xuyn thm dung mi lun ngp mt
dc liu 2-3 cm.
Tc rt dch chit ph thuc vo lng dc liu em dng
Bng 7.1. Tc rt dch chit tng ng vi lng dc liu
ngm nh git
Khi lng ca dc liu (g)

Th tch dch chit rt trong mt pht (ml)

Di 1.000 gam

0,5 -1 ml

Di 3.000 gam

1 - 2 ml

Di 10.0000 gam

2 - 4 ml

Phng php ngm kit c u im l chit kit c hot cht,

tn t dung mi, dch chit u m c c th ring, trnh tip xc
vi nhit khi cn c c.
Phng php ngm kit thng c p dng vi cc dc liu
c hot cht c mnh (nh cc alcaloid, glycosid...) vi ung mi
ethanol - nc. Vi dc liu cha nhiu tinh bt, cht nhy khng
nn p dng phng php ngm kit vi dung mi c nc v cc
cht ny c th trng n lm cho dung mi khng i qua c liu.
Hin nay, c nhiu phng php ngm kit ci tin (ngm kit
phn on ngm kit c tc ng ca p sut, ngm kit ngc dng
lin tc v khng lin tc) cho hiu sut chit cao, t tp cht vi
lng ung mi ti thiu.

II. MT S DNG THUC BO CH BNG PHNG

PHP HO TAN - CHIT XUT
1. Cn thuc
1.1 nh ngha v phn loi
Cn thuc l nhng ch phm lng c iu ch bng cch
chit xut hot cht c trong dc liu hoc ho tan cc cao thuc,
cc ho cht vi ethano c nng thch hp.
Cn thuc c phn loi theo nhiu cch khc nhau:
Theo thnh phn: cn thuc c iu ch t mt nguyn liu
c gi l cn thuc n. Cn thuc c iu ch t nhiu nguyn
liu khc nhau c gi l cn thuc kp.
Theo phng php iu ch: cn thuc iu ch bng phng
php ngm lnh, ngm kit, ho tan.

1.2. Dc liu v dung mi iu ch cn thuc

Dc liu: cn t cc tiu chun quy nh v hm lng hot
cht, m, t l tp cht. m cao s lm long dung mi, gim
lng dc liu v gim hiu sut chit xut.
Dc liu em s dng cn c chia nh n mn thch hp
vi phng php chit xut v nng ethanol s ng. Nu dng
ethanol long th ch nn phn chia dc liu thnh bt mn va, nu
ng ethanol cao c th phn chia dc liu thnh bt mn. Ngm
kit phn chia dc liu thnh bt na mn, ngm lnh phn chia
dc, liu thnh bt th.

Dung mi: iu ch cn thuc dng dung mi ethanol.

Ethanol phi t cc tiu chun theo quy inh trong Dc in Vit
Nam 3. Kh nng ho tan ca ethanol thay i theo nng ethanol
nn tu theo thnh phn ca dc liu m chn nng ethanol thch
hp:
Ethanol 30 - 60 dng cho dc liu cha hot cht d tan trong
nc.
Ethanol 70 thng dng cho dc liu cha alcaloid, glycosid.
Ethanol 80 - 90 dng cho dc liu cha tinh du, nha thm
nh qu, cnh kin trng.
Ethanol 90 - 95 dng cho dc liu c hot cht d b thu
phn nh u.
Mun c ethanol c nng khc nhau phi xc nh hm lng
ethanol v ph long ethanol.

- Xc nh hm lng ethanol ( cn):

Hm lng ethanol l lng ethanol tinh khit c trong ung dch
ethanol. C th biu th hm lng ethanol theo % th tch (tt/tt) - l
s ml ethanol tinh khit c trong 100 ml dung dch ethanol hoc biu
th theo % khi lng (kl/kl) l s g ethanol tinh khit c trong 100 g
dung dch ethanol nhit 15C
C th i t % khi lng sang % th tch v ngc li theo
cng thc:
V* 0,790796
g=

Trong :
- g: cn % theo khi lung.
- V: cn % theo th tch.
- 0,79067: l t trng ethanol tinh khit 15C
- d: t trng ca dung dch ethanol.

V d chuyn t ethanol c cn theo th tch 50 sang cn

theo khi lng nh sau:
50* 0,790796
g=
0,9318
xc nh hm lng ethanol c th dng cc phng php
khc nhau:
+ Phng php cn.
+ Phng php sc k kh (DVN 3).
+ Phng php dng tu k bch phn.

Tu k bch phn c thang chia t 0 - 100, vch 0 l vch

ch mt phng cht lng khi nhng tu k trong nc ct + 15C
v vch 1100 l trong ethanol tinh khit +15C. Mi vch chia
trong khong 0 l00 biu th 1/100 th tch ethanol tinh khit trong
dung dch ethanol. Khong cch gia cc vch chia trn tu k
khng u nhau l do khi trn ln ethanol v nc ct c hin tng
co th tch ca hn hp v s co th tch thay i tu theo t l nc
v ethanol. Khong cch gia cc vch chia nh dn t 0 n 20 v
ln dn t 30 n 100.
Khi dng tu k xc nh hm lng ethanol s bit c
hm & lng phn trm th tch ca ethanol tinh khit c trong
dung dch ethanol.

 cn c xc nh nhit + 15C l cn thc, cn

nhit khc l cn biu kin. cn thc c tnh t cn
biu kin nh sau:
Nu cn biu kin t 25 - 56 phi dng cng thc:
X = c 0,4t
Trong :
X: l cn thc.
C: l cn biu kin.
T: l chnh lch nhit lc o v 15C
Khi nhit thp hn 15C tr s 0,4 mang u (+). Khi nhit
cao hn 15c t s 0,4 mang u (-).
Nu cn biu kin > 56, c th tra bng lin h gia cn
biu kin vi cn thc 15c.
.

- Pha long ethanol:

+ Trng hp pha long ethanol cao vi nc thu c
ethanol thp , dng cng thc:

x=px

b
a

Trong :
X: l khi lng hoc th tch ca ethanol cao cn ly.
p: l khi lng hoc th tch ca ethanol cn pha.
a :l cn % khi lng hoc % th tch ca ethanol cao .
B: l cn % khi lng hoc % th tch ca ethanol cn pha.

Ly lng ethanol cao tnh, sau thm nc ct va th tch

hoc khi lng quy nh.
+ Trng hp pha ethanol cao vdi ethanol thp c ethanol
c cn trung gian, p dng cng thc:
(b-c)
x=px
(a-c)
Trong :
X: l khi lng hoc th tch ethanol cao cn ly.
p: l khi lng hoc th tch ca ethanol c cn trung gian,
a: l cn % theo khi lng hoc theo th tch ca ethanol cao .
b: l cn % theo khi lng hoc theo th tch ca ethanol trung
gian,
c: l cn % theo khi lng hoc theo th tch ca ethanol thp .
Ly khi lng hoc th tch tnh c, thm ethanol thp t
khi lng hoc th tch ethanol trung gian cn c.
Ngoi ra cn c th s dng cc bng pha long ethanol theo khi
lng v theo th tch.

1.3. K thut iu ch
Cn thuc c th iu ch theo 3 phng php: ngm, ngm nh
git v ho tan.
1.3.1. Phng php ngm lnh
Cho dc liu phn chia n kch thc quy nh vo 1 bnh
y kn, nhit phng. Ngm trong thi gian xc nh; hng
ngy c khuy trn. Sau gn ly dch ngm, p b thu dch p.
Trn dch ngm v dch p, lc u lng. Gn, lc ly dch trong.
Dng c ngm lnh cn y kn trnh bay hi dung mi.
Phng php ngm lanh thng dng iu ch cn thuc khng
cha hot cht c mnh. V d: cn ti, cn v cam, v qu, cn
gng, cn cnh kin trng, cn hi...

1.3.2. Phng php ngm kit

Qu trnh ngm kit c tin hnh nh trnh by phn k
thut chung, nhng khi rt dch chit c 2 trng hp:
Nu cn thuc c quy nh hm lng hot cht: khi rt c 3/4
tng lng dch chit qui nh th ngng rt dch chit, p b ly dch
p. Trn ch chit, dch p v nh lng hot cht. Tu theo kt qu
nh lng iu chnh hm lng hot cht theo ng quy nh ca
Dc in.
Nu cn thuc khng quy nh hm lng hot cht, khi thu
c 4/5 tng lng ch chit quy nh, p b thu dch p. Trn dch
chit v dch p. Thm dung mi va lng quy nh.
Phng php ngm kit thng c dng iu ch cn thuc c
hot cht c mnh. V d: cn benladon, cn u, cn c c
dc...

1.3.3. Phng php ho tan

Ho tan cao thuc, ho cht, tinh du vo ethanol c nng
thch hp, khi tan hon ton lc ly dch trong.
V d; cn opi, cn m tin, cn opi kp, cn opi-benzoic, cn i
t ho cht v tinh u (xem phn dung dch cn).
Phng php ho tan c p dng iu ch cn thuc i t
dc liu c cha tp cht nh nha, cht bo, v.v... nn phi dng
cao thuc, v cao thuc c loi tp cht trong qu trnh iu ch.
Cc cn thuc c iu ch bng phng php ho tan bo qun d
hn. Tuy nhin, cn thuc iu ch bng phng php ny c thnh
phn khng hon ton ging nh phng php ngm kit.
Khi iu ch cn thuc kp do thnh phn c nhng dc liu
khc nhau nn cn kt hp cc phng php.

1.4. Bo qun cn thuc

a s cc cn thuc sau 1 thi gian bo qun thng xy ra hin
lng ng do s ng vn ca albumin, tanin, gm, nha, tinh bt, ,
cht nhy. Kt ta c th ko theo cc hot cht nh alcaloid.
glycosid lm gim tc dng ca cn thuc.
Mu ca cn thuc c th bin i trong thi gian bo qun do
hin tng oxy ho clorophil, nha, tinh du di tc ng ca nh
sng.
V vy cn bo qun cn thuc trong chai l, y nt kn. trnh
nh sng, ni mt. Trong qu trnh bo qun cn thuc c th c
tua. cn lc loi ta v kim tra lai cc tiu chun, nu t vn c th
dng c.

1.5 Yu cu cht lng cn thuc

Cn thuc phi t cc ch tiu sau y:
Cm quan: mu sc, mi v.
T trng: cn thuc thng c t trng trong khong 0,87-0,98. C
th xc nh bng t trong k.
H s vn c: l lng nc ct thm vo 10 ml cn thuc to
thnh vn c. V d h s 1-2 i vi cn cnh kin trng. 2-3 vi cn
valerian, 5-6 vi cn qu, cn canh ki na, 8-9 vi cn long no.
Hm lng ethanol ca cn thuc c xc nh theo chuyn lun
trong Dc in.
T cn kh: xc nh bng cch cn lng cn kh cn li sau khi
bc hi cch thu mt th tch cn thuc, ri sy kh 100 105 C
trong 3 gi.
inh tnh hoat cht.
nh lng hot cht: hm lng hot cht trong cn thuc c
xc nh theo chuyn lun ring.

1.6 Mt s v d cn thuc
1.6.1. Cn thuc iu ch bng phng php ngm lnh
V d 7.1: cn cnh kin trng (DVN I - tp 1 )
Cnh kin trng tn mn
200 g
Ethanol 90
va
Dc liu cnh kin trng c cha cc hot cht chnh l acid
benzoic, acid cinamic; cc este nha benzyl benzoat, benzyl cinamat,
tinh du, vanilin, cc hot cht d bay hi v d tan trong ethanol cao
; tp cht chnh l nha.
Ethanol 90 l dung mi thch hp ho tan hot cht.
iu ch: ngm 200 g cnh kin trng tn mn vi 1000 ml
ethanol 90, trong bnh nt kn, trong thi gian 10 ngy; thnh thong
lc. Sau gn ly dch chit, lng 24 gi, lc, thm ethanol 90
va qua phu lc c 1000 ml cn thuc.

Cn cnh kin trng c mu vng nu, mi t trng 25c l

0,865 - 0,875 v t l cn 8-10%. Hm lng ethanol khng di 75%
khi lng.
Cn cnh kin trng dng phi hp trong cc potio v siro cha
ho.
V d 72 : cn ti (DVNI - tp 1)
Ti 1
200
g
Ethanol 60 1000 ml
iu ch: bc ht ln v cng ca cc nhnh ti, thi mng, cho
vo ci s c dung tch 500 ml, nghin nt, ri cho vo mt bnh
cha sn khong 900 ml ethanol 90. Dng lng ethanol cn li
trng ci v tp trung vo binh.
Ngm trong 10 ngy, thinh thong lc. Gn cn ti sang mt bnh
khc. p b ti. Tp trung dch chit, lc qua vi gc hoc giy lc th.
c cn ti.

1.6.2. Cn thuc iu ch bng phng php ngm kit

V d 7.3: cn qu (DVNI - tp 1)
V qu (bt na mn)
200g
Ethanol 80
va
iu ch:
Cn bt qu, thm m bng 100 ml ethanol 80, y kn, yn
2-3 gi.
Cho dc liu thm m vo bnh ngm kit.
+ Lt mt t bng xung y bnh, t giy lc ln trn bng.
+ Cho dc liu thm m vo bnh, va cho va san u.

+ t t giy lc va vn vi ng knh ca bnh ln trn mt

dc liu, cho mt t vin bi thu tinh ln trn.
Cho dung mi:
+ M kho bnh ngm kit.
+ t t dung mi vo bnh n khi c vi git dung mi chy
ra, kho vi tip dung mi ngp dc liu 2-3 cm.
Ngm lnh 24 gi.
Rt dch chit: tc rt lml/pht, ng thi b sung dung mi
lun ngp dc liu. Tip tc rt dch chit n khi thu c 1000
ml. lng 2-3 ngy, gn lc ly dch trong.
ng l thu tinh, dn nhn ng qui nh.

V d 7.4: cn u (DVNI - tp 1);

u, bt na mn
100g
Ethanol 90
va
u l dc liu c, c cha hot cht chnh l aconitin d b thu phn
thnh benzoyl aconin, lm gim tc dng iu tr. V th. iu ch cn u
dng ung mi thch hp l ethano l 90. Cn u l cn thuc c quy inh
hm lng hot cht.
iu ch: bng phng php ngm kit (thc hin k thut ngm kit ging
nh khi iu che cn qu). Sau khi ngm lnh, rt c khong 800 g dch chit
th ngng chit. nh lng alcaloid lon phn trong dch chit v iu chinh
thu c cn thuc cha 0,050% alcaloid ton phn tnh theo aconitin. ng
cn thuc vo chai thu tinh, nt kn, ch mt.
Cn u c mu vng nu nht, v ng v c cm gic kin cn u li.
Nu thm ng khi lng nc s c l. Ty trng 25l C l 0,825 - 0,835.
Cn u dng phi hp trong cc n thuc ung cha ho v dng ngoi
xoa bp gim au dy thn kinh.

1. 6.3. Cn thuc iu ch bng phng php ho tan

V d 7.5: cn m tin (DVNI - tp I)
Cao lng m tin
85 g
Ethanol 70 v
1000ml
Cao lng m tin iu ch t ht m tin vi ethanol 700 v loi cht
bo, cha 1,425 - 1,575% strichnin. Cn m tin khng c cht bo, khi phi
hp trong cc n thuc khng b ta v cn thuc d bo qun hn. ng
cn thuc vo chai thu tinh, nt kn, ch mt..
Cn m tin l cht lng trong, mu vng nu, v ng, c hm lng
strichnm 0,12 - 0,13 %.
Cn m tin dng phi hp trong cc thuc ung, kch thch tiu ho v
thuc dng ngoi xoa bp khi nhc mi.

2. Ru thuc
2.1. nh ngha, c im v thnh phn
2. 1.1 nh ngha
Ru thuc l dng thuc ng, c iu ch bng cch chit xut dc liu
thc vt hoc ng vt ch bin theo vu cu vi ru hoc ethanol c nng
thch hp, c thm cc cht lm thm, lm ngt.
2.1.2. c im v thnh phn
Khc vi cn thuc, ru thuc thng c cn thp hn. Cng thc theo
cc bi thuc c truyn hoc theo n nn thnh phn c th c nhiu dc liu
khc nhau.
Dc liu tho mc: thng dng cc dc liu c tiu chun ho v
t ng dc liu c. Dc liu ng vt: rn, tc k. cng c tiu chun
ho trong Dc in.
Dung mi: ethanol hoc ru iu ch t ng cc (trong sut, c mi thm,
t cht c nh methanol, aldehyd, cn 40 - 50). Tu tng loi dc liu
dng ru, ethanol c nng thch hp.
Cht ph: ch yu l ng, mt ong, cc cht lm thm, cht nhum mu
nh dch chit cc dc liu c mu, caramen, mu thc phm

2.2 K thut iu ch
Chun b nguyn liu vt dung mi:
Dc liu sy kh, chia nh thch hp hoc sao tm theo yu cu ca
n thuc.
Dung mi: pha ethanol hoc ruu c nng thch hp.
Chit xut iu ch cc dch chit dng cc phng php:
+ Phng php ngm lnh nh phn k thut chit xut chung. Trong
ng y, mt s ru thuc ngm h th, thng p dng vi nguyn liu
ng vt, ru c ngm trong thi gian di (c th ti vi thng).
+ Phng php sc dc liu vi dung mi nc ri pha dch chit vi
ethanol hoc ru. Phng php ny nhanh, hiu sut cao nhng ru d b
ta v sm mu.
+ Phng php ngm kit ging k thut chung.
+ Phng php ho tan i t cao (v d cao h ct. ban ong).

Pha ru: ru thuc i t nhiu nguyn liu khc nhau, mi nguyn

liu c th c chit xut vi ethanol c cn khc nhau, v th khi phi
hp cc dch chit cn ch :
+ Khi phi hp c th c ta, hn ch ta, thng phi hp cc dch
chit c hot cht v cn gn nhau trc.
+ C th phi hp vo cc dch chit ng hoc sa, mt ong hn
ch ta.
+ Thm cc cht iu v nh ng, mt ong, saccarin; cc cht iu
hng nh cc dch chit dc liu c mi thm, cc tinh du, cc hng
liu tng hp dng trong thc phm; cc cht mu. iu chnh ru thuc
c cn khong 20 - 30.
+ Trn u, lng 1-2 ngy, gn lc ly dch trong, ng chai, dn
nhn ng quy nh.
Hon chnh ch phm v ng gi. Kim nghim thnh phm.

2.3 Yu cu cht lng

Ru thuc phi t cc ch tiu cht lng v:
Mu sc, mi v, t trng, t theo quy nh trong chuyn
lun ring.
lng cn: ru thuc trong qu trnh bo qun c th
lng cn nhng khng c vt qu gii hn cho php vi
tng loi ru.
cn: ru b khong 20, ru c dc liu ng vt
30-35 nhng khng qu 45.
Th tch: m bo sai s th tch.
nh tnh cc dc liu in hnh.
nh lng hot cht (nu thy cn thit v c th nh
lng c).

2.4 Mt s v d ru thuc
V d 7.6 : ru b sm
Cng thc (cho 1 chai):
Nhn sm 1 c (10-I2g)
Ru 40% 400 ml
Siro n
65 g
Cht mu
va
Nc tinh khit va 500 ml
K thut bo ch:
+ Chn c sm t khi lng v cht lng theo tiu chun Dc in Vit
Nam 3, ra sch bng ethanol 70.
+ Cho c sm vo chai dung tch 500 ml ra sch, sy kh.
+ Ngm lnh vi 400 ml ru 40 trong 7 ngy.
+ Gn, lc ly dch chit trong.
+ Thm siro em, nc, cht mu vo dch chit va 500ml.
+ Rt ru vo chai c c sm, y kn. Dn nhn ng qui nh.

V d 7.7: ru b huyt tr phong (DVN 3) Cng thc (cho 1 chai):

Cu tch
20 g
Ng gia b
10 g
Tang chi
30 g
Ngu tt
10 g
H th
40g
Thin nin kin
30 g
Hong tinh
20 g
Th phuc inh
10 g
Huyt gic
lOg
Tuc oan
20 g
Hy thim
30 g
ng trng
130 g
K huyt ng
40 g
Ethanol 28 %
1300 ml

K thut bo ch:
+ Dc liu loi b tp, xay thnh bt th qua ry 10 mm.
+ Ngm lnh 2 ln, n u vi 60 % lng ethanol, ln sau vi lng
ethanol cn li, mi ln ngm 8 ngy.
+ Gn, p, lc ly dch ngm, thm so, lng 48 gi, lc trong.
+ Thm nc va 1000 ml thnh phm.
+ ng chai, nhn ng quy nh.

3. Cao thuc
3.1. nh ngha - c im - Phn loi
3.1.1. nh ngha
Cao thuc l ch phm c iu ch bng cch c c hoc sy fw
A ct quy nh cc dch chit thu c n dc liu thc vt hoc ng vt
vi cc dung mi thch hp (DVN 3).
c im Cao thuc c 1 s c im sau:
c loi b 1 phn hoc hon ton cc tp cht (cht nhy, gm,
cht bo, nha... ).
Trong qu trnh iu ch c th hnh thnh 1 s cht l sn phm ca
qu trnh oxy ho, tm phn, tc dng ca enzym. T l hot cht trong cao
thuc (c kh) thng cao hn t l hot cht trong dc liu. Ring cao
lng th t l hot cht c th bng t l hot cht c trong c liu.
Cao thuc thng t khi c s dng trc tip m dng bo ch cc
dng thuc khc nh so, potio, vin trn, thuc m, thuc n, thuc trng,
vin nn, thuc bt.

3.1.3 Phn loi

- Theo th cht:
+ Cao lng: c th cht lng snh, thng quy c 1 ml cao lng tng
ng vi 1 g dc liu.
+ Cao c: c th cht snh cha khong 15 - 20% nc hoc c th cht
do s khng nh tay, m 10 - 15% nc.
+ Cao kh: c th cht kh ti, rt d ht m, cha di 5% nc.
Theo dung mi: c cao thuc iu ch vi dung mi nc (cao c cam
tho, cao c i hong...), cao thuc iu ch vi dung mi ethanol (cao lng
m tin, cao lng benlaon...)Phn loi cao thuc theo phng php chit xut: ngm lnh, ngm kit,
sc.
3.2. K thut iu ch
Qu trnh iu ch cao thuc thng bao gm nhng giai on sau:
iu ch dich chit. Loi tp cht trong dch chit.
C c, sy kh. Hon chnh ch phm.

3.2.1. iu ch dch chit

Chun c liu: dc liu thng c sy kh v phn chia
Li mn thch hp.
Dung mi iu ch cao thuc c th l nc, ethanol c nng
khc nhau, ethanol - glycerin - nc, hoc dng dung mi ethanol
trc, sau dng nc cho dch chit sau, ri gp cc dch chit li.
Tu theo bn cht ca dc liu v dung mi m p dng phng
php chit xut thch hp.
+ Phng php hm hoc sc: thng p dng vi dung mi l
nc; dc liu c cho vo ni hm hay sc c v bng kim loi
dc liu khng tip xc vi y trnh b chy v c v p c
liu khng ni ln; cho nc ngp dc liu; tin hnh hm hoc sc
trong thi gian quy nh; c th sc mt ln hoc 2 -3 ln.
V d: cao b ph, cao hy thim, cao ch mu.

+ Phng php ngn kit: thng p dng iu ch cao thuc

m dung mi chit xut l ethanol, i khi cng c th ngm kit vi
nc acid ho nh khi iu ch cao lng canhkina.
Khi iu ch cao thuc bng phng php ngm kit c u im
l dch chit u m c (cha phn ln hot cht chit c) c
ring khng cn bc hi hoc bc hi sau cng nn hn ch tc
ng ca nhit ti hot cht.
Lng dch chit u thng rt 80-100% lng dc liu em
chit. Cc ch chit sau c c n th cao mm sau trn vi dch
chit u.
Ngi ta c th dng phng php ngm kit ci tin (chit xut
ngc dng hay ngn kit phn on) iu ch cao lng khng cn
qua giai on c c.
Cn tin hnh c nhit thp, thi gian c ngn, c dch chit
long trc dch chit c sau hn ch gy phn hu hoi cht c
trong dch chit.

Cc phung php c c:
+ C p sut thng: ngi ta thng c c b mt bc
hi ln v nng. Trong qu trnh c cn tin hnh khuy trn
n trnh to vng trn b mt cn tr s bc hi dung mi
v trnh chy y dng c. C th dng qut hoc phng
tin thng gi lu thng lp khng kh bo ho dung mi
b mt dch chit.
+ C p sut gim: ngi ta dng cc ' :hit b c c b
phn to chn khng. dch chit khng si bt manh khi
p sut ni c gim, c th thm vo dch chit 1 t b cacao
hay pararin.

3.2.4 Sy kh
iu ch cao kh cn tip tc sy kh dch chit c thnh
cao lng hoc cao mm hm lng m trong cao kh ch cn di
5%.
Ngi ta thng dng cc thit b sy kh khc nhau, nhng tt
nht vn l sy di p sut gim v nhit di 50C. Phng php
ny c u im l sy nhanh v bo ton c lng hot cht c
trong cao thuc. Khi sy dch chit c c c tri thnh nhng lp
mng trn cc khay thp khng ri hoc st trng men.
Ngi ta c th tri cao thnh nhng lp mng trn giy
polyethylen vic ly cao sy kh c d ng.
Sy kh bng my sy tc (xem phn kv thut lm kh chng
2) c u im l thi gian lm kh nhanh rong vi giy. Nu my
c t trong bung chn khng, nhit sy thp, m bo cht
lng ca cao. Sn phm thu c c dng mnh ph hp cho nhiu
mc ch.

3.2.5 Hon chnh ph phm

Xc inh t l hot cht v iu chnhcho ng quy nh hot cht
trong cao.
Trng hp ch phm c t l hot cht thp hn quy nh, ngi
ta c th c tip, loi bt dung mi, hoc dng cao c hot cht cao
hn iu chnh.
Trng hp ch phm cha t l hot cht cao hn quy nh ca
Dc in, ngi ta phi pha long. Cc cht pha long c th dng
nh sau: cao lng phi thm dung mi chit, cao mm, cao c dng
cao dc liu thch hp hoc glycerin, cao kh c th dng tinh bt,
lactose, glucose, magnesi oxyd hay b dc liu nghin mn.
Lng cht kh cho vo c tnh ton tu trng hp c th.
i vi cao lng ung thm cc cht iu hng v nh sir
n. menthol, tinh du, bc h, vanilin...
Thm cc cht bo qun chng nm mc nh: glycerin, acid boric,
acid benzoic, natri benzoat, nipagin, nipasol.

3.3 Bo qun
Cao thuc c ng trong chai l, nt kn, trnh nh sng. ni
kh ro, thong mt.
Yu cu cht lng
Cao thuc phi t cc ch tiu cht lng chung sau:
V cm quan: c th cht lng, c, kh tu loi cao. C mi ca
dc liu tng ng.
tan: 1 g cao lng tan trong 20 ml dung mi c dng chit
xut khi iu ch cao.
Cn kh sau khi bc hi i vi cao lng (theo chuyn lun ring).
Mt khi lng do sy kh i vi cao c khng qu 20%. cao
kh khng qu 5% (tin hnh theo Dc in Vit Nam 3).
nhim khun: t quy nh v nhim khun theo ph lc
10.7 ca Dc in Vit Nam 3.
nh tnh, nh lng hot cht theo phng php ghi trong cc
chuyn lun ring.

2. Mt s khi nim trong k thut bo ch nh tng

C mt s khi nim hay gp trong k thut bo ch nh tng
thuc:
Pha ni: cht lng b phn tn thnh git nh c gi l pha ni
hay pha phn tn hay pha khng lin tc.
Pha ngoi: cht lng cha cht lng b phn tn c gi l pha
ngoi hay pha lin tc hay mi trng phn tn.
Hai pha lng khng ng tan trong mt nh tng, c qui c
gi l pha du v pha nc, tu theo mc phn cc ca chng:
Pha du (k hiu l D): bao gm cc cht khng phn cc nh du
lc, du hng ng, du pararin. dorolorm. bromolorm. menthol...
dc cht v cc cht tan trong nhng cht lng khng phn cc n.
Pha nc (k hiu l N): bao gm cc cht lng phn cc nh
nc, ethanol, glycerin, cc c cht v cc cht ph (cht lm ngt,
cht bo qun...) ho tan trong cc cht lng phn cc ni trn.

3. Phn loai
3.1 Theo ngun gc
Nh tng thin nhin gm cc sn phm c sn trong thin
nhin di dng nh tng (sa, lng trng) v cc nh tng
c bo ch t cc loi ht c du nh hnh nhn, lc, b...
Nh tng nhn to l cc nh tng c bo ch bng cch
ng cc cht nh ho thch hp phi hp ha pha du v nc
to thnh nh tng.
Theo nng pha phn tn
Nh tng ong: gm nhng nh tng c nng pha phn
tn < 2%.
Nh tng c: l nhng nh tng c nng pha phn tn
> 2%. a s cc nh tng thuc l nh tng c.

3.3 Theo mc phn tn

Vi nh tng: c kch thc cc tiu phn phn tn nh
gn bng tiu phn keo (10 -100 run) nn nhn b ngoi, vi
nh tng trong sut hay trong m.
Nh tng mn: c cc tiu phn pha phn tn c 0,5 -1
n1.
Nh tng th: c cc tiu phn c kch thc t vi
micromet tr ln.
3.4 heo kiu nh tng

a: Nh tng D/N

: Du
o : Nc
Hnh 8.1 Kiu nh tng quan st di kinh kin vi

b: Nh tng

Nh tng thuc kiu D/N: pha phn tn l pha du v

mi trng phn tn l pha nc.
Nh tng kiu N/D: pha phn tn l pha nc V mi trng
phn tn l pha du.
Nh tng kp N/D/N: pha phn tn l mt nh tng N/D v
m trng phn tn l N.
nhn bit kiu nh tng, c th xc nh bng cc
phng php:
+ Pha long: nh mt git nc ct vo mt lng nh nh
tng ng trn mt lam knh. Nu thy git nc khuch tn
nhanh chng vo khi nh tng v nh tng vn gi c
nguyn tnh ng nht th nh tng em th kiu nhu tng
D/N.

Nu git nc vn ng thnh khi ring trn b mt ca

nh tng th l nh tng kiu N/D.
+ Nhum mu: cht mu c s dng tan trong pha no
ca nho tng pha s c mu, pha th hai s hon ton
khng mu. Trn nguyn tc ny c th ng cc cht mu
tan trong nc hoc irons du pha vo nh tng ri quan st
trn knh hin vi xc nh kiu nh tng.
+ o dn in: da trn nguyn tc pha nc ca nh
tng (c bit khi c cc cht in ly) dn in, cn pha u
khng dn in. Nh tng cho dng in chy qua th mi
trng phn n ca nh tng l nc

3.5. Theo ng s dng thuc

Nh tng dng trong: nh tng tim, tim truyn v
nh tng ung.
+ Nh tng tim, truyn: tim bp c th dng 2 kiu nh
tng D/N v N/D. Tim tnh mch ch dng kiu nh tng
D/N. Truyn tnh mch vi liu ln cc nh tng cung cp
nng ng phi l kiu nh tng D/N, c kch thc tiu
phn pha phn tn nh hn 0.5 m trnh gy tc mch.
Khng c tim nh tng thuc trc tip vo ct sng bt
k nh tng l D/N hay N/D.

+ Nh tng ung: ch ung cc nh tng kiu D/N (nh

tng N/D c mi v kh chu rt kh ung). Cc nh tng
ung thng l cc potio nh tng, trong thnh phn c mt
ca cc cht iu v, iu hng.
Nh tng dng ngoi:
Cc nh tng dng ngoi dng bi, xoa, p, t ln
(mt v nim mc c dng c 2 kiu D/N v N/D. Nh
tng D/N u ra sch v khng gy bn qun o hn.

4. u, nhc im
4.1 u im
Nh tng cho php phi hp dng cc dc cht lng
khng ng tan hoc cc dc cht rn ch tan trong mt loi
dung mi.
Nh tng cn lm cho dc cht pht huy tt hn tc dng
iu tr v di dng nh tng, dc cht thng t phn
tn cao v ng nht, khi s dng s c din tip xc ln vi cc
t chc ca c th.
i vi thuc ung ch di dng nh tng kiu D/N, cho
php phi hp cc cht thn nc vi cc dc cht khng lan
trong nc nh cc loi du v nhiu dc cht khng phn cc
khc, pht huy tt tc dng ca thuc do chng d c hp th
hn; ng thi cn che du mi v kh ung, gim kch ng ca
dc cht i vi nim mc ng tiu ho.

i vi thuc tim nh tng kiu D/N, c th ch c

thuc tim cha cc dc cht khng tan hoc rt t tan trong
nc di dng thuc tim tnh mch.
Thuc m, thuc xoa ch di dng nh tng c th d
dng phi hp nhiu loi dc cht khc nhau vi cc t c
thnh cc ch phm ng nht, c th cht mm, mn mng, c
tc dng du i vi da, nim mc, t gy nhn, bn da v qun
o, ng thi c th iu khin c tc dng ca thuc trn
b mt da, nim mc hoc tc dng su cc t chc di da
bng cch bo ch thnh nh tng D/N hoc N/D.

i vi thuc n, trng ch di dng nh tng c th

dng phi hp ng u nhiu loi dc cht khc nhau
vi cc t dc, lm thnh vin c bn c hc m bo,
vin d tan r, m bo s gii phng hp th dc cht tt
khi t thuc vo cc hc ca c th. Ring i vi thuc n
c th lm cho thuc ch tc dng ti ch l hoc gy tc
dng ton thn bng cch ch di thnh nh tng D/N hoc
N/D
Nhc im:
Nh tng l h phn tn c hc, khng ng th nn
khng bn. d b tch lp (tch pha) trong qu nh bo qun.
Vic phn liu nh tng thuc se khng m bo chnh
xc khi nh tng b tch pha.

II. THNH PHN CA NH TNG THUC

Mt nh tng thuc c 3 thnh phn chnh l:
Pha du
Pha nc
Cht nh ho (cht gy phn tn)
Cc dc cht v cht ph l cht rn s tham gia vo nh
tng dng dung dch. Cc cht ny c ho tan trong pha
du hoc pha nc thnh dung ch tu theo kh nng ho tan
ca chng, iruc khi phn tn hai pha vo nhau.

1. Pha du
Bao gm cc cht khng phn cc tan trong du l:
Cc dc cht tan trong du: bromoform, menthol,
vitamin A. D, E...
Cc duc cht tan trong du: cc cht chng oxy ho nh
buthyl hydroxy anisol (BHA), buthyl hydroxytoluen (BHT)t
isopropyl galai, tocoferol. Cc cht l thm nh cc tinh
du...
Du thc vt, u parafin, vaselin, parafin, cc alcol bo;
acid bcO) Spt

2. Pha nc
Bao gm cc cht phn cc l:
Cc dc cht tan trong nc hay cc dung mi phn cc.
Cc cht ph:
+ Cc cht bo qun nh nipagin vi nng t 0.1 - 0.2%.
nipasol vi nng t 0,01 - 0,02%,... dng trong cc nh tng
thuc ung. Benzalkonium clorid vi nng 0,01% hoc
ocreso! t 0.1 * 0,2%,... dng trong cc nh tng thuc dng
ngoi. i vi cc nh tng ch vi cc loi du d b oxy ho
c th cho thm cc cht chng oxy ho thch hp.
+ Cc cht lm ngt, cht lm thm, cht gi m,... tan trong
nc hay cc dung mi phn cc.
Cc cht lng phn cc nh nc, ethanol, glycerin...

3. Cht nh ho thng dng trong bo ch nh tng

thuc
Cc nh tng thuc thng c nng pha phn tn cao,
mun thu c nh tng bn vng, trong thnh phn ca
nh tng phi c cc cht gip cho nh tng hnh thnh v
n nh, l cc cht nh ho.
Cht nh ho c tc dng lm gim sc cng b mt phn
cch pha, lm gim nng lng t do b mt m cho nh
tng d hnh thnh v n nh.
Mt s cht nh ho cn lm tng nht ca mi trng
phn tn gi cho nh tng n nh hn.

3.1. Cc cht nh ho thin nhin

Cc hydrat carbon: hay dng gm Arabic, gm adragant,
thch...
+ Gm Arabic thng dng lm cht nh ho ong cc
potio nh tng to kiu nh tng D/N. Gm Arabic ch ho
tan hon ton trong lng nc gp i lng gm, khi n
mi c tc dng nh ho tt. Gm Arabic c kh nng nh
ho nhanh c khi iu ch nh tng bng dng c th s nh
ci chy.
+ Gm adragant c nht gp khong 50 ln nht
ca dung dch gm Arabic c cng nng .
V th, thng dng gm aragant lm cht n nh phi
hp vi gm Arabic trong cc nh tng thuc ung.

Cc saponin: thng dng cn thuc (1/5) iu ch t cc

dc liu c saponin nh b hn, b kt, quillaya,
salsepareille lm cht nh ho cho cc nh tng dng
ngoi.
Cc protein dng lm cht nh ho c gelatin, gelatose.
sa, casein v cc dn cht.
Cc sterol: cht nh ho in hnh trong cc sterol l
cholesterol c nhiu trong lanolin (sp lng cu), trong m
ln, du c v lng trng; ngi ta cng dng cc acid mt
nh acid cholic, taurocholic, glycolic... lm cht nh ho.
Cc phospholipid: in hnh l lecithin. c nhiu trong
lng trng, trong tng..., khng c nn l cht nh
ho thch hp cho nh tng tim.

3.2 Cc cht nh ho tng hp v bn tng hp

So vi cc cht nh ho thin nhin, cc cht nh ho
tng hp v bn tng hp c tc dng nh ho mnh, vng
bn, t b nh hcVng ca cc yu t nh pH, rihit , vi
khun, nm nn c s dng kh rng ri lm cht nh ho,
cht gy thm trong bo ch cc nh tng hay hn ch
thuc.
Cc cht nh ho tng hp v bn tng hp c xp
thnh 2 nhm l: cc cht din hot (cht nh ho thc s) v
cc cht nh ho n nh.

3.2 .1. Cc cht din hot

Cc cht din hot l mt nhm ln gm rt nhiu cht. Cc cht
din hot in hnh l nhng hp cht lng thn, trong phn t cua
chng c cha cc nhm thn nc v thn du.
Cc cht din hot dng trong c phm gm 4 phn nhm:
Cht din hot anion: l nhng cht trong phn t c cc nhm thn
nc mang in tch m nh nhm carboxyl (RCOO >. sulfonat
(RSO) hay Sulfat (ROSO3 ). Cc cht thng dng l mui natri hay
kali hay calci ca acid bo (cc x phng), natri lauryl sulfat, kali
laurat...
Cht din hot catin: l nhng cht trong phn t c cc nhm
thn nc mang in tch dng nh mui halogenid ca amoni bc
4 c cng thc chung R4N+X\ Cc cht thng dng c cetrimid.
benzalkonium clorid, ngoi tc dng nh ho, cc cht ny cn c tc
ng st khun.
Cht din hot lng tnh: thc t t dng irong bo ch nh
tng thuc.

Chi in hot khng ion ho: l nhng hp cht c phn

thn nc ca phn t khng mang in nhung n vn c tnh
thn nc o cha cc nhm chc c phn cc cao nh
nhm hydroxyl hay polyoxyeihvkn. Dng nhiu trong bo
ch l cc cetomacrogol (Brij), cc sarbitan este (Span) v cc
polysorbat (Tween). Tn gi cc cht din hot ny thng
km theo mt ch s, v d Tween 80, Tween 20, span 60.
span 80...
Cc cht din hot d tan trong nc nh x phng natri.
Tween dng cho nh tng kiu D/N, cc cht din hot d
tan trong du nh x phng calci, Span dng cho nh tng
kiu N/D. Nhng cng c th dng 2 cht nh ho ngc pha
nhau trong cng mt cng thc nh tng thu c nh
tng bn vng.

3.2.2 Cc cht nh ho n nh
Cc polyethylen glycol (vit tt l PEG km theo s chi
khi lng phn t ca chng, v d PEG 400, PEG 6000,...).
Cc PEG cn c tn gi khc l macrogol hay car bo wax.
nhit thng, cc PEG c khi lng phn t t
200-700 c th cht lng snh, cc PEG c khi lng phn
t > 1000 c th cht t mm nh vaseline n rn nh sp.
Cc PEG d ho tan trong nc v chng khng phi l
cht nh ho thc s nhng l cht n nh tt i vi nh
tng thuc. Do c tnh thm nc mnh nn c kh nng
gy thm bin dc cht rn s nc thnh thn nc nn hay
c dng lm cht gy thm trong bo ch cc dng hn
dch thuc.

Cc alcol polyvinylic: l nhng sn phm trng hp cao

phn t ca alcol vinylic, tan trong nc v glycerin. Dung
dch trong nc c sc cng b mt thp, pH gn trung tnh
v nhi tha) i ph thuc vo nng . Cc alcol
polyvinylic hay c dng lm cht gy thm v cht nh ho
trong bo ch cc hn dch v nh tng thuc ung, tim v
dng ngoi.
Cc alcol polyvinylic rt thch hp trong bo ch cc nh
tng, hn dch v dung dch thuc nh mt v cc cht ny
hon ton tr v mt ho hc, c th tit khun c v thch
hp vi cc nim mc mt, gip cho s phc hi nhanh chng
cc tn thng v mt v gi cho thuc tip xc lu hn vi
nim mc mt.

Cc dn cht ca cellulose:
Cc dn cht ca cellulose c nhiu tnh cht ging vi
cc cht keo thin nhin nhng c u im: tinh khit, vng
bn, t b tc dng ca vi khun nm mc, t chu nh hng
ca nhit nn c th tit khun m khng b hng.
Do c cc u im ni trn, cc cht ny hay c ng
m cht nh ho, gy thm trong bo ch nh tng v hn
dch thuc ung, tim hay dng ngoi, lm t dc trong
thuc vin, thuc m (k c thuc m tra mt).
Thng dng methyl cellulose, hydroxymethyl cellulose,
carboxymethyl cellulose, natri carboxymethyl cellulose,
carboxy polymethylen (Carbopol),...

Cc loi dn cht ny u tan trong nc to ra dch keo.

c pH gn trung tnh, c nht tu theo loi dn cht v
nng ca n c trong dung dch.
ho tan nhanh cc dn cht ca celuose trong nc
cn thm t chng vi nc nng v cho chng trng
n trong mt thi gian, sau mi khuy trn n khi thu
c mt dch th ng nht.

3.3 Cc cht nh ho rn dng ht nh

L nhng cht rn di dng bt rt mn khng tan trong
nc v du- Mun c tc dng nh ho, kch thc ca cc
tiu phn bt phi b hn rt nhiu ln kch thc cc tiu
phn pha phn tn ca nh tng.
Loi cht no d thm nc hn du s cho nh tng
D/N. d thm du hn nc s cho nh tng N/D. Nhng
cht kh nng thm nc v du nh nhau th nu trn cht
nh ho vi pha no trc th pha s l mi trng phn
tn ca nh tng.
Mt s cht thng dng l bentonit. magnesi nhm silicat
(Veegum), hectorit.

III. K THUT BO CH NH TNG THUC

Nguyn tc chung trong bo ch cc nh tng thuc l s
dng nhng k thut phn tn thch hp, phn tn pha du
vo pha nc hoc ngc li, to ra nh tng thuc bn
vng. Cc nh tng thuc tim, thuc m, thuc t, do c
nhng yu cu ring v cht lng cn xem thm trong cc
chng tng ng. C 3 phng php chung bo ch nh
tng thuc:

1. Phng php keo kh

p dng khi dng cht nh ho ch thnh bt mn.
Thc hin qua cc bc nh sau:
Phi hp cc thnh phn ca pha ni vi nhau.
Trn pha ni v mt lng pha ngoi va ho tan
cht nh ho.
Dng lc gy phn tn to ra mt nh trig m c.
Thm dn tng lng nh pha ngoi cn li, khuy trn
ha u.
y l phng php c p ng ch yu trong k thut
iu ch cc nh tng lng kiu D/N, quy m bo ch nh.
bng phng tin th s nh ci chy v dng cht nh ho l
cc cht keo thn nc nh gm arabic, gelatose... (v d xem
n thuc 8.1).

2. Phng php keo t

Vic iu ch cc nh tng bng phng php keo t c
thc hin qua cc bc sau:
Phi hp cc thnh phn c trong pha du. un nng n 60
70 C.
Phi hp cc thnh phn c trong pha nc, un nng n 60
- 70 C.
Cht nh ho tan c trong pha no th ho tan vo pha .
Thm n tng lng nh pha ni vo pha ngoi, ng thi
tc dng lc gy phn tn to ra nh tng.
y l phng php thng c p ng khi c phng tin
gy phn tn mnh nh thit b ng nht ho. thit b khuy
siu m... bo ch nh tng (v d: xem cc cng thc hay
n thuc t 8.2 n 8.5).

Cc thit b gy phn tn (hay thit b ng nht ho nh

tng) dng trong sn xut cng nghip thng da trn
nguyn tc p nh tng qua mt van ng nht c bit vi
p sut rt ln (c th ln ti 1500 bar) kt hp vi khuy
trn c hc mnh nn c th gim c kch thc ht nh
tng xung di 1 m. lm cho nh tng c n nh
vt l cao (hnh 8.2).

3. Phng php tch pha t dung mi ng tan vi c ha

pha
L phng php dng mt dung mi c th ng tan vi pha
ngoi ho tan pha ni v cht nh ho sau em dung dch trn
vi pha ngoi.
V d bo ch nh tng thuc c thnh phn:
Creosot
33g
Lecithin
2g
Nc ct va
100g
Creosot v lecithin u d ho tan trong ethanol v ethanol li
ng tan vi nc, nn c th dng l0g ethanol ho tan ereosot v
lecithin, sau cho dn hn hp ny vo nc, lc mnh to ra
nh tng.
Trn thc t, phm vi p ng ca phng php ny rt hn ch
do rt kh tan c mt dung mi chung c th ho tan c pha ni v
cht nh ho, ng thi l ng tan vi pha ngoi nh trng hp
trn.

4. ng gi v bo qun nh tng thuc

C th ng nh tng thuc trong cc loi bao b lm bng
thu tinh, cht do, kim loi c hnh dng v kch thc ph hp
vi tng ch phm.
Cn bo qun cc nh tng thuc ni kh v mt. nhit
t thay i. Khng bo qun trong t lnh hoc ni c nhit cao
s lm cho nh tng nhanh chng b tch lp.

IV. YU CU CHT LNG NH TNG THUC

Nh tng thuc cn phi t cc ch tiu cht lng sau:
V cm quan: nh tng thuc khng c tch lp. Vi nh
tng thuc ung c th tch lp nhng phi phn tn ng nht
tr li khi lc, v th cn c dng ch Lc trc khi dng' trn
nhn thuc.
V kch thc pha phn tn cn ch c bit vi cc nh
urng tim truyn, kch thc git phi < 0,5 m.
Nh tng thuc phi t cc ch tiu v nh tnh, nh
lng, gii hn tp cht, sai s th tch hay khi lng, nhim
khun hay v khun... theo tng chuyn lun ring.

V. MT S N V CNG THC NH TNG THUC

n thuc 8.1:
Rp. Bromoform
2,0g
Natri benzoat
4,0g
Codein phosphat
0,2g
Siro n
20,0g
Gm arabic
9,0g
Du lc
10,0ml
Nc tinh khit va
100,0ml
M. f. emul.
K thut bo ch:
Lm nh tng c:
+ Chun b ci chy sch, kh.
+ Nghin mn gm arabic trong ci.
+ Ho bromorm vo u lc.

+ Cho dung dch u vo gm, o nh.

+ Thm 18 mi nc, nh nhanh, mnh, 1 chiu, lin tc
cho n khi hnh thnh nh tng c (trng, c ting ku lp
bp).
Pha long nh tng:
+ Trch khong 15 ml nc ho tan codein phosphat v
natri benzoat.
+ Pha long t t nh tng c bng lng nc cn li.
+ Phi hp dung dch codein - natri benzoat vo nh
tne.
+ Thm sir n trn u.
+ Thm nc va 100 ml. Khuy u.
+ ng chai, dn nhn ng quy nh.
Cng dng: potio nh tng c tc dng cha ho do co
tht, long m. Ung mt tha canh (15 ml)/ln, 2-3 ln/ngy.

Cng thc 8.2: Nh tng du parafin (BP 2003)

Du parafin
500 ml
VaniIIin
500 mg
Cloroform
2,5 ml
Dung dch acid benzoic
20,0ml
Methylcellulose
20,0g
Natri saccarin
50,0mg
Nc tinh khit va
1000,0ml
Trong dung dch acid benzoic (BP 2003) c pha
theo cng thc:
Acid benzoic
50g
Propylene glycol
750 ml
Nc tinh khit va un si, ngui va 1000 ml

K thut bo ch (pha ch ngay trc khi dng):

un si 120 ml nc tinh khit, thm methylcellulose v
trng n hon ton. Thm nc ang tan cho va
350 ml, khuy k n ng nht.
Trn u cloroform v dung dch acid benzoic, ho tan
vanilin trong hn hp ny ri thm dung ch
methylcellulose, khuy k trong 5 pht.
Ho tan natri saccarin trong mt t nc ri phi hp vo
dung dich trn. Thm nc va 500 ml.
Thm du parafin, khuy u ri cho qua my ng nht
ho.
ng chai, dn nhn ng quy nh.
Cng dng: thuc nhun, ty. nhun trng, ung 30
ml nh tng/ln. ty ung 60 ml nh tng/ln.

n thuc 8.3:
Rp. Du parafin
35.0
Tween 80
4,3g
Span 80
1,68g
Nc tinh khit va 1000,0ml
M. f. emul.
K thut bo ch.
un nng du parafin n khong 60C ho tan span 80.
un nng nc n khong 65 C, ho tan Tween 80.
Phi hp 2 pha, cho nh tng qua my ng nht ho.
ng chai, dn nhn ng quy nh.
Cng dng: dng lm thuc nhun, ty. Ung 50 ml nh
tng/ln c tc dng nhun trng, ung 100 ml nh
tng/ln c tc dng ty.

Cng thc 8.4: nh tng gim au (Analgesic Balm)

Sp nh ho (BP 2003) 15.0 g
Du parafin
10,0 g
Methy salicylat
10.0g
Menthol
5.0g
Nc tinh khit
60,0g
K thut bo ch.
Trn u methyl salicylat v menthol c mt dung
dch trong sut. Trn dung dch ny vi mt na lng du
parafin (1).
un nng sp nh ho v mt na lng du parafin cn
li n 55 - 60C. Khuy u (2).

un nng nc n khong 60C ri thm (2). khuy

mnh.
Tip tc thm (1), khuy mnh ri cho qua my ng
nht ho.
ng chai, dn nhn ng quy nh.
Cng dng: cha au c, au lng, au khp, cng vai,
mi c, au dy thn kinh, vt bm, bong gn, cng c. thp
khp. Xoa thuc ln ch au, kt hp vi bp 2-4 ln/ngy.

n thuc 8.5:
Acid stearic
5,00 g
Du vaselin
7.00 g
Kali carbonat
0.50 g
Natri borat
0,25 g
Nc ct va
50,00g
M. f. Cream.
K thut bo ch:
Ho tan kali carbonat, natri borat trong ton b lng nc c trong
n ri un nng n khong 65 - 70 C, rt vo ci s nng (1).
ng thi un nng hn hp acid stearic v u vaselin trong mt bt
s khc n khong 60 - 65 C (2).
Rt t t (2) vo (1) ng thi dng chy nh nhanh, lin tc cho
n khi cream c hnh thnh.
ng vo l rng ming hoc tup, dn nhn ng quy nh.
Cng dng: kem lm mm v du da nht l ma hanh kh.

Chng 9

K THUT BO CH HN DCH THUC

MC TIU HC TP
1. Nu c nh ngha, phn loi, ric im ca hn dch
thuc.
2. Trnh b c thnh phn chung ca cc hn dch thuc.
3.Trnh by c nguyn tc tin hnh ca cc phng php bo
ch hn dch thuc.
4.Nu c yu cu cht lng chnh ca hn dch thuc.
5.Vit c trnh t pha ch ca mt s hn dch thuc

I. I CNG
1. nh ngha
Hn dch thuc l cc ch phm thuc lng ung,
tim, dng ngoi, cha cc dc cht rn khng tan dng
ht nh (ng knh > 0,1 micromet) phn tn u trong cc
cht dn.
nh ngha trn mi ch cp n cc hn dch thuc
dng lng. Thc t trong bo ch, cc dng thuc bn rn nh
thuc n hoc dng thuc mm nh thuc m hoc dng kh
nh thuc phun m, u c cc ch phm c cu trc hn
dch, nhng ni dung c vit trong cc chng tng
ng. Trong chng ny ch yu vit v hn dch thuc
dng lng.

2. Phn loi
Cc hn dch thuc c phn loi theo nhiu cch:
Theo tnh cht ca cc cht dn: c hn dch nc, hn ch
du, hn dch glycerin...
Theo ng dng: c hn dch ung (l cc hn dch nc),
hn dch tim v dng ngoi (c th l hn dch nc hoc hn
dch du).
Theo kch thc ca tiu phn dc cht rn phn tn, c 2
loi:
+ Hn dch th cn gi l hn dch phi lc, trong tiu
phn c cht rn c ng knh khong 1-100 micromet. di
tc dng ca trng lc, cc hn ch th thng b sa lng v
ng cn y chai trong qu trnh bo qun. V th, trc khi
dng phi lc chai thuc dc cht phn tn ng u tr li
mi rt ra dng.

Cc hn ch thuc pha ch theo n trong phng bo ch nh.

bng phng php phn tn c hc, vi cc phng tin th cng th
s nh nghin, khuy bng ci chy u l cc hn dch th.
+ Hn dch mn cn gi l hn dch c, trong tiu phn
c cht rn phn tn c ng knh trong khong 0,1-1 micromet,
c kch thc nh gn nh cc ht keo nn l h phn tn kh vng
bn, nhn b ngoi hn dch l cht lng c. V mt cu trc i ho,
cc hn dch ny l nhng h phn tn vi d th.
Cc hn dch thuc cng cn c gi tn theo cch s dng, v
d: potio (l hn dch nc c siro lm ngt v c pha ch theo n
bnh nhn ung tng tha), thuc xoa (linimentum). thuc bi xc
(lotio), thuc sc ming (gargansmata), thuc nh mt (ocu(oguuae)...
Ngoi dng hn dch lng hin nay cn c dng Ihuc bt hoc
cm pha hn dch. Trc khi dng, thuc c chuyn thnh dng
hn dch bng cch lc vi nc hay cht dn thch hp.

3. u, nhc im u im:
C th ch c dng thuc lng t cc dc cht rn khng tan hoc rt
t tan trong cc dung mi thng thng nn c th dng thuc theo ng
tim hay nh ln cc nim mc nh thuc nh mt (l nhng ng dng
thuc i hi thuc phi dng lng) v khi dung theo ng ung rt d
nut i vi tr em v ngi gi.
Hn ch c nhc im ca ca mt s dc cht m khi pha thnh
ung dch s khng vng bn, hoc c mi v kh ung hoc gy kch ng
i vdi nim mc ng tiu ho.
C th ko di tc dng ca thuc so vi khi dng thuc dng dung
dch (thuc tim hn ch, thuc nh mt hn dch).
C th hn ch tc dng ca thuc ti ch: v cc mui ch dng ngoi
c tc dng sn se, st khun nhng nu dng di dng dung dch, ch c
th c hp thu vo mu gy c. hn ch tc dng ca chng ti ch
trn da hoc trn nim mc ni dng thuc, ngi ta bo ch dui dng hn
dch dng ngoi. in hnh cho loi ny l nc trng ch bng cch lc
dung dch acetat ch kim vi nc thng theo t l 0,2%.

Nhc im:
Hn dch l nhng h phn tn d th th, rt khng bn v
trng thi phn tn, d phn lp do s sa lng ca cc tiu phn
c cht rn.
Kh m bo liu lng chnh xc nu bnh nhn khng lc
k chai thuc trc khi dng. V th, trn nhn thuc phi c
dng ch Lc k trc khi ng v mt s Dc in cn
quy nh khng bo ch cc dc cht c bng A, B di dng
hn dch khi chng khng tan trong mi trng phn tn.

II. THNH PHN HN DCH THUC

Ni chung, hn dch thuc c 3 thnh phn chnh l: pha
phn tn, mi trng phn tn v cht gy thm.
1. Pha phn tn
Pha phn tn l cc dc cht rn khng tan trong mi
trng phn tn c phn chia thnh cc tiu phn c 1 - 100
micromet hay nh hn nh bt siu mn.
Pha phn tn c th l cc tiu phn dc cht rn khng tan
trong mi trng phn tn c hnh thnh do s ngng kt khi
iu ch hn dch thuc.

2. Mi trng phn tn
Mi trng phn tn (hay cht dn) c th l nc v cc ung mi ha
tan vi nc nh ethanol, propylen glycol, glycerin. khi iu ch hn dch
nc.
Mi trng phn tn c th l du thc vt khng c tc ng dc l
ring khi iu ch hn dch du.
Trong mi trng phn tn ca mt hn ch thuc c th c nhiu thnh
phn khc nhau ho tan trong nh:
+ Cc dc cht ho tan hon ton trong mi trng phn tn.
+ Cc cht n nh dc cht nh cht iu chnh pH, cht chng oxy
ho.
+ Cc chit lm tng nht ca mi ng phn tn, m chm qu
trnh sa lng ca hn dch thuc.
+ Cc cht bo qun chng s pht trin ca cc vi khun, nn mc...
+ Cc cht lm ngt (hn dch ung), lm thm (hn dch ung v dng
ngoi).
- Cc cht mu (hn ch ung v dng ngoi).

3. Cht gy thm
Khi bo ch hn dch thuc c dc cht rn (pha phn tn)
kh thm mi trng phn tn, mun thu c hn dch ng
nht, nht thit phi dng cht gy thm.
Cc cht gy thm c tc dng lm cho b mt cc tiu phn
dc cht rn tr thnh d thm mi trng phn tn nn d
dng phn tn ng nht vo mi trng phn tn khi pha ch
hn dch.
Cc cht thng dng lm cht gy thm trong bo ch hn
dch thuc cng l cc cht nh ho - n nh c dng khi
bo ch nh tng thuc (xem chng 8, phn cht nh ho).

III. K THUT BO CH HN DCH THUC

Cc hn dch thuc c th c bo ch theo cc phng
php sau:
1. Phng php phn tn
Dc cht rn khng tan trong cht dn c phn tn vo
cht dn bng cc phng php c hc nh nghin, xay, khuy,
trn,... hoc dng siu m.
Trong thc hnh, phng php phn tn c hc l phng
php ch yu c p dng trong bo ch hn ch thuc.
- quy m bo ch nh, vi phng tin nh ci chy, trnh
t bo ch mt hn ch thuc thng tin hnh qua 4 bc:
+ Pha dung dch cht dn: ho tan cc cht tan c trong
dung mi c trong cht dn thnh dung dch v ic (nu cn).
+ Nghin kh: nghin cc c cht rn bng chy ci kh
n mn ti a c th t c (cng mn cng tt).

Nu lng c cht rn tng i ln, sau khi nghin phi

ry qua hai c ry thch hp thu c bt mn c kch thc
tiu phn tng i ng nht.
+ Nghin t to hn dch c: Chia lm hai trng hp
Nu dc cht rn d thm cht n (v d cht dn l nc
v dc cht d thm nc) th ch vic thm vo bt dc cht
mt lng cht dn va (bng 1/2 n bng lng c cht)
to thnh mt khi bt nho c, tip tc nghin k cho t khi
thu c khi nho tht mn.
Nu dc cht rn kh thm cht dn (v d cht dn l nc
v dc cht s nc) th thm vo bt dc cht mt lng
ch th cht gy thm hoc mt lung bt cht gy thm v
mt ng cht dn va to thnh mt khi bt nho c ri
tip tc nghin k cho ti khi thu c mt khi nho tht mn.

+ Pha long hn ch c: thm dn tng lng nh cht n vo khi

bt nho mn ni trn, va thm va nghin, yn hn hp trong 1-2
pht, gn lp cht lng c trn vo chai. Tip tc nghin k cn cn li
trong ci, ri li cho thm mt lng cht dn na vo nghin v lng gn
nh trn. C tip tc nh th cho ti khi dng ht lng cht dn
chuyn bt dc cht thnh hn dch.
quy m sn xut ln, c my mc, thit b thch hp th bo ch hn
dch qua cc bc sau:
+ Xay nghin dc cht rn n mn xc nh, ry qua hai c dy
thch hp thu c bt dc cht c kch thc tiu phn ng nht.
+ Pha dung dch cht dn, lc (nu cn), chuyn sang my 1 khuy
trn.
+ Thm dn bt c cht vo cht n trong khi vn khuy trn.
+ Cui cng cho hn hp thu c chy qua my xay keo lm mn
v lm ng nht hn dch.
+ ng hn dch thuc vo bao b x l trc. Ch ch ng y
n 2/3 dung tch ca bao b lc c trc khi dng.

2. Phng php ngng kt

Ngng kt l phng php iu ch cc hn dch thuc,
trong dc cht rn dng tiu phn c kch thc > 0,1
micromet ch c hnh thnh trong qu trnh iu ch hn dch,
do s thay i dung mi hoc phn ng trao i ion vi nhau,
to ra kt ta hay nhng cht mi khng tan hoc rt t tan trong
cht dn.
Phng php ngng kt cng c p dng iu ch cc
hn dch c dc cht rn khng tan trong cht dn ca thuc
nhng li rt d tan trong cc dung mi tr khc, bng och ho
tan dc cht rn vo dung mi tr, ri phi hp t t vo cht
dn thu c hn dch mn.
Khi p dng phng php ngng kt bo ch cc hn
dch thuc, mun thu c hn dch thuc c cht lng cao,
kt ta phi nh mn, cn ch :

+ Vi trng hp hn dch c to ra o c hot cht b kt ta, do

thay i dung mi, khi phi hp vi cht dn (v d pha potio hoc otio,
c thnh phn l cn thuc hoc cao lng ch t cc dc liu cha tinh
u hoc cht nha, vi cht dn nc) th phi trn cn thuc hay cao
lng vi siro hoc dung ch ca mt cht keo thn nc hoc glycerin
hoc Tween 80... Ri t t tng t mt hn hp ny vo ton b
lng cht dn, va va khuy.
+ Vi trng hp hn dch c to thnh do cc dc cht phn
ng trao i vi nhau, to ra cht mi khng tan trong cht dn th phi
dng ton b lng cht dn c trong cng thc hoc n thuc, ho tan
ring cc dc cht s tham gia phn ng thnh dung dch thi long,
ri phi hp dn dn vi nhau ng thi khuy trn thu c hn
dch mn, ng nht.
Tu theo thnh phn ca hn dch thuc, c trng hp phi p
dng kt hp c hai phng php phn tn v ngng kt nu trn
pha ch hn dch.

IV. YU CU CHT LNG HN DCH THUC

Dc in Vit Nam 3 cha quy nh c th v cc ch tiu cht
lng ca cc hn dch thuc. Theo cc ti liu chuyn mn, hn dch
thuc phi t cc yu cu cht lng sau:
V mt cm quan: khi yn, dc cht rn phn tn c th tch
thnh lp ring lng xung y chai l nhng phi tr li trng thi phn
tn ng u trong cht dn khi lc nh chai thuc trong I -2 pht v gi
nguyn c trng thi phn tn u trong vi pht. Yu cu ny ch
l tl thiu, nhm m bo khi s dng thc, lng dc cht c
phn phi tng i u trong cc liu.
kim tra mc phn tn ng u ca dc cht trong hn
dch thuc, c th nh gi bng cch lc u chai thuc, ri ly nhng
th tch thuc nh nhau, em ly tm, tch ly cn em cn.
Kch thc tiu phn dc cht ong hn ch (thng ch p dng
vi cc hn dch tim hay nh mt): c th xc nh bng soi knh hin
vi hoc thit b m tiu phn t ng.

Xc nh vn tc lng cn: lc u hn dch, rt vo ng

ong c chia vch, yn, c lp cn sau tng khong thi
gian xc nh. Ngi ta cho rng chun hn dch t cht lng
tt nu sau 24 gi, lp cn chim 85% th tch ca hn hp v
dng tr li trng thi phn tn u khi lc nh nhng.
Hn dch thuc cn phi t cc ch tiu v pH, nh tnh,
nh lng, gii hn tp cht, sai s th tch/khi lng... theo
tng chuyn lun ring.

V. MT S N V CNG THC HN DCH THUC

n thuc 9.1:
Rp. Terpin hydrat
2,0g
Gm arabic
1.0 g
Natri benzoat
2,0 g
Siro codein
15,0 g
Nc ct va
75 ml
M. t potio
K thut bo ch theo phng php phn tn, qua cc bc:
Cn v nghin tht mn terpin hydrat (nn thm vi git
ethanol 90 cho d nghin mn v gm labic, trn thnh bt kp.
Thm ng lng so codein nghin tht k thnh bt
nho.

Cho siro codein cn li vo chai.

Ho tan natri benzoat vo nc (un nng nu cn), dng
dung dch ny ko dn hn dch vo chai c siro codein.
B sung nc va 75 ml, lc u.
ng chai, dn nhn ng qui ch, nhn c thm dng ch
Lc trc khi dng.
Cng dng: cha ho, long m. Ung 1-2 tha canh (15 - 30
ml)/ln, 2-3 ln/ngy.

Cng thc 9.2: hn dch bari sulfat

Bai Sulfat
100,0 g
Natri benzoat
0,06 g
Natricarboxy methyl Cellulose 1,0 g
Natri saccarin
0,2 g
So n
10,0 g
Cn vanilin 10%
10 git
Nc tinh khit va
100 ml
K thut bo ch theo phng php phn tn:
Cn natri carboxymethyl cellulose, ngm trong khong 10
ml nc m khong 50c cho trng n hon ton.
Cn bari Sulfat nghin tht mn trong ci, ry qua ry s
180.

Cho dch natri carboxymethyl cellulose vo ci c bari

Sulfat, nghin tht k thnh bt nho.
Ho tan natri saccarin, natri benzoat vo lng nc cn li
ri phi hp vi bt nho.
Cho hn dch vo chai c siro n.
Thm cn vanilin lc u.
Thm nc va 100 ml.
ng chai, dn nhn ng qui ch, nhn c thm ng ch
Lc trc khi dng.
Cng dng, cch dng: hn dch thuc ung khi chp X
quang d dy. Liu mt ln chp 150 - 200 ml. Lc k trc
khi ung.

Ngoi dng hn dch trn, ngi ta cn bo ch bt bari sulfat

pha hn dch theo cng thc (D Hungary VI):
Vanilin
0,04 g
Sacarin
0,06 g
Metyl cellulose
3,00 g
Bari Sulfat
96,9 g
Cng thc 9.3: hn dch Cotrimoxazol
Sulfamethoxazol
2,4 g
Trimethoprim
0,48g
Nipagin
0,136g
Natri carboxymethyl cellulose
0,3g
Natri saccarin
0,06g
Tween 80
0,12g
Propylen glycol
2,4g
Acid citric
0,064g
Cht thm
va
Nc ct
60ml

K thut bo ch theo phng php phn tn:

Cn sulfamethoxazoi v trimethoprim, nghin mn, trn thnh bt
kp trong ci.
Ngm natri carboxymethyl cellulose trong khong 10 ml nc m
cho trng n hon ton, thm Twen 8.0 vo trn u.
Cho hp dch ny vo ci c dc cht, nghin k thnh bt nho.
Ho tan nipagin vo propylen glycol. Ho tan natri saccarin v acid
citric vo nc. Phi hp 2 dung dch v dng ko hn dch vo chai.
Thm cht thm.
Thm nc va , lc u.
ng chai, dn nhn ng qui ch. Nhn c thm dng ch Lc
trc khi dng.
Cng dng, cch dng:
Thuc ung iu tr cc bnh nhim khun: ng h hp (vim
ph qun kh qun) ng tit niu, ng sinh dc, ng tiu ho.
Liu dng: 10 ml/ln, ngy 2- 3 ln. t iu tr t 7-10 ngy.
Khng nn dng cho bnh nhn suy thn.

n thuc 9.4:
Rp. Long no
1,0g
Lu hunh
4,0 g
Glycerin
20,0 g
Nc ct va
100 ml
M. f. lotio
Bo ch lotio ny bng phng php phn tn.
em thuc 9.5:
Rp. Acid salicylic
1,0 g
Long no
1,0 g
Lu hunh kt ta
4,0 g
Ethanol
20,0 g
Glycerin
20,0 g
Ne ct va
100 ml
M.f. lotio

Bo ch n thuc hn dch ny bng cch kt hp phng

php phn tn v phng php ngng kt:
Nghin mn lu hunh trong ci, thm ng lng glycerin,
tip tc nghin thnh khi nho mn.
Ho tan acid salicylic v long no trong ethanol (1).
Phi hp lng glycerin cn li vi lng nc c trong
cng thc (2).
Rt t t (1) vo (2) ng thi vi khuy trn c hn ch
(3).
Dng hn dch (3) pha long bt nho lu hunh v ko vo
chai.
Thm nc va 100 ml
ng chai, dn nhn ng qui ch. Nhn c thm dng ch
Lc trc khi dng.

Chng 10

K THUT BO CH THUC PHUN M

MC TIU HC TP
1. Trnh by c nguyn tc hot ng, phn loi v u nhc im ca
thuc phun m.
2. Nu c 5 thnh phn cu to chung ca thuc phun m.
3. Trnh by c nguyn tc sn xut thuc phun m.
4. Nu c yu cu cht lng chnh ca thuc phun m.
5. Hng dn s dng ng cc loi thuc phun m trn c s hiu bit v
cu to v nguyn tc hot ng ca dng thuc.

I. I CNG
1. Khi nim
Thuc phun m l dng thuc khi s dng, thuc c phn tn
thnh nhng tiu phn rt nh th rn hoc th lng trong khng
kh. Dc cht c th dng bt, dung dch, hn dch, nh tng
c ng trong bao gi kn v c y ti ni iu tr nh p
sut ca kh nn, kh ho lng hoc nh lc c hc do ngi dng
thuc to ra.
Thuc phun m c ch nh dng ti ch trn da,, nim mc,
dng cho cc hc ca c th nh tai, trc trng, m o hoc dng
xng ht qua ng h hp thuc vo xoang mi, vo phi gy
tc dng ti ch hay ton thn.
Do c im thuc to ra h phn tn cc tiu phn rt mn
trong khng kh nn thuc phun m c tn gi chung l aerosol (kh
dung).

2. Phn loi
Theo ng dng: thuc phun m dng ti ch trn da, dng
cho tai, trc trng, m o, thuc xng ht (inhaler) thuc phun
m ng theo ng h hp qua ming, mi vo phi, vo xoang
mi, di li...
Theo trng thi tp hp ca thuc v cht y trong bnh cha:
thuc phun m hai pha (pha lng gm dung ch thuc tan trong
cht y lng v pha hi ca cht y), thuc phun m ba pha bao
gm hn dch hoc nh tng thuc v cht y th kh.

Hnh 10.1. Cc dng thuc phun m

Theo cu trc ho l ca h thuc c th c cc loi: thc phun

m dung dch, hn dch, nh tng, bt xp. Ngoi ra cn c loi
bt hoc nang (cha bt thuc siu mn) dng xng ht. Loi
thuc phun m ny thng dng lc c hc bt v ti, chc thng
nang bt mn c ht vo ng h hp (mi ng tc bt lc
c hc gii phng mt liu thuc xc nh).
Theo loi dng c thit b to phun m c cc loi: thuc phun
m c van nh liu, c van phun lin tc, c bm nh liu khng
dng cht y, loi thuc cn dng c to phun m dng cho iu
tr cc khoa phng bnh vin, thuc phun m dng kh nn, dng
kh ho lng, loi c piston t do (to vch ngn thuc vi cht y)
hoc loi c ti cht do (ng thuc tch bit khi cht y).
Cn lu phn bit thuc phun m (aerosol) cho cc tiu phn
phun ra rt nh (di 50 m) vi loi thuc phun xt (spray) cn gi
l thuc phun m th i, phun ra cc tiu phn ln trn 100 m

3. u nhc im
u im:
- S dng rt thun tin, d dng v nhanh chng to ra mt liu
thuc khng cn ng mt dng c trung gian no khc, m bo v
sinh.
Thuc c ng trong bnh kn khng c s xm nhp ca hi
m, khng kh v vi sinh vt, v vy thuc phun m c n nh cao,
trnh c s phn hu do cc tc nhn ho hc hay tc nhn vi sinh
vt.
Vi thuc phun m c van inh liu, m bo s phn liu chnh
xc.
Thuc c phun ra ph nh ln da hay nim mc, hn ch ti a
cc tc ng gy kch ng ni dng thuc.
Thuc phun m c th c dng thay cho dng thuc tim i vi
mt s loi thuc nh hormon (v d insulin), thuc chng virus... bng
cch xng ht qua ng h hp rt thun tin cho bnh nhn.

Thuc phun c hiu lc iu tr cao: Khi dng ti ch, dc cht

c tip xc tt trn da hay nim mc. Khi dng xng ht qua ming,
mi vo phi, thuc c th pht huy tc ng ton thn o dc cht
c hp thu qua mao mch di li hay mao mch ph nang vo
mu, trnh c s phn hu dc cht ng tiu ho v vng
tun hon qua gan vi thuc khng i qua ng ny.
Ni chung thuc phun m s ng liu lng thp, c th hn ch
c tc ng khng mong mun.

Nhc im:
K thut sn xut thuc phun m ni chung tng i phc tp.
Thuc phun m i hi bao gi bao gm bnh cha, h van, u
phun... Qu trnh ng np cht y ng thi vi qu trnh ng gi
hon chnh to bnh thuc kn i hi thit b phc tp.
Thuc phun m s dng cht y loi dn cht fluocarbon l cht
ph hu tng ozon ca kh quyn tri t. Loi cht y l
hydrocarbon khng c nhc im ny nhng li l cc cht d gy
chy n khi tip xc vi nhit.
Mt s thuc phun m dng ti ch khi dng nhm vo ng h
hp c th gy nguy him cht ngi.
Thuc phun m dng xng ht vo phi nu khng c s phi hp
nhp ht th theo ng yu cu s dng, liu thuc s khng dc hp
thu y , khng t c hiu lc iu tr mong mun.

II. THNH PHN CU TO CA THUC PHUN M

Thuc phun m c th cha mt hay nhu loi dc cht cng
vi cht y, dung mi cht n, cht bo qun, cht lm tng tan,
cht n nh...
Cc thnh phn c trng v quan trng ca thuc phun m l:
cht y, bnh cha, van, u phun (nt bn) v thuc.
I. Cht y
Cht y trong thuc phun m l cc kh nn hoc kh ho lng,
to ra p sut cao trong bnh phun thuc ra khi bnh khi bm m
van. Kh ho lng gm 2 nhm l cc dn xut ca fluocarbon v cc
hydrocarbon. Kh nn thng dng cho thuc phun m l nit, carbon
ioxyd v nit oxyd.

1.1. Cc kh ho lng dng lm cht y cho thuc phun m

Kh ho lng c u im hn kh nn v nhiu mt nn thng
c dng trong cc thuc phun m yu cu cht lng cao. Bnh
thuc phun m cha kh ho lng c th tch gn nh do kh lng c
th tch nh. Mt khc do c s cn bng gia 2 pha lng - hi nn
bnh thuc gi c p sut hng nh trong qu trnh s dng, m
bo chnh xc phn liu v mn ca cc tiu phn.
Kh ho lng cn ng vai tr tc nhn gy phn tn, l thnh
phn trong tiu phn thuc phun ra t bnh cha, hi kh lng ho
thot ra khi tiu phn, lm cho cc tiu phn thuc tip tc b phn
chia nh hn, ong mt s trng hp ring c-th to bt xp.

1.1.1 Cc fluocarbon
Thng dng triclo monofluo methan, diclo difluo methan, diclo
tetrafluo ethan, monoclo difluo ethan, difluo ethan, monoclo difluo
methan.
Cc cht y nhm fluocarbon thng c gi tt l freon hoc
propellant km s k hiu c th tm ra cng thc ho hc ca
chng. S k hiu c quy c nh sau: s hng n v tng ng
vi s nguyn t fluo trong phn t, s hng chc tng ng vi s
nguyn t hydro cng 1, s hng trm tng ng vi s nguyn t
carbon tr 1, s nguyn t clo c suy t hiu s c tr s trn m
bo bo ho ho tr ca carbon, nu hp cht ng vng th thm ch
c trc cc con s, nu c nhiu ng phn th thm ch a, b, c ng
sau cc con s.

V d: cht y 11, 12, 114 c tnh ra c cng thc ho hc sau:

Cc dn cht fluocarbon ni chung tng i tr v ho hc, t c hi v khng

d chy. Do c nhng u im nh nu trn nn chng c ng cho cc thuc
phun m xng ht qua mi hoc ming to ra cc tiu phn c mn cao thuc d
hp thu, pht huy hiu lc iu tr tt. Tuy nhin, chng ph hu tng ozon ca kh
quyn tri t nn b cm s dng cho cc thuc phun m thng thng. Thuc phun
m dng xng ht qua mi, qua ng ming, to bt xp dng cho m o cha
cc cht st khun, thuc phun m cha khng sinh cho php khng p dng qui ch
ny.
Cc cht y fluocarbon thng c dng phi hp theo t l sao cho t c
mt p sut hi thch hp cho tng ch phm thuc phun m.

1.2. Cc cht y l hydrocarbon

Cc hydrocarbon c dng lm cht y c u im so vi cc
fluocarbon l gi thnh r v khng gy tc hi n kh quyn. Tuy nhin,
chng d chy n. Cc cht hay dng l propan, butan v isobutan. hn
ch kh nng chy n c th trn ln vi cc fluocarbon hoc s dng bnh
phun m c lp vn thch hp.
1.1.2. Cc kh nn dng lm cht y
Cc kh nit, dinit oxyd, carbon dioxy c dng m chy y trong
thuc phun m. Tu theo bn cht ca cng thc thuc v cu to ca van,
thuc c phn tn ra khi bnh to thnh m, bt xp hoc th mm nh
thuc m.
Cc kh nn cn c u im l tr v mt ho hc, khng phn ng
tng tc vi dc cht trong h. Kh nit v carbon dioxyd cn c vai tr
y loi khng kh trong h bnh thuc phun m, lm tng n nh ca
thuc.
Khc vi kh ho lng, thuc phun m s dng kh nn c nhc im l
khi s ng p lc trong bnh s gim dn nn phn liu khng

2. Bnh cha
Bnh cha thuc phun m c lm bng cc vt liu c kh nng chu p
sut cao (12,5 -13,5 atm 55C) v khng b cht y hay cc thnh phn
khc ca thuc n mn nh kim loi (nhm, thp khng g thp m thic),
thu tinh.
Tu loi thuc phun m m bnh cha c dung tch v hnh th khc nhau.
3. Van
Van lm nhim v bt kn bnh cha v phn phi thuc phun ra khi bnh
ti ni iu tr nh p sut cao trong bnh. C hai loi van:
Van phun lin tc: l loi khi bm nt m van, thuc c phun ra Hn
tc ch ngng khi b tay, nt bm tr v v tr ban u ng van li.
Van nh liu: l loi van khi bm nt m van, thuc ch c phun ra
mt liu lng xc nh. C s ca vic to ra mt liu thuc chnh xc l nh
nguyn tc van c mt khoang trng, kch thc ca khoang trng ny quyt
nh lng thuc y ra.
Van nh iu c 2 kiu c bn: kiu van s dng th thng ng v
kiu quay u ngc xung. Kiu van dng thng ng vi ng nhng nh
thng dng cho thuc h dung dch. Kiu van quay ngc thng khng c
ng nhng dng cho h thuc phun m cha hn dch,, nh tng.

4. u phun v nt bm
u phun ng thi l nt bm, ming phun lm nhim v gii phng
thuc ra khi bnh cha, hng thuc phun vo ni cn iu tr. u phun
c gn lin vi h van khi bm, van s m ra v cng nhanh chng
ng li khi thi khng bm nt nh l xo trong van.
C mt s loi u phun c bn nh sau:
u phun m: c s dng rng ri, c kh nng to ra cc tiu phn
lng i nh bng cch cho hoi y qua cc l h. u phun c th c t 1
n 3 l m c ng knh t 0,4 n 1 mm.
u phun to bt xp: c l thot tng i rng, t 1,78 n 3,81 mm
v c th rng hn. Cc l thot cho thuc i vo mt khoang ch rng sau
tip tc c y ra ngoi qua mt ming phun.
u phun to cc thuc th mm: phn tn thuc ra c th cht nm nh
thuc m, bt nho, cu to tng t loi u phun to bt xp.
Cc u phun c bit: nhiu thuc phun m c mc ch s ng ring
i hi cc u phun c thit k hnh dng cu to c bit sao cho thuc
c a n ni iu tr cn thit nh ming, yt bu, mi, mt, m
o...

5. Thuc
Tu theo ng dng thuc, ni cn iu tr, bn cht ca c cht v
cht y s dng trong h m cho thm cc t dc cn thit vo thuc v
bo ch thuc thnh dung dch, hn dch, hay nh tng... ng np vo
bnh.

III. NGUYN TC SN XUT THUC PHUN M

Sn xut thuc phun m gm hai giai on ch yu l: iu ch
thuc ng np vo bnh v ng np cht y vo bnh thuc (ng
thi hon chinh ng kn bnh thuc).
Giai on iu ch thuc i hi k thut v dng c thit b nhu
i vi vic sn xut cc dng bo ch thng thng thuc h ung
dch, hn dch, nh tng, bt thuc...
Giai on np cht y c th thc hin bng phng php ng p
sut hoc ng lnh:
Nguyn tc ng p sut c thc hin qua cc bc:
+ Np thuc vo bnh cha cha gn van (cht lng, mm hoc
bt).
+ t van, vng m vo b ming bnh, ui khng kh ra khi
bnh (cho vo bnh vi git kh ho lng, kh bc hi s ui khng kh
ra), ng kn van.
+ Np cht y qua van vo bnh di p sut cao (ngc chiu vi
s vn hnh bnh thng ca van).

+ u phun c t vo sau cng.

Nguyn tc ng lnh: thc hin nhit thp, kh ho lng thuc
c np vo bnh, sau t van ng kn trc khi nhit tr li
bnh thng.
Tu theo quy m sn xut nh hay quy m cng nghip m s dng
cc thit b my mc thch hp.
+ u phun c t vo sau cng.
Nguyn tc ng lnh: thc hin nhit thp, kh ho ln thuc
c np vo bnh, sau t van ng kn trc khi nhit , tr li
bnh thng.
Tu theo quy m sn xut nh hay quy m cng nghip m s dng
cc thit b my mc thch hp.
nh tnh nh lng, gii hn tp cht, nhim khun.

IV. YU CU CHT LNG THUC PHUN M

Thuc phun m l ch phm c bit ng trong bnh c p sut cao
nn c nhiu php th cn thit m bo an ton cho qu trnh bo
qun v s dng. Cc ch tiu sau thng c quy nh trong cc Dc
in:
ng u ca cc liu phun: phun tng liu thuc vo mt
dng c ly mu c bit. nh lng t l dc cht c trong mi
Iij ri so snh.
mn ca cc tiu phn phun ra: c xc nh bng dng c
nh gi mn ca tiu phn da trn nguyn tc kh ng lc hc..
S liu trong mt n v ng gi: khng c t hn s liu gh
trn nhn.

V. MT S CNG THC THUC PHUN M

Cng thc 10.1: dung dch xng ht Bricanyl (dng thit b to
phun m)
Thnh phn:
Terbutalin Sulfat loi pha tim
100 mg
Natri clorid
580 mg
Clorobutol
500 mg
Dung ch acid hyrocloric 2M va n pH 3,0
Nc ct pha thuc tim va
100 ml
Cng thc 10.2: thuc phun m Salbuvent (dng xng ht)
Thnh phn cho 200 liu:
Salbutamol (siu mn)
20 mg
Lecithin u tng
7 mg
Sorbitan trioleat
5 mg
Cht y 1 1 (triclo monoAuo methan)
4,14 mg
Cht y 12 (diclo difluo methan)
9,66 mg

Cng thc 10.3: thuc phun m Serobid (dng xng ht)

Thnh phn cho 100 liu:
Salmeterol xinafoat (bt siu mn) 7,0 mg
Lecithin
0,7 mg
Cht y 11
3,7 mg
Cht y 12
10,0 mg
Cng thc 10.4: thuc bt Salmeterol (dng xng ht, hp 60 liu,
mi ln s dng tay bt lc c hc to phun m 1 liu thuc bt).
Thnh phn cho 1 liu:
Salmeterol xinafoat
72,5 mcg
Fluticasion propionat
500,0 mcg
Lactose va
12,5 mg
(3 thnh phn u dng bt siu mn)
Cng thc 10.5: thuc phun di li nitroglcerin
Nitroglycerin
0,41 mg
Diclo difluo methan
10,66 mg
Diclo tetrafluo methan
16,01 mg
Cht iu hng, iu v, n nh... 22,92 mg

Chng 11
K THUT BO CH THUC M
MC TIU HC TP
1. Nu c nh ngha, phn loi v yu cu cht lng ca thuc
m.
2. Trnh by c cu to, u nhc im ca cc t dc ng
bo ch thuc m.
3. Trnh by c k thut bo ch thuc m bng phng php
ho tan, trn u n gin, trn u nh ho v nh ho trc tip.
4. Nu c trnh t pha ch mt s cng thc thuc m c th.

I. I CNG
1. nh ngha
Thuc m dng thuc th mm dng bi lrt da hoc nim mc nhm
bo v da hoc a thuc thm qua da,
2. Phn loi
2.1. Da vo th cht v thnh phn
Ngi ta chia thuc m lm 4 loi:
Thuc m mm: L dng thuc m hay gp nht, c th cht mm ging
nhe vaseiin hoc m ln.
Thuc m c hay bt nho: L ng thuc m c th cht c do trong
thnh phn c cha dc cht dng bt khng tan > 40%.
Sp: L dng thuc m c th cht do qunh do trong thnh phn c cha
mt t l ng k cc sp hoc aicol bo cao.
Kem bi a: L thuc m c th cht mm, mn mng do trong thnh phn
c cha mt t l ln cc cht th lng nh nc, glycerin, propylen glycol,
du thc vt, du khong. Cc kem thng c cu trc kiu nh tng D/N hoc
N/D.
Gel: L thuc m c th cht mm, trong mt hay nhiu dc cht c
ho tan hay phn tn trong t dc polyme thin nhin hoc tng hp.

2.2. Da vo cu trc
Ngi ta chia thuc m thnh cc loi nh sau:
Thuc m thuc h phn tn ng th (thuc m mt pha, thuc m
kiu dung dch) loi ny c cht tan trong t dc.
Thuc m thuc h phn tn d th (thuc m nhiu pha). Loi ny
dc cht v t dc khng ng tan. Cc thuc m thuc h ny c
xp thnh 3 phn nhm:
+ Thuc m kiu hn dch: Dc cht dng bt mn phn tn u
trong t dc.
+ Thuc m kiu nh tng: Dc cht th lng hoc mm phn
tn u trong t dc khng ng tan.
+ Thuc m c cu trc phc tp: Loi ny t dc c cu trc nh
tng, dc cht c th l cht rn, lng, tan hoc khng tan trong t
dc.
Thuc m c cu trc kiu hn - nh tng hoc dung dch - hn
dch - nh tng.

II. THNH PHN THUC M

1. Dc cht
Dc cht dng trong thuc m rt phong ph, bao gm cc cht th
rn, lng, mm, tan hoc khng tan trong trong t dc. Dc cht phi t
tiu chun dc dng, phi c ho tan hoc phn tn ng nht trong t
dc.
2. T dc
2.1 Cc t dc thn du
2.1.1. Cc du m sp v dn cht
a. Cc du m: Cc du m l este ca glycerin vi cc acid bo cao no
hay khng no, c u nhc im sau:
u im:
+ D bt nh ln da v nim mc.
+ Cc du m c ngun gc ng vt thng c kh nng thm su.
Nhc im:
+ Trn nhn, kh ra sch bng nc, cn tr s trao i binh thng
ca da v nim mc (to nhit v tit m hi).
+ D b i kht trng qu trnh bo qun.

T dc in hnh:
+ Du c: Thu c bng cch p t gan cc loi c thu, c th
cht lng snh, mu hi ng vng, c mi v c bit. Do c cha mt t
l ng k cc vitamin A v D nn du c thng c dng iu ch
thuc m bi vt bng hoc vt thng trong qu trnh ln da non.
+ Du lc: Thu c bng cch p t ht cy lc, c th cht lng
snh, khng tan trong nc, d tan trong cc ung mi hu c, thng
c s dng phi hp vi t c du m sp iu chnh th cht.
+ Du vng: Thu c bng cch p t ht cy vng (cy m), l
cht lng snh, du vi da v nim mc, ngoi vic s dng lm t dc
thuc m, du vng cn c dng iu ch du cao xoa, cao dn
ng y.
+ M ln: M ln thu c bng rn nh la nhng l m ln tt,
th cht mm, mu trng, c mi v c bit. Trong m ln c mt
lng nh cholesterol, do vy m ln c kh nng nh ho 12% nc,
20% glycerin. M ln c kh nng thm su nn c dng lm t c
thuc m cn tc dng ni b, h b.

b, Cc sp
Cc sp c cu to ch yu l este ca acid bo cao vi cc alco bo
cao v cc alcol thm.
So vi cc du m, cc sp thng c nhit nng chy cao hn,
kh nng nh ho tt hn nn hay c dng iu chnh th cht tng
kh nng nh ho ca t c.
+ Sp ong: Thu c t t cc loi ong mt, c cu to l este ca
cc acid bo cao vi alcol bo cao, ch yu l cetyl paimitat sp ong:
Sp ong vng c th cht do, qunh, mu vng.
Sp ong trng l sp ong c ty mu, tuy c mu trng nhung!
th cht hi gin, d b v vn.
Sp ong c dng phi hp vi t c du m iu chnh th
cht.
+ Lanolin (sp lng cu): thu c bng cch tinh ch cc cht bo
ly t nc git lng cu trong k ngh lm len. Lanolin c cu to l
este ca cc acid bo vi cc alcol thm c nhn steroid nh:
cholesterol,... nn lanolin c kh nng nh ho mnh.

C 2 loi lanolin:
Lanolin khan nc: loi ny khng c nc trong thnh
phn nn c mu sm hn, bn vng trong qu trnh bo qun,
c kh nng nh ho c 200% nc. C th coi lanolin khan
nc l mt t dc nh tng khan.
Lanolin ngm nc: Loi ny trong thnh phn c cha 25
- 30% nc. So vi lanolin khan nc, loi ny mu nht hn,
th cht mm hn, v c nc trong thnh phn nn khng bn
vng, d b i kht trong qu trnh bo qun. Mc d c nc
trong thnh phn Lanolin ngm nc vn nh ho c 100%
n nc l mt t dc nh tng hon chnh.

c. Cc dn cht ca du m sp
Cc du m hydrogen ho: L sn phm ca phn ng cng
hp hydro bo ho cc y ni i ca cc gc acid bo
khng no c trong du m, lm cho du m c th cht c hn,
nhit nng chy cao hn, vng bn hn, khng b i kht khi
bo qun. Cc du Hydrogen ho thng dng lm t dc
thuc m:
+ Du lc hydrogen ho.
+ Du hng dng hydrogen ho.
+ Du u tng hydrogen ho.
+ Du bng hydrogen ho.

Cc acid bo cao c phn lp t du m:

+ Acid stearic: L hn hp gm c acid stearic v acid
palmitic trong acid stearic khng di 40%, c nhit nng
chy 54 - 57C.
Trong thuc m, acid stearic c s dng lm pha u
trong cc nh tng, c phi hp vi cc t dc du, m,
sp iu chnh th cht ca thuc m, to x phng vi cc
hydroxyd kim hoc cc amin kim lm cht nh ho.
+ Acid oleic: C th cht lng snh mu hi vng, c khi
lng ring 0,8 - 0,9, nhit ng rn 10C. Acid oleic c
s dng lm pha du trong cc nh tng lm tng tnh thm
qua da ca nhiu dc cht.

Cc alcol bo cao c phn lp t cc sp:

+ Alcol cetylic: L mt cht th rn, cha khng di 90%
octadecanol, dng tinh th hoc mnh ng nh, khng mu,
khng tan trong nc, tan trong ethanol cao , clorofonn,...
thng c dng phi hp vi cc t dc du, m, sp
iu chnh th cht ca
thuc m.
+ Alcol cetostearylic: l hn hp c t 50 - 70% alcol
stearylic v 20 - 35% alcol cetylic, nhit nng chy t 48 55 C, thng c phi hp vi cc t dc trong nhm du
m, sp iu chnh th cht ca thuc m.

2.1.2. Cc hydrocarbon
Cc hydrocarbon l sn phm tinh ch cc d phm ca du m.
Cc hydrocarbon no th lng, mm hoc rn, khng tan trong
nc, t tan trong ethanol, d tan trong ether, clorofonn, c th trn u
vi cc t dc du, m, sp.
Cc t dc hydrocarbon c cc u nhc im sau:
u im:
+ Bn vng v mt ho hc, khng b cc vi c, nm mc lm
hng.
+ C th phi hp vi nhiu loi dc cht bo ch thuc m.
+ R tin, d kim.
Nhc im:
+ Gii phng dc cht chm.
+ Kh nng nh ho km.
+ Cn tr s trao i bnh thng ca da (to nhit v tit m hi).
+ Gy bn da v qun o, kh ra sch bng nc.

Cc t dc thng dng:
+ Vaselin: L hn hp cc hydrocarbon no th mm, c nhit
nng chy 38 - 42 c, C hai loi vaselin l vaselin vng v vaselin
trng. Vaselin vng c th eht do qunh, mu vng v rt trung tnh.
Vaselin trng thu c t vaselin vng do ty mu bng acid nn
khng tht trung tnh, th cht mm, mu trng nh m ln nhng
do v trong hn.
Vaselin c kh nng ho tan cc dc cht thn du nh tinh u,
menthol, long no, c kh nng phi hp vi nhiu dc cht iu
ch thuc m. Vaselin thng c phi hp vi lanolin khan nc
lm t dc thuc m khng sinh, thuc m tra mt.
+ Du vaselin hay du parafin: L hn hp cc hydrocarbon no
th lng, th cht lng snh nh du, khi lng ring 0,85 - 0,89,
khng mu, khng mi, khng tan trong nc, d tan trong cc dung
mi hu c, d trn u vi cc t c du, m, sp.

Du parafin thng c s dng lm pha du trong cc nh

tng hoc phi hp vi cc t c du m sp iu chnh th
cht |ca thuc m.
+ Parafin: L hn hp hydrocarbon no c th cht rn, mu trng
ng nh s nhn tay, nhit nng chy t 50 - 60C, khng tan
trong nc, d tan trong cc dung mi hu c. Parafin thng c
dng phi hp vi cc t dc du, m, sp iu chnh th cht.

2.13. Cc Silicon
Cc Silicon hay polyoxan c cng thc tng qut nh sau:

Dimethyl polyoxan (dimethicon) c R = CH3 l cht lng snh

nh du nn cn gi l du silicon, khng mu, khng mi, khng v,
khng tan trong nc. Tu theo mc trng hip, cc silicon c
nht khc nhau. Cc silicon c nht 200, 300, 500 v 1000 Cps
c dng lm t dc thuc m.
Silicon c c im tr v mt ho hc, khng kch ng da v
nim mc, khng thm qua da nn thch hp lm t dc thuc m
bo v da v nim mc.

2.2. Cc t dc thn nc
Cc t dc thn nc gm nhng t dc c th ho tan hoc
trng n trong nc to h gel.
u im:
+ C kh nng ho tan hoc trn u vdi chiu loi dc cht.
+ Gii phng dc cht nhanh.
+ Khng cn tr s trao i bnh thng ca da.
+ Khng trn nhn, d ra sch bng nc.
Nhc im:
+ Khng bn vng, d b vi khun, nm mc pht trin, lm hng
thuc trong qu trnh bo qun.
+ D b mt nc v tr nn kh cng trong qu trnh bo qun.
V vy trong thnh phn t dc gel thng c cc cht bo qun
chng nm mc nh natri benzoat, nipagin, nipasol v cc cht gi
m nh glycerin, sorbibol, propylen glycol.

2.2.1 Gel polysaccarid

Bao gm cc gel ch t tinh bt, thch v alginat
Alginat c chit t cc loi rong bin, gi thnh r nn
hay c dng lm t dc thuc m. Ngi ta thng s dng
cc alginat kim vi nng t 5 - 10%.
V d t dc c thnh phn sau:
Natrialginat
5,0 g
Glycerin
10,0 g
Natri benzoat
0,2 g
Nc tinh khit v
100,0 g

2.2.2 Gel carbopol

Carbopol (carbomer, carboxy vinyl polyme) l sn phm trng
hip ca acid acrylic c cng thc tng qut nh sau:

L dng bt mu trng, t tan trong nc nhng trng n to

gel, c pH acid v nht khng cao, khi trung ho bng cc amin
kim, cc gel ny c pH trung tnh v nht cao, c th cht hch
hp lm t dc thuc m. to gel earbopol, c th dng vi
nng t 1 -5%. V d thnh phn sau:
Carbopol 934
2,0 g
Triethanolamin
v (va )
Glycerin
20,0 g
Nipagin
0,2 g
Nc tinh khit v 100,0 g

2.2.3 Gel dn cht cellulose

lm t dc thuc m, ngi ta s dng cc dn cht ca
cellulose c kh nng trng n to gel nh: methyl cellulose,
Carboxymethyl cellulose, natri carboxymethyl cellulose,
Hydroxypropylmethyl cellulose.
Ngoi nhng u im chung k trn, cc gel dn cht ca
cellulose cn c u im l tng i bn nhit cao khi tit
khun v c th diu chnh pH bng h m, cho nn c th s ng
lm t dc thuc m tra mt.
Cc dn cht ca cellulose thng c s dng vi nng t
2 - 7% lm t dc thuc m.
V d thnh phn t dc sau:
Methyl cellulose
5,0g
Lycerin
10,0g
Dung dch thu ngn phenyl borat 2%
0,5g
Nc ct v
100,0ml

2.2.4. T dc polyethylenglycol
Polyethylenglycol (Macrogol, earbowax, PEG) l sn phm trng
hip ca ethylenglycol c cng thc tng qut sau:
Tu theo mc trng hip, cc PEG c khi lng phn t v th
cht khc nhau.
Cc PEG 300,400,600 th lng Cc PEG 1000,1500 th mm
Cc PEG 2000,4000,6000 th rn.
lm t dc thuc m ngi ta thng phi hp cc PEG th
lng, mm v rn theo mt t l thch hp.
V d mt s thnh phn sau:
+ PEG 400 500 g
PEG 4000 500 g
+ PEG 400 600 g
PEG4000 400 g
+PEG3350 400 g
PEG400
600 g

2.3. T dc nh tng
C hai loi t dc nh tng l t dc nh tng khan v t
dc nh tng hon chnh.
23.1. T dc nh tng khan
T dc nh tng khan (t dc nh ho, t dc ht, t dc
khan) trong thnh phn c pha du v cht nh ho thn du, c kh
nng ht nc v cht lng phn cc to thnh nh tng kiu N/D,
chng c cc u nhc im sau:
u im:
+ Bn vng trong qu ttnh bo qun.
+ Gii phng dc cht nhanh.
+ C kh nng thm su.
Nhc im:
+ Cn tr s trao i bnh thng ca a.
+ Trn nhn, kh ra sch bng nc.

Mt s t dc nh tng khan:

+ Lanolin khan nc.

+ T dc thuc m tra mt (Dc in Anh 1998)
Du parafn
100 g
Lanolin khan nc
100 g
Vaselin
800 g
+ T dc nh ho
Cholesterol
30 g
Alcol cetylic
30 g
Sp ong trng
80g
Vaselin
860g

2.3.2. T dc nh tng hon chnh

T dc nh tng hon chnh l nhng t dc trong thnh phn
c y pha du, pha nc v cht nh ho, tu thuc vo bn cht
ca cht nh ho ta c t dc nh tng kiu D/N hoc kiu N/D.
Chng c u nhc im sau:
u im:
+ C th cht mm, mn mng hp dn.
+ Gii phng dc cht nhanh v c kh nng thm su.
+ T dc nh tng kiu D/N khng cn tr s trao i bnh
thng ca da, d ra sch bng nc.
Nhc im:
+ Khng bn vng, d b tch lp do nh hng ca nhit,
+ D b vi khun, nm mc pht trin nn cn thm cht bo qun
chng nm mc thch hp.
+ T dc nh tng kiu N/D cn tr s trao i bnh thng ca
da, kh ra sch bng nc,

Mt s v d t dc nh tng kiu D/N:

+ Acidstearic
24g
Triethanolamin
Glycerin
Nc tinh khit
+ Acidstearic
Dung dch NaOH 30%
Glycerin
Nc tinh khit

1g
13g
62g
14g
3g
21g
62

Mt s v d t dc nh tng kiu N/D:

+ Lanolin ngm nc
+ Alcolcetylic
Lanolin khan nc
Vaselin
Nc tinh khit
+ Lanolin khan nc
Vaselin
Nc tiah khit

15g
35g
30g
20g
35g
45g
20g

II. K THUT BO CH THUC M

1. Phng php ho tan
1.1 iu kin p dng
Phng php ho tan c p dng bo ch thuc m khi:
Dc cht l nhng cht th lng hoc th rn tan c trong t
dc.
T c c th l t dc thn du, t dc thn nc hoc t dc
nh tng khan.
Thuc m to thnh thuc h phn tn ng th (kiu dung dch)
1.2 Cc bc tin hnh
1.2.1. Chun b dc cht
Cn cc dc cht, nghin nh c cht rn tng tc ho tan.
1.2.2. Chun b t dc
Cn v phi hp cc thnh phn t dc. Nu l t dc thn du v t
dc nh tng khan th un chy, lc (nu cn)
Nu l t dc PEG th phi hp ri un chy. Nu l t dc gel cn
c thi gian ngm trong mi trng phn tn gel trng n hon ton

1.2.3. Ho tan dc cht vo t dc

C th ho tan nhit thng hoc nhit cao, nhng thng
un nng nh ho tan nhanh hn. Trong trng hp cn un nng,
nu t dc cht d bay hi thi phi ho tan trong dng c c np y
kn hn ch s bay hi ca dc cht.
1.3 Mt s v d
Xem cc cng thc 11.1,11.2 v 11.3
2. Phng php trn u n gin
iu kin p dng Phng php trn u n gin c p dng
bo ch thuc m khi:
Dc cht l nhng cht rn khng tan hoc t tan trong t dc.
Cc dc cht c tng k vi nhau nu di dng dung dch.
Thuc m cn hn ch tc dng ti ch ca cc dc cht.
T c l t dc thn du, thn nc hoc nh tng khan.
Thuc m to thnh thuc h phn tn d th (kiu hn dch).

2.2. Cc bc tin hnh

2.1 Chun b dc cht
Cn, nghin tht mn cc c cht, ry qua ry thch hp, trn
thnh bt kp ng nht.
2.2.2. Chun b t dc
Chun b t dc ging nh phng php ho tan.
2.2.3. Phi hp dc cht vo t dc
- Cho ng lng t c vo dc cht nghin mn trong
ci
- Phi hp t dc cn li vo m c theo nguyn tc ng
lng, dng chy trn u cho ti khi thu c thuc m mn mng
ng nht.
quy m cng nghip, thuc m c pha ch bng nhng
thit b dng trong sn xut nh: My nho trn thuc m (hnh
11.1), my cn lm ng nht thuc m (hnh 11.2), my ng
thuc m .(hnh 11.3).

23. Mt s v d
Xem cc cng thc 11.4,11.5, 11.6 v 11.7
3. phng php nh ho
3.1. Phng php trn u nh ho
3.1.1. iu kin p dng
Phng php trn u nh ho c p dng bo ch thuc
m trong trng hp sau:
Thuc m cha cc dc cht th lng phn cc hoc bn phn
cc khng tan trong t dc: Thu ngn, kim loi, ichtyol, hc n, tho
mc, bm peru, du cade...
Dc cht l nhng cht rn d tan trong cc dung mi tr phn
cc: Cc cao thuc, mui ancaloid, ng v km sulfat.
- Dc cht l nhng cht rn chi pht huy tc dng di dng
dung; dch ong nc: iod, cc loi bc keo (argyron, colacgon,
protacgon...).
T c thuc loi t dc nh tng khan:Thuc m to thnh c
cu trc kiu nh tng N/D.

3.1.2. Cc bc tin hnh

Chun b c cht:
+ Nu dc cht th lng th phi cn ong trdng dng c thch
hp.
+ Dc cht th rn tan trong nc (ng, km slfat,...) th
ho tan trong mt lng nh nc chuyn v dng lng.
+ Duc cht l cao mm, cao kh dc liu thl ho tan trong mt
phn glycerin hoc hn hp glycerin - ethanol - nc chuyn v
dng lng.
Chun b t dc: Phi hp, un chy, lc nu cn ri ngui.
Phi hp dc cht vo t dc:
+ Cho t dc vo ci.
+ Cho t t dc cht dng lng vo, dng chy trn u cho ti
khi thu c thuc m kiu nh tng n nh bn vng.

3.1.3. Mt s v du
Xem cc cng thc 11.8 v 11.9.
3.2. Phng php nh ha trc tip
3.2.1 iu kin p dng
Phng php nh ho trc tip c p ng bo ch thuc m
trong cc trng hp sau:
Dc cht l cht th rn, th lng tan trong nc hoc trong du.
T dc cha c sn nhng trong thnh phn c y pha du, pha
nc v cht nh ho. Tu thuc vo bn cht ca cht nh ho m thuc
m to thnh c cu trc nh tng kiu D/N hoc kiu N/D.
Cc bc tin hnh
Ho tan cc cht tan trong nc vo nc, un nng n 60 - 70C
Ho tan cc cht tan trong du vo du, un nng ln nhit tng t.
Phi hp hai pha u v nc cng nhit (60 - 70 C), kt hp
vi khuy trn cho ti khi thu c thuc m kiu nh tng n inh bn
vng.
3.2.1 Mt s v d Xem cng thc 11.10.

4. ng gi, bo qun
Thuc m thng c ng trong l rng ming hoc tup.
Bo qun ni kh mt, nhit < 30 C.
IV.YU CU CHT LNG THUC M
Thuc m phi t cc ch tiu cht lng sau:
Phi l hn hp hon ton ng nht, trong dc cht
phi t phn tn cao. Dc in Vit Nam 3 qui nh ly 4
n v ng gi, mi n v 0,02 - 0,03 g, tri ln 4 tiu bn t
trn phin knh, y ln trn mi tiu bn phin knh th 2, p
mnh to thnh cc vt c ng knh 2 cm, quan st bng mt
thng, t nht 3 trong 4 tiu bn khng c nhn thy cc tiu
phn.

C th cht mm, mn mng, khng chy lng nhit

thng, d bm thnh lp mng ln da v nim mc. nh gi
tiu chun ny ngi ta xc nh mn, nhit nng chy,
nhit ng c, bm dnh...
Phi t ng u khi lng khi ng gi, Dc in
Vit Nam 3 qui nh:
Thuc m di 10 g, sai s khi lng so vi khi lng
trung bnh < 15%.
Thuc m t 10 - 20 g, sai s khi lng so vi khi lng
trung bnh < 10%.
Ngoi cc tiu chun trn, thuc m cn phi c nh
tnh, nh lng cc dc, cht, theo qui nh ca tng chuyn
lun hoc theo tiu chun c s.

V. MT S N V CNG THC THUC M

Cng thc 11.1: Cao sao vng
Menthol
12,5 g
Long no
12,5 g
Tinh du bc h
17,0 g
Tinh u long no
10,5 g
Tnh du khuynh dip
5,0 g
Tinh du hng nhu
2,5g
Tinh u qu
1,0g
Vaselin
Lanolin khan nc
Sp ong
v 100g
Cerezin
Ozokerit

Pha ch:
Cn dc cht v t dc.
Cho menthol, long no v cc tinh du vo cc trn cho
chy u.
un chy hn hp t dc, lc vo dng c kn c np y.
Cho hn hp tinh du vo t dc nhit 70C, khuy
trn u, duy tr nhit 60 - 70C trong khong 1 gi.
ngui n 40 - 50C, rt cao xoa vo hp, ngui, y
np. Dn nhn thnh phm dng ngoi, bng thng.

Cng thc 11.2 : Thuc m methyl salicylat

Methyl salicylat
10,0g
Long no
8,0g
Cloral hydrat
4,0g
Menthol
1,0g
Acid salicylic
1,0g
Lanolin
20,0g
Vaselin
51,0g
Sp ong
5,0g
Pha ch:
Cn dc cht v t dc.
Cho long no, menthol, cloral hydrat, methyl saiicylat vo mt cc thu
tinh, trn cho chy lng, cho acid salicylic vo ho tan.
un chy cch thu hn hp t dc ong mt dng c kn c np y,
ngui n 60C.
Cho hn hp dc cht vo t dc, y kn, khuy trn u, ngui.
ng l rng ming hoc tup.
Dn nhn thuc dng ngoi, bng thng.

Cng thc 11.3 : Gel lidocain 3 %

Lidocain hyroclorid
3,00 g
Nipagin
0,18 g
Nipasol
0,02 g
Ethanol 90%
2,00 g
Glycerin
10,00 g
Carboxymethyl cellulose
4,00 g
Nc tnh khit v
100,00 g
Pha ch:
Cn dc cht v t dc.
Ho tan lidocain hydroclori vo nc.
Cho t t carboxymethyl cellulose vo ung dch trn, trn nh
nhng, yn cho gel trng n hon ton (1).
Ho tan nipagin, nipasol trong ethanol, cho glycerin vo trn u (2).
Cho hn hp (2) vo (1) trn u.
ng l rng ming hoc tup.
Dn nhn thnh phm bng B, dng ngoi.

Cng thc 11.4: Thuc m benzosali

Acid benzoic
6,0 g
Acid salicylic
1,0 g
Sp nh ho
30,0 g
Du parafm
31,5g
Vaselin
31,5g
Pha ch:
un chy sp nh ho, du parafin v vaselin, khuy ngui
Nghin mn acid benzoic, acid salicylic, trn thnh bt kp.
Cho ng lng t dc vo trn u v nghin k cho ti khi
thu c bt nho m.
Thm dn tng phn t c cn li vo trn u cho ti khi thu
c thuc m mn ng nht.
ng l rng ming hoc tup.
Nhn thuc dng ngoi, bng thng

Cng thc 11.5: Thuc md tetracyclin hydroclorid 1%

Tetracyclin hydroclorid
10,0 g
Lanolin khan nc
70,0 g
Parafin
30,0 g
Vaselin
890,0 g
Pha ch:
Cn hn hp t dc, un chy, lc (nu cn) v ngui.
Cho t dc vo my nho trn, bt cho my chy.
Nghin nh tetracyclin hydroclorid trong ci s, cho ng lng t
dc vo trn u, nghin k, thm dn tng phn t dc vo ci s trn
u cho ti khi thu c chng 50 g m c.
Chuyn m c vo my nho trn c t uc, tip tc cho my
chy cho ti khi thu c thuc m mn mng, ng nht.
ng tup, dn nhn thuc dng ngoi.
Nu l thuc m tra mt, phi s dng dc cht tetracyclin l loi bt
mn dng cho thuc m tra mt. T c sau khi lc phi tit khun
120C trong thi gian 1 gi. Pha ch v ng gi trong iu kin v khun.

Cng thc 11.6: Bt nho Darier

Km oxyd
25,0 g
Calci carbonat
25,0 g
Glycerin
25,0 g
Nc tinh khit
25,0 g
Pha ch:
Nghin mn km oxyd, calci carbonat trong ci, trn thnh bt kp.
Cho hn hp glycerin v nc vo trn u nghin k cho ti khi thu c bt
nho mn. ng l rng ming. Nhn thuc dng ngoi, bng thng.
Cng thc 11.7: Bt nho Lassar
Tinh bt
25,0 g
Km oxyd
25,0 g
Lanolin khan nc
25,0 g
Vaselin
25,0 g
Pha ch:
Nghin mn tinh bt v km oxy trong ci s, trn thnh bt kp.
Cho lanolin v vaselin vo trn u, nghin k cho ti khi thu c bt nho mn.
ng l rng, ming hoc tup. Nhn thuc dng ngoi, bng thng.

Cng thc 11.8: Thuc m Dalibour

ng sulfat
0,3 g
Km Sulfat
0,5 g
Nc ct
30,0 g
Lanolin khan nc
50,0 g
Vaselin
100,0g
Pha ch: un chy hn hp lanolin v vaselin, cho vo ci s ngui.
Ho tan ng Sulfat v km Sulfat vo nc. Cho t t dung dch ng v km
Sulfat vo t dc, dng chy trn u cho ti khi thu c thuc m kiu nh tng
mn mng, ng nht. ng l hoc tup. Nhn thuc dng ngoi, bng thng.
Cng thc 11.9: Thuc m cao benladon
Cao mm benlaon
5,0 g
Glycerin
5,0 g
Lanolin khan nc
20,0 g
Vaselin
20,0 g
Pha ch: Cho hn hp t dc vo ci s.
Ho tan cao mm benladon vo glycerin. Cho t t ung dch cao benladon vo
t dc, dng chy trn u cho ti khi thu c thuc m nh tng, ng nht,
ng l rng ming hoc tup. Nhn thnh phm bng A, dng ngoi.

Cng thc 11.10: kem cloramphenicol 1%

Cloramphenicol
1,0 g
Alcol cetylic
4,0 g
Acid stearic
6,0 g
Du parafin
10,0 g
Triethanolamin
4,0 g
Nipagin
0,18 g
Nipasol
0,02g
Propylenglycol
10,0g
Nc tinh khit va
100,0g
Pha ch:
un chy cch thu acid stearic v alcol cetylic trong 1 cc thu tinh, cho du
parafin vo trn u, duy tr nhit 60 - 70C.
Trong 1 cc thu tinh khc, ho tan trethanolamin trong nc, un nng cch
thu ln nhit tng t.
Phi hp hai pha du v nc cng nht (60 - 70C), khuv trn mnh, lin
tc cho ti khi thu c nh tng n nh bn vng. Ho tan nipagin, nipasol,
cloramphenicol trong propylenglycol, cho t t dung dch ny vo nh tng trn
nh nhng. ng tup hoc l rng ming. Nhn thuc dng ngoi, bng thng.

Chng 12

K THUT BO CH CC DNG THUC T

MC TIU HC TP
1.Phn bit c cc dng thuc t: Thuc n, thuc trng v thuc bt ch.
2.Nm c cu to, u nhc im ca cc t dc hcnig dng iu ch
thuc dt.
3.Trnh by c k thut iu ch thuc t bng phng php un chy
khun.
4.Nu c trnh t bo ch mt s cng thc thuc t.

I.I CNG
1. nh ngha
Thuc t l dng thuc phn liu, c th rn nhit thng, khi
t vo cc hc t nhin ca c th th chy lng hoc ho tan vo nim
dch gii phng dc cht nhm gy tc dng ti ch hoc ton thn.
Thuc t l tn gi chung cho cc dng thuc n, thuc trng v
thuc bt ch. Tuy c hnh th, kch thc v khi lung khc nhau
nhng cc ng thuc ny thng c xp chung v ging nhau v
thnh phn t dc, k thut bo ch, v ging nhau v cch s dng l
t vo cc hc t nhin ca c th.
2. Phn loi thuc t
Cn c vo ni t thuc ngi ta chia thuc t ra lm 3 loi nh
sau:
t trc trng - c tn gi l thuc n.
t m o - c tn gi l thuc trng.
t niu o hoc cc hc nh hn hoc cc l r gi l thuc bt
ch.

3. c im
3.1. Hnh th, kch thc v khi lng
Thuc n: Thng c dng hnh tr, hnh nn v hnh thu li (1.1 ca hnh
12.1), c ung knh t 10 - 15 mm, chiu di 30-4(1 mm, khi lng t 1 n 3
gam, trung bnh 2 gam, loi dng cho tr em, thng c khi lng 1 gam.

- Thuc trng : Thng c dng hnh cu, hnh trng v hnh li (1.2 ca hnh
12.1), c khi lng t 2 -10 gam, trung bnh 5 gam.
- Thuc bt ch: Thng c hnh li bt ch mt u nhn (1.3 ca hnh 12.1),
ng knh t 1 - 4 mm, chiu di t 6 - 20 cm, khi ng t 0,5 - 4 gam.
Ngoi cc dng thuc t ni trn, cn c dng thuc vin nn t m o (xem
chng k thut bo ch thuc vin nn)

3.2. V tc dng
Cc dng thuc trng, thuc bt ch c dng ch yu gy tc
dng iu tr ti ch nh: St trng, gim au, cm mu, lm du, lm
sn se, chng nm, chng vim...
Ring dng thuc n, ngoi cc tc dng ti ch nh trn, cn
c dng ph bin gy tc dng iu tr ton thn. Trong thc t
thng gp cc thuc n h st gim au, an thn gy ng, cha hen
ph qun, st rt, thp khp...
II. THNH PHN THUC T
1.Dc cht
Dc cht dng cho thuc t rt a dng v phong ph, bo ch
thuc t, dc cht phi t tiu chun c dng. Dc cht phi
c ho tan hoc phn tn ng nh trong ton vin thuc.
2.T dc
T c dng trong bo ch thuc n c nhiu loi, da vo kh
nng ho tan v c ch gii phng dc cht ngi ta chia t dc thuc
t lm ba nhm:

2.1. Cc t dc bo chy lng thn nhit gii phng c cht

2.1.1.Cc du m sp
a. B cacao
B cacao thu c bng cch p t ht ca cy cacao. L cht th rn,
mu vng ng, c mi thm d chu, t trng 20C l 0,94-0,96, nhit
nng chy 34-35C, nhit ng rn 25C khng tan trong nc, t tan
trong ethanol.
Cu to l este ca glycerin vi cc acid bo cao no v cha no nh:
acid palmitic, stedric, oleic, linoieic.
u im:
+ C kh nng phi hp vi nhiu loi dc cht iu ch thuc t.
+ Thch hp vi nhiu phng php iu ch: khun, nn, p khun.
+ Chy lng thn nhit gii phng dc cht, du vi nim mc.
Nhc im:
+ Nhit nng chy hi thp nn khng thch hp lm t dc thuc
t cc nc nhit i nht l v ma h.

+ Kh nng nh ho km nn kh phi hp vi cc c cht th

lng phn cc hoc dung ch dc cht trong nc.
+ Nhc im ln nht ca b cacao l hin tng a hnh. B!
cacao tn ti di 4 ng kt tinh, , , , c chy v ng' rn
khc nhau. Trong ch c dng l n nh c nhit nng chy 34 35C Khi un nng b cacao ln nhit > 36C th b cacao s chuyn
sang cc dng khng n nh , v , c nhit nng chy t 22 26C v nhit ng c t 16 - 19C, gy nn hin tng chm ng.
-Cch s dng:
khc phc nhc im ca b cacao khi dng lm t sc p
thuc t
+ Ngi ta thng phi hp b cacao vi mt t l thch hp cc t
dc bo c nhit nng chy cao hn nh sp ong vi t l 3 - 6%,
hay parafin vi t l 2 - 5 % tng nhit nng chy ca b cacao.

+ tng kh nng nh ho ca b cacao ngi ta thng phi hp vi mt

t l nht nh cc cht nh ho thch hp nh lanolin khan nc vi t l 5 - 10%
hay cholesterol vi t l 3 - 5 %.
+ trnh hin tng chm ng ngi ta ch un chy cch thu 2/3 lng
b cacao nhit < 36 C, gi li 1/3 lng b cacao lm vn, trn vo sau
cng nhm lm mi cho b cacao ng rn dng n nh.
b. Cc cht thay th b cacao
V b cacao l nguyn liu phi nhp nn nhiu nc s dng cc cht
thay th b cacao, cht c thay th b cacao quen thuc nht l t dc butyrol.
T dc butyrol: l hn hp ca b cacao vi cc t dc du, m, sp c
thnh phn nh sau:
B cacao
25,0g
M ln
63,0g
Sp ong
3,5g
Parafin
6,0g
Glycerin 0,5g
Butyrol c nhit nng chy 36C, c kh nng nh ho tt hn b cacao,
nhng khng bn vng, d b i kht, ch iu ch khi dng ngay. Nu lu phi
c thm cht bo qun chng nm mc thch hp

2.1.2. Cc dn cht ca du m sp
Cc dn cht ca du m sp c dng ph bin lm t
dc thuc t l cc triglycerid bn tng hp.
Cc triglycerid bn tng hp l nhng t dc bo c iu
ch bng cch lm phn ng este ho gia glycerin v cc acid bo
cao no, phn t c t 10 - 18 cacbon. Nhng t dc ny c
nhiu hng ho cht sn xut v c gi di nhiu tn thng
mi khc nhau: Witepsol, Estarinum, Massupol.
V cu to ch yu l triglycerid, ngoi ra cn c mt t l nh
mono v diglycerid lm cho cc t dc ny c kh nng nh ho
cc cht lng phn cc. Tuy nhin, t l mono v diglycerid trong
mi loi Witepsol c khc nhau lm cho cc loi t dc ny c
nhng ch s c trng ( chy, ng c, nht v ch s
nc... ) khc nhau.

Nhng cht tiu biu c th k n:

+ Witepsol H loi ny gm 1 lot cht Witepsol H12, Witepsol H15,
Witepsol vit gn li l Witepsol H(12,15,19) C c m chung l nhit
ng c nh, dng iu ch thuc t cha cc c cht lm tng
nhit nng chy ca t dc.
+ Witepsol w(12,15,19) c c im chung l khong cch gia nhit
nng chy v nhit ng c ln, nht tng i cao, thch hp
iu ch thuc t c c cht kh phn tn, cn khuy trn lu.

+ Witepsol w(52,55,58) c c im chung l nhit nng chy

tng i thp, khi chy c nht cao, thch hp iu ch thuc t
cha dc cht c t trng ln, lng khi khun.
+ Witepsol w(75,76,79,85) c c im chung l c nhit nng
chy tng i cao, thch hp iu ch thuc t c cha dc cht lm
h nhit nng chy ca t dc v thuc t cn hn ch tc dng ti
ch .

u im ca t dc Witepsol:
C kh nng phi hp vi nhiu loi dc cht khc nhau i ch cc
thuc t vi nhng yu cu khc nhau.
Thch hp vi nhiu phng php iu ch thuc t.
Du vi nim mc ni t. V vy cc lot Witepsol c s dng rng ri
tt c cc nc trn th gii lm t dc thuc t.
2.2 Cc t dc thn nc ho tan trong nim dch gii phng dc
cht
2.2.1. Cc keo thn nc c ngun gc t nhin
Thng dng t dc gelatin - glycerin, theo DVN, t dc c thnh phn:
Gelatin
l0g; Glycerin
60g; Nc
30 g
Pha ch:
+ Lm nh gelatin, ngm vo nc cho trng n hon ton.
+ un nng glycerin ln 60C, cho gelatin ngm trn vo khuy cho ti
khi tan hon ton.

Khi iu ch t c gelatin glycerin cn ch :

+ Khng un nng hn hp qu 60C v nh hng ti kh
nng to gel ca gelatin.
+ Ch iu ch t dc ny khi s dng, nu lu phi cho
thm cht bo qun chng nm mc thch hp nh nipagin,
nipasol vi t l 0.1 - 0,2%.
+ T l gelatin, glycerin v nc c th thay i cht t cho
ph hp vi iu kin kh hu v thi tit.

2.2.2. Cc keo thn nc c ngun gc tng hp

Cht thng dng nht l polyethylenglycol (PEG). lm t dc thuc
t ngi ta s dng cc hn hp PEG th lng, mm v rn hn hp
thu c c nhit nng chy t 45 - 55 c.
u im:
+ C nhit nng chy cao hn thn nhit nn vin thuc c bn c
hc cao hn vin thuc ch t t dc bo, v vy PEG l t dc thch hp
vi iu kin kh hu nhit i.
+ Thch hp lm t dc ch thuc t c cha cc dc cht t tan
trong nc.
Nhc im:
+ Do cng ca vin thuc ln nn c th gy au nu ni t b tn
thng (tr hu mn).
+ C tnh ho m nn khi t, vin ht nim dch mnh, kch thch nhu ng
lm cho vin thuc b y ra ngoi. Do vy khi s ng PEG lm t dc thuc
t ngi ta phi bit cch khc phc bng cch nhng t vin thuc vo nc
sch trc khi t trnh hin tng kch thch nhu ng rut.

C th s dng cc hn hp t c PEG sau y lm t dc thuc

t:
Hn hp 1:
PEG400
25%
PEG 4000 75%

Hn hp 2:
PEG1000 75%
PEG 4000 25%

Hn hp 3 :
PEG 1540 96%
PEG 4000 4%

2.3. Cc t dc nh ho
Cc t dc nh ho thng l mt cht hoc hn hp cc cht c kh
nng nh ho mnh, khi t vo cc hc t nhin ca c th th va c kh
nng ht nim dch, va c kh nng chy lng gii phng dc cht.
Tuy nhin, m bo kh nng gii phng dt cht mt cch chc chn
ngi ta ch s ng cc t dc nh ho c nhit nng chy thp hn
thn nhit.
u im:
C kh nng phi hp vi nhiu loi dc cht iu ch thuc t,
bn vng trong qu trnh bo qun.
Thch hp vi nhiu phng php iu ch.
Gii phng dc cht nhanh.

Mt s t dc nh ho:
Tween 61 (Polyetylenglycol 4 - sorbitan monostearat):
L cht nh ho to kiu nh tng D/N. C th cht rn, mu hi
ng, nhit nng chy 35 - 37C, c th dng mt mnh lm t dc
thuc t.
Cng c th s dng cc hn hp sau:
+ Tween 61
60%
Glycerin monostearat
40%
+ Tween 61
50%
Du lc hydrogen ho 50%
+ Acid stearic
80%
Natri stearat
20%

III. K THUT BO CH THUC T

Cc thuc t c th c bo ch bng phng php un
chy khun, phng php nn v phng php p khun.
Trong ba phng php trn, phng php un chy
khun l thng dng nht, c p dng c quy m bo ch
nh v quy m sn xut cng nghip, hai phng php sau ch
p dng quy m bo ch nh.
Phng php un chy khun
Phng php un chy khun c thc hin theo hai
giai on.
Chun b dng c v nguyn ph liu.
Phi hp c cht vo t dc v khun.

1.1. Chun b dng c v nguyn ph tiu

1.1.1 Dng c
quy m bo ch nh thng s dng cc dng c sau:

Hnh 12.2. Khun thuc n Dao bng thp khng r

Dao bng thp khng r v ci chy s lm vn t dc

v lm mn dc cht.
+ Cc loi khun bng ng, nhm, hoc thp khng g, c
hnh vin thch hp, c th tho lp d dng ly vin thuc ra
khi khun (hnh 12.2).
Dng c dng bo ch thuc t phi c ra sch, lm kh
v tit khun bng phng php thch hp.
Khun thuc sau khi tit khun phi c bi trn. Nu
thuc iu ch bng t dc bo th phi bi trn khun bng
dung dch x phng trong cn. Nu thuc iu ch bng t dc
thn nc phi bi trn khun bng du paraTin.

 quy m cng nghip ngi ta sn xut thuc t bng my

t ng, dn v p khun bng cht do, sau rt thuc un
chy vo bng chic bm chnh xc, hn kn khun, lm lnh, in
nhn trn vin thuc v ct thnh v thuc (Hnh 12.3)

2. Nguyn ph liu
m bo thu c ng s lng vin thuc d inh, khi
tnh ton nguyn ph liu, cn tnh d 10% tr hao phn nh
dng c.
Trng hp dc cht v t dc c t trng khc nhau v
lng dc cht trong mt vin thuc > 0,05g, phi a vo h
s thay th (HSTT) ca dc cht vi t dc tnh chnh xc
lng t dc cn ly, m bo cho mi vin thuc iu ch
cha ng lng dc cht theo yu cu.
HSTT thun E ca mt dc cht vi t c l lng dc
cht thay th c mt gam t dc khi khun.
HSTT nghch F = ca mt dc cht vi mt t dc l
lng dc c th tch bng th tch ca mt gam dc cht.
HSTT thun v nghch ca cc dc cht vi t c b
cacao c tnh sn (Bng 12.1).

Bng 12.1. H s thay th ca mt s dc cht vi b cacao

hoc t dc bo c d = 0,95
STT

Tn dc cht

H s thay th
E

Analgin
Anestesin

1,27
1,33

0,79
0,75

Antipirin

1,25

0,80

Acid boric

1,50

0,66

Acid benzoic

1,50

0,66

Acid galic

2,00

0,50

Acid salicylic

130

0,77

Acid tanic

1,60

0,63

Bismuth carbonat

4,50

0,22

10

Bismuth salicylat

4,50

0,22

11

Bismuth galat basic

2,70

0,37

Bng 12.1. H s thay th ca mt s dc cht vi b

cacao hoc t dc bo c d = 0,95 (tip theo)
Tn dc cht

STT

H s thay th

12

Bismuth nitrat basic

6,00

0,16

13

Bm peru

1,10

0,91

14

Cao benladon.

1,30

0,77

15

Cao Opi

1,40'

0,70

16

Ch acetat

2,50

0,40

17

Cloral hydrat

1,50

0,67

18

Cocain hydroclorid

1,30

0,77

19

Codein phosphat

1,50

0,67

20

Euphylin

1,10

0,91

21

Papaverin hydroclorid

1,59

0,63

22

Phenobarbital

1,20

0,83

Bng 12.1. H s thay th ca mt s dc cht vi b

cacao hoc t dc bo c d = 0,95 (tip theo)
Tn dc cht

STT

H s thay th
E

23

Phenol

0,90

1,1

24

Iodoform

4,00

0,25

25

Kali clorid

4,50

0,22

26

Kali bromid

1,00

1,00

27

Km oxyd

4,00

0,25

28

Km sulfat

2,80

0,35

29

Quinin Sulfat

1,00

1,00

30

Lu hunh kt ta

1,60

0,62

31

Menthol

0,70

1,40

32

Morphin hydroclorid

1,60

0,62

33

Natri bromid

2,30

0,43

Bng 12.1. H s thay th ca mt s dc cht vi b

cacao hoc t dc bo c d = 0,95 (tip theo)
Tn dc cht

STT

H s thay th

34

Procain hydroclorid

E
1,20

35

Resocin

1,40

0,71

36

Santonin

1,30

0,77

37

Sulfanilamid

1,70

0,60

38

Sulfathiazon

1,60

0,62

39

Theobromin

1,40

0,71

40

Theophylin

1,23

0,81

- V d cch tnh nguyn ph liu cho n thuc sau:

Rp.Decmato
l0,15g
Ichtyo
l0,15g
B cacao v
3,00g
M.f. Supp D.t.d N10

F
0,83

n thuc trn ghi lng dc cht v t dc cho mt vin thuc

yu cu lm 10 vin thuc nh vy.
Khun thuc 3,0 gam, c ngha l khun thuc cha c 3 gam
cacao khng c dc cht. Vn t ra l phi tnh xem decmatol v
ichtyol thay th c bao nhiu b cacao v cn bao nhiu b Jaeao
na cho va y khun. Bit rng dc cht v b cacao c khi
lng ring khc nhau.
bo ch c 10 vin thuc ta phi tnh nguyn ph liu d 10%
c ngha l tnh nguyn ph liu cho 11 vin.
Lng Decmatol cn ly
0,15 X 11 = l,65g
Lng Ichytol cn ly
0,15 X 11 = 1,65g
Chng ta tip tc tnh xem lng b cacao cn ly l bao nhiu.
Tra bng ta bit:
HSTT ca Decmatol i vi b cacao E = 2,7 v F = 0,3 7
HSTT ca Ichtyol vi b cacao
E = 1,1 v F = 0,9

C hai cch tnh nh sau:

+ Cch th nht da vo HSTT thun E:
HSST thun E ca decmatol vi b cacao E = 2,7. C ngha l
2,7gam decmatol thay th c 1 gam b cacao.
Vy th 1,65 gam decmatol thay th c X gam b cacao.
Suy ra

x=

1,65 x 1
2,7

= 0,6g

Tng t nh vy:
C 1,1 gam Ichtyol thay th c 1gam b cacao.
Vy th 1,65gam Ichtyol thay th c y gam b cacao.
Suy ra

y=

1,65 x 1
1,1

= 1,5g

Vy lng b cacao cn ly iu ch c 10 vin thuc l:

3 x 11 - (0,6 + 1,5) = 30,9 gam

Trong bng, ngi ta ch tnh sn h s thay th ca cc dc vi t

dc b cacao. Khi bit h s thay th ca dc cht vi dc b
cacao ngi ta c th tnh c HSTT ca c cht cc t dc
khc theo biu thc sau:

L HSTT ca c cht vi t dc khc

dc cht vi t dc b cacao

: L HSTT ca

: L khi lng ring ca b cacao : L khi lng ring ca t

dc khc
V d khi bit HSTT ca decmatol vi b cacao l
= 2,7. Ta
c th tnh c HSTT ca decmatol vi t dc gelatin glycerin, khi
lng ring ca t dc b cacao l
= 0,95 v khi lng ring- ca
t dc gelatin glycerin l
= 1,15.
y = 2,7
x

0,95
1,15

= 2,15

1.2. Phi hp dc cht vo t dc v khun

1.2.1. Phi hp dc cht vo t dc
phi hp dc cht vo t c cn da vo tnh cht ca dc
cht v t dc m s dng ring r hoc kt hp cc phng php ho
tan, trn u n gin hoc trn u nh ho.
a. i vi t dc bo v t dc nh ho thng gp 4 trng hp
sau:
Trng hp thuc t c cc dc cht d tan trong t dc (cloral
hydrat, anestesin... ) th ho tan dc cht trong mt phn t dc un
chy cch thu, cho phn t dc cn li vo trn cho chy u (xem n
thuc 12.1).
Trng hp thuc t cc (cc loi bc keo, novocain hydrococ cc
dc cht th lng phn cc hoc d tan trong dung mi tr phn cc...),
ho tan dc cht trong mt lng ti thiu dung mi, ri nh ho dung
dch vo t c un chy cch thu, nu nh dc khng c kh
nng nh ho th phi thay 1 phn t c bng cht nh ho thch hp
(xem n thuc 12.2).

Trng hp thuc t cha cc c cht khng tan trong t dc

Rcng khng tan trong nc (sulfamid, paracetamol, indomethacin...) P
nghin dc cht thnh bt mn, cho mt phn t dc vo trn u,
un chy cch thu phn t dc cn li, cho hn hp trn vo trn cho
chy u (xem cng thc 12.3).
- Trng hp thuc t cha thnh phn dc cht phc tp th phi
kt hp mt cch hp l cc phng php phi hp dc cht vo t
dc (xem n thuc 12.4).
b, i vi t dc thn nc (t dc geatin glycerin) ta cng gp
trng hp tng t:
Trng hp thuc t cha cc dc cht d tan trong nc (cao
mm benladon, penicilin...) th ho tan dc cht trong mt lng nh
nc hoc glycerin ri phi hp vo t dc mi iu ch, nhit
gn nhit ng c (xem cng thc 12.5).

- Trng hp thuc t c cha dc cht d tan trong dung mi tr

khng phn cc (progesteron, vitamin D2...) th ho tan dc cht trong
mt lng ti thiu du tho mc, sau trn u nh ho vo t dc
mi iu ch, nhit gn nhit ng c (xem cng thc 12.6).
Trng hp thuc t cha dc cht khng tan trong nc cng
khng tan trong du (sulfatazon, cloramphenicol... ) th nghin nh dc
cht trong ci, thm ng lng glycerin vo trn thnh bt nho, ri
phi hp bt nho vo t dc mi iu ch nhit gn nhit
ng c (xem cng thc 12.7).
Trng hp thuc t c thnh phn dc cht phc tp th phi s
dng hp l cc phng php phi hp dc cht vo t c (xem
cng thc 12.8).

1.2.2. khun
Sau khi phi hp dc cht vo t dc, phi ch cho khi thuc
ngui n gn nhit ng c mi vo khun c bi trn.
Vi t dc b cacao thng khun nhit 27 - 28C vi
dc gelatin glycerin phi khun nhit 37 - 38C.
Phi y khun khi ng c vin thuc khng b lm mt
Sau khi , khun phi nhit 5 - 10C, ch cho thuc ng
rn, dng dao ct b phn thuc tha, tho khun ly vin thuc ra.
2. Phng php nn
Phng php nn l mt phng php ht sc n gin, c p
dng bo ch thuc t trong trng hp khng c y trang thit
b hoc trong trng hp dc cht khng bn nhit cao.

Phng php nn c u im: K thut bo ch n gin, khng cn

dng c phc tp
Nhc im: Ch p dng c vi cc t dc bo. Vin thuc khng
p.Khng m bo v sinh, v khun. Ch bo ch c mt s lng nh
vin thuc.
3. Phng php p khun
V nguyn tc, phng php ny phi ch khi thuc ging nh
phng php nn, sau a khi thuc vo thit b kiu pt tng, p khi
thuc vo cc khun c hnh th kch thc ph hp vi ni t (hnh 12.4).
Phng php p khun cho vin thuc c hnh th p hn so vi
phng php nn nhng cng c cc nhc im nh phng php nn
4. ng gi, bo qun
- quy m bo ch nh, Vn thuc c gi bng giy chng m,
ng trong l rng ming.
- quy m cng nghip thuc c ng trong tng v, ng thi l
khun thuc bng cht do, c in tn thuc, cc v thuc c ng trong
hp giy cng. Bo qun ni kh mt, nhit < 30 C

IV. YU CU CHT LNG THUC T

Nhn chung cc dng thuc t phi p ng cc ch tiu cht
lng sau:
Phi c hnh th, kch thc v khi lng ph hp vi noi t,
sai s v khi lng tng vin so vi khi lng trung bnh khng
qu 5%
- Mi vin thuc phi cha ng lng dc cht yu cu, dc
cht phi c phn tn ng u trong ton vin, mt ct ca vin
thuc phi ng nht v hm lng dc cht trong mt, nh lng
bng phng php quy nh, sai lch khng qu 10% so vi hm
lng yu cu.
- Vin thuc phi c bn c hc gi c hnh th
trong qu trnh bo qun v khi s dng c th dng tay t vo cc
hc ca c th mt cch d dng.
- Phi nhanh chng chuyn sang lng sau khi t gii phng
dc cht. Thi gian bin dng hon ton khng qu 30 pht vi t
dc bo v khng qu 60 pht vi t dc thn nc.

V. MT S N V CNG THC THUC T

n thuc 12.1:
Rp: Cloral hydrat 0,5g
B cacao v 3,0g
M.f. Supp D.t.d Nolo.
Clorai hydrat tan trong b cacao nn p dng phng php
ho tan
Da vo h s thay th tnh chnh xc lng clorai v b
v phi thay 5% b cacao bng sp ong tng cng ca
vin thuc.
Bo ch:
+ un chy cch thu sp ong v 2/3 lng b ca cao, duy
tr nhit < 36 C, cho clorai hydrat vo trn u ho tan.
+ Cho nt lng b cacao cn li vo trn cho chy u.
+ ngui n gn nhit ng c th khun.

n thuc 12.2:
Rp: Colacgon
0,2 g
B cacao v
2,0 g
M.f. Supp D.t.d N 10.
Colacgon l loi bc keo d tan trong nc, do vy phi phi dung dch
dc cht vo t dc bng phng php trn u nh ho B cacao khng c
kh nng nh ho, do vy phi thay 10% b cacao bng lanolin khan nc
lm cht nh ho.
Tnh lng dc cht v t dc iu ch 10 vin thuc. Thay 10% b
cacao bng lanolin khan nc lm cht nh ho. Thay 5% b cacao bng
sp ong tng cng ca vin thuc.
Bo ch:
+ Ho tan Colacgon vo bng phn nc.
+ Cho lanolin khan nc vo trn u ht dung dch trn.
+ Cho mt phn b cacao vo trn u.
+ un chy cch thu sp ong v b cacao cn li nhit < 36C +
Cho hn hp trn vo trn cho chy u. + ngui n gn nhit ng
c th khun.

Cng thc 12.3: thuc n Efferangan 80 mg

X Paracetamol
80mg
Witepsol H15
1,0 g
Paracetamol khng tan trong t dc Witepsol o vy phi
phi hp vo t dc bng phng php ttn u n gin.
Bo ch:
+ Tnh lng paracetamol v t dc Witepsol iu ch
s vin thuc n d nh (v d 10 vin thuc).
+ Nghin nh paracetamol trong ci, cho mt phn t dc
Witepsol vo trn u.
+ un chy cch thu Witepsol cn li nhit < 40 C.
+ Cho hn hp trn vo trn cho chy u.
+ ngui gn n nhit ng c th khun.

n thuc 12.4:
Decmatol: 0,20 g; Anestesin: 0,01 g; Novocain hydroclorid: 0,04 g
Dung dch adrenalin 2: II ngit; B cacao v: 2,00 g;
M.f. Supp D.t.d N10.
Decmatol khng tan trong b cacao nn s dng phng php trn u
n gin. Anestesin tan trong b cacao s dng phng php ho tan.
Novocain tan c trong dung dch arenalin do vy phi hp vo b cacao
bng phng php ttn u nh ho.
B cacao khng c kh nng nh ho do vy phi thay 10% b cacao
bng lanolin khan nc lm cht nh ho.
Thay 5% b cacao bng sp ong tng cng vin thuc.
Bo ch n thuc trn nh sau:
+ Trc tin tnh lng dc cht v t dc iu ch 10 vin thuc,
sau thay 10% b cacao bng lanolin khan nc v thay 5 b cacao bng
sp ong. + Ho tan novocain vo dung dch adrenalin. + Cho lanolin khan
nc vo trn u ht dung dch trn. + Cho ecmatol v mt lng nh
b cacao vo ttn u. + un chy cch thu sp ong v b cacao cn li,
cho anestes vo ho tan, duy tr nhit < 36 C. + Cho hn hp trn
vo trn cho chy u ri khun.

Cng thc 12.5: thuc trng penciin

Penicilin
10.000IU
T dc gelatin glycerin v
1 vin
Lm 10 vin thuc trng nh vy.
Tnh lng penicilin v t dc cho 10 vin thuc trng.
Bo ch:
+ Ho tan penicilin vo 2 ml nc ct.
+ iu ch t dc gelatin glycerin ngui n 40 C.
+ Cho dung dch pemcilin vo trn u ri khun.
Cng thc 12.6: thuc trng progesteron
Progesteron
0,002g
T dc gelatin glycerin v
1 vin
Lm 10 vin thuc trng nh vy.
Tnh lng progesteron v t c iu ch 10 vin thuc trng
-Bo ch:
+ Ho tan progesteron vo mt lng t thiu u tho mc.
+ iu ch t dc gelatin glycerin ngui n 40 C.
+ Cho dung ch progesteron vo trn u ri khun.

Cng thc 12.7: thuc trng cloramphenicol

Goramphenicol 0,25 g
T c gelatin glycerin v 1 vin
Lm 10 vin thuc trng nh vy.
Tnh Lng cloramphenicol v t dc iu ch 10 vin.
Bo ch:
+ Nghin nh cloramphenicol cho bng lng glycerin vo trn
thnh bt nho.
+ Ch t dc gelatin glycerin ngui n 40 C.
+ Cho bt nho trn vo trn u ri khun.

Cng thc 12.8: Thuc trng tanin

Tanin:
0,3g;
Gelatin:
1,0g;
Glycerin: 6,0g;
Nc:
3,0g
Lm 10 vin thuc trng nh vy
n thuc ny c tng k do tanin to tanat gelatin khng tan trong
nc nhit thp, do vy phi khc phc bng cch un nng I ln
105 c ho tan tanat gelatin.
- Bo ch:
+ Ho tan tanin vo nc.+ Cho gelatin vo dung dch tanin
galatin trng n hon ton. + un nng glycerin ln 60 C.
Cho gelatin ngm trn vo trn u. Tip tc un nng ln
105C. Khuy trn lin tc cho ti khi gelatin tan hon ton. Ch
khng un nng qu lu, gelatin s b thu phn, nh hng ti cng
ca vin thuc.
+ ngui n gn nhit ng c th khun.

Chng 13

K THUT BO CH THUC BT

MC TIU HC TP
1.Trnh by c khi nim, phn loi thuc bt.
2. Nu c cc t dc s dng trong bo ch thuc bt.
3. M t c trnh t bo ch bt thuc, thuc bt n v thuc bt kp.
4. Nu c yu cu cht lng ca thuc bt.
5. Vit c cch bo ch mt s n v cng thc thuc bt.

I.I CNG
1. nh ngha
Thuc bt l dng thuc rn, gm cc ht nh, kh ti, c
mn xc nh, cha mt hoc nhiu dc cht. Ngoi dc cht,
trong thuc bt cn c th thm cc t dc nh cht iu
hng, cht mu, t dc n. Thuc bt c th dng ung
hoc dng ngoi, xng ht, pha tim.
Trong y hc c truyn, thuc bt ue gi l thuc tn.
Thuc bt l mt trong nhng dng thuc c dng sm
nht trong bo ch. Nhng gn y, do s ra i ca nhiu dng
thuc mi i t bt thuc nh vin nn, nang cng,... nn vic
s dng thuc bt gim i ng k.

2. Phn loi
C nhiu cch phn loi thuc bt:
2.1. Da vo thnh phn:
Thuc bt n: trong thnh phn ch c 1 loi bt. V d:
Rp. Natli hydrocarbonat
2,0 g
M.f.p.
Thuc bt kp: trong thnh phn c t 2 loi bt tr ln. V d:
Rp. Menthol
0,1 g
Bt talc v
10g
Tinh u bc h
v
M.f.p.
2.2 Da vo cch phn liu, ng gi
2 2.1. Bt phn liu
L thuc bt sau khi u ch xong, c chia sn thnh liu mt
ln ng. Thuc bt phn liu thng dng ung (cng thc
13.5,13.8).

2.2.2 Bt khng phn liu

L thuc bt c ng gi trong nhng bao b thch hp,
bnh ^ nhn t phn liu ly khi ng. Bt khng phn liu
thng l brH dng ngoi (cng thc 13.1) hoc cc bt pha
so, pha hn dch (cng thc 13.2).
3. u, nhc im
Thuc bt c mt s u im nh sau:
K thut bo ch n gin, khng i hi trang thit b phc
tp, d ng gi v vn chuyn.
Thuc bt ch yu i t dc cht rn nn n nh v mt ho
hc, tng i bn trong qu tnh bo qun, tui th ko di,
thch hp vi cc dc cht d b thu phn, d b oxy ho, d
bin cht trong qu trinh sn xut v bo qun.

Do , hin nay nhiu loi dc cht khng bn v mt ho hc

thng c bo ch di dng bt pha dung dch, b pha hn
dch, dng ung hay tim (bt penicilin pha tim, bt
erythromycin pha hn dch,) Cng do i t dc cht rn t
xy ra tng, tng k gia cc c cht vi nhau hn trong
dng thuc lng, nn mt ch phm thuc bt d phi hp nhiu
dc khc nhau.
Thuc bt d gii phng dc cht v do c sinh kh dng
cao hn cc dng thuc rn khc.
- Nhc im ca thuc bt l d ht m, khng thch hp vi
cc dc cht c mi, v kh chu v kch ng nim mc ng
tiu ho.

II. THNH PHN THUC BT

1. Dc cht
Dc cht dng bo ch thuc bt ch yu l dc cht rn
c phn chia n kch thc xc nh (gi l bt thuc).
Ngoi ra c th c cc dc cht lng hay mm nhng khng
c gy nh hng n th cht kh ti ca thuc bt (cng
thc 13.1).
2. T dc
Trong thuc bt thng dng cc loi t dc sau:
T duc n hay pha long: hay gp trong bt nng , dng
pha long cc due cht c hay tc ng mnh. Trong hay
dng nht l lactose.
T dc ht: dng cho cc bt kp c cht lng, mm, cht ho
m c trong thnh phn ca thuc bt.

Hay dng cc loi nh calci carbonat, magnesi carbonat, magnesi

oxyd,... Lng dng tu theo t l cc cht lng, mm c trong
cng thc thuc bt
T dc bao: dng cch ly cc dc cht tng k trong bt
kp. Thng dng cc bt tr nh magnesi oxyd, magnesi
carbonat,... Lng dng bng mt na cho n ng lng vi
cc cht cn bao.
T dc mu: thng dng cho bt kp cha cc dc cht c
hay tc dng manh, chim t l nh trong hn hp bt kp,
kim tra s phn tn ng nht ca cc dc cht ny trong khi
bt- Cc cht mu hay c dng nhu erythrocin (mu ),
tartrazin, quinolein (mu vng), st oxyd (mu nu),...
T dc iu hng, v: thng dng bt ng, ng ho
(saccarin, cyclamat, aspartam...), cc loi tinh du hoc cc cht
tng hp nh vi cc dng thuc khc.

3. Bao b
Thng thng thuc bt c ng gi di 2 dng: ng
ti, ng l.
Cc thuc bt phn liu dng ung nh thuc bt, bt
hn dch, pha siro... thng c ng vo ti. Ti ng thuc
thng lm bng vt liu l giy kt hp vi mng nhm v cht
do c th hn c bng nhit . V d: giy - polyethylen nhm polyethylen.
Qu trnh ng thuc c thc hin trn thit b ti t
ng.
Cc thuc bt khng phn liu thng ng trong l (thu
hay cht do) nh cc l thuc bt pha hn dch, pha siro...
Thuc dng ngoi c th ng trong l c np c l c th
rc, bi, xoa d dng.

III. K THUT BO CH THUC BT

1. K thut bo ch bt thuc
Qua hai bc c bn: Phn chia nguyn liu v ry.
1.1 Phn chia nguyn liu
Tu theo bn cht nguyn liu m ngi ta chn phng php, dng c
v thit b phn chia thch hp (xem chng 2 - phn cc k thut nghin
tn).
1.2 Ry
L bin php la chn cc tiu phn c kch thc mong mun v
m bo ng nht ca bt.
Thuc bt an, bo ch qua cc bc nghin v ry nh vi bt c dng
ry gm c: Li ry, thn ry, y ry v np ry. Quan trong nht l
li ry c lp gia thn ry v y ry. Tu ng knh mt ry hoc
cnh mt ry m c cc c ry khc nhau. Cc c ry quy nh trong
Dc in cc nc khng ging nhau. Dc in Vit Nam 3 quy nh
c ry theo t chc tiu chun ic t ISO (xem chng 2 - phn cc k
thut ry).

Khi ry cn ch :
-Khng nn vo ry nhiu bt qu v nn o u bt trn ry tng
kh nng tip xc ca tiu phn vi l mt ry.
- m bt nn va phi, bt m qu kh lt qua ry.
-Khi ry, nn ry nh nhng, khng ch xt nhiu trn ry d lm dn
li mt ry.
- Ry dc cht c cn phi y np.
2. K thut bo ch thuc bt
Thuc bt n, bo ch qua cc bc nghin v ry nh vi bt thuc
Thuc bt kp, bo ch qua 2 giai on: nghin bt n v trn bt
kp

2.1 Nghin bt n
Trong mt n bt kp, cc thnh phn (bt on) c nghin theo
nguyn tc khi trn vi nhau, chng phi m bo c s phn tn
ng nht ca hn hp bt kp. C th l:
- V khi lng: Dc cht c khi lng ln th nghin trc, sau
xc ra khi ci ri nghin tip de cht c khi lng t hn.
Nh vy dc cht c khi lng nh nht sau khi nghn xong s
li lun trong ci bt u trn bt kp, trnh phi xc i xc li
nhiu ln.
- V t trng: Nu trong thnh phn bt kp c cc dc cht c t
trng chnh lch nhau th dc cht c t trng ln, cn phi nghin
mn hn gim bt khi lng ca tiu phn dc cht, lm cho bt
kp d trn thnh khi bt ng nht, trnh hin tng phn lp.

2.2 Trn bt kp
m bo yu cu ng nht ca bt kp, ngi ta tin hnh trn
bt theo nguyn tc trn ng lng: Bt u t bt n c khi
lng nh nht ri thm n bt c khi lhg ln hn, mi ln
thm lng tng ng vi lng c trong ci. Ring vi cc
bt nh ngi ta trn sau cng trnh bay bi, gy nhim
khng kh v hao bt dc cht.
Thi gian trn l yu t quan trng nh hng n s ng nht
ca bt. Thi gian ny ph thuc vo tnh cht ca tng loi bt
Nhiu kt qu nghin cu cho thy, sau khi bt phn tn ng
nht nu ko di thi gian trn, bt li b phn lp tr li.
Ry l bin php trn bt tt.
Thit b v cch trn c nh hng n s ng nht ca bt .
Trong sn xut dng cc loi my trn khc nhau (xem chng 2
phn k thut trn).

IV. YU CU CHT LNG THUC BT

1. Cm quan
nh gi s kh ti: Quan st mc kh ri, linh ng, trn: chy
ca khi bt s b nhn nh v s kh ri hay vn cc ca khi
bt.
nh gi s ng nht: i vi thuc bt kp c mu, mu sc ca
khi bt phi ng nht khi quan st bng mt thng di nh sng
t nhin, vi mt lng bt va , c phn tn u trn mt t
giy trng mn (DVN 3).
nh gi mn: Ly mt t bt xoa ln ch da mng phn bit
cm gic mn mng ca bt mn hay cm gic ln nhn ca bt
th.
2. m
Thuc bt khng c cha qu 9% hm lng nc. y l iu
kin m bo tnh cht kh ti ca thuc bt (DVN 3).

3. mn
Thuc bt phi t mn trong chuyn lun. Nu khng c ch
ring th thuc bt dng ngoi v thuc bt dng cho thuc tra phi
l bt mn hoc rt mn. Dc in Vit Nam 3 chia mn |a bt
thnh 5 loi:
- Bt th (1400/355) l bt m khng t hn 95% phn t qua ry
400 v khng qu 40% qua c ry s 355.
- Bt na th (710/250) l bt m khng t hn 95% phn t qua
ry 710 v khng qu 40% qua c ry s 250.
- Bt na mn (355/180) l bt m khng t hn 95% phn t qua
ry 355 v khng qu 40% qua c ry s 180.
Bt mn (180/125) l bt m khng t hn 95% phn t qua ry 180
v khng qu 40% qua c ry s 125.
Bt rt mn ( 125/90) l bt m khng t hn 95 % phn t qua ry
125 v khng qu 40% qua c ry s 90.

4. ng u khi lng
Theo Dc in Vit Nam 3, sai s khi lng ca thuc bt phi
t gii hn nh ghi bng 13.1.
Bng 13.1. Sai s khi lng thuc bt theo DVN 3
Khi lng ghi trn nhn (g)

Di hoc bng 0,5

Trn 0,5 - 1,5
Trn 1,5 - 6,0
Trn 6,0

K % chnh lch so vi khi lng

ghi trn nhn

10,0
7,0
5,0
3,0

Ngoi ra thuc bt cn phi t cc ch tiu khc nh: nh tnh,

nh lng, gii hn nhim khun...

V. MT S N V CNG THC THUC BT

n thuc 13.1:
Rp.
Lu hunh kt ta
1,0g
Km oxyd
1,0g
Magnesi carbonat
2,0g
Bt talc
5,0g
Du parafin
1,0g
M.f.p.
Trnh t pha ch: Nghin bt talc, xc ra giy. Nghin Magnesi
carbonat, trn vi du parafin, xc ra giy. Nghin tip km oxyd,
lu hunh. Trn bt kp theo th t: lu hunh, km oxyd, hn
hp magnesi carbonat - du paraln, talc.

Cng thc 13.2: thuc bt amoxicilin pha hn dch

Amoxicilin trihydrat 1,725 g (tng ng vi l,5g amoxicilin )
Natri benzoat
0,06g
Natrisaccarin
0,03g
Gm xanthan
0,20g
Riboflavin
0,05g
Bt ng
15,00g
Lactose
12,72g
Vanilin
0,01g
A moxicilin d b phn hu bi cc yu t bn ngoi nh m,
nh sng, nhit . Ch di dng bt pha hn dch ko di c
tui th ca thuc. pha hn dch, thnh phn bt phi c cc
cht lm tng nht, cht gy thm. iu hng, iu v
thnh phn ca bt pha hn dch c cc cht lm ngt, lm thm.
K thut bo ch: Cn lactose nghin thnh bt, xc ra li
khong 1 g trong ci

Cn v cho vo ci ln lt vanilin, natri saccarin, natri benzoat, gm

xanthan, n u. Cn amoxycilin trihydrat v ribonavin cho vo hn hp
trn trn nhanh, trn nt lng lactose. Cn bt ng cho vo trn u,
ry nhanh. ng trong l kn vch 60 ml. Dn nhn ghi r cch dng liu
lng.
- Cch ng v liu lng: Thm nc un si ngui n vch 60ml lc
k. Mi tha c ph cha 125 mg amoxicilin.
Cng thc 13.3: thuc bt pha dung dch (tnh cho 1 gi thuc)
Acid boric
4,350 g
Nhm - kali sulfat
0,600 g
Berberin
0,001 g
Mentol
0,012 g
Thymol
0,015 g
Phenol
0,005 g
y l cng thc thuc bt dng pha thnh dung dch ra. Thuc c
ng ti, khi dng pha 1 gi vo 2 lt nc, khuy cho tan hon ton.

Cng thc 13.4: thuc bt Oresol

Glucose khan
20,0 g
Natri clorid 3,5 g
Natri citrat 2,9 g
Kali clorid 1,5 g
Thuc bt dng b nc v cht in gii trong trng
hp b mt nc nh tiu chy, st cao.... Thuc bt c
ng ti chng m. Khi dng, pha 1 gi vo mt cc
nc (200 ml).

Cng thc 13.5: Bt si bt h st

Paracetamol
0,15 g
Acid citric khan
0,12 g
Natri hydrocacbonat 0,20 g
Natri carbonat
0,10 g
Natri saccarin
0,002 g
Natri benzoat
0,20 g
Sorbitol
0,21 g
Trn ring paracetamol, natri carbonat, natri hydrocarbonat,
natri saccarin, sorbitol, natri benzoat. Sau trn nhanh acid
citric khan ng ti. Pha ch v ng ti trong iu kin nhit
di 25C, m di 25%. Thuc c cng dng h nhit,
gim au dng cho tr em.

Cng thc 13.6: Bt dng ngoi

Lu hunh
8,5g
Km undecylenat
1,0g
Bismuth galiat base 0,5g
Menthol
0,5g
Camphor
1,0g
Acid salicylic
0,5g
Km oxyd
9,0g
Acid boric
9,0g
Tinh du thm
0,25g
Talc v
100,0g
y l cng thc thuc bt dng ngoi iu tr eczema, nm a.
Thuc c th c ng trong l dng rc, xoa.

Cng thc 13.7: thuc bt c tng k

Ti A:
Sorbitol
1,845g
Acid citric
0,878g
T dc: saccarose, tinh du cam, tinh du chanh.
Ti B:
Arginin hyroclorid 0,5g
Natri sulfat khan
0,066g
Natri hydrophosphat 0,119 g
T dc: natri hyrocarbonat, saccarose, tnh du cam, chanh.
Bo ch ring ti A v ti B v trong cc cng thc c cc thnh
phn tng k vi nhau nu tip xc vi m. Khi pha ch v ng
ti nn tin hnh iu kin nhit di 25C, m di 40%.
Khi dng ho tan ti A v B vo 1 ly nc, khuy cho si bt v
tan hon ton trc khi ung.
Cng dng: iu tr chng kh tiu, to bn.

Cng thc 13.8: Thuc bt erythromycin (cng thc tnh cho 1gi thuc)
Erythromycin
250 mg
Lactose
800 mg
ng sacarose
1450 mg
Vanilin
0,05 mg
Trn bt kp erythromycin, lactose, sacarose, vanilin, ng ti.
Cng thc 13.9: Cm Cefixim (cng thc tnh cho 1 gi)
Cefixim trihydrat
56 mg (tng ng cefixim 50 mg)
Lactose
500 mg
ng sac arose
1500 mg
Aerosil
3 mg
Mu vng
0,3 mg
Cht thm
10 mg
Nc ct
0,16 ml
Trn bt kp cefixim trihydrat, lactose, sacarose, cht mu. Dng nc nho
m, xt ht qua ry 0,8 mm, sy ht 50C ti m 1 - 2%: Trn cm kh vi
Aerosil, cht thm, ng ti.

Cng thc 13.10: Cm acetylcystein (cng thc tnh cho mt gi

thuc)
Aeeiylcystein
100 mg
Aspartam
40 mg
Lactose
855,75 mg
Mi cam bt
4mg
Mu vng cam
0,25 mg
Nc tinh khit
v
Trn bt kp acetylcystein, lactose, aspartam, cht mu. Dng
nc nho m, xt ht qua ry 0,6 mm, sy ht 50 - 60C ti
m 2-3%. Trn cm kh vi cht thm, ng ti.

Chng 14
K THUT BO CH THUC NANG
MC TIU HC TP
1.Trnh by c khi nim, phn loi, u nhc im ca thuc nang.

2. Phn bit c nang cng v nang mm gelatin v cu to v nang, dng

bo ch ng vo nang, phng php ng nang.
3. Nhn bit c vai tr, cch dng ca cc t dc dng bo ch thuc
ng nang cng v nang mm.
4. Nu c nguyn tc ng thuc vo nang cng v nang mm.
5. Trnh by c yu cu cht lng nang thuc.
6. Nu c cch pha ch mt s cng thc thuc nang.

I. ICNG
1. Khi nim
Thuc nang l mt dng thuc phn liu bao gm:
- Mt v rng ng thuc (thng l gelatin), gn lin vi
thuc v a vo c th cng vi thuc. Sau khi r, gii phng
thuc, v nang c tiu ho.
- Mt n v phn liu ca dc cht c bo ch di cc
dng thch hp ng vo v nang (bt, ht, dung dch, vin
nn...)
- C th quan nim thuc nang l hnh thc trnh by c bit
ca nhiu dng bo ch khc nhau nh: dung dch, vin nn,
cm thuc...
-Thuc nang ch yu dng ung, ngoi ra cn dng t
(nang t trc trng, nang t m o), hoc xng ht

2. Phn loi
Da vo tnh cht c hc ca v nang, thuc nang c chia hai loi:
thuc nang cng gelatin v thuc nang mm gelatin.
Dc in Vit Nam 3 phn thuc nang thnh 4 loi: Thuc nang cng,
thuc nang mm, thuc nang tan trong rut v thuc nang gii phng
hot cht c bit.
- Nang mm: V nang mm, do dai do ngoi gelatin cn c mt t l
ln cht ho do.
Nang mm do Mothes, mt sinh vin ngi Php sng ch nm vo1834
bng phng php nhng khun. Su nm sau (1840) phng php p
khun gia hai tm kim loi c pht minh v n nm 1832 phng
php ny c ci tin thnh phng php p gia hai trc quay.

- Nang cng:
V nang cng gm hai na y v np lng kht vo nhau (hnh
14.2). Nang cng c 8 c, c dung tch t 0,13-1,36 ml (bng
14,1)
Bng 14.1. Cc cd v dung tch ca v nang cng
C nang

00

000

Dung tch nang (ml) 0,13 0,20 0,27 0,37 0,48 0,67 0,95 1,36

Nang cng do mt dc s ngi Php Lehuby pht minh vo nm

1846. Hin nay nang cng c sn xut rng ri bi nhiu hng
sn xut v nang ni ting nh Eli Lilly v Parke Davis (M).
Vit nam, c s sn xut c v nang (cng ty c phn Dc Cu
Long).
3. Mc ch ng thuc vo nang
- Che du mi, v kh chu ca dc cht, v d nang du giun, du
c, chloramphenicol, nang tetracyclin...
- Bo v dc cht trnh tc ng bt li ca ngoi mi nh m,
nh sng.
- Hn ch tng k ca dc cht.
- Khu tr tc dng ca thuc rut, trnh phn hu thuc bi dch v.
- Ko di tc dng ca thuc: nang tc dng ko di (Spansules).

4. u nhc m ca nang thuc

u im:
D nut do hnh dng thun, mm (nang mm), b mt trn (nang
cng). iu ny rt c ngha vi tr em v ngi cao tui.
Tin dng: V y l dng thuc phn liu, ng gi gn, d bo
qun v vn chuyn nn tin dng nh vin nn.
D sn xut ln: Hin c nhng my ng nang hin i sut cao.
Sinh kh dng cao: Do cng thc bo ch n gin, t s n dc, t
tc ng ca k thut bo ch (so vi vin nn), v nang tan r gii
phng dc cht trong ng tiu ho nn thuc nj thng c sinh
kh dng cao.
Nhc im: Cc dc cht kch ng nim mc ng tiu ho
khng nn ng nang v sau khi v nang r s tp trung nng th
cao ti ni gii phng thuc (th d: natri nitrofurantoin).

II. THNH PHN THUC NANG

1. Dc cht
Dc cht c bo ch di dng thuc nang rt
phong ph. C th bo ch thuc nang vi c cc dc
cht rn, lng, thuc c ngun gc thc, ng vt.
Trc khi ng vo nang, dc cht phi c bo ch
dui dng thch hp. Thuc ng nang mm thng l
cc cht lng, dung dch du, hn dch hoc cc bt
nho, i khi c th ng c dng nh tng. Nang
cng c th ng bt thuc, cm thuc, pellet, bt
nho, vin nn...

2. T dc
2.1 T dc to v nang
Thnh phn chnh ca v nang gm: Gelatin, cht ho do, nc, cht bo
qun, cht mu..
Gelatin lm v nang phi l loi c dng, t cc chi tiu v gii hn
kim loi nng, asen, mc nhim vi sinh vt. Ngoi ra phi lu n
bn gel l hai yu t quyt nh kh nng to mng ca gelatin.
Yu cu v bn gel tu thuc vo phng php iu ch. nht ca
dung dch gelatin ch v nang cng nh hng n cng ca v v cc
thng s trong qu trnh bo ch. Nu nht thp, v nang thng mng,
thi gian sy kh lu. Nu nht cao qu v nang dy v cng.
Ngoi gelatin, c th dng cc t dc khc to v nang nh cc dn cht
ca cellulose (HPMC, HPC...).
Cht ho do dng cho nang mm c t l cao hn trong cng hc ca v
nang cng. Cht ho o thng ng l glycerin, ngoi ra th thm cc cht
khc lm tng do dai ca mng nh propylen glycol, sorbitol...
T l cht ho do ph thuc vo thnh phn v bn cht thuc ng nang

2.2 Cc t dc dng bo ch thuc ng vo nang

2.2.1 T dc dng bo ch thuc ng nang mm
T c bo ch thuc ng nang mm c th phn
thnh hai loi:
Cht lng thn du nh du thc vt, u khong,
trigiycerid...
Cht lng thn nc nh: PEG 400- 600, triacetin,
polyglyceryl este. Propylen glycol v glycerin c th
c dng nhng vi nng thp (5- 10%) trnh
ho tan v lm mm v nang.
Ngoi ra trong thnh phn ca thuc ng nang c th
cho thm cc cht iu chnh th cht nh sp ong, cc
cht gy thm hay nh ho nh lecithin...

2.2.2. T dc dng bo ch thuc ng nang cng

T dc trn: iu ho s chy, gip cho bt hoc ht chy
u vo nang nhm m bo s ng nht v khi lng v hm
lng dc cht. T dc trn hay dng nh : Magnesi
stsarat, calci stearat, Aerosil... vi t l 0,5- \%.
T dc n: Dng trong trng hp liu hot cht thp khng
chim ht dung tch nang. Cng c nhng trng hp bt dc
cht trn chy km, phi cho thm t dc n trn chy tt
nh tinh bt bin tnh, lactose phun sy...
i khi tng kh nng thn t khi bt trong dch tiu bo
ngi ta c th cho thm vo cng thc mt t l cht din hot,
v d: natri lauryl sunfat.
Mt s bt thuc kh trn chy khi ng nang phi to ht, th
cn phi thm t dc dnh (xem chng vin nn).

III. K THUT BO CH THUC NANG

1. Bo ch dung dch v nang
ch dung dch v nang, ngi ta ho tan cht mu, cht bo
qun v cc cht ph khc vo nc. Ngm gelatin vo dung
dch cho trng n hon ton. un nng glycerin, cho gelatin
trng n vo un cch thu ho tan. Lc gi nng ch
v nang.
2. Cc phng php ng nang
2.1. Nang mm gelatin
2.1.1. Phng php nh git
Thc hin nh cc my to nang nh git qui m nh hoc
qui m cng nghip (hnh 14.3). Qu trnh to v v ng thuc
xy ra ng thi

Khi ch nang, trc ht dung dch v nang (duy tr khong

60C) c dn qua u nh git to ra mt v rng, ca ra
ca u nh git dung dch v nang c chn gia bi u
nh git dung dch dc cht. Ngay lc , ngi ta iu khin
van cho dung dch dc cht nh vo v nang, lm cho nang
ct git v v nang c ng kn. Nang c ng bng du
parafin lnh (khong 10C) s ng rn li.

Hnh 14.3. S thit b to nang nh git

1- Dung dch dc cht
2- Dung dch gelatin
3- Du parafin lnh

Chn nhng nang t yu cu, tn u ra, thi gi

lnh. Ra sch du parafin bng hn hp dung mi
hu c (ethanol- aceton), ri sy 4-45C cho bay ht
dung mi. Kim tra loi ht nhng nang khng t
yu cu (nang b dnh, nang c v dy qu...).
Trong sn xut ln, ngi ta dng cc my c nhiu
dng nh git. Nang ch theo phng php nh git
thng cha cc dng dch du nh du c, vitamin tan
trong du. Phng php ny thng mc sai s vi
khi lng ln do khng p dng cho cc dc cht
c tc dng mnh. Hn na hiu sut to nang khng
cao nn hin nay t dng.

2. Phng php p khun

u tin ngi ta ch nang th cng bng cch p gia hai tm
lom loi c to khun. Hin nay dng cc my p nang c
nng sut cao, to ra c nhiu loi nang c hnh dng, mu sc
khc nhau (hnh 14.4).
Khi ch nang, dung dch v nang
cha trong bnh c rt thnh
mt lp mng sang b mt
trng quay c lm lnh trc.
Gp lnh, gelatin ng cng thnh
mng mng. Mng chuyn ln
ng bi du v a vo trc to
nang c lm nng.

Trc to nang l hai ng hnh tr quay ngc chiu, trn mi trc

c khun mt na v nang, i xng nhau. Khi hai na v nang
tip xc nhau, y nang c hn kn trc, cng lc dc
cht c ng vo nang nh mt piston phn phi. Hai trc
khun tip tc quay, nang c hn kn v ct ri khi mng
gelatin.
Phng php p khun cho hiu sut cao, phn liu chnh xc nh
pistol phn liu t ng (sai s khi lng nang khong 1-5%).
Phng php ny c th to ra nhiu nang c hnh dng khc
nhau, c th c hai mu khc nhau trn mt nang (do hai gii
geletin c nhum mu khc nhau).
Nang p khun c th d dng phn bit vi nang nh git hay
nhng khun do trn thn nang c mt g nh. Nang p khun
cha c nhiu loi dc cht: dung dch du, bt nho thn
u, bt nho thn nc... do hin nay pht trin kh mnh.

2.2. Nang cng gelatin

Khc vi nang mm, v nang cng c ch ring, cc c s
thng mua v nang v ng thuc.
ng thuc vo nang, trc ht phi chn c nang cho ph hp
vi lng dc cht cn ng. i vi cc thit b th cng v
ng nang theo phng php th tch c th xc nh c nang theo
cng thc:
Khi lng thuc ng nang = KLR biu kin x Dung tch nang
Cch xc nh khi lng ring (KLR) biu kin n gin nh l
cn mt lng bt nht nh, chuyn vo ng ong, g nh nhng
cho n th tch khng thay i ri tnh theo cng thc:
Sau khi bit KLR biu kin c th chn c nang theo biu tnh
sn hoc tnh tip dung tch biu kin ca cht ng nang:
ri chn c nang thch hp.

V d: Chn c nang ng 500 mg bt thuc c KLR 0,8 g/ml, 500

mg bt thuc ny chim dung tch l:
.Dung tch ny
gn vi nang s 0 (c dung tch 0,67ml). Vy chn nang s 0. Lng t
dc cn thm vo ng y nang l 0,67- 0,63 = 0,04 ml. Chn t
dc n a vo, xc nh KLR ca t dc n t suy ra khi
lng t dc n.
Qui trnh ng thuc vo nang c 3 giai on:
-M v nang
-ng thuc vo thn nang
-ng np nang
Vic m v nang c th thc hin bng tay cc thit b th cng hoc
m bng chn khng i vi cc thit b t ng hoc bn t ng. Do
hai na v nang c lp vi nhau bng khp s b nn dng chn
khng c th m ra c. Sau khi m, hai phn np v thn c phn
ring. Phn thn nang nm trn bn ng nang hay mm quay ca thit
b ng thuc vo. Nu ng th cng th bt thuc c ln bn
ng nang, dng dng c gt y vo thn nang.

Trong cng nghip c nhiu phng php ng thuc vo nang

ph thuc vo loi thit b ng nang. C th chia thnh hai
phng php chnh: Phng php ng theo th tch v phng
php phn liu bng piston.
+ Phng php ng theo th tch: Bt thuc c phn phi
qua phu, trong khi mm ng thn nang quay. Bt chy qua
phu vi tc khng i, lng bt ng vo nang nhiu hay t
ph thuc vo tc quay ca mm. Mm quay nhanh, khi
lng bt ng gim v ngc li. Trong phng php ny bt
ng nang phi trn chy tt m bo ng u v khi lng.
+ Phng php ng bng piston: Khi bt trc khi ng vo
nang c nn li bng piston. C nhiu cch nn bt nh cho
bt chy vo cc ci ri nn bng piston, lp i lp li nhiu ln
to thi trc khi ng vo nang hoc dng piston cm vo
thng bt nn s b khi bt thnh thi ri th vo thn nang
(hnh 14.5)

Lng b ng vo mi nang c tnh ton khng ging nh

phng phap ong theo th tch m phi tnh da vo p lc nn
ca piston, th tch bung piston, Mi nng chu nn ca khi bt.
Ngoi ra cng phi a thm t dc trn bt c th chy vo
bung nn v thi bt c th y ra khi piston, ri vo nang mt
cch dng.
Sau khi ong thuc,
np nang c lp
vo thn nang bng
khp chnh. C th
dng p lc khng kh
ng np nang.
Nang sau c
lm sch bt, nh
bng v ng gi.
Hnh 14.5. Nguyn tc ng nang bng piston

IV. YU CU CHT LNG THUC NANG

Theo DVN 3, thuc nang c nh gi v cc ch tiu sau:
1. ng u v hm lng
p dng vi nang c hm lng dc cht nh hn 2mg hoc
nh hn 2% khi lng trong mt nang.
2. ng u v khi lng
- Th vi 20 nang. Cn tng nang. i vi nang cng, tho np
nang ht thuc ra, lau sch v nang. i vi nang mm, ct
m nang, ra v nang bng dung mi thch hp, bay hi dung
mi. Cn tng v nang, Tnh ra khi lng thuc trong mi
nang. Khng c qu hai nang vt qu gii hn sau:
Khi lng trung bnh vin

Gii hn

<300 mg

10%

> 300 mg

7,5%

3. r
Th nh i vi vin nn.
Nang cng v nang mm phi r trong vng 30 pht.
Nang tan trong rut sau khi khng dch v -2 gi phi
r trong dch rut trong vng 60 pht.
4. Th ho tan
Xem phn vin nn.
Ngoi ra thuc nang cng phi c nh gi cc ch
tiu nh cm quan, nh tnh nh lng... nh i vi
cc dng thuc khc.

V. MT S CNG THC THUC NANG

Cng thc 14.1: Nang tetracyclin hydroclorid
Tetracyclin hydroclorid 250 mg (250000 UI), 500 mg (500000 UI) Tinh
bt bin tnh va
Bt tetracyclin c khi lng ring (KLR) tng i ln v trn chy tt
nn c th ng vo nang cng bng phng php ong theo th tch.
Phng php bo ch nh sau:
- Xc nh KLR biu kin ca tetracyclin bng cch cn 5 g bt cho vo
ng ong kh, t vo my g 30 giy. c th tch biu kin. T tnh
ra KLR biu kin ddc= m/Vbk. Dung tch ca tetracyclin V=0,25(0,5)/ddc.
Chn c nang ph hp.
Tnh lng t dc n a vo bng cch xc nh KLR biu kin ca
t dc theo cch tng t. Dung tch ca t dc Vtd= Vn- Vdc
Khi lng t dc mtd= Vtd x dtf
Nhn khi lng dc cht v t dc ca 1 vin vi s nang tu thuc
vo bn ng nang. Trn bt kp c cht v t dc, ry qua ry 250.
ng nang.

Cng thc 14.2: mng amoxicilin

Amo xicilin
500 mg
Croscarmelose
15 mg
Lactose hydrat
176,5 mg
PVP K-30
0,5 mg
Magnesi stearanatri laurylsulfat (9:1) 8mg
Ho tan PVP trong cn 90% c nng 10%. Trn bt kp
amoxicilin, croscarmelosse, lactose. Cho cn PVP vo nho
thnh khi m. Xt ht qua ry 0,8 mm. Sy ht ti m 3-4 %.
Trn t dc n, ng nang s 0 bng phng php ng piston.
Cng thc 14.3: nang cephalexin.
Cephalexin
500 mg
Natri lauryl sulfat
4 mg
Magnesi stearat
7 mg
Talc
10 mg
Aerosil
2,5 mg
Nghin trn bt kp, ry qua ry 0,4 mm. ng nang cng s 0

Cng thc 14.4: vin nang mm nifedipin 10 mg

Nifedipin
10 mg
T dc pha thuc ng nang: PVP (Polyvinylpyrrolidone),
Tween80 menthol, natri saccarin, tettahydrofurfuryl alcol,
poiyethylenglycolether va .
T dc v nang: Gelatin, glycerin, dioxyd titan, oxyd st , nc
tinh khit va .
Trn dc cht vi cc t c cho ng nht. iu ch dch v
nang. ng nang bng phng php p khun.
Vin dng ung iu tr au tht ngc, hoc ngm di li khi
cao huyt p.

Cng thc 14.5: nang t ph khoa

Neomycin sulfat
35000 UI
Polymycin Sulfat
35000 UI
Nystatin
100000 UI
Dimethylpolysiloxan
2,2 g
Sucroglycerid
v
Du c
v
Du u nnh hydrogen ho v
T c v nang: Gelatin, glycerin, dioxyd titan, kali sorbat, nc
tinh khit va .
y l dng thuc nang mm dng t ph khoa. Trn dc
cht vi cc t dc cho ng nht, iu ch dch v nang, sau
ng nang theo phng php p khun.

Cng thc 14.6: nang tioconazole

Tioconazole 300mg
Glycin, lecithin, du thc vt hydrogen ho, polysorbat 80, du
parafin v.
T dc v nang: gelatin, glycerin, kali sorbat, titan dioxyd v.
y l dng thuc nang mm ng t ph khoa iu tr nm.
Trn dc cht v cc t dc cho ng nht, iu ch dch v
nang, sau ng nang theo phng php p khun.
Cng thc 11.7. nang du gan c
Du gan c cha vitamin A tng ng 50000 UI.
T dc v nang: gelatin, glycerin, dung dch sorbitol 70%, nc
tinh khit va .
C th ng nang mm ny bng phng php p khun hoc nh
git.

Chng 15
K THUT BO CH THUC VIN NN
MC TIU HC TP
1.Nu c khi nim, u nhc im, phn loi thuc vin nn.
2.Trnh by vai tr, c im, cch s dng ca cc nhm t dc:
n, r, dnh, trn, bao dng bo ch vin nn.
3.Vit c cc bc c bn ca 3 phng php bao ch vin nn:
xt ht t, xt ht kh, dp thng.
4. Nu c yu cu cht lng vin nn;
5. Trnh by c cc bc bo ch mt s cng thc thuc vin nn.

I. I CNG
1. Khi nim
Vin nn l dng thuc rn, c bo ch bng cch nn mt
hay nhiu loi dc cht (c thm hoc khng thm t dc),
mi vin l mt n v liu.
Quy trnh sn xut vin nn c a ra ln u tin nm 1843
trong bng pht minh ca Thomas Brockedon. n 1874 my
p vin nn ra i. Cng vi qu trnh hin i ho my dp
vin, ci tin ng vin vo v, nhiu loi t dc mi ra i,
lm cho vin nn tr thnh mt dng thuc ph bin nht hin
nay.

2. u, nhc im
Vin nn c s ng rng ri l do dng thuc ny c nhiu u im:
- c chia liu 1 ln tng i chnh xc.
-Th tch gn nh, d vn chuyn, mang theo ngi.
-D che u mi v kh chu ca dc cht.
-Dc cht n nh, tui th di hn dng thuc lng.
-D u t sn xut ln, do gi thnh gim.
-Din s dng rng: C th nut, nhai, ngm, cy, t, pha thnh
dung dch, hn dch...
-Ngi bnh d s dng, trn vin thng c ch d nhn bit tn thuc.
Tuy nhin vin nn cng c nhiu nhc im:
Khng phi tt c cc dc cht u bo ch c thnh vin nn.
SKD vin c th b thay i trong qu trnh bo ch o c nhiu yu t
tc ng n n nh ca dc cht v kh nng gii phng dc cht
ca vin nh: m, nhit , t dc, lc nn,...

3. Phn loi
Theo cch dng, c cc loi vin nn sau: vin nut, vin ngm,
vin t di li, vin t m o, vin nhai, vin si bt v vin
tc dng ko di.
II. THNH PHN THUC VIN NN
1. Dc cht
C mt s dc cht c cu trc tinh th u n c th p thnh
vin m khng cn cho thm t dc. Tuy nhin, s c cht ny
khng nhiu. Vi a s dc cht, mun dp thnh vin nn, ngi ta
phi cho thm t dc.
2. Cc t dc c s dng trong thuc vin nn
Yu cu chung ca t dc vin nn l:
-m bo bn c hc ca vin.
- m bo n nh ca c cht v ca vin.
-Gii phng ti a c cht ti vng hp thu.
- Khng c tc dng dc l ring, khng c, d p vin, gi c
hp l

Sau y l mt s nhm t dc hay dng:

2.1 T dc n
Cn gi l t c pha long, c thm vo vin m bo khi
lng cn thit ca vin hoc ci thin tnh cht c l ca dc
cht (tng trn chy, chu nn,... ), lm cho qu trnh dp
vin c Id dng hn.
2.1.1 Nhm tan trong nc
- Lactose:
L t dc n c ng kh ph bin trong vin nn. Lactose d
tan trong nc, v d chu, trung tnh, t ht m, d phi hp c
vi nhiu loi dc cht Lactose c 2 dng: khan v ngm nc
(tu theo -iu kin kt tinh).
Lactose phun sy c ch t lactose ngm nc nhng do trn
chy v chu nn tt hn lactose nn c dng dp thng.

-Bt ng (saccarose)
tan v ngt, do thng dng lm t dc n v dnh kh
cho vin ho tan, vin nhai, vin ngm. Khi dng lm t dc n,
c th to ht m vi hn hp nc - ethanol. Bt ng lm cho
vin d m bo bn c hc nhng kh r, khi dp vin d gy
dnh chy.
Trn th trng c mt s loi t c bt ng dng dp thng
nh:
+ Di-Pac: l sn phm ng kt tinh ca 97% ng v 3% dextrin
di dng ht, trn chy tt. Khi dp vin, vin b cng dn trong
qu trnh bo qun.
+ Nutab: l ng tinh ch, kt hp vi 4% ng kh, 0,1 - 0,2%
tinh bt ng v lm trn bng magnesi stearat, trn chy tt.

-Glucose:
D tan trong nc, v ngt hn Sactose, do hay c dng vin ho tan
nh vi bt ng. Glucose n chy km, d ht m m bo bn c
hc cho vin nhng c xu hng lm cho vin cng dn trong qu trnh bo
qun, nht l glucose khan. Glucose cng c th lm bin mu cc dc cht
kim v amin hu c trong trnh bo qun ging nh lactose.
Emdex l sn phm phun sy ca glucose vi 3 - 5% maltose, trn,
chy v chu nn tt, nhng vn rt ho m.
-Manitol:
Rt d tan trong nc, v hi ngt, li cm gic mt d chu trong ming
khi ngm, do rt hay c dng cho vin ngm, vin nhai (cng thc
15.7). Manitol dng tinh th u n c th dng dp thng, nht l vi
vin pha dung dch.
-Sorbitol:
L ng phn quang hc ca manitol, d tan v v d chu nhi manitol, cho
nn hay dng trong vin ngm, vin nhai phi hp vb manitol. Sorbitol c
th ng dp thng, tuy nhin do ho m heto: manitol nn t l t dc trn
phi ng nhiu hn v m trong phng p vin phi < 50%.

2.1.2. Nhm khng tan trong nc

- Tinh bt:
L t dc r tin, d kim, do hay c dng nc ta
hin nay. Tuy nhin tinh bt trn chy v chu nn km,
ht m, lm cho vin b dn ra v d b nm mc trong qu
trnh bo qun. Khi dng tinh bt, thng phi phi hp
vi khong 30% bt ng m bo chc ca vin.
- Tinh bt bin tnh:
L tinh bt qua x l bng cc phng php l - ho
thch hp. Tinh bt bin tnh chu nn v trn chy tt hn
tinh bt, ho tan tng phn trong nc tu theo mc
thu phn. Trn th trng c nhiu lot tinh bt bin tnh
vi cc tn thng mi khc nhau: Starch 1500, Primojel,
Eragel...

Cellulose vi tnh th:

L t dc dng ngy cng nhiu, nht l trong vin nn dp
thng do c nhiu u im: chu nn tt, tran chy tt, lm cho
vin d r. Trn th trng c nhiu loi cellulose vi tinh th c
tn gi khc nhau Avicel, Emcocel,...
Cellulose vi tinh th l t dc dp thng c dng nhiu nht.
Tuy nhin vin cha nhiu Avicel khi bo qun m cao c
th b mm i do ht m. C th khc phc bng cch kt hp
vi cc t dc trn chy t ht m hn nh Fast - Flo lactose.
Trn th trng hin nay thng dng 2 loi Avicel: pH 101 c
kch thc ht trung bnh 50m v pH 102 c kch thc ht
90m.

- Calci dibasic phosphat (dicalci phosphat):

L t dc v c, bn v l - ho, khng ht m, n chy
tt. T dc dp thng cha dicalci phosphat c tn thng
mi l Emcompress hoc Ditab (trong dicalci phosphat
c phi hp vi 5 - 20% cc t dc khc nh tinh bt,
Avicel, magnesi stearat) (cng thc 15.6). Vin dp vi
dicalci phosphat c bn c hc cao, r chm, v vy
khng nn dng t l cao vi dc cht t tan.
Dicalci phosphat c tnh kim nh (pH 7 - 7,3), do
khng dng cho cc dc cht khng bn trong mi trng
kim. trong ng tiu ho, t dc ny c th to phc,
lm gim hp thu mt s dc cht (tetracyclin, phenytoin...).

- Calci carbonat, magnesi carbonat:

L nhng t dc c kh nng ht nn c th dng cho
vin nn cha cao mm dc liu, cha dc cht ho m,
du v tinh du. Trong mt s vin, cc t dc ny cn
ng vai tr antacid hoc cung cp ion v c cho c th.
Tuy nhin, y l nhng t dc c tnh kim, cho nn
khng dng cho cc dc cht c tnh acid, cc mui
acid...

2.2 T dc dnh
L tc nhn lin kt cc tiu phn to hnh vin, m bo
ca vin.
2.2.1. Nhm t dc dnh lng
T c dnh lng dng trong phng php xt ht t. C
nhiu loi t dc dnh lng c mc kt dnh khc nhau:
Ethanol:
Ethanol dng khi thnh phn vin c cc cht tan c troi
ethanol (cao mm c liu, bt ng,.. J to nn kh
nng dnh. V cao mm, ethanol cn gip cho vic phn tn
cao v khi bt d hn, lm cho ht d sy kh hn.

H tnh bt:
H tinh bt l t dc dnh thng dng hin nay, d kim, gi r d
trn u vi bt dc cht, t c xu hng ko di thi gian r ca
vin. Thng dng loi h t 5 - 15%, trn vi bt dc cht khi h
cn nng. Nn iu ch dng ngay trnh b nm mc.
Dch th gelatin:
Gelatin trng n v ho tan trong nc, to nn dch th c kh nng
dnh mnh, thng dng cho vin ngm ko di thi gian r hoc
dng cho dc cht t chu nn. Hay dng dch th 5 -10%, trn vi
bt dc cht khi t dc cn nng, c th kt hp vi h tinh bt
tng kh nng dnh cho h.
Dch nc gelatin c nht ln, kh trn u vi bt dc cht, ht
kh sy kh. V vy ngi ta hay dng dch th gelatin trong ethanol
c thu phn trong mi trng acid hay mi trng kim.
So vi dch nc, dch ethanol cn hn ch c s thu phn ca
mt s dc cht v lm cho ht d sy kh.

Dch gm arabic:
Gm arabic c kh nng dnh mnh, ko di thi gian r ca
vin, thng dng trong vin ngm. Tuy nhin, dch gm d b
nm nn ch dng ngay. Thng dng dch th trong nc cha
5 - 15% gm.
Dung dch PVP:
PVP dnh tt, t nh hng n thi gian r ca vin, ht d sy
kh. Vi dc cht s nc, t tan trong nc, PVP c kh nng
ci thin tnh thm v tan ca dc cht (barbituric, acid
salicylic...), dch PVP trong ethanol dng thch hp cho vin s
m v nhit (aspirin, khng sinh...).
Tuy nhin, PVP ho m, vin cha nhiu PVP d thay i th
cht trong qu trnh bo qun.

Dn cht cellulose: C nhiu loi khc nhau:

+ Methyl cellulose: Dng ch th 1 - 5% trong nc, kh nng
kt dnh tt. Trn th trng c nhiu loi c nht khc nhau.
+ Na tri carboxymethyl cellulose (Na.CMC): Thng dng dch
th 5 - 15% trong nc. Ht to ra khng chc bng PVP v c xu
hng ko di thi gian r. Tng k vi mui calci, nhm v magnesi.
+ Ethyl cellulose: Thng dng loi c nht thp vi nng 2 10% trong ethanol. Kh nng kt dnh mnh, thng dng cho cc dc
cht t chu nn nh paracetamol, cafein, meprobamat, st fumarat v
cc dc cht s m.
2.2.2. Nhm t dc dnh th rn
Thng dng cho vin xt ht kh v dp thng. Dng cc loi bt
ng, tinh bt bin tnh, dn cht cellulose, Avicel... Cc t c (tnh
rn tan c trong nc v cn c th xt ht t vi hn hp nc cn cc t l khc nhau.

2.3 T dc r
T dc r lm cho vin r nhanh v r mn, gii phng ti a b mt tip
xc ban u ca tiu phn dc cht ^i mi trng ho tan, to iu kin
cho qu trnh hp thu c cht v sau.
Khi tip xc vi dch tiu ho, vin ht nc v r ln th 1, gii phng ra
ht dp vin (r ngoi). Tip ht r ln th 2, gii phng tr li cc tiu
phn ban u (r trong).
V c ch r ca vin c gii thch nh sau: Cc t dc r c cu trc
xp sau khi dp vin li h thng vi mao qun phn b ng u trong
vin. Khi tip xc vi dch tiu ho, h thng vi mao qun c tc dng ko
nc vo lng vin nh lc mao dn. Nc s ho tan v lm trng n cc
thnh phn ca vin v ph v cu trc ca vin. Nh vy, s r ca vin
ph thuc vo xp v vo s phn b h thng vi mao qun trong vin.
Ring vin nn si bt th r theo c ch sinh kh: Ngi ta a vo trong
vin ng thi mt acid hu c (citric, tartaric,...) v mt mui kim (natri
carbonat, natri hydrocarbonat, magesi carbonat,...). Khi gp nc hai thnh
phn ny tc dng vi nhau gii phng ra C02 lm cho vin r ra nhanh
chng.

Cc loi t dc r hay dng:

Tinh bt: C cu trc xp, sau khi dp vin to ra c h thng vi
mao qun phn b kh ng u trong vin, lm r vin theo c ch vi
mao qun.
Thng dng tinh bt ng, khoai ty, hong tinh,... v t l t 5 20% so vi vin. Bnh thng tinh bt hp ph kh nhiu nc, o
, tng kh nng lm r, trc khi dng phi sy kh. Cch r ca
vin ph thuc mt phn vo cch phi hp tinh bt. Thng thng
ngi ta chia tinh bt thnh 2 phn: phn r trong (khong 50 - 75%)
v phn r ngoi (25 - 50%).
Tinh bt bin tnh: Hay dng natri starch glycolat tn thng mi l
Primogel, Explotab). y l t dc gy r vin rt nhanh (siu r) do
kh nng trng n mnh trong nc, kh nng r t b nh hng bi
lc nn. Cc loi tinh bt bin tnh khc nh starch 1500, pregelatined
starch... cng u l nhng t c r tt. T l thng dng 2 - 6%.

Avicel: Lm cho vin r nhanh do kh nng ht nc v trng mnh,

t l 10% trong vin th hin tnh cht r tt; kt hp c va r va
dnh. Nu xt ht t th kh nng r b gim.
- Bt cellulose: Dng loi tinh ch, trng, trung tnh. Dng mt Knh hay
phi hp vi cc t dc r khc nh tinh bt, Veegum, phch hp cho
cc c cht nhy cm vi m.
Ngoi ra cn mt s cc t dc siu r hin nay rt hay dng nh patri
croscarmellose (Ac-Di-Sol), Crospovidon (Polyplasdon XL)...
2.4. T dc trn
T c trn l nhm t dc c nhiu tc dng ong qu trnh dp vin:
- Chng ma st gia vin v thnh ci sinh ra khi p vin.
- Chng dnh khi dp vin: di tc ng ca lc nn, vin c th dnh
vo b mt chy trn. Hin tng dnh chy thng xy ra khi vin cha
dc cht ho m (cao thc vt, mtropui...), khi ht sy chua I kh, khi
m trong phng dp vin qu cao hoc khi chy c khc ch, logo,

- iu ho s chy: khi dp vin, bt hay ht phi chy qua phu,

phn phi vo bung nn. Nu nguyn liu p vin kh n chy, 1
vin s kh ng nht v khi lng v hm lng c cht.
Lm cho mt vin bng p.
Tuy nhin, do phn ln t dc trn l nhng cht s nc, lm cho
vin kh thm nc, do c xu hng ko di thi gian r ca vin.
Mt khc, mt lng qu tha t dc trn s lm cho vin kh m
bo bn c hc do lm gim lin kt lin ht (ngc li vi tc
dng ca t c dnh).
Cc loi t dc n hay dng:
Acid stearic v mui: l nhng t dc n thng dng, c tc dng
gim ma st v chng dnh. Cc mui calci stearat v magnesi stearat
c kh nng bm dnh tt, thng dng t l khong 1% so vi ht
kh.

Talc: c tc dng lm trn v iu ho s chy. Kh nng bm

dnh ht km hn magnesi stearat do t l dng cao hon (1 3%). Aerosil, Cap-O-Sil: bt rt mn v nh nn kh nng bm
dnh b mt ht rt tt, do t l dng thp (0,1 - 0,5 %). Tc
dng chnh l iu ho s chy. y l t dc trn hay dng
nht hin nay cc nc.
Tinh bt: C tc dng iu ho s chy. Thng dng trong
phng php xt ht kh v dp thng, vi t l t 5 - 10% v
phi sy kh trc khi dng.
Ngoi ra cn nhiu loi t dc trn khc nh Avicel, PEG
4000 v 6000, PEG monostearat, natri lauryl Sulfat, natri
benzoat, veegum,...

2.5. T dc bao
Bao vin nhm cc mc ch sau:
-Che du mi v ca dc cht.
- Bo v dc cht, trnh cc yu t tc ng ngoi mi nh: m, nh sng,
oxy khng kh..., lm tng n nh ca ch phm.
- Thun li trong qu trnh ng gi v khng gy bn thit b, nhim cho do
bay bi.
- Ci thin hnh thc ca vin, tng cng cho vin.
Ci thin sinh kh dng ca dc cht: bao tan rut, bao gii phng dc cht
ko di, bao vin thm thu...
Phng php bao vin ph bin hin nay l bao mng mng. bao mng
mng, nguyn liu chnh c dng l polyme. Tu theo mc ch bao m chn
loi polyme thch hp:
Dn cht cellulose: hin nay c s dng kh rng ri:
+ Hydroxypropylmethyl cellulose (HPMQ: L t dc bao bo v, bn vi
cc yu t ngoi mi, khng c mi v ring, d phi hp vdi cht nhum mu.
+ Ethyl cellulose (EC): Khng tan trong nc, tan trong dung mi hu c, bn
vi ngoi mi. Dng lm t dc bao vin tc dng ko di. C th phi hp
EC vo mng, bao HPMC gim tan trong nc ca mng bao.

+ Cellulose acetat phthalat (CAP): L este kp ca cellulose,

tan trong dch rut, do dng bao tan rut. Mng bao
khng dch v (chi tan pH > 6), nhng d thm dch v. Khi
bao, thng phi cho thm cht lm do.
+ Hydroxypropylmethyl cellulose phtalat (HPMCP): L este
ca HPMC vi acid phthalic, dng bao tan rut. Thng dng
di dng hn dch nc.
-Nha methacrylat: L sn phm trung hp ca acid
methacrylic. Sn phm thng mi c tn gi l Eudragit. C
nhiu loi Eudragit c tan v cch dng khc nhau:
+ Eudragit E tan trong dch v (pH < 5), dng bao bo v.
+ Eudragit L v s khng tan trong dch v, dng bao tan rut:
Euragit L tan pH 6. Eudragit S tan pH 7.
Ngoi ra cn nhiu t dc khc phi hp trong thnh phn
mng bao nh PEG, talc, titan dioxyd...(xem cng thc 15.5).

III. K THUT BO CH VIN NN

C 3 phng php bo ch vin nn l to ht t, to ht kh
v dp thng.
1. Phng php to ht t
Phng php to ht t c nhiu u im: D m bo bn
c hc ca vin, dc cht d phn phi vo tng vin nn
m bo s ng nhit v khi lng vin v hm lng dc
cht). Quy trnh v thit b n gin, d thc hin.
Tuy nhin, phng php to ht t cng c nhng nhc
im nh: chu tc ng ca m v nhit (khi sy ht), c th
lm gim n nh ca dc cht. Quy trnh ko di qua nhiu
cng on:

Quy trnh ko di qua nhiu cng on:

1.1. Trn bt kp
Trc khi trn bt kp phi phn chia nguyn liu n mn
quy nh. Khi trn bt kp cn p dng k thut trn ng
lng m bo dc cht c phn phi ng u trong
vin, c bit vi cc vin nn cha hm lng dc cht thp.
Khi lng dc cht trong vin nh c th khng trn bt kp
m ho dc cht vo t c nh lng hoc vo dung mi
thch hp xt ht hoc trn vo ht trc khi p vin.
1.2. To ht
To ht nhm trnh hin tng phn lp ca khi bt trong qu
trnh dp vin, ci thin chy ca bt dp vin, tng cng
kh nng lin kt ca bt lm cho vin d m bo chc v
gim hin tng dnh ci chy khi dp vin.

 d dp vin, ht phi d chy v chu nn tt. Mun vy, ht phi p

ng mt s yn cu sau:
C hnh dng thch hp: Tt nht l hnh cu. Ht hnh cu c ma st nh
d chy, khi nn d lin kt thnh vin.
C kch thc thch hp v kch thc cng ng nht cng d m bo
s ng nht v khi lng vin. Thng thng kch thc ht thay i
t 0,5 - 2 ram theo ng knh vin (vin cng b th nn xt ht cng
nh v ngc li).
C th to ht ut bng cch xt ht qua ry hoc bng thit b tng si.
Xt ht c thc hin qua cc bc sau
To khi m: Thm t dc dnh lng vo khi bt, trn cho n lc t
dc thm u vo khi bt. t dc d thm vo khi bt, nn ng
t dc nng, nht l vi nhng t dc c nht cao nh dch th
gelatin, h tinh bt. Lng t c v thi gian trn quyt nh n kh
nng lin kt ca ht. V th, phi tun th ng yu cu v thi gian v
cc thng s k thut khc. qui m nh c th nho m bng chy ci,
vi qui m ln dng cc thit b nh my nho trn, my nho siu tc...

Xt ht: Khi m sau khi trn u, n nh trong mt khong thi

gian nht nh ri xt qua c ry quy nh. thu c ht c hnh dng
gn vi hnh cu, tt nht l xt ht qua ry c l vi lc xt ht va
phi. C th xt ht bng tay qua ry hoc xt bng my xt ht. Vi
dc cht kh to ht hoc ht c mu nn xt ht hai ln thu c
ht t yu cu v c mu sc ng nht.
Sy ht: Ht sau khi xt, tri thnh lp mng v sy nhit quy nh.
Trc khi sy, c th thong gi cho ht se mt, sau a vo
bung sy v nng nhit t t cho ht kh u. Trong qu trnh sy,
thinh thong o ht, tch cc cc vn v kim tra nhit sy. Hoc
sy bng my sy tng si gim thi gian sy. Thng sy ht cho
n m t 1 -1% tu tng loi vin.
Sa ht: Ht sau khi sy xong, phi xt li nh nhng qua c ry quy
nh (thng l bng hay to hn c ry xt ht m) ph v cc cc
vn, to ra c khi ht c kch thc ng nht hn.
hn ch tc ng ca m v nhit, tit kim mt bng sn xut, hin
nay trong sn xut cng nghip, ngi ta c th to ht bng thit b tng
si.

1.3. Dp vin
Ht sau khi sy n m quy nh, trn vi t c trn, t duc r
ngoi ri dp thnh vin. C nhiu loi my dp vin khc nhau hot
ng theo nguyn tc: Nn hn hp bt hoc ht gia hai chy; trong
mt ci (bung nn) c nh.

Trong nghin cu v sn xut nh, ngi ta dng my dp vin tm sai, c

cu to nhu hnh 15.1.
Chu k dp vin trong my tm sai
c th chia thnh 3 bc (Hnh 15.2):
Np nguyn liu: Khi np nguyn
liu, dung tch bung nn phi
mc ln nht. Do , chy dui
phi v tr thp nht, chy trn
Phi v tr cao nht. Phu
v tr trung tm v np y nguyn
liu vo bung nn.
Nn (dp vin): Phu dch xa khi
trung tm, chy di ng yn,
chy trn tin dn xung v tr thp
nht t lc nn ti a. Cc tiu
phn c nn st li vi nhau hnh
thnh vin nn.

Gii nn (y vin ra khi ci): Sau khi nn xong, chy trn gii
tnn tin v v tr trc kh nn. ng thi chy dui tin dn ln v
tr (cao nht (ngang vi mt bng ci) y vin ra khi ci. Phu
tin y v tr trung tm gt vin ra khi mm my v tip tc np
nguyn liu cho chu k sau. Trong cng nghip vin c dp bng
thit b quay trn (hnh 15.3)
2. Phng php to ht kh
Phng php to ht kh (cn gi l phng php dp kp) c u
im l trnh c tc ng ca m v nhit vi dc cht, do
c dng cho cc vin cha dc cht khng bn vi m v nhit
(aspain, vitamin c, ampicilin...). To ht kh tit kim c mt bng
v thi gian hn to ht m. Hn ch ca phng php to ht kh :
Dc cht phi c kh nng trn chy v lin kt nht nh v kh
phn phi ng u vo tng vin (do hin tng phn lp xy ra khi
dp vin), hiu sut to ht khng cao v vin kh m bo bn c
hc.

Phng php to ht kh c tin hnh qua cc cng on sau:

Trn bt kp: ch yu l trn bt dc cht vi bt t dc nh
kh, t dc r. Tin hnh trn v kim tra nh vi phng
php xt ht t.

Dp vin to v to ht: bt c dp thnh vin to (c ng

khong 15 - 2 cm). Cn v vin to to ht. Ry chn ly ht c
kch thc quy nh. Loi ht b cha t kch thc quy nh tip
tc c dp vin to to ht li.
khc phc nhc im ny, hin nay ngi ta dng phng
php cn p (to ht compact): Bt kp c cn p thnh tm mt
(dy khong 1 mm) gia hai trc ln. Sau xt v tm mng qua
ry to ht (hnh 15.4).
Dp vin: Sau khi c ht kh, tin
hnh dp vin c khi lng quy
nh ging nh vi phng php
to ht t.

3. Phng php dp thng

Dp thng l phng php dp vin khng qua cng on to hL Do
tit kim c mt bng v thi gian sn xut, trnh c tc ng ca
m v nhit ti dc cht. Vin dp thng thng r nhanh nhung
bn c hc khng cao v chnh lch hm lng dc cht gia cc vin
nhiu khi l kh ln.
Trn thc t, c mt s dc cht c cu trc tinh th u n, trn chy
v lin kt tt, c th dp thng thnh vin m khng cn thm t dc
(nh natri clorid, urotropin...). Tuy nhin s c cht khng u.
Trong a s trng hp, mun dp thng, ngi ta phi thm t dc
dp thng ci thin trn chy v chu nn ca dc cht. Tu theo
tnh cht ca dc cht m lng t c p thng thm vo nhiu hay
t. Nu dc cht t trn chy v chu nn, t dc dp thng c th
chim ti 70 - 75% khi lng ca vin. Cc t dc dp thng hay
dng hin nay l: cellulose vi tinh th (Avicel), lactose phun sy (LSD),
dicalci phosphat (Emcompress), tinh bt bin tnh...Trong , cellulose
vi tinh th c coi l t c c nhiu u im hn c (xem v d 15.6
)

IV. YU G CHT LNG VIN NN

1. Tiu chun Dc in
Theo DVN, yu cu k thut chung ca thuc vin nn bao gm:
1.1. r
r ca vin c xc nh bng thit b th r (xem trong
DVN 3 trang PL 136 - 137). Mi trng th l nc ct, nhit
3TC 2C (nu khng c ch dn trong chuyn lun ring). Mi ln
th 6 vin, mu th t yu cu nu 6 vin r ht.
Tu loi vin m yu cu thi gian r khc nhau: Vin nn khng ba
phi r trong vng 15 pht. Vin bao bo v r trong vng 30 phtVin bao tan trong rut phi chu c mi trng H 0,1M trong 2
gi v phi r trong h m phosphat pH 6,8 trong vng 60 pht. Vin
tan trong nc phi r trong vng 3 pht. Vin si bt r trong vng 5
pht (th trong cc c m cha 200 ml nc ct 15 - 25C).

1.2. ng u khi lng

Th vi 20 vin. lch cho php phi t yu cu nh ghi bng sau:
Khi lng trung bnh ca vin % chnh lch so vi khi lng trung bnh
Ti 80 mg
10
80 - 250 mg
7,5
> 250 mg
5
1.3 ng u hm lng
p dng cho vin c hm lng dc cht t hn 2mg hoc t hn 2%
khi lng vin. Th vi 10 vin, khng c c vin no nm ngoi
gii hn 85-115% hm lung trung bnh. Nu c mt vin nm ngoi gici
hn trn nhung nm trong gii hn 75 - 125% hm lng trung bnh th
th li vi 20 vin khc. Thuc t yu cu nu trong 30 vin khng c
qu 1 vin nm ngoi 85 -115% v khng c vin no nm ngoi 75 125% hm lng trung bnh.

1.4 nh lng
Th vi 10 20 vin theo chuyn lun ring, tnh hm lng hot!
cht trong mi vin theo khi lng trung bnh ca vin.
1.5 Th nghim ho tan
Thit b nh gi l my o ho tan, gm thit b kiu gi quay*
kiu cnh khuy v kiu dng chy (DVN 3 ang PL 133-134).
Dc in Vit Nam quy nh, nu th mi ln 1 vin th phi th II
6 ln. Nu c 1 vin khng t th phi th li vi 6 vin khc v c 6
vin phi t yu cu. Nu th mi ln 2 vin tr ln th phi th tt
c 5, 6 ln v tt c cc vin u phi ho tan trn 70% lng dc
cht quy nh nu khng c cc ch dn khc trong chuyn lun. Vin
th tan khng cn th r.
Ngoi cc ch tiu k thut trn, mt s D cn quy nh nh gi
ng nht v ng knh vin.

2. Tiu chun nh sn xut

nng cao cht lng vin nn, m bo ng nht gia cc l m sn
xut, cc nh sn xut cn a ra mt s ch tiu cht lng khc cho vin
nn:
2.1. mi mn - b vn
Thit b bao gm mt trng quay c gn vi mt mot quay tc 251
vng/pht (hnh 15.5).

Theo Dc in M 26: Lng mu vin cho vo trng quay c qui

nh nh sau: Nu khi lng trung binh vin nh hn hoc bng 650
mg th cn s vin tng ng vi khong 6,5 g. Nuvin c khi lng
ln hn 650 mg th cn khi lng ca 10 vin. Cho vin cn chnh
xc ti mg vo trng quay v quay 100 vng hoc trong khong thi
gian nht nh . Ly vin ra, sng sch bt v cn li khi lng. Tnh
mi mn (b vn) bng % khi lng vin b mt. Nu khng c
quy nh ring, mi mn (b vn) khng c qu 1%.
2.2 Lc gy v vin
Xc nh bng thit b o lc gy v vien da trn nguyn tc: Tc
ng 1 lc qua ng knh vin cho n lc vin b v. Gii hn lc
gy v vin tu thuc vo tng loi vin.

V. MT S CNG THC THUC VIN NN

Cng thc 15.1: vin nn vitamin B1 0,01 g
Thiamin hydroclorid
10 mg
Lactose
30 mg
Tinh bt
60 mg
H tinh bt 10%
va
Talc
3 mg
Magnesi stearat
1 mg
Vin nn vitamin B1 thng c iu ch bng phng php xt ht
t theo cc bc sau:
Cn lactose, tinh bt, vi tam in B1. Nghin mn cc bt trn v trn thnh
hn hp bt kp ng nht.
Cho h tinh bt vo hn hp bt trn, nho trn thnh khi bt va
m xt ht.

Xt ht qua li (ry) c kch thc mt li 0,8 mm.

Sy ht trong t sy 15 pht nhit 50 - 60c, ri xt li ht qua
li (ry) c kch thc mt li 0,6 mm.
Sy ht cho ti khi t m 2 - 3% (dng cn xc nh nhanh
m).
Trn ht kh vi t c trn c nghin mn, ry qua ry 180.
Dp vin vi chy c ng knh 6 mm, lc gy v vin 5-7 kg.
ng l, dn nhn ng qui ch.
Vin nn vitamin B1 cng c dp thng vi cc t dc dp thng
nh Avicel, lactose phun sy, tinh bt bin tnh,...
Cng thc 15.2: vin nn paracetamol
Paracetamol
325 mg
Avicel pH 101
80 mg
Tinh bt
80 mg
H tinh bt 10%
va
Hn hp talc - magnesi stearat (9: 1)
14 mg
Paracetamol l dc cht t tan, ti xp, kh lin kt.

Khi p vin hay b bong mt, st cnh. V vy trong cng thc c

Avicel ci thin kh nng chu nn, ng thi phi kt hp vi tinh bt
lm cho vin r mn ho tan tt dc cht. Vin c u ch bng
phng php xt ht ut vi t dc dnh l h tinh bt qua cc bc nha
sau: Cn tinh bt, paracetamol, Avicel.
Nghin mn tinh bt, paracetamol, n thnh hn hp bt kp ng nht.
Cho h tinh bt vo hn hp bt trn, nho trn tht k thnh khi bt
va m xt ht.
Xt ht qua li (ry) c kch thc mt li 1,0 mm. Sy ht trong t
sy 15 pht nhit 60 - 70C. Xt li ht qua ry c kch thc mt
0,8 mm.
Sy ht cho ti khi t m 2-3% (dng cn xc nh nhanh m).
Trn ht kh vi t c trn ue nghin mn, ry qua ry 180.
- Dp vin vi chy c ng knh 12 mm, lc gy v vin 8 -10kg.
- ng l, dn nhn ng qui ch.

Cng thc 15.3: vin nn Cotrimoxazol

Sulfamethoxazol
400 mg; Trimethoprim
80 mg
Avicel pH 101
30 mg;
Tinh bt
70 mg
H tinh bt 10%
va ;
Tale
10 mg
Magnesi stearat
5 mg;
Natri laurylsulfat 2 mg
Bo ch vin nn bng phng php xt ht t qua cc bc:
Cn Sulfamethoxazol, trmethoprim, tinh bt, Avicel.
Nghin mn cc bt trn, trn thnh hn hp bt kp ng nht.
Cho h tnh bt vo hn hp bt trn, nho trn thnh khi bt va m
xt hat.
Xt ht qua li (ry) c kch thc mt li 1,2 mm. Sy ht trong t
sy 15 pht nhit 50 - 60c. Xt li ht qua ry c kch thc mt 1,0
mm.
Sy ht cho ti khi t m 3 - 4% (dng cn xc nh nhanh m).
Trn ht kh vi t dc trn c nghin mn, ry qua ry 180.
Dp vin vi chy c ng knh 13 mm, lc gy v vin 8-10 kg.
ng l, dn nhn ng qu ch.

Cng thc 15.4: vin nn aspirin

Aspirin
325mg
Tinh bt kh 32,5 mg
Cap-O-Sil
0,1 mg
Aspririn c kh nng chu nn, khng bn vi m v nhit nn
dp vin bng phng php xt ht kh l thch hp v thc
hin qua cc bc:
Dng bt aspirin ry qua ry s 250, trn vi cc t dc cn li
Dp vin vi chy c ng knh 1 cm, lc gy v vin 4-5 kg.
Nghin v vin, chn ht qua ry 500 v 710
Dp vin vi chy c ng knh 10mm, lc gy v vin 5-7kg
ng l, dn nhn ng quy ch

Cng thc 15.5: vin bao vitamin c

Cng thc vin trn:
Acid ascorbic 250 mg
Avicel pH 101 84mg
Starch 1500
75,5 mg
Acid stearic
8,5 mg
Cap- o- Sil
2 mg
- Acid ascorbic dng dng bt kt tinh hoc ht c kh nng trn
chy, ry qua ry 250. Trn aeid ascorbic, Avicel, Starch 1500 thnh
hn hp bt kp ng nht. Nghin mn acid stearic, trn u vi hn
hp bt kp trn. Dp vin vi chy c ng knh 11 mm, lc gy v
vin 7- 9 kg.
Cng thc bao: tnh cho 1 kg vin:
HPMC
7,5g; PEG 400
1g
Titan dioxyd 3g;
Ethanol 90% 100ml
Nc
20ml

Hn dch bao c pha ch nh sau:

- Ho tan HPMC, PEG trong khong 20 ml nc. Thm 80 ml
Ethanol, khuy thnh dung dch trong sut.
Nghin mn titan dioxyd trong ci, thm mt t ethanol to thnh bt
nho thm dn ethanol pha long hn dch. Cho hn dch ny vo
dung dch HPMC v PEG.
Khuy lin tc bng my khuy a trong vng 1 gi. Trc khi bao
nng nhit hn dch ln khong 50C, lc qua ry 180.
Tin hnh bao vin: cho vin vo ni bao quay 5 pht, sy nng v
ht bi do vin to ra. Phun dch bao vi tc thch hp, ng thi
thi kh nng lm kh vin. Qu trnh bao kt thc khi dch bao
c phun ht. Tip tc sy vin thm khong 5 pht.

Cng thc 15.6: vin vitamin B6

Pyridoxin hydroclorid 10 mg
Emcompress
180 mg
Avicel
9 mg
Magnesi stearat
1 mg
Vin nn trn c iu ch bng phng php dp thng:
Nghin, ry pyridoxin qua ry 250, trn vi Emcompess thnh hn
hp ng nht. Trn thm Avicel, magnesi stearat ( c nghin,
ry qua ry 180).
Dp vin vi chy c ng knh 8 mm, lc gy v vin 5-7 kg.
ng l, dn nhn ng qui ch.
Cng thc 15.7: Vin nhai khng dch v
Magnesi hyroxyd (bt mn)
80mg
Nhm hydroxyd (gel kh)
400mg
Manitol
180mg
ng
20mg
PVP
30mg

Cap-O-Sil
3 mg
Magnesi stearat
7 mg
Tinh du bc h
v
Vin khng dch v c bo ch i dng vin nhai, khi nglL dc
cht v thnh ht nh trn vi nc bt thnh khi nho, vo % dch v
nhanh chng to thnh hn ch pht huy nhanh kh nng trung ha acid,
o tc ng cao hn vin ung thng thmg. Vin nhai c bo
ch nh sau:
Nghin mn dc cht, ng, manitol, ry qua ry 250,
Trn bt kp cc bt trn to thnh hn hp ng nht.
Pha dung dch PVP 10% trong ethanol 50%. Cho dch PVP trong ethanol
vo khi bt kp trn nho thnh khi m.
Xt ht qua li (ry) c kch thc mt li 1,0 mm, sy nhit 60 70C ti hm m cn 3 - 4%.
Trn tinh u bc h, t dc trn nghin mn ry qua c ry 180.
Dp vin vi chy c ng knh 14 mm, lc gy v vin 8-10 kg.
ng l, dn nhn ng qui ch.

Cng thc 15.8: vin nn ph khoa nystatin

Nystatin
500000 UI (113,5 mg)
Lactose
500 mg
Tinh bt m
500 mg
PVP
50 mg
Magnesi stearat
12 mg
Vin nn trn c th bo ch bng phng php xt ht t:
Nghin ry nystatin, lactose, tinh bt, PVP qua ry 250; magnesi
stearat qua ry 180.
Trn btt kp cc bt trn, tr magnesi stearat. Cho mt lng nc
va nho thnh khi bc m.
Xt ht qua li (ry) c kch thc mt li 1,2 mm. Sy ht n
m 3 - 4% nhit 60-65C,
Trn t dc trn, dp vin mng hnh ovan d t.
C th ng gi trong ng nha hoc p trong v nhm.
Cch ng: t mt vin trc khi i ng, dng 10 ngy lin tc.

Cng thc 15.9: vin ngm metytestosteron

Metyl testosteron
10 mg
Sacearose
87 mg
Lactose
86 mg
Gm Arabic
10 mg
Talc
6mg
Magnesi stearat
1 mg
Nc ct
v
Vin ngm c iu ch bng phng php xt ht t:
Trn dc cht vi ng, gm Arabic thnh bt kp ng nht.
Dng lng nc ct va nho m, xt ht qua li (ry) c
kch thc mt li 0,6 mm, sy ht nhit khong 40oC ti
m khong 2-3%.
Trn t c trn magnes stearat, talc vi ht kh v dp vin. Vin
thng c dp mng d ngm. ng l, dn nhn ng quy ch.

Cng thc 15.10: vin si bt

Aspirin
81 mg;
Phenylpropanolamin HCL
6mg
Mi hoa qu 20 mg;
Cht mu
2 mg
Natri hydrocarbonat (ht) 550 mg; Acid citric khan (ht)
650 mg
Vin c bo ch theo phng php p thng:
Trn u natri hydrocarbonat vi acid citric, phenylpropanolamincc cht
iu bng v.
Trn aspirin vi hn hp trn v p vin vi chy c ng knh 1,8 cm.
Sy vin 50C trong 1 gi ri ng gi kn.
Vin si bt phi c bo ch trong iu kin kh hu c kim sot,
m tng i phi < 40% (l tng nht l khong 25%), nhit khong
25c. Nu m cao, phn ng si bt c th xy ra ngay trong qu trnh
bo ch.
Vin si bt ht m. Khi c nc, phn ng si bt xy ra tc thi,
lm tui th ca vin gim nhanh. Hin nay ngi ta thng ng tng
vin trong v nhm hn kn hoc ng tup nha c cha cht ht m
nt.

Chng 14

K THUT BO CH THUC NANG

MC TIU HC TP
1. Trnh by c khi nim, phn loi, u nhc im ca thuc nang.
2. Phn bit c nang cng v nang mm geatin v cu to v nang,
dng bo ch ng vo nang, phng php ng nang.
3. Nhn bit c vai tr, cch dng ca cc t dc dng bo ch
thuc ng nang cng v nang mm;
4. Nu c nguyn tc ng thuc vo nang cng v nang mm.
5. Trnh by c yu cu cht lng nang thuc.
6. Nu c cch pha ch mt s cng thc thuc nang.

I. ICNG
1. Khi nim
Thuc nang i mt dng thuc phn liu bao gm:
Mt v rng ng thuc (thng l gelatin), gn lin vi thuc
v a vo c th cng vi thuc. Sau khi r, gii phng thuc, v
nang c tiu ho.
Mt n v phn liu ca dc cht c bo ch di cc dng
thch hp ng vo v nang (bt, ht, duag ch, vin nn...)
C th quan nim thuc nang l hnh thc trnh by c bit ca
nhiu dng bo ch khc nhau nh: dung ch, vin nn, cm
thuc...
Thuc nang ch yu dng ung, ngoi ra cn dng t (nang
t trc trng, nang t m o), hoc xng ht.

2. Phn loi
Da vo tnh cht c hc ca v nang, thuc nang c chia thnh
hai loi: thuc nang cng gelatin v thuc nang mm gelatin.
Dc in Vit Nam 3 phn thuc nang thnh 4 loi: Thuc nang
cng, thuc nang mm, thuc nang tan trong rut v thuc nang
gii phng hot cht c bit.
- Nang mm:
V nang mm, do dai do ngoi gelatin cn c mt t l ln cht
ho do.
Nang mm do Mothes, mt sinh vin ngi Php sng ch nm vo
1834 bng phng php nhng khun. Su nm sau (1840
phng php p khun gia hai tm kim loi c pht minh v
n nm 1832 phng php ny c ci tin thnh phng php
p gia hai trc quay.

- Nang cng:
V nang cng gm hai na y v np lng kht vo
nhau (hnh 14.2). Nang cng c 8 c, c dung tch
t 0,13-1,36 ml (bng 14,1)
Bng 14.1. Cc c v dung tch ca v nang cng
C nang

00

000

Dung tch nang (ml) 0,13 0,20 0,27 0,37 0,48 0,67 0,95 1,36

Nang cng do mt dc s ngi Php tn Lehuby pht

minh vo nm 1846. Hin nay nang cng c sn xut
rng ri bi nhiu hng sn xut v nang ni ting nh
Eli Lily v Pake Davis (M). Vit Nam, c c s sn
xut c v nang (cng ty c phn Dc Cu Long)

3. Mc ch ng thuc vo nang
- Che du mi, v kh chu ca dc cht, v d nang du giun, du c,
chloramphenicol, nang tetracyclin...
Bo v dc cht trnh tc ng bt li ca ngoi mi nh m, nh sng. Hn ch
tng k ca dc cht.
Khu tr tc dng ca thuc rut, trnh phn hu thuc bi dch v. Ko di tc
dng ca thuc: nang tc dng ko di (Spansules).
4. u nhc m ca nang thuc
u im: D nut do hnh dng thun, mm (nang mm), b mt n (nang cng).
iu ny rt c ngha vi tr em v ngi cao tui.
Tin dng: V y l dng thuc phn liu, ng gi gn, d bo qun v vn
chuyn nn tin dng nh vin nn.
D sn xut ln: Hin c nhng my ng nang hin i , nng sut cao.
Sinh kh dng cao: Do cng thc bo ch n gin, t s dng t dc, t tc ng
ca k thut bo ch (so vi vin nn), v nang d tan r gii phng dc cht trong
ng tiu ho nn thuc nang thng c sinh kh dng cao.
Nhc im: Cc dc cht kch ng nim mc ng tiu ho th khng nn ng
nang v sau khi v nang r s tp trung nng thuc cao ti ni gii phng thuc
(th d: natri nitrofurantoin).

II. THNH PHN THUC NANG

1. Dc cht
Dc cht c bo ch di dng thuc nang rt phong ph. C
th bo ch thuc nang vi c cc dc cht rn, lng, thuc c
ngun gc thc, ng vt. Trc khi ng vo nang, dc cht
phi c bo ch dui dng thch hp. Thuc ng nang mm
thng l cc cht lng, dung dch du, hn dch hoc cc bt
nho, i khi c th ng c dng nh tng. Nang cng c th
ng bt thuc, cm thuc pellet, bt nho, vin nn...
2. T dc
2.1 T dc to v nang
Thnh phn chnh ca v nang gm: Gelatin, cht ho do, nc,
cht bo qun, cht mu...
Gelatin lm v nang phi l loi c dng, t cc chi tiu v
gii hn kim loi nng, asen, mc nhim vi sinh vt.

Ngoi ra phi lu n bn gel l hai yu t quyt nh kh

nng to mng ca gelatin. Yu cu v bn gel tu thuc vo
phng php iu ch. nht ca dung dch gelatin ch v
nang cng nh hng n cng ca v v cc thng s trong
qu trnh bo ch. Nu nht thp, v nang thng mng, thi
gian sy kh lu. Nu nht cao qu v nang dy v cng.
Ngoi gelatin, c th dng cc t dc khc to v nang nh
cc dn cht ca cellulose (HPMC, HPC...).
Cht ho do dng cho nang mm c t l cao hn trong cng
hc ca v nang cng. Cht ho o thng ng l glycerin,
ngoi ra c th thm cc cht khc lm tng do dai ca
mng nh propylen glycol, sorbitol... T l cht ho do ph
thuc vo thnh phn v bn cht thuc ng nang.

2.2 Cc t dc dng bo ch thuc ng vo nang

T dc dng bo ch thuc ng nang mm
T dc bo ch thuc ng nang mm c th phn thnh
hai loi:
Cht lng thn du nh du thc vt, du khong, trigiycerid...
Cht lng thn nc nh: PEG 400- 600, triacetin, polyglyceryl
este. Propylen glycol v glycerin c th c dng nhng vi
nng thp (5- 10%) trnh ho tan v lm mm v nang.
Ngoi ra trong thnh phn ca thuc ng nang c th cho thm
cc cht iu chnh th cht nh sp ong, cc cht gy thm hay
nh ho nh lecithin...

2.2.2. T dc dng bo ch thuc ng nang cng

T dc trn: iu ho s chy, gip cho bt hoc ht chy
u vo nang nhm m bo s ng nht v khi lng v hm
lng dc cht. T dc trn hay dng nh : Magnesi stsarat,
calci stearat, Aerosil... vi t l 0,5- \%.
T dc n: Dng trong trng hp liu hot cht thp khng
chim ht dung tch nang. Cng c nhng trng hp bt dc
cht trn chy km, phi cho thm t dc n trn chy tt
nh tinh bt bin tnh, lactose phun sy...
i khi tng kh nng thm t khi bt trong dch tiu ho
ngi ta c th cho thm vo cng thc mt t l cht in hot,
v d: natri lauryl sunfat.
Mt s bt thuc kh trn chy khi ng nang phi to ht, th
cn phi thm t dc dnh (xem chng vin nn).

III. K THUT BO CH THUC NANG

1. Bo ch dung dch v nang
ch dung dch v nang, ngi ta ho tan cht mu, cht bo qun v
cc cht ph khc vo nc. Ngm gelatin vo dung dch ny cho trng
n hon ton. un nng glycerin, cho gelatin trng nc vo un
cch thu ho tan. Lc gi nng ch v nang.
2. Cc phng php ng nang
2.1. Nang mm geladn
2.7.7. Phng php nh git
Thc hin nh cc my to nang nh git qui m nh hoc qui m cng
nghip (hnh 14.3). Qu trnh to v v ng thuc xy ra ng thi. 1
Khi ch nang, trc ht dung dch v nang (duy tr khong 60C) c
n qua u nh git to ra mt v rng, ca ra ca u nh I git dung
dch v nang c chn gia bi u nh git dung dch I dc cht.
Ngay lc , ngi ta iu khin van cho dung dch dc cht nh vo
v nang, lm cho nang ct git v v nang c ng kn. Nang c
n bng du parafin lnh (khong 10C) s ng rn li.

hnh 14.3

Chn nhng nang t yu cu, tn u ra, thi gi lnh. Ra

sch du parafin bng hn hp dung mi hu c (ethanolaceton), ri sy 40-45C cho bay ht dung mi. Kim tra
loi ht nhng nang khng t yu cu (nang b dnh, nang c
v dy qu...).
Trong sn xut ln, ngi ta dng cc my c nhiu dng nh
git. Nang ch theo phng php nh git thng cha cc
dng dch du nh du c, vitamin tan trong du. Phng php
ny thng mc sai s khi lng ln do khng p dng cho
cc dc cht c tc dng mnh. Hn na hiu sut to nang
khng cao nn hin nay t dng.

2. Phng php p khun

u tin ngi ta ch nang th cng bng cch p gia hai tm
kim loi c to khun. Hin nay dng cc my p nang c
nng sut cao, to ra c nhiu loi nang c hnh dng, mu
sc khc nhau (hnh 14.4).

Khi ch nang, dung dch v nang cha trong bnh c rt

thnh mt lp mng sang b mt trng quay c lm lnh
trc. Gp lnh, gelatin ng cng thnh mng mng. Mng
chuyn ln ng c bi du v a vo trc to nang c lm
nng. Trc to nang l hai ng hnh tr quay ngc chiu, trn
mi trc c khun mt na nang, i xng nhau. Khi hai na v
nang tip xc nhau, y nang c hn kn trc, cng lc
dc cht c ng vo nang nh mt piston phn phi. Hai
trc khun tip tc quay, nang c hn v ct ri khi mng
gelatin.

Phng php p khun cho hiu sut cao, phn liu chnh xc
nhi pistol phn liu t ng (sai s khi lng nang khong 15%). Phng? php ny c th to ra nhiu nang c hnh dng
khc nhau, c th co hai mu khc nhau trn mt nang (do hai
gii geletin c nhum mu khc nhau).
Nang p khun c th d dng phn bit vi nang nh git hay
% nhng khun do trn thn nang c mt g nh. Nang p
khun cha 11 c nhiu loi dc cht: dung dch du, bt
nho thn u, bt nho 11
thn nc... do hin nay pht trin kh mnh.

2.2. Nang cng gelatin

Khc vi nang mm, v nang cng c ch ring, cc c s
thng mua v nang v ng thuc.
ng thuc vo nang, trc ht phi chn c nang cho ph hp
vi lng dc cht cn ng. i vi cc thit b th cng v
ng nang theo phng php th tch c th xc nh c nang theo
cng thc:
Khi lng thuc ng nang = KLR biu kin X Dung tch nang
Cch xc nh khi lng ring (KLR) biu kin n gin nh l
cn mt lng bt nht nh, chuyn vo ng ong, g nh nhng
chon th tch khng thay i ri tnh theo cng thc:
.
Sau khi bit KLR biu kin c th chn c nang theo biu tnh
sn hoc tnh tip dung tch biu kin ca cht ng nang:
, ri chn c nang thch hp.

V d: Chn c nang ng 500 mg bt thuc c KLR 0,8

g/ml.
500 mg bt thuc ny chim dung tch l: vbk =
Dung tch ny gn vi nang s 0 (c dung tch 0,67ml). Vy
chn nang s 0. Lng t dc cn thm vo ng y nang
l 0,67- 0,63 = 0,04 ml. Chn t dc n a vo, xc nh
KLR ca t dc n t suy ra khi lng t dc n.
Qui trnh ng thuc vo nang c 3 giai on:
M v nang
ng thuc vo thn nang
ng np nang

Vic m v nang c th thc hin bng tay cc thit b th

cng hoc m bng chn khng i vi cc thit b t ng
hoc bn t ng. Do hai na v nang c lp vi nhau bng
khp s b nn ng chn khng c th m ra c. Sau khi
m, hai phn np v thn c phn ring. Phn thn nang nm
trn bn ng nang hay mm quay ca thit b ng thuc
vo. Nu ng th cng th bt thuc c ln bn ng
nang, dng dng c gt y vo thn nang.
Trong cng nghip c nhiu phng php ng thuc vo nang
ph thuc vo loi thit b ng nang. C th chia thnh hai
phng php chnh: Phng php ng theo th tch v phng
php phn liu bng piston.

+ Phng php ng theo th tch: Bt thuc c phn phi

qua phu, trong khi mm ng thn nang quay. Bt chy qua
phu vi tc khng i, lng bt ng vo nang nhiu hay
t ph thuc vo tc quay ca mm. Mm quay nhanh, khi
lng bt ng gim v ngc li. Trong phng php ny bt
ng nang phi trn chy tt m bo ng u v khi
lng.
+ Phng php ng bng piston: Khi bt trc khi ng vo
nang c nn li bng piston. C nhiu cch nn bt nh
cho bt chy vo cc ci ri nn bng piston, lp i lp li nhiu
ln to thi trc khi ng vo nang hoc dng piston cm
vo thng bt nn s b khi bt thnh thi ri th vo thn
nang (hnh 14.5).

Lng b ng vo mi nang c tnh ton khng ging nh

phng phap ong theo th tch m phi tnh da vo p lc nn
ca piston, th tch bung piston, Mi nng chu nn ca khi
bt. Ngoi ra cng phi a thm t dc trn bt c th
chy vo bung nn v thi bt c th y ra khi piston, ri
vo nang mt cch d dng.
Sau khi ong thuc, np nang c lp vo thn nang bng
khp chnh. C th ng p lc khng kh ng np nang.
Nang sau c lm sch bt, nh bng v ng gi.
IV. YU CU CHT LNG THUC NANG
Theo DVN 3, thuc nang c nh gi v cc ch tiu sau:
1. ng u v hm lng
p dng vi nang c hm lng dc cht nh hn 2mg hoc
nh hn 2% khi lng trong mt nang.

2. ng u v khi lng
Th vi 20 nang. Cn tng nang. i vi nang cng, tho np
nang ht thuc ra, lau sch v nang. i vi nang mm, ct
m nang, ra v nang bng dung mi thch hp, bay hi dung
mi. Cn tng v nang, Tnh ra khi lng thuc trong mi
nang. Khng c qu hai nang vt qu gii hn sau:
Khi lng trung bnh vin

Gii hn

<300 mg

10%

> 300 mg

7,5%

3. r
Th nh i vi vin nn.
Nang cng v nang mm phi r trong vng 30 pht.
Nang tan trong rut sau khi khng ch v -2 gi phi r trong
dch rut trong vng 60 pht.
4. Th ho tan
Xem phn vin nn.
Ngoi ra thuc nang cng phi c nh gi cc ch tiu nh
cm quan, nh tnh nh lng... nh i vi cc dng thuc
khc.

V. MT S CNG THC THUC NANG

Cng thc 14.1: Nang tetracyclin hydroclorid
Tetracyclin hyroclorid 250 mg (250000 UI), 500 mg (500000 UI) Tinh bt
bin tnh va
Bt tetracyclin c khi lng ring (KLR) tng i ln v trn chy tt
nn c th ng vo nang cng bng phng php ong theo th tch.
Phng php bo ch nh sau:
- Xc nh KLR biu kin ca tetracyciin bng cch cn 5g bt cho vo ng
ong kh, t vo my g 30 giy. c th tch biu kin T tnh ra
KLR biu kin ddc =m/Vbk. Dung tch ca tetracyclin Vdc = 0,25 (0,5)/ddc.
Chn c nang ph hp.
Tnh lng t dc n a vo bng cch xc nh KLR biu kin ca t
dc theo cch tng t. Dung tch ca t dc Vtd= Vn- Khi lng t
dc mtd= Vtd xdtd.
Nhn khi lng dc cht v t dc ca 1 vin vi s nang tu thuc vo
bn ng nang. Trn bt kp c cht v t dc, ry qua ry 250. ng
nang.

Cng thc 14.2: nang amoxicilin

Amoxicilin
500 mg
Croscarmelose
15 mg
Lactose hydrat
176,5 mg
PVP K-30
0,5 mg
Magnesi stearanatri laurylsulfat (9:1) 8mg
Ho tan PVP trong cn 90% c nng 10%. Trn bt kp
amoxicilin, croscarmelosse, lactose. Cho cn PVP vo nho thnh
kh m. Xt ht qua ry 0,8 mm. Sy ht ti m 3-4 %. Trn t
dc trn, ng nang s 0 bng phng php ng piston.
Cng thc 14.3: nang cephalexin.
Cephalexin
500 mg
Natri lauryl sulfat
4 mg
Magnesi stearat
7 mg
Talc
10 mg
Aerosil
2,5 mg
Nghin trn bt kp, ry qua ry 0,4 mm. ng nang cng s 0

Cng thc 14.3: nang cephalexin.

Cephalexin
500 mg
Natri lauryl sulfat
4 mg
Magnesi stearat
7 mg
Talc
10 mg
Aerosil
2,5 mg
Nghin trn bt kp, ry qua ry 0,4 mm. ng nang cng s.0.
Cng thc 14.4: vin nang mm nifedipin 10 mg
Nifedipin
10 mg
T dc pha thuc ng nang: PVP (Polyvinylpyrrolidone), Tween
menthol, natri saccarin, tettahydrofurfuryl alcol, poiyethylenglycol tier
va .
T dc v nang: Gelatin, glycerin, dioxyd titan, oxyd st , nc tinh
khit va .
Trn dc cht vi cc t c cho ng nhit. iu ch dch v nang.
ng nang bng phng php p khun.
Vin dng ung iu tr au tht ngc, hoc ngm di li khi tr cao
huyt p.

Cng thc 14.5: nang t ph khoa

Neomycin sulfat
35000UI
Polymycin Sulfat
35000 UI
Nystatin
100000 UI
Dimethylpolysiloxan
2,2 g
Sucroglycerid
v
Du c
v
Du u nnh hydrogen ho v
T c v nang: Gelatin, glycerin, ioxyd titan, kali sorbat, nc
tinh khit va . y l dng thuc nang mm dng t ph
khoa. Trn dc cht vi cc t dc cho ng nht, iu ch dch
v nang, sau ng nang theo phng php p khun.

Cng thc 14.6: nang tioconazole

Tioconazole 300
mg
Glycin, lecithin, du thc vt hydrogen ho, polysorbat 80, du
parafin v. T dc v nang: gelatin, glycerin, kali sorbat, titan
dioxyd v.
y l dng thuc nang mm ng t ph khoa iu tr
nm. Trn dc cht v cc t dc cho ng nht, iu ch
dch v nang, sau ng nang theo phng php p khun.
Cng thc 11.7. nang du gan c
Du gan c cha vitamin A tng ng 50000 UI.
T dc v nang: gelatin, glycerin, dung ch sorbitol 70%,
nc tinh khit va .
C th ng nang mm ny bng phng php p khun hoc
nh git.

Chong 15
K THUT BO CH THUC VIN NN
MC TIU HC TP
1. Nu c khi nim, u nhc im, phn loi thuc vin nn.
2. Trnh by vai tr, c im, cch s dng ca cc nhm t dc:
n, r, dnh, trn, bao dng bo ch vin nn.
3. Vit c cc bc c bn ca 3 phng php bao ch vin nn: xt
ht t, xt ht kh, dp thng.
4. Nu c yu cu cht lng vin nn;
5. Trnh by c cc bc bo ch mt s cng thc thuc vin nn.

I. I CNG
1. Khi nim
Vin nn l dng thuc rn, c bo ch bng cch nn mt
hay nhiu oi dc cht (c thm hoc khng thm t dc),
mi vin l mt n v liu.
Quy trnh sn xut vin nn c a ra ln u tin nm 1843
trong bng pht minh ca Thomas Brockedon. n 1874 my
p vin nn ra i. Cng vi qu trnh hin i ho my dp
vin, ci tin ng vin vo v, nhiu loi t dc mi ra i,
lm cho vin nn tr thnh mt dng thuc ph bin nht hin
nay.

2. u, nhc im
Vin nn c s ng rng ri l do dng thuc ny c nhiu u im:
c chia liu 1 ln tng i chnh xc.
Th tch gn nh, d vn chuyn, mang theo ngi.
D che u mi v kh chu ca dc cht.
Dc cht n nh, tui th di hn dng thuc lng.
D u t sn xut ln, do gi thnh gim.
Din s dng rng: C th nut, nhai, ngm, cy, t, pha thnh dung
dch, hn dch... Ngi bnh d s ng, trn vin thng c ch d
nhn bit tn thuc.
Tuy nhin vin nn cng c nhiu nhc im:
Khng phi tt c cc dc cht u bo ch c thnh vin nn.
SKD vin c th b thay i trong qu trnh bo ch o c nhiu yu t
tc ng n n nh ca dc cht v kh nng gii phng dc cht
ca vin nh: m, nhit , t dc, lc nn,...
3. Phn loi: Theo cch dng, c cc loi vin nn sau: vin nut,
vin ngm, vin t di li, vin t m o, vin nhai, vin si bt
v vin tc dng ko di.

II. THNH PHN THUC VIN NN

1. Dc cht
C mt s dc cht c cu trc tinh th u n c th p
thnh vin m khng cn cho thm t dc. Tuy nhin, s c
cht ny khng nhiu. Vi a s dc cht, mun dp thnh
vin nn, ngi ta phi cho thm t dc.
2. Cc t dc c s dng trong thuc vin nn
Yu cu chung ca t dc vin nn l:
- m bo bn c hc ca vin.
- m bo n nh ca c cht v ca vin.
- Gii phng ti a c cht ti vng hp thu.
- Khng c tc dng c l ring, khng c, d p vin, gi
c

Sau y l mt s nhm t dc hay dng:

2.1. T dc n
Cn gi l t c pha long, c thm vo vin m bo khi
lng cn thit ca vin hoc ci thin tnh cht c l ca dc
cht (tng trn chy, chu nn,... ), lm cho qu trnh dp
vin c Id dng hn.
2.1.1 Nhm tan trong nc
- Lactose:
L t dc n c ng kh ph bin trong vin nn. Lactose d
tan trong nc, v d chu, trung tnh, t ht m, d phi hp c
vi
nhiu loi dc cht Lactose c 2 dng: khan v ngm nc (tu
theo iu kin kt tinh).
Lactose phun sy c ch t lactose ngm nc nhng do trn
chy v chu nn tt hn lactose nn c ng dp thng.

- Bt ng (saccarose)
D tan v ngt, do thng dng lm t dc n v dnh kh
cho vin ho tan, vin nhai, vin ngm. Khi dng lm t dc
n, c th to ht m vi hn hp nc - ethanol. Bt ng
lm cho vin d m bo bn c hc nhung kh r, khi p
vin d gy dnh chy.
Trn th trng c mt s loi t c bt ng dng dp
thng nh:
+ Di-Pac: l sn phm ng kt tinh ca 97% ng v 3%
dextrin di dng ht, n chy tt. Khi dp vin, vin b cng
dn trong qu trnh bo qun.
+ Nutab: l ng tinh ch, kt hp vi 4% ng kh, 0,1 0,2% tinh bt ng v lm trn bng magnesi stearat, trn chy
tt.

- Glucose: D tan trong nc, v ngt hn lactose, do hay c dng

vin ho tan nh vi bt ng. Glucose trn chy km, d ht m m
bo bn c hc cho vin nhng c xu hng lm cho vin cng dn
trong qu trnh bo qun, nht l glucose khan. Glucose cng c th lm
bin mu cc dc cht kim v amin hu c trong qu trnh bo qun
ging nh lactose.
Emdex l sn phm phun sy ca glucose vi 3 - 5% maltose, trn chy v
chu nn tt, nhng vn rt ho m.
- Manitol:
Rt d tan trong nc, v hi ngt, li cm gic mt d chu trong
ming khi ngm, do rt hay c dng cho vin ngm, vin nhai (cng
thc 15.7). Manitol dng tinh th u n c th dng dp thng, nht
l vi vin pha dung dch
- Sorbitol:
L ng phn quang hc ca manitol, d tan v v d chu nh manitol, cho
nn hay dng trong vin ngm, vin nhai phi hp vi manitol. Sorbitol c
th dng dp thng, tuy nhin do ho m hn manitol nn t l t dc trn
phi dng nhiu hn v m trong phng dp vin phi < 50%.

2.1.2. Nhm khng tan trong nc

Tinh bt:
L t dc r tin, d kim, do hay c dng nc ta hin
nay. Tuy nhin tinh bt trn chy v chu nn km, ht m, lm
cho vin b dn ra v d b nm mc trong qu trnh bo qun.
Khi dng tinh bt, thng phi phi hp vi khong 30% bt
ng m bo chc ca vin.
Tinh bt bin tnh:
L tinh bt qua x l bng cc phng php l - ho thch
hp. Tinh bt bin tinh chu nn v trn chy tt hn tinh bt,
ho tan tng phn trong nc tu theo mc thu phn. Trn
th trng c nhiu lot tinh bt bin tnh vi cc tn thng
mi khc nhau: Starch 1500, Primojel, Eragel...

Cellulose vi tnh th:

L t dc dng ngy cng nhiu, nht l trong vin nn dp
thng do c nhiu u im: chu nn tt, tran chy tt, lm cho
vin d r. Trn th trng c nhiu loi cellulose vi tinh th c
tn gi khc nhau nh Avicel, Emcocel,...
Cellulose vi tinh th l t dc dp thng c dng nhiu nht.
Tuy nhin vin cha nhiu Avicel khi bo qun m cao c
th b mm i o ht m. C th khc phc bng cch kt hp
vi cc t dc trn chy t ht m hn nh Fast - Flo lactose.
Trn th trng hin nay thng dng 2 loi Avicel: pH 101 c
kch thc ht trung bnh 50 m v pH 102 c kch thc ht 90
m.

Calci dibasic phosphat (dicalci phosphat):

L t dc v c, bn v l - ho, khng ht m, n chy tt.
T pc dp thng cha dicalci phosphat c tn thng mi l
Emcompress hoc Ditab (trong dicalci phosphat c phi
hp vi 5 - 20% cc t dc khc nh tinh bt, Avicel, magnesi
stearat) (cng n thc 15.6). Vin dp vi dicalci phosphat c
bn c hc cao, r chm, v vy khng nn dng t l cao vi
dc cht t tan.
Dicalci phosphat c tnh kim nh (pH 7 - 7,3), do khng
dng cho cc dc cht khng bn trong mi trng kim.
trong ng tiu ho, t dc ny c th to phc, lm gim hp
thu mt s s dc cht (tetracyclin, pheny-toin...).

- Calci carbonat, magnesi carbonat:

L nhng t dc c kh nng ht nn c th dng cho vin nn
cha cao mm dc liu, cha dc cht ho m, du v tinh
du. Trong mt s vin, cc t dc ny cn ng vai tr
antacid hoc cung cp ion v c cho c th.
Tuy nhin, y l nhng t dc c tmh kim, cho nn khng
dng cho cc c cht c tnh aci, cc mui acid...
2.2 T dc dnh
L tc nhn lin kt cc tiu phn to hnh vin, m bo
chc ca vin.
2.2.1. Nhm t dc dnh lng
T c dnh lng dng trong phng php xt ht t. C
nhiu loi t dc dnh lng c mc kt dnh khc nhau:

Ethanol:
Ethanol dng khi thnh phn vin c cc cht tan c trong
ethanol (cao mm c liu, bt ng,.. to nn kh nng
dnh. Vi cao mm, ethanol cn gip cho vic phn tn cao v
khi bt d dng hn, lm cho ht d sy kh hn.
H tinh bt:
H tnh bt l t dc dnh thng dng hin nay, d kim, gi r
d trn u vi bt dc cht, t c xu hng ko di thi gian
r ca vin. Thng dng loi h t 5 - 15%, trn vi bt dc
cht khi h cn nng. Nn iu ch dng ngay trnh b nm
mc.

Dch th gelatin:
Gelatin trng n v ho tan trong nc, to nn dch th c
kh nng dnh mnh, thng dng cho vin ngm ko i
thi gian ra hoc dng cho dc cht t chu nn. Hay dng dch
th 5 -10%, trn vi bt dc cht khi t dc cn nng. C th
kt hp vi h tinh bt tng kh nng dnh cho h.
Dch nc gelatin c nht ln, kh trn u vi bt dc
cht, ht kh sy kh. V vy ngi ta hay dng dch th gelatin
trong ethanol c thu phn trong mi trng acid hay mi
trng kim.
So vi dch nc, dch ethanol cn hn ch c s thu phn
ca mt s dc cht v lm cho ht d sy kh.

Dch gm arabic:
Gm arabic c kh nng dnh mnh, ko i thi gian r ca
vin, thng dng trong vin ngm. Tuy nhin, dch gm b
nn nn ch dng ngay. Thng dng dch th trong nc cha
5 - 15% gm.
Dng dch PVP:
PVP dnh tt, t nh hng n thi gian r ca vin, ht d sy
kh. Vi dc cht s nc, t tan trong nc, PVP c kh nng
ci thin tnh thm v tan ca dc cht (barbituric, acid
salicylic...), dch PVP trong ethanol dng thch hp cho vin s
m v nhit (aspirin, khng sinh...).
Tuy nhin, PVP ho m, vin cha nhiu PVP d thay i th
cht trong qu trnh bo qun.

Dn cht cellulose: C nhiu loi khc nhau:

+ Methyl cellulose: Dng ch th 1 - 5% trong nc, kh nng
kt dnh tt. Trn th trng c nhiu loi c nht khc nhau.
+ Na tri carboxymethyl cellulose (Na.CMC): Thng dng dch
th 5 - 15% ong nc. Ht to ra khng chc bng PVP v c
xu hng ko di thi gian r. Tng k vi mui calci, nhm
v magnesi.
+ Ethyl cellulose: Thng dng loi c nht thp vi nng
2-10% trong ethanol. Kh nng kt dnh mnh, thng dng
cho cc dc cht t chu nn nh paracetamol, cafein,
meprobamat, st fumarat v cc dc cht s m.

2.2.2. Nhm t dc dnh th rn

Thng dng cho vin xt ht kh v dp thng. Dng cc loi
bt ng, tinh bt bin tnh, dn cht cellulose, Avicel... Cc t
dc (tnh rn tan c trong nc v cn c th xt ht t
vi hn hp nc - cn cc t l khc nhau.
2.2.3 T dc r
T dc r lm cho vin r nhanh v r mn, gii phng ti a
b mt tip xc ban u ca tiu phn dc cht ^i mi trng
ho tan, to iu kin cho qu trnh hp thu c cht v sau.
Khi tip xc vi dch tiu ho, vin ht nc v r ln th 1,
gii phng ra ht dp vin (r ngoi). Tip , ht r ln th 2,
gii phng tr li cc tiu phn ban u (r trong).

V c ch r ca vin c gii thch nh sau: Cc t c r

c cu trc xp sau khi dp vin li h thng vi mao qun
phn b ng u trong vin. Khi tip xc vi dch tiu ho, h
thng vi mao qun c tc dng ko nc vo lng vin nh lc
mao dn. Nc s ho tan v lm trng n cc thnh phn ca
vin v ph v cu trc ca vin. Nh vy, s r ca vin ph
thuc vo xp v vo s phn b h thng vi mao qun trong
vin.
Ring vin nn si bt th r theo c ch sinh kh: Ngi ta ua
vo trong vin ng thi mt aci hu c (citric, tartaric,...) v
mt mui kim (natri carbonat, natri hydrocarbonat, magUesi
carbonat,...). Khi gp nc hai thnh phn ny tc dng vi
nhau gii phng ra CO2 lm cho vin r ra nhanh chng.

Cc loi t dc r hay dng:

Tinh bt: C cu trc xp, sau khi dp vin to ra c h thng vi
mao qun phn b kh ng u trong vin, lm r vin theo c ch vi
mao qun.
Thng dng tinh bt ng, khoai ty, hong tinh,... v t l t 5 20% so vi vin. Bnh thng tinh bt hp ph kh nhiu nc, o
, tng kh nng lm r, trc khi dng phi sy kh. Cch r ca
vin ph thuc mt phn vo cch phi hp tinh bt. Thng thng
ngi ta chia tinh bt thnh 2' phn: phn r trong (khong 50 - 75%)
v phn r ngoi (25 - 50%).
Tinh bt bin tnh: Hay dng natri starch glycolat tn thng mi l
Primogel, Explotab). y l t dc gy r vin rt nhanh (siu r) do
kh nng trng n mnh trong nc, kh nng r t b nh hng bi
lc nn. Cc loi tinh bt bin tnh khc nh starch 1500, pregelatined
starch... cng u l nhng t c r tt. T l thng dng 2 - 6%.

- Avicel: Lm cho vin r nhanh do kh nng ht nc v

trng mnh, t l 10% trong vin th hin tnh cht r
tt; kt hp c va r va dnh. Nu xt ht t th kh nng
r b gim.
- Bt cellulose: Dng loi tinh ch, trng, trung tnh. Dng mt
mnh hay phi hp vi cc t dc r khc nh tinh bt,
Veegum, phch hp cho cc c cht nhy cm vi m.
Ngoi ra, cn mt s cc t dc siu r hin nay rt hay dng
nh
patri
croscarmellose
(Ac-Di-Sol),
Crospovidon
(Polyplasdon XL)...
2.4. T dc trn
T c trn l nhm t dc c nhiu tc dng ong qu trnh
dp vin:
- Chng ma st gia vin v thnh ci sinh ra khi p vin.

-Chng dnh khi dp vin: di tc ng ca lc nn, vin c th dnh

vo b mt chy trn. Hin tng dnh chy thng xy ra khi vin
cha dc cht ho m (cao thc vt, mtropui...), khi ht sy chua
kh, khi m trong phng dp vin qu cao hoc khi chy c khc
ch, logo,
- iu ho s chy: khi dp vin, bt hay ht phi chy qua phu,
phn phi vo bung nn. Nu nguyn liu p vin kh trn chy,
vin s kh ng nht v khi lng v hm lng c cht.
Lm cho mt vin bng p.
Tuy nhin, do phn ln t dc trn l nhng cht s nc, lm cho
vin kh thm nc, do c xu hng ko di thi gian r ca vin.
Mt khc, mt lng qu tha t dc trn s lm cho vin kh m
bo bn c hc do lm gim lin kt lin ht (ngc li vi tc
dng ca t dc dnh).

-Cc loi t dc trn hay dng:

-Acid stearic v mui: l nhng t dc h thng dng, c tc dng
gim ma st v chng dnh. Cc mui caici stearat v magnesi stearat c
kh nng bm dnh tt, thng dng t l khong 1% so vi ht kh.
-Talc: c tc dng lm trn v iu ho s chy. Kh nng bm dnh ht
km hn magnesi stearat do t l dng cao hon (1 - 3%).
-Aerosil, Cap-O-Sil: bt rt mn v nh nn kh nng bm dnh b mt
ht rt tt, do t l dng thp (0,1 - 0,5 %). Tc dng chnh l iu
ho s chy. y l t dc trn hay dng nht hin nay cc nc.
-Tinh bt: C tc dng iu ho s chy. Thng dng trong phng
php xt ht kh v dp thng, vi t l t 5 - 10% v phi sy kh
trc khi dng.
-Ngoi ra cn nhiu loi t dc trn khc nh Avicel, PEG 4000 v
6000, PEG monostearat, natri lauryl Sulfat, natri benzoat, veegum,...

2.5. T dc bao
Bao vin nhm cc mc ch sau:
Che du mi v ca dc cht.
Bo v dc cht, trnh cc yu t tc ng ngoi mi nh: m,
nh sng, oxy khng kh..., lm tng n nh ca ch phm.
Thun li trong qu trnh ng gi v khng gy bn thit b, nhim
cho do bay bi.
Ci thin hnh thc ca vin, tng cng cho vin.
Ci thin sinh kh dng ca dc cht: bao tan rut, bao gii phng
dc cht ko di, bao vin thm thu...
Phmg php bao vin ph bin hin nay l bao mng mng. bao
mng mng, nguyn liu chnh c dng l polyme. Tu theo mc
ch bao m chn loi polyme thch hp:

Dn cht cellulose: hin nay c s dng kh rng ri:

+ Hydroxypropylmethyl cellulose (HPMQ: L t dc bao bo v,
bn vi cc yu t ngoi mi, khng c mi v ring, d phi hp vdi
cht nhum mu.
+ Ethyl cellulose (EC): Khng tan trong nc, tan trong dung mi
hu c, bn vi ngoi mi. Dng lm t dc bao vin tc ng ko
di. C th phi hp EC vo mng, bao HPMC gim tan trong
nc ca mng bao.
+ Cellulose acetat phthalat (CAP): L este kp ca cellulose, tan
trong dch rut, do dng bao tan rut. Mng bao khng dch v
(chi tan pH > 6), nhng d thm dch v. Khi bao, thng phi cho
thm cht lm do.
+ Hydroxypropylmethyl cellulose phtalat (HPMCP): L este ca
HPMC vi acid phthalic, dng bao tan rut. Thng dng di
dng hn dch nc.

Nha methacrylat: L sn phm trung hp ca acid methacrylic. Sn

phm thng mi c tn gi l Eudragit. C nhiu loi Eudragit c
tan v cch dng khc nhau:
+ Eudragit E tan trong dch v (pH < 5), dng bao bo v.
+ Eudragit L v S khng tan trong dch v, dng bao tan rut:
Eudragit L tan pH < 6. Eudragit s tan pH > 7.
Ngoi ra cn nhiu t dc khc phi hp trong thnh phn mng bao
nh PEG, talc, titan dioxyd...(xem cng thc 15.5).

III. K THUT BO CH VIN NN

C 3 phng php bo ch vin nn l to ht t, to ht kh v dp
thng.
1. Phng php to ht t
Phng php to ht t c nhiu u im: D m bo bn c hc ca
vin, dc cht d phn phi vo tng vin nn m bo s ng nhit
v khi lng vin v hm lng dc cht). Quy trnh v thit b n gin,
d thc hin.
Tuy nhin, phng php to ht t cng c nhng nhc im nh: chu
tc ng ca m v nhit (khi sy ht), c th lm gim n nh ca dc
cht. Quy trnh ko di qua nhiu cng on:
1.1. Trn bt kp
Trc khi trn bt kp phi phn chia nguyn liu n mn qut nh.
Khi trn bt kp cn p ng k thut trn ng lng m bi c
cht c phn phi ng u trong vin, c bit vi cc vin nj cha
hm lng dc cht thp. Khi lng dc cht trong vin nh ct th
khng trn bt kp m ho dc cht vo t c nh lng hoc vo l ung
mi thch hp xt ht hoc trn vo ht trc khi p vin

1.2. To ht
To ht nhm trnh hin tng phn lp ca khi bt trong qui
trnh dp vin, ci thin chy ca bt dp vin, tng cng
kh nng lin kt ca bt lm cho vin d m bo chc v
gim hin tng dnh ci chy khi dp vin.
d dp vin, ht phi d chy v chu nn tt. Mun vy, ht
phi p ng mt s yn cu sau:
C hnh dng thch hp: Tt nht l hnh cu. Ht hnh cu c
ma st nh d chy, khi nn d lin kt thnh vin.
C kch thc thch hp v kch thc cng ng nht cng d
m bo s ng nht v khi lng vin. Thng thng kch
thc ht thay i t 0,5 - 2 ram theo ng knh vin (vin
cng b th nn xt ht cng nh v ngc li).
C th to ht ut bng cch xt ht qua ry hoc bng thit b
tng si.

Xt ht c thc hin qua cc bc sau:

To khi m: Thm t dc dnh lng vo khi bt, trn cho n
lc t dc thm u vo khi bt. t dc d thm vo khi
bt, nn ng t dc nng, nht l vi nhng t dc c nht
cao nh dch th gelatin, h tinh bt. Lng t c v thi gian
trn quyt nh n kh nng lin kt ca ht. V th, phi tun
th ng yu cu v thi gian v cc thng s k thut khc.
qui m nh c th nho m bng chy ci, vi qui m ln dng
cc thit b nh my nho trn, my nho siu tc...
Xt ht: Khi m sau khi trn u, n nh trong mt khong
thi gian nht nh ri xt qua c ry quy nh. thu c ht
c hnh dng gn vi hnh cu, tt nht l xt ht qua ry c l
vi lc xt ht va phi. C th xt ht bng tay qua ry hoc xt
bng my xt ht. Vi dc cht kh to ht hoc ht c mu nn
xt ht hai ln thu c ht t yu cu v c mu sc ng
nht.

Sy ht: Ht sau khi xt, tri thnh lp mng v sy nhit

quy nh. Trc khi sy, c th thong gi cho ht se mt,
sau a vo bung sy v nng nhit t t cho ht kh
u. Trong qu trnh sy, thinh thong o ht, tch cc cc vn
v kim tra nhit sy. Hoc sy bng my sy tng si
gim thi gian sy. Thng sy ht cho n m t 1 -1% tu
tng loi vin.
Sa ht: Ht sau khi sy xong, phi xt li nh nhng qua c ry
quy nh (thng l bng hay to hn c ry xt ht m) ph
v cc cc vn, to ra c khi ht c kch thc ng nht
hn.
hn ch tc ng ca m v nhit, tit kim mt bng sn
xut, hin nay trong sn xut cng nghip, ngi ta c th to
ht bng thit b tng si.

1.3. Dp vin

Ht sau khi sy n m quy nh, trn vi t dc trn, t

dc r ngoi ri dp thnh vin. C nhiu loi my dp vin
khc nhau hot ng theo nguyn tc: Nn hn hp bt hoc ht
gia hai chy trong mt ci (bung nn) c nh.
Trong nghin cu v sn xut nh, ngi ta dng my dp vin
tm sai, c cu to nh hnh 15.1.

Chu k dp vin trong my tm sai c th chia thnh 3 bc (Hnh

15.2):
Np nguyn liu: Khi np nguyn liu, dung tch bung nn phi
mc ln nht. Do , chy dui phi v tr thp nht, chy trn
phi v tr cao nht. Phu v tr trung tm v np y nguyn
liu vo bung nn.
Nn (dp vin): Phu dch xa khi trung tm, chy di ng yn,
chy trn tin dn xung v tr thp nht t lc nn ti a. Cc
tiu phn c nn st li vi nhau hnh thnh vin nn.
Gii nn (y vin ra khi ci): Sau khi nn xong, chy trn gii
nn tin v v tr trc kh nn. ng thi chy dui tin dn ln
v tr (cao nht (ngang vi mt bng ci) y vin ra khi ci.
Phu tin y v tr trung tm gt vin ra khi mm my v tip
tc np nguyn liu cho chu k sau.
Trong cng nghip vin c dp bng thit b quay trn (hnh
15.3)

2. Phng php to ht kh
Phng php to ht kh (cn gi l phng php dp kp) c
u im l trnh c tc ng ca m v nhit vi dc
cht, do c dng cho cc vin cha dc cht khng bn
vi m v nhit (aspin, vitamin c, ampicilin...). To ht kh tit
kim c mt bng v thi gian hn to ht m. Hn ch ca
phng php to ht kh l: Dc cht phi c kh nng trn
chy v lin kt nht nh v kh phn phi ng u vo tng
vin (do hin tng phn lp xy ra khi dp vin), hiu sut to
ht khng cao v vin kh m bo bn c hc.
Phng php to ht kh c tin hnh qua cc cng on sau:
Trn bt kp: ch yu l trn bt dc cht vi bt t dc nh
kh, t dc r. Tin hnh trn v kim tra nh vi phng
php xt ht t.

Dp vin to v to ht: bt c dp thnh vin to (c ng

knh khong 15 - 2 cm). Cn v vin to to ht. Ry chn ly
ht c kch thc quy i. Loi ht b cha t kch thc quy
nh tip c dp vin to to ht
khc phc nhc im ny, hin nay ngi ta dng phng
php cn p (to ht compact): Bt kp c cn p thnh tm
m (dy khong 1 mm) gia hai trc ln. Sau xt v tm
mng qua ry to ht (hnh 15.4).

Dp vin: Sau khi c ht kh, tin hnh dp vin c khi lng quy nh ging
nh vi phng php to ht t.
3. Phng php dp thng
Dp thng l phng php dp vin khng qua cng on to ht. Do tit
kim c mt bng v thi gian sn xut, trnh c tc ng ca m v
nhit ti dc cht. Vin dp thng thng r nhanh nhng bn c hc
khng cao v chnh lch hm lng dc cht gia cc vin nhiu khi l kh
ln.
Trn thc t, c mt s dc cht c cu trc tinh th u n, trn chy v
lin kt tt, c th dp thng thnh vin m khng cn thm t dc (nh natri
clorid, urotropin...). Tuy nhin s c cht khng nhiu. Trong a s
trng hp, mun dp thng, ngi ta phi thm t dc dp thng ci
thin trn chy v chu nn ca dc cht. Tu theo tnh cht ca dc cht
m lng t c p thng thm vo nhiu hay t. Nu dc cht t trn chy
v chu nn, t dc dp thng c th chim ti 70 - 75% khi lng ca vin.
Cc t dc dp thng hay ng hin nay l: cellulose vi tinh th (Avicel),
lactose phun sy (LSD), dicalci phosphat (Emcompress), tinh bt bin tnh...
Trong , cellulose vi tinh th c coi l t c c nhiu u im hn c
(xem v d 15.6 )

IV. YU CU CHT LNG VIN NN

1. Tiu chun Dc in
Theo DVN, yu cu k thut chung ca thuc vin nn bao gm:
1.1. r
r ca vin c xc nh bng thit b th r (xem trong DVN 3
trang PL 136 - 137). Mi trng th l nc ct, nhit 3TC 2C (nu
khng c ch dn trong chuyn lun ring). Mi ln th 6 vin, mu th t
yu cu nu 6 vin r ht.
Tu loi vin m yu cu thi gian r khc nhau: Vin nn khng bao phi
r trong vng 15 pht. Vin bao bo v r trong vng 30 pht. Vin bao tan
trong rut phi chu c mi trng HCL 0,1M trong 2 gi v phi r
trong h m phosphat pH 6,8 trong vng 60 pht. Vin tan trong nc phi
r trong vng 3 pht. Vin si bt r trong vng 5 pht (th trong cc c
m cha 200 ml nc ct 15 - 25C).
1.2. ng u khi lng
Th vi 20 vin. lch cho php phi t yu cu nh ghi bng sau:

Khi lng trung bnh ca

vin

% chnh lch so vi khi

lng trung bnh

Ti 80 mg
80 - 250 mg
> 250 mg

10
7,5
5

1.3 ng u hm lng
p dng cho vin c hm lng dc cht t hn 2mg hoc t hn
2% khi lng vin. Th vi 10 vin, khng c c vin no nm
ngoi gii hn 85-115% hm lung trung bnh. Nu c mt vin
nm; ngoi gii hn trn nhng nm trong gii hn 75 - 125% hm
lng trung bnh th th li vi 20 vin khc. Thuc t yu cu
nu trong 30 vin khng c qu 1 vin nm ngoi 85 -115% v
khng c vin no nm ngoi 75 - 125% hm lng trung bnh.

1.4 nh lng
Th vi 10 20 vin theo chuyn lun ring, tnh hm lng
hot! cht trong mi vin theo khi lng trung bnh ca vin.
1.5 Th nghim ho tan
Thit b nh gi l my o ho tan, gm thit b kiu gi quay
kiu cnh khuy v kiu dng chy (DVN 3 trang PL 133-134).
Dc in Vit Nam quy nh, nu th mi ln 1 vin th phi th
6 ln. Nu c 1 vin khng t th phi th li vi 6 vin khc v
c 6vin phi t yu cu. Nu th mi ln 2 vin tr ln th phi
th tt c 5, 6 ln v tt c cc vin u phi ho tan trn 70%
lng dc cht qu nh nu khng c cc ch dn khc ong
chuyn lun. Vin th tan khng cn th r.
Ngoi cc ch tiu k thut trn, mt s D cn quy nh nh gi
ng nht v ng knh vin.

2. Tiu chun nh sn xut

nng cao cht lng vin nn, m bo ng nht gia cc l, m sn xut, cc
nh sn xut cn a ra mt s ch tiu cht lng khc cho vin nn:
2.1. mi mn - b vn
Thit b bao gm mt trng quay c gn vi mt mot quay tc 251
vng/pht (hnh 15.5).
Theo Dc in M 26: Lng mu vin cho vo trng quay c qui nh nh
sau: Nu khi lng trung binh vin nh hn hoc bng 650 mg th cn s vin
tng ng vi khong 6,5 g. Nu vin c khi lng ln hn 650 mg th cn khi
lng ca 10 vin. Cho vin cn chnh xc ti mg vo trng quay v quay 100
vng hoc trong khong thi gian nht nh. Ly vin ra, sng sch bt v cn li
khi lng. Tnh mi mn (b vn) bng % khi lng vin b mt. Nu khng
c quy nh ring, mi mn (b vn) khng c qu 1%.
2.2. Lc gy v vin
Xc nh bng thit b o lc gy v vien da trn nguyn tc: Tc lng 1 lc qua
ng knh vin cho n lc vin b v. Gii hn lc gy v vin tu thuc vo
tng loi vin.

V. MT S CNG THC THUC VIN NN

Cng thc 15.1: vin nn vitamin B1 0,01 g
Thiamin hydroclorid
10 mg
Lactose
30 mg
Tinh bt
60 mg
H tinh bt 10%
va
Talc
3 mg
Magnesi stearat
1 mg
Vin nn vitamin B1 thng c iu ch bng phng php xt ht
t theo cc bc sau:
Cn lactose, tinh bt, vi tam in B1
Nghin mn cc bt trn v trn thnh hn hp bt kp ng nht.
Cho h tinh bt vo hn hp bt trn, nho trn thnh khi bt va
m xt ht.

Xt ht qua li (ry) c kch thc mt li 0,8 mm.

Sy ht trong t sy 15 pht nhit 50 - 60c, ri xt li qua li
(ry) c kch thc mt li 0,6 mm.
Sy ht cho ti khi t m 2 - 3% (dng cn xc nh nhanh
m).
Trn ht kh vi t dc trn c nghin mn, ry qua ry 180,
Dp vin vi chy c ng knh 6 mm, lc gy v vin 5-7 kg,
ng l, dn nhn ng qui ch.
Vin nn vitamin B1 cng c dp thng vi cc t dc dp thng
nh Avicel, lactose phun sy, tinh bt bn tnh,...

Cng thc 15.2: vin nn paracetamol

Paracetamol
325mg
Avicel pH 101
80mg
Tnh bt
80mg
H tinh bt 10%
va
Hn hp talc - magnesi stearat (9: 1) 14 mg
Paracetamol l dc cht t tan, ti xp, kh lin kt. Khi p vin hay b bong
mt, st cnh. V vy trong cng thc c Avicel ci thin kh nng chu nn,
ng thi phi kt hp vi tinh bt lm cho vin r mn ho tan tt dc cht.
Vin c iu ch bng phng php xt ht ut vi t dc dnh l h tinh bt
qua cc bc nha sau:
Cn tinh bt, paracetamol, Avicel.
Nghin mn tinh bt, paracetamol, trn thnh hn hp bt kp ng nht.
Cho h tinh bt vo hn hp bt trn, nho trn tht k thnh khi bt va m
xt ht.
Xt ht qua li (ry) c kch thc mt li 1,0 mm. Sy ht trong t sy 15
pht nhit 60 - 70C. Xt li ht qua ry c kch thc mt 0,8 mm.
Sy ht cho ti khi t m 2-3% (dng cn xc nh nhanh m).
Trn ht kh vi t c trn c nghin mn, ry qua ry 180.
- Dp vin vi chy c ng knh 12 mm, lc gy v vin 8 10kg.
- ng l, dn nhn ng qui ch.

Cng thc 15.3: vin nn Cotrimoxazol

Sulfamethoxazol
400 mg
Trimethoprim
80 mg
Avicel pH 101
30 mg
Tinh bt
70 mg
H tinh bt 10%
va
Tale
10 mg
Magnesi stearat
5 mg
Natri laurylsulfat
2 mg
Bo ch vin nn bng phng php xt ht t qua cc bc:
Cn Sulfamethoxazol, trmethoprim, tinh bt, Avicel.
Nghin mn cc bt trn, trn thnh hn hp bt kp ng nht.
Cho h tnh bt vo hn hp bt trn, nho trn thnh khi bt va m xt
ht.
Xt ht qua li (ry) c kch thc mt li 1,2 mm. Sy ht trong t sy 15
pht nhit 50 - 60C. Xt li ht qua ry c kch thc mt 1,0 mm.
Sy ht cho ti khi t m 3 - 4% (dng cn xc nh nhanh m).
Trn ht kh vi t dc trn c nghin mn, ry qua ry 180.
Dp vin vi chy c ng knh 13 mm, lc gy v vin 8-10 kg.
ng l, dn nhn ng quy ch.

Chng 16

K THUT BO CH THUC VIN TRN

MC TIU HC TP

1. Trnh by c nh ngha v phn loi vin trn.

2. K tn cc t dc thng dng trong vin trn.
3. M t c k thut bo ch vin trn theo phng php chia vin, bi vin.
4. Nu c yu cu cht lng vin trn.
5. Trnh by c trnh t bo ch mt s cng thc vin trn.

I. I CNG
1. nh ngha
Vin trn l dng thuc rn, hnh cu, c bo ch t bt thuc v cc
t dc, thcrng dng ung, nhai hoc ngm. Vin trn ng dc
gi l thuc hon mt s vin trn vn c sn xut, ch yu l l
thuc hon.
Vin trn l dng thuc c dng t lu. Cch y 3000 nm c
ti liu ghi chp v thuc hon ca Trung Quc. Trc th k 19, vin
trn c dng rng ri. Nhng t khi vin nn v nang thuc ra
i, vin trn c thay th dn bi cc dng thuc ny. Ngy nay,
mt s vin trn vn c sn xut, ch yu l l thuc hon.
2. Phn loi
2.1. Theo ngun gc
Vin trn c chia thnh hai loi:
Vin trn ty y: Ch yu bo ch t cc ho dc, thng c khi
lng t 0,1 - 0,5 g/vin.
Thuc hon: Ch yu bo ch t cc loi bt mn dc H ch chit
dc liu, cc t dc thch hp. Thuc hon li chia nhiu loi:

Theo loi t dc dnh:

+ Mt hon: dng mt ong hoc mt ong phi hp vi nuc lm
dc dnh.
+ Thu hon: dng nc, ru go, gim, nc ng, dch
chit dc liu lm t dc dnh
+ H hon: dng h tinh bt lm t dc dnh.
Theo th cht:
+ Hon cng.
+ Hon mm.
2.2. Theo phng php bo ch
Vin chia: c bo ch theo phng php chia vin nh vin
trn ty y, hon mm.
Vin bi: c bo ch theo phng php bi vin nh cc loi
hon cng.

3. u nhc im
u im:
K thut bo ch n gin, khng i hi trang thit b phc
tp, do d p dng tuyn y t c s.
L dng thuc rn nn tng i n nh v mt ho hc, d
phi hp nhiu loi dc cht trong vin, th tch gn nh, d
vn chuyn, bo qun.
C th bao ngoi bo v dc cht, che du mi v kh chu
hay khu tr tc dng ca thuc rut.
Nhc im:
Kh tiu chun ho v mt cht lng nh: Bin thin khi
lng ca vin trn kh ln. c bit l vi thuc hon bo ch
t cc loi dc liu cha bit r hot cht th vic nh gi cht
lng l rt kh khn.
Vin trn bo ch theo phng php chia vin quy m nh,
kh m bo v sinh.

II.THNH PHN THUC VIN TRN

1. Dc cht
Dc cht em bo ch vin trn c th l ho dc hoc dc
liu. theo y hc c truyn, ri tn thnh bt mn. Ngoi ra mt
s dc liu cn ch thnh cao tng hm lng hot cht
trong vin, gim bt s lng vin cho mt ln ung, ng thi
kt hp lm t dc dnh.
2. T dc
T dc dng trong vin trn c nhiu nhm ging vi t dc
trong vin nn nh t dc n, t dc ht, t c mu. Tuy
vy, vi vin trn, quan trng nht l nhm t dc dnh, v y
l yu t to hnh chnh ca vin. Cc nhm t dc dng trong
vin trn l:

2.1. T dc dnh
Nc: Dng trong trng hp c cht c th ho tan hay
trng n trong nc to ra kh nng dnh nht nh. Thng
dng trong thuc hon bo ch theo phng php bi vin
gy nhn hay ch loi hon nh (thu hon). Trong mt s
trng hp, nc c phi hp vi cc t dc dnh lng khc
nh glycerin, siro, mt ong,... d iu chnh dnh.
Mt ong: Kh nng nh tt, iu v v kt hp c vi tc
dng ca c cht. Thng dng cho hon mm c tc dng
b kh, nhun ph, gii c... Dng lm t dc dnh cho hon
mm, mt ong gip m bo c th cht nhun do ca vin.

 tinh ch v tng kh nng dnh, ngi ta thng tin hnh

"luyn mt: Cho thm vo mt ong khong 20% nc, un si,
lc qua gc loi bt tp cht c hc. Sau c cch thu cho
n lc thnh chu (nh git mt vo cc nc lnh, git mt
khng tan trong nc). Tu theo mc luyn m ngi ta chia
ra 2 loi mt: Mt non, luyn khong 105C, cn cha khong
20% nc v mt gi luyn khong 110C cho n hm lng
nc di 10%.
Siro n: dnh va phi, d phi hp vi c cht, khng
nh hng nhiu n kh nng r, gii phng dc cht ca vin,
c kh nng iu vi.
H tinh bt: Dng lm t dc dnh trong vin trn ty y bo ch
theo phng php chia vin v ch h hon theo phng php
chia vin hoc bi vin. H tinh bt c th phi hp vi cc loi
t dc dnh khc nh dch th gelatin, siro gm,... H tinh bt
phi dng ngay trnh nhim cc vi sinh vt

Dch th gelatin: Thng dng loi ch th 5 - 20 % trong nc,

thch hp cho cc loi dc cht kh, ri, kh kt dnh hoc nhng
vin cn tan r gii phng c cht chm. Tuy nhin, dch nc
c nhc im l lm cho vin kh sy kh do c th dng dch
th gelatin trong ethanol nh trong vin nn.
Dch gm: Thng dng dch gm arabic 5 - 10 % trong nc cho
nhng vin c dc cht kh kt dnh hoc cho nhng vin c
cht lng kh phn tn trong khi bt. Dch gm hay c phi
hp lm tng dnh ca mt s t dc khc nh glycerin, h
tinh bt...
T dc dnh tng hp: Dng cc loi t c hay dng trong vin
nn nh dch th CMC, NaCMC, PVP,..
Trong mt s trng hp, trong cng thc vin trn cha cc dc
cht lng, mm, t kh nng dnh, ngi ta c th dng mt s t
dc dnh th rn to khi do nh bt ng, bt gm, bt
PVP,...

2.2 T c dn
Dng trong trng hp dc cht trong vin khng khi lng
quy nh ca vin, nht l vin cha dc cht c, tc dng mnh
dng liu thp. Thng dng cc loi:
Tinh bt: Tng i tr v mt ho hc v dc l, d kim lm
cho vin d r. C th phi hp vi bt ng m bo chc
ca vin.
Bt ng: Tng i tr v mt dc l, lm cho vin d m
bo chc, c tc dng iu v cho vin.
Bt mn v c: Hay dng cc loi bt magnesi oxyd, magnesi
carbonat, calci carbonat, kaolin,... Cc t dc ny c kh nng
ht tt, dng cho vin cha c cht lng, mm, ho m.
Cng c th dng bt dc liu c trong cng thc hay bt b
dc liu.

2.3 T dc r
C th dng cc loi t dc ho tan nh bt ng, lactose,...
hoc t dc r trng n nh tinh bt, tinh bt bin tnh, dn
cht cellulose,... nh i vi vin nn.
Ngoi ra, trong vin trn cn cn dng cc loi t dc khc nh
t dc ht, t dc m, t dc mu,...
3. ao b
Thuc hon c bo ch t bt dc liu, cao dc liu, d ht
m, d nhim nm mc, nht l vi hon mm v hon mm hm
lng nc cn li trong vin tng i cao. Trc y, hon
mm c ng trong v sp hn kn, cch ly vi mi trng bn
ngoi do bo qun c kh lu. Hin nay, dng v polyme
thay cho v sp hoc ng gi 2 v, 1 v polyme, mt v sp
tng tui th cho ch phm. Cc vin hon cng thng c
ng trong cc l cht do, hoc ng ti chia sn liu mt ln
dng nh i vi thuc bt.

III. K THUT BO CH THUC VIN TRN

1. Phng php chia vin
Nguyn tc ca phng php ny l to khi do t bt dc
cht v t dc ri chia thnh vin trn c kh lng quy nh.
Phng php chia vin p dng khi iu ch vin trn ty y,
hon mm. Trnh t bo ch qua cc bc sau:
2. To khi do
Phi hp bt dc cht v bt t c vi t dc dnh lng
to thnh khi do c th cht do dai, s khng dnh tay v
khng dnh vo dng c, ng nht v c m thch hp.
y l giai on quan trng nht, quyt nh th cht ca vin.
Nu khi bnh vin mm qu, vin s b bin dng trong qu
trnh bo qun, d b dnh vi nhau v dnh vo bao gi,
Ngc li, nu khi 5 bnh vin cng qu, vin d b nt v khi
chia vin, vin kh trn u, b mt khng bng.

 m bo cht lng ca vin, trong qu trnh ch khi do cn

ch :
Phi hp dc cht v t dc mt cch hp l:
Nu l dc cht rn th nghin mn, trn bt kp vi t dc rn (t
dc n, r, bt mu,...), ri thm dn t dc dnh th lng hay
mm nho trn k.
Nu dc cht l cc cht mm, lng th thm t dc th rn (t
dc ht, n, dnh, r,.,.) v nho trn to khi do.
Nu dng t dc dnh l loi c snh (h tinh bt, dch th gelatin,
mt luyn,...), kh trn u vi bt dc cht, nht l v ma lnh th
cn un nng t dc trc khi trn vi dc cht, lm cho t dc
d thm vo khi bt, tng ng nht ca khi do.
Tng cng nghin trn to khi do ng nht. Trong bo ch
nh, nghin trn khi do trong ci s hay ci ng. Trong sn xut
ln, dng cc my nho trn, trn trong khong 30 - 45 pht.
Khi nghin trn xong, cn cho khi do n nh trong khong 5 30 pht.

3. Chia vin v hon chnh vin

Sau khi khi do n nh, tin hnh
chia vin trn bn chia vin hoc my
chia vin. Bn chia vin (hnh 16.1) cu
to ch yu gm bnh ln (1), thanh ln
(2), ao ct bng kim loi hay g cng
(3), bn hng vin (4).
Cho khi do ln bn ln rc bt trn
chng dnh (v d bt talc). Sau
dng mt trn ca dao ct hay thanh
ln, ln khi bnh vin thnh thi hnh
tr (thng gi l ln a) c di
bng s vin cn chia. t khi do
ln ln dao ct, ct ri thnh tng vin
v lm trn vin trn dao ct. Sau
tip tc hon chnh vin bng bn xoa,
to o vin bng mt lp bt mng.

Khi sn xut mt lng vin tng i ln, ngi ta dng cc loi

my chia vin. Hot ng ca my chia vin, v nguyn tc cng
ging nh bn chia vin, trong dao ct c thay bng trc ct.
Hin nay mt s c s sn xut dng cc loi my hon mm (hnh
16.2), trong vin c chia v lm trn hon chinh.

2. Phng php bi vin

Nguyn tc ca phng php bi vin trong vin trn l i t nhn
c bn, ri bi dn tng lp c cht nh cc t dc dnh lng, cho
n lc vin t kch thc quy nh. bi vin thng dng ni
bao vin. K thut bo ch qua cc bc sau:
2.1 Gy nhn
Nhn l cc ht nh c ng knh khong 0,5 - 1 mm lm c s
bi cc vin to. Vi vin trn ty y, thng chn cc ht ng c
kch thc thch hp lm nhn. Vi vin hon, thng gy nhn t
bt dc liu bng cch xt ht, chi ht hoc phun t dc lng vo
khi bt. Sau chn ht ri bi ht cho thnh nhn.
y l giai on kh thc hin, nh hng nhiu n cht lng
vin v sau, do phi tnh ton ng lng nhn cn phi lm v
dng t dc dnh c dnh thp trnh gy bt dnh. Nhn lm
xong c sy kh.

2.2. Bi vin
Cho mt lng nhn thch hp vo ni, tih hnh bi vin vi bt
dc cht v t dc dnh lng n kch thc hay khi lng quy
nh theo nguyn tc bi dn tng lp mt. C mi lp t c dnh
li bi mt lp bt dc cht.
Lng t dc dnh v bt thuc dng cho mi ln bi phi va .
nu tha t dc th vin d bt dnh thnh khi. Nu tha bt th d
to thnh cc nhn mi. Lng bt v t dc cho mi ln bi tng
dn theo khi lng ca vin.
m bo thu c vin c kch thc ng u, trong qu trnh
bi vin, thnh thong phi sng chn vin qua cc c ry quy nh.
Nhng vin to trn sng c ring, nhng vin nh di sng
a bi tip cho bng vin to. Sau gp chng li v tip tc bi
cho n lc t kch thc quy nh.
m bo chc v trn u ca vin, cn tin hnh sy vin
trong qu trnh bi.

3. Bao vin
Vin trn bo ch bng cc phng php khc nhau, sau khi c vin
hon chnh, c th a bao lp o ngi nhm cc mc ch khc
nhau:
Trnh vin nh vo nhau v dnh vo bao gi.
Che du mi v kh chu ca thuc.
Bo v hot cht trnh tc ng ca ngoi mi.
Hn ch kch ng ca thuc vi nim mc ng tiu ho.
Khu tr tc dng ca thuc rut.
Lm cho vin hp dn hn vi ngi dng.
Tu mc ch bao m p dng cc cch bao khc nhau:

3.1 Bao bt mn
Mc ch chnh l trnh nh vin, Thng p dng cho vin chia
quy m nh. C th bao bng cc loi bt mn nh talc, than hot,
bt dc liu cam tho.
Bt talc: Bt mn, n, lm bng vin, chng dnh tt.
Bt than tho mc: Bt mn, bt dnh tt, thng dng cho vin
hon.
Khi bao, rc mt t bt ln khi vin trong mt dng c thch hp
ri lc cho bt bm u ln mt vin.
3.2. Bao mng mng
Mc ch chnh l bo v vin, hn ch mi v kh chu ca thuc
hoc bao tan rut. T dc v phng php bao ging nh bao
mng mng trong phn vin nn.
Ngoi cc phng php trn, hin nay c th ng dng cc thit b
bo ch pellet ch vin trn cho nng sut cao, v d thit b n
to cu. Tuy nhin khi bo ch vi cc thit b ny, cn phi hp vi
cc t dc n, dnh, to cu ph hp.

IV. YU CU CHT LNG THUC VIN TRN

1. Hnh thc
Vin phi trn u, gi nguyn hnh dng khi bo qun, mt vin phi
kh nhn. Vin ct i ra phi thy c cu trc bn trong ng
nht.
m:
Tu theo loi vin, v d: Hon mm: khng qu 15 %
Hon cng:
+ Hon mt ong nc: < 12%;
+ Hon nc, hon h: < 9%
r:
Ch p dng cho hon cng, th theo php th ca vin nn.
r khng qu 1 gi, ring hon h, r khng qu 2 gi.
ng dn khi lng
Qui nh theo liu dng ca thuc (xem trong DVN 3)
Cc ch tiu khc: Ngoi ra vin trn cn phi t cc ch tiu nh
nhim khun, c tnh bt thng, nh tnh, nh lng...

IV. MT S CNG THC THUC VIN TRN

Cng thc 16.1: vin trn terpin - codein
Terpin hydrat
0,05 g
Codein
0,10 g
Gm Arabic
0,015 g
Tinh bt
0,03 g
Cht mu
v
H tinh bt 10%
v
Vin terpin - codein c bo ch bng phng php chia vin:
Chun b bn chia vin: st trng bng cn, bi trn bng bt talc.
Nghin mn terpin v codein.
Trn codein vi cht mu, thm terpin, gm, tinh bt.
Thm h tinh bt to khi bnh vin. Ln a, chia vin, hon chnh
vin. Bao vin vi mt t bt talc.
Sy kh vin, ng l, dn nhn ng quy ch.
Hin nay, vin terpin - codein thng c ch di dng vin nn,
vin nang.

Cng thc 16.2: hon iu kinh

Hng ph
240,0 g
ch mu
160,0 g
Ngi cu
160,0 g
Bch ng n 120,0 g
Trn b
180,0 g
Mai mc
80,0 g
T dc
va
Vin hon c iu ch bng phng php bi vin:
- ch mu, ngi cu ra sch, ct on, cho vo ni nu cao, nn
cht, thm nc cho ngp dc liu, un si lin tc trong 2 gi
gn dch chit, c thnh cao lng 1/1 bi vin.
Cc dc liu khc, sao tm ch bin theo quy nh, xay nghin
thnh bt min, trn u.
Gy nhn t bt thuc ri bi vin vi cao lng theo k thut
chung (vin c ng knh khong 4 ram). o vin bng than hot
v nh bng vi parafin

Cng thc 16.3: Hon lc v

Hoi sn
96,0g
n b
71,0g
Phc linh
71,0g
Sn th
96,0g
Thc a
115,0g
Trch t
71,0g
Mt luyn
v
y l vin hon mm c iu ch bng phng php chia vin:
Thc a thi mng, tm ru cho mm ri gi tht nhuyn.
Cc dc liu khc loi b tp, ch bin, sy kh, nghin thnh bt
mn.
Trn thc a vi bt thuc cho tht u, sy kh, nghin mn.
Thm mt luyn v nho trn k thnh khi do ng nht.
Chia vin 12 g theo k thut chung.
ng tng vin trong v polyme y kn.

Chng 17

THC HNH TT SN XUT THUC

MC TIU HC TP
1. Trnh by c ngha v mc tiu ca Thc hnh tt sn xut
thuc.
2. Nu c cc khi nim chung v ni dung c bn ca Thc hnh
tt sn xut thuc.

I. I CNG
1. Khi nim
Thuc l Mt loi hng ho c bit bi v lin quan trc tip n sc
kho con ngi. Nu thuc khng m bo cht lng s:
Khng t c mc tiu phng, cha bnh.
Khng an ton cho ngi s dng.
Thit hi v kinh t cho khch hng.
Thit hi v kinh t v mt uy tn ca cng ty (x nghip, nh sn xut).
Nhm m bo cht lng thuc sn xut trn ton th gii, T chc Y t
Th gii khuyn co cc nc thc hin theo Thc hnh tt sn xut
thuc vit tt l GMP, nguyn gc: Good Manufacturing Practice.
2. Mc tiu ca Thc hnh tt sn xut thuc
Sn xut c sn phm thuc dng phng, iu tr v chn on
bnh cho ngi, t 3 tiu chun:
Tinh khit: l hc, ho hc v vi sinh vt.
An ton : i vi ngi s dng v mi trng.
Hiu qu: v iu tr v kinh t.

3. Gii thiu v GMP

C th coi GMP l mt h thng nhng nguyn tc hay hng dn
nhm m bo tt c cc sn phm u c sn xut v kim sot
cht lng mt cch ng nht theo cc tiu chun v cht lng.
Vn bn d tho u tin ca T chc Y t Th gii (WHO) v
Thc hnh tt sn xut thuc (WHO Good Manufacturing
Practice Guidelines) ban hnh nm 1967. Sa i nm 1975 v
1992. T n nay, tuy khng c sa i nhng tip tc ban
hnh nhiu vn bn hng n b sung v mt s vn c lin
quan.
Hng n thc hnh tt sn xut thuc ca khi ASEAN
(ASEAN Good Manufacturing Practice Guidelines) c trin
khai ln u tin vo nm 1984, c sa li vo nm 1988. Ln
xut bn th 2 bao gm 10 chng nh hin nay. Ln xut bn th
3, nm 1996 c b sung mt s ph lc v mt s phn mi nh
sn xut theo hp ng...

4. Qu trnh thc hin GMP nc ta

nng cao cht lng thuc sn xut trong nc, chun b hi
nhp vo khu vc ng Nam , thc hin c mc tiu c
bn ca Chnh sch quc gia v thuc ca Vit Nam, B trng B
Y t ban hnh Quyt nh s 1516/BYT-Q ngy 9/9/1996 v
vic trin, khai p dng cc nguyn tc, tiu chun Thc hnh tt
sn xut thuc ca Hip hi cc nc ng Nam (GMPASEAN) tt c cc c s sn xut thuc tn dc v Thng t s
12/BYT-TT ngy 12/9/1996 hng dn thc hin quyt nh trn.
tin ti nn kinh t ton cu, ho hp vdi tiu chun quc t v
Thc hnh tt sn xut thuc v thc y vic xut khu, hp tc
vi cc nc trn th gii, B trng B Y t ban hnh Quyt
nh s 3886/2004/BYT-Q ngy 03/11/2004 v vic trin khai p
dng nguyn tc, tiu chun Thc hnh tt sn xut thuc theo
khuyn co ca T chc Y t lhg gii (Good Manufacturing
Practice Guidelines' Recommended by World Health
Organization), vit tt l GMP-WHO.

Ngy 05/7/2005, B trng B Y t ban hnh Quyt nh s

co ca T chc Y t Th gii. Trong ghi r l trnh phi thc
hiu i vi cc c s sn xut thuc trong c nc:
Khuyn khch cc c s trin khai p dng nguyn tc, ti
chun Thc hnh tt sn xut thuc theo khuyn co ca T
chc Y t Th gii (GMP-WHO)
Cc c s sn xut thuc tn dc xy dng mi phi t
nguyn tc, tiu chun Thc hnh tt sn xut thuc ASEAN
hoc WHO.
n ht ngy 31/12/2005, tt c cc c s sn xut thuc tim,
thuc tim truyn, thuc c khng sinh nhm beta-lactam phi
t nguyn tc, tiu chun GMP-ASEAN hoc GMP - WHO.
n ht ngy 31/12/2006, tt c cc c s sn xut thuc tn
dc phi t nguyn tc, tiu chun GMP - WHO.

n ht ngy 31/12/2007, tt c cc c s c php sn

xut thuc tn dc phi t nguyn tc, tiu chun GMPASEAN hoc GMP - WHO.
n ht ngy 31/12/2010, tt c cc c s sn xut thuc t
c I liu phi t nguyn tc, tiu chun GMP - WHO.
Ngy 19/7/2005, B trng B y t ban hnh thng t s
19/2005/Tt- BYT hng dn trnh t, th tc v thm quyn cp
giy chng nhn cho cc c s t tiu chun Thc hnh tt
sn xut vaccin v sinh phm y t km theo Quyt nh s
5405/2002/BYT-Q, ngy 31/12/2002.

5. Mt s thun l v kh khn kh trin khai thc hin GMP nc ta

5.1. Thun li
C th hc tp kinh nghim trin khai GMP v tng cng s h tr ca cc
nc trong khu vc v trn th gii.
Thuc sn xut trong nc mi ch p ng c khong 40% tnh theo gi
tr tin, cn li phi nhp ngoi.
c nhiu cn b c s v trung ng c hun luyn, o to v GMP
trong nc cng nh nc ngoi.
c mt s c s u t xy dng nh my theo tiu chun GMP, v vy
c th hc tp, rt kinh nghim cho nhng c s tin hnh sau
c nh hng pht trin ngnh cng nghip dc Vit Nam n 2015,
trong ghi r mc tiu chung: pht trin ngnh c linh mt ngnh kinh
t - k thut theo hng cng nghip ho, hin i ho, ch ng hi nhp
khu vc v th gii, nhm m bo cung ng thuc thng xuyn c cht
lng, bo m s dng thuc hp l v an ton, phc v s nghip chm sc
v bo v sc kho nhn n.
Lut dc ban hnh, trong ghi r: Pht trin ngnh dc thnh mt
ngnh kinh t - k thut mi nhn, u tin pht trin cng nghip dc.

5.2 Kh khn
Trin khai GMP cn mi, b ng, nht l i vi cc c s
chuyn kinh doanh, cha c kinh nghim trong sn xut.
Cc cn b v chuyn gia trong ngnh cn lng tng trong vic
thit k, xy dng nh xng theo GMP.
Trin khai GMP i h kinh ph ln.
T duy sn xut nh, lc hu khng thch hp vi GMP do
phi o to hun luyn cn thn.
Nn kinh t chung cn cha pht trin, thu nhp thp, cha thch
hp vi cc sn phm gi thnh cao.

6. V tr ca GMP trong h thng m bo cht lng thuc

Mt sn phm thuc c sn xut phc v cho mc tiu
phng, cha v chn on bnh phi tri qua nhiu giai on
nghin cu, pht trin. Sau khi sn xut sn phm cn phi c
bo qun, tn tr tt; phn phi hp l, ng i tng v c
bit phi hng dn s dng ng cho ngi dng thuc. Cng
tc m bo cht lng c tin hnh v coi trng trong tt c
cc gia on, t thit k dng thuc cng thc, quy trnh sn
xut, cho n sn xut, kim tra cht lng, bo qun, phn phi
v hng dn s dng.
C th khi qut vai tr, v tr ca GMP trong h thng m bo
cht lng thuc s sau:

7. Li ch ca thc hin GMP

Nu khng sn xut theo GMP, c th gp nhiu sai st, sn phm b thu hi.
Vic pht hin sai st v x l sn phm thu hi s rt tn km, cn hn c xy
dng, thc hin GMP. Mt khc, thc hin GMP gip md rng hn c hi xut
khu dc phm bi v cc nc trn th gii ch cho php nhp khu v bn
cc sn phm thuc c sn xut theo tiu chun WHO -GMP.
Nhm mc ch khuyn khch cc c s sn xut tch cc u tu, thc hin
GMP, B y t c Cng vn s 284/QLD, ngy 14/1/1998, bao gm mt s
ni dung:
c php in thm dng ch: x nghip t tiu chun Thc hnh tt sn xut
thuc - GMP trn nhn thuc.
c to iu kin thun li sn xut hng xut khu.
c hp tc sn xut v nhng quyn i vi mt s sn phm ca cc nh
sn xut dc phm ln, c uy tn trn th gii.
c u tin khi tham gia cc chng trnh u thu quc gia v quc t
cung cp thuc cho cc chng trnh Y t quc gia.
c u tin cung ng thuc thit yu cho cc bnh vin,
-c u tin cp s ng k sn xut k c sn phm thuc danh mc cc
hot cht hn ch cp s ng k.

II. NI DUNG C BN CA THC HNH TT SN XUT

THUC (WHO-GMP)
1. Mt s khi nim
Hot cht dc dng (API, active pharmaceutical ingredien): n cht hay
hp cht s dng trong mt dng thuc gi vai tr l thnh phn hot tnh
(iu tr phng v chn on bnh).
Cht gi (airlock): mt khng gian khp kn, gii hn bi 2 hay nhiu ca
i, nm gia hai hay nhiu bung (thuc cc cp sch khc nhau), nhm
mc ch kim sot lung khng kh gia cc khu vc. Cht gi c thit
k dng cho ngi hay nguyn vt liu, thit b.
-L (lot hoc bach): mt lng nguyn liu ban u, nguyn liu bao gi
hoc sn phm thuc c bo ch trong mt chu k sn xut nh trc
v theo mt trnh t nht nh, hon ton ng nht v cht lng
-S l (bach number hoc lot number): k hiu bng s hoc chi hoc kt
hp nhn dng duy nht mt l sn phm, c ghi trn ; nhn, trong h
s l, trn phiu kim nghim. S l gip ta tra cu lch s y ca mt
l sn xut bao gm cc cng on ca qu trnh sn xut, kim tra v phn
phi l sn phm

H s l (batch records): tt c ti liu lin quan n sn xut mt l bn

thnh phm hoc thnh phm, th hin lch s, cht lng ca mi l sn
xut.
Khu vc sch (clean area): khu vc m mi trng c kim sot v
tiu phn v vi khun, c xy dng v s dng lm gim thiu
nhim sn phm.
Nhim cho (cross-contaminatin): vic nhim nguyn liu ban u, sn
phm trung gian hay thnh phm ny sang nguyn liu hoc sn phm
khc trong qu trnh sn xut.
Cng thc gc (master formula): mt ti liu hay b ti liu ch r
nguyn liu ban u, khi lng, bao b, cc quy trnh thao tc chun
(SOP) sn xut ra mt lng xc nh thnh phm, trong c m t
y thng s trong qu trnh sn xut cng nhu kim tra trong qu
trnh sn xut IPC (Integrated Process Control).
H s gc (master record): mt ti liu hay b ti liu dng lm I bn gc
cho h s l (h s l trng).

Phc hi (recovery): vic a mt phn hay ton b l sn xut trc

c cht lng t quy nh.
Ch bin li (reprocessing): ua mt phn hay ton b l/m thuc ang
trong qu trnh sn xut, sn phm trung gian, bn thnh phm ca mt
l/m n l tr li buc sn xut trc trong qu trnh sn xut c
thm nh o khng p ng c tiu chun cht lng.
Ti ch (reworking): sn xut li mt sn phm ang bo ch, Sn phm
trung gian, bn thnh phm ca mt l/m n l khng t tiu chun
cht lng theo mt qu trnh sn xut khc.
- Nguyn liu bao gi (packaging material): nguyn vt liu, k c vt
liu c in n, s dng trong ng gi dc phm, tr ng gi bn ngoi
vn chuyn. Nguyn liu bao gi c gi l bao b s cp hay bao b
th cp tu thuc vo bao b c tip xc trc tip vi sn phm hay
khng.

- Tiu chun (specification): cc ch tiu c th quy nh v cht lng

cho nguyn liu, bn thnh phm hay thnh phm. Tiu chun c ng
lm c s nh gi cht lng sn phm.
- Giy php lu hnh., giy php sn phm, giy chng nhn ng k
(marketing authorization, product licence, registration certifcate): ti liu
php l do c quan qun l dc phm quc gia c thm quyn cp,
trong xc nh thnh phn hoc cng thc ca sn phm, tiu chun
cht lng nguyn liu ban u, quy cch ng gi, nhn v iu kin
bo qun sn phm.
Quy trnh thao tc chun (Standard operating procedure - SOP): mt quy
trnh bng vn bn v c ph duyt, a ra ch dn thc hin cc
thao tc, v d: vn hnh, bo dng v lm v sinh my, thm nh, v
sinh nh xng v kim sot mi trng, ly mu v thanh tra. Mt s
SOP c th c s dng b sung cho h s sn phm v h s sn
xut gc cho mt sn phm c th.

- Tp nhim (contamination): s nhim khng mong mun cc tp cht

c bn cht ho hc hoc vi sinh, tiu phn l vo nguyn liu ban u
hoc sn phm trung gian trong qu trnh sn xut, ly mu, ng gi,
bo qun, vn chuyn.
- Sn xut (manufacture): ton b cc hot ng t khi mua nguyn liu
v sn xut kim tra cht lng, xut xng, bo qun, phn phi thnh
phm v cc bin php c lin quan khc.
Nh sn xut (mamtfacturer): mt cng ty thc hin cc hot ng nh:
sn xut ng gi, ng gi li, dn nhn v dn nhn li dc phm.
Kim tra cht lng (quality control - QC): tt c mi bin php
kim a c p dng trong sut thi gian sn xut m bo lng
sn phm lun lun m bo tiu chun quy nh v nh tnh, nng
, hm lng, tinh khit v cc c tnh khc
m bo cht lng (quality assurance - QA): l mt khi nim rng,
bao trm tt c nhng vn c nh hng chung hoc ring bit ti
cht lng mt sn phm.

Bit tr (quarantine): nguyn liu ban u, bao b, sn phm n trung gian

hoc thnh phm c ring bit trong mt khu vc cch ly hoc bin
php thch hp ch: kim nghim, tin hnh mt cng on khc
trong qu trnh sn xut xut xng, ti ch hay ioi b.
Nguyn liu ban u starng materia): bao gm hot cht (active
ingredient) v t dc (excipient) khng phi l nguyn liu bao gi
dng cho sn xut thuc.
Sn phm trung gian (intermediate product): sn phm ang trong gia
on sn xut, cha hon chinh.
Thnh phm (finished product): sn phm hon thin, k c ng gi
vo bao b cui cng v dn nhn.
Thm nh (validation): phng php thch hp chng minh rng
nguyn liu, cng thc bo ch, quy trnh sn xut, quy trnh thao tc
chun, nh xng, thit b, h thng h tr uc s dng trong qu trnh
sn xut v km tra cht lng lun lun t c kt qu mong mun.

2. m bo cht lng
2.1, H thng m bo cht lng
H thng m bo cht lng ph hp cho sn xut dc phm phi t
c nhng ni dung c bn sau:
Sn phm c thit k v a vo sn xut phi p ng c nhng
yu cu ca GMP v nguyn tc c lin quan nh: Thc hnh tt phng
th nghim - GLP, Thc hnh tt th lm sng - GCP.
Cc thao tc trong qu trnh sn xut v kim tra cht lng c ghi r
rng bng vn bn, theo ng quy nh ca GMP.
Trch nhim qun l c nu r trong bn m t cng vic ca c nhn.
S dng ng nguyn liu ban u v bao b ghi trong cng thc gc
trong qu trnh sn xut.
Thc hin y cc bc kim tra nguyn liu ban u, sn phm trung
gian, bn thnh phm, thnh phm cng nh kim tra trong qu trnh sn
xut (IPC), thm nh chun ho.
Cn thc hin vic nh gi thng xuyn i vi cht lng dc phm
nhm chng minh n nh ca quy trnh sn xut.

2.2. Trch nhim cua nh sn xut v h thng cht lng

Nh sn xut phi chu trch nhim v cht lng sn phm, theo ng
quy nh trong giy php lu hnh, nhm mc ch cung cp cho ngi
s dng nhng ch phm m bo cht lng, an ton v hiu qu
t c mc tiu v cht lng mt cch ng tin cy, cn c mt h
thng m bo cht lng c thit k ton din v trin khai, p dng
nghim tc trong kt hp cht ch gia Thc hnh tt sn xut GMP v kim tra cht lng - QC
H thng cht lng phi c lu gi h s y v theo di v hiu
qu hot ng.
Tt c cc b phn trong h thng m bo cht lng phi y nhn
vin c nng lc, nh xng, my mc - thit b v c s ph hp.

3. Nhn s
3.1. Quy nh chung
Phi s nhn vin cn thit trong sn xut v kim tra cht lng.
C bn m t cng vic c th cho tng nhn vin.
3.2 Hun luyn
Tt c nhn vin cn c hun luyn y , chi tit, cp nht v nng cao
kin thc chuyn mn. Trong gm:
Hun luyn chung v GMP: khi nim chung, m bo cht lng, nhn s, nh
xng, thit b, v sinh, sn xut, thm nh - chun ho, kim tra cht lng,
x l sn phm thu hi, khiu ni, t thanh tra v thanh tra cht lng, h thng
h s.
Hun luyn chuyn , v d: h thng cung cp v x l khng kh, qun l
cht lng, h thng m s - m vch, nghin cu n nh v tui th ca
thuc, thm nh quy trnh sn xut, thm nh phng php phn tch, sn xut
thuc beta-lactam, vin nn si bt vin tc dng ko di, thuc tim ng kh,
phng php thit k cng thc cc ng thuc, h thng ISO...
H s hun luyn:
+ Cng ty, x nghip: chng trnh, k hoch, ni dung, thi gian, ngi hun
luyn v kt qu.
+ C nhn: ni dung, thi gian, ngi hun luyn v kt qu.

3.3 Sc kho nhn vin

Kim a trc khi tuyn dng, nh k v sau khi ngh m au.
3.4. Nhn vin ch cht
Trng b phn sn xut
Trng b phn kim tra cht lng
Ngi c u quyn
c o to bi cc chuyn ngnh: ho hc (hu c, phn tch) hoc ho
sinh, cng ngh ho hc, vi sinh, dc l - c cht, sinh l hc hoc cc
ngnh khoa hc khc.
Trch nhim v quan h gia hai b phn sn xut v kim tra cht lng
Hot ng c lp nhng quan h mt thit, hp tc, tng tr.
Mt s trch nhim chung:
Ph duyt cc quy trnh thao tc chun (SOP).
Theo di v kim sot mi trng sn xut, v sinh.
Thm nh, chun ho.
o to, lu tr h s.
Ph duyt v theo di nh cung cp nguyn liu, nh sn xut theo hp
ng...

4. Nh xng
4.1. Quy nh chung
Xung, y truyn, nh my sn xut dc phm phi c xy dng khu
vc sao cho hn ch ti thiu hoc trnh c:
+ nhim do mi trng xung quanh, v d: bnh vin, nh my khc...
+ Nhim cho
+ L lt
+ Gy nhim, nh hng ti mi trng xung quanh.
Xng, dy truyn, nh my sn xut c phm c thit k sao cho:
+ Thun tin cho sn xut: b tr dy truyn hp l, cp sch tu theo tng
khu vc ph thuc vo loi ch phm sn xut v cng ngh.
+ Thun tin cho qu trnh vn chuyn nguyn liu v li i ca nhn vin
cng nh khch thm quan, khi kim tra khng nh hng ti sn xut.
+ Hp l cho lp t thit b.
+ Thun tin cho qu trnh bo tr, sa cha
+ D dng lm v sinh.
+ Lp t h thng ng ng ng quy nh
+ Phi c cc khu vc ring cho sn xut nh: tip nhn, bit tr, bo qun
nguyn liu, cn v cp pht, pha ch, bo qun bn thnh phm, ng gi, bit
tr v bo qun thnh phm.

+ Phi c cc khu vc ring dng : tho d bao b nguyn liu, ng thng

xut kho, ly mu, ra dng c, thit b, kim tra trong qu trnh sn xut
(IPC), ti ch sn phm, phng thay qun;! o v khun...
+ Phi c cc khu vc ring dng sn xut: sn phm khng v khun, sn
phm v khun, ch phm cha dc cht nhm beta- lactam, c ngun gc
sinh hc...
+ Phi c cc khu vc ring tch bit vi khu vc sn xut dng cho nhn
vin nh: phng ngh, cng tin, phng thay qun o bnh thng, nh v
sinh, khu vc nui ng vt th nghim.

4.2 Xy dng
Anh sng, nhit , m v thng gi cn thit k, lp t sao cho ph hp
vi: sn xut, bo qun v vn hnh thit b.
H thng ng dn, thng kh, in... phi c lp t sao cho d dng lm v
sinh.
Cc sn phm c bit (P-lactam, c ngun gc sinh hc, hormon, thuc chng
ung th...): c sn xut trong khu vc bit p, c h thng x l khng kh
ring.
i vi cc cng on, thao tc trong sn xut sinh bi, cn phi c: h thng
ht v lc bi.
Ngn nga ti a nh hng xu ca mi trng bng cc bin php:
+ Chng m: sn mt ngoi tng bng sn chng m chng thm cho nn nh
bng vt liu thch hp, dng my ht m cc b cho cc phng cn m
thp...
+ Phng chng l, lt bng cch xy dng nh xng ni cao, c h thng
thot nc tt.
Phng chng cn trng, chut b..
H thng chng t nhp. H thng bo chy v cha chy.
Cn c ca thot him ph hp vi tng khu vc ring.
Ngn cch khu vc c cp sch khc nhau bng cc cht gi.

4.3. Vt tiu
GMP-WHO khng quy nh c th, nhng cn tun theo mt s yu
cu:
Vt liu dng xy dng sn, trn v tng cn phi: rn chc, khng
thm, khng xp, chu c ma st o lm v sinh.
Mt trong ca sn, trn v tng cn phi: nhn, khng nt n, khng
c k h, nhng ch tip gp phi c hn kn, khng bong lc sn,
d dng lm v sinh.
C th s dng mt s vt liu sau:
Sn:
B tng trng xi mng: gi thnh r, tuy nhin kh lau chi ch tip
gip, khng chu c ho cht, khng p, nn dng cho nh kho.
- B tng c lt mt lp gch men: cng v bn, chu c ho cht,
t b mn, d sa cha, trn khi b m, thng ng cho rphng th
nghim.
- B tng lt mi: kh sa cha, chu ho cht c mc , hp ph
cc cht bn, thch hp cho khu vc sn xut thuc thng thng.

- B tng lt polyvinyl: chu ho cht c mc , d b try xc, kh nng

chu lc khng cao, thch hp cho vn phng, hnh lang v phng th
nghim.
- B tng trng epoxy (Polyurethan): cng, khng trn, t b nhim khun, d
b try xc, thch hp cho cc khu vc sn xut thuc v khun.
Tng:
- Tng bng gch hay tng, c sn chng thm: c th nt n nu xy
khng tt, c th sinh bi khi sa cha.
Vt liu m kim loi, nhm hoc thp khng r: khng bong lc, bn vng,
kh sa cha khi cn thit, gi thnh cao.
Trn, trn cng tc:
Trn b tng: chu lc tt, d i li sa cha, thit k phi chnh xc, thch
hp cho phng pha ch thuc v khun...
Trn cng tc: cn c khung chu lc, khng thch hp cho phng v khun.
Hin nay, mt s c s s dng panen ch sn c kh nng chu lc tt,
chng chy xy dng nh xng. u im l xy dng nhanh, p.
Nhc im: gi thnh kh cao.

Thit b, my dng cho sn xut v kim tra cht ng

Yu cu chung v thit k, ch to
Phi d dng khi c ra, v sinh.
Khng c dng vt liu amian (lc, ng gi...).
Cc cht bi trn khng c tip xc vi sn phm.
Vt liu lc khng c nh si vo dung ch.
Hiu nng phi ng nht.
B mt tip xc: khng phn ng, khng hp ph cc thnh phn trong dng
thuc.
C th tit khun c i vi cc ch phm v khun.
Lp t
B tr c trt t trnh nhim, nhm ln, nn s dng thit b kn.
Vi thit b hng, cn a ra khi khu vc sn xut kim a cht lng.
Nu cha hoc khng chuyn c, cn dn nhn ghi r my hng phng
v s dng trong qu trnh sn xut v kim tra cht lng.
Vi thit b khng i chuyn, phi c nh vi sn.
Bin php an ton
Thit b lm vic vi vt liu d chy n phi c b phn chng n.
Thit b sinh tnh in hay thng cha dung mi d chy phi c dy ni t.

4.5 S dng
Trong khi vn hnh phi c nhn ghi r tn sn phm ang sn
xut, s l.
c dn nhn lm v sinh sau khi sn xut.
5.5. Ti liu
- Phi c y cc quy trnh thao tc chun (SOP) v lp t,
vn hnh, thm nh, chun ho, v sinh, bo dng, sa cha.
L lch thit b
S tay s dng
Hng n an ton lao ng
6. Bin php v sinh v tiu chun v sinh
6.1 Mc tiu
Hn ch ti mc thp nht nhim, nhim cho cho sn phm,
nhm sn xut c sn phm t 3 yu cu: tinh khit, an ton,
hiu qu.

6.2 Quy nh chung

iu kin v sinh:
S dng cc cht ty ra v ty u thch hp, c tiu chun.
Trnh dng kh nn, bn chi v chi lm v sinh nh xng, thit b.
Nc dng trng thit b v thng cha: nc kh khong cho cc sn phm
khng v khun nh thuc ung, thuc vin... Nc ct pha tim cho sn phm
v khun nh thuc tim, thuc tim truyn, thuc nh mt...
Tin hnh v sinh nh xng, thit b, con ngi phi theo cc SOP c
thm inh trc khi ban hnh v ti thm nh. Sau khi lm v sinh phi ghi y
trong h s l sn xut.
V sinh c nhn:
Yu cu v sc kho: nhn vin tham gia sn xut phi c khm sc kho
nh k. Sau khi ngh m, au phi khm li. Ngi mc cc bnh truyn nhim,
bnh ngoi da, vt thng h khng c vo khu vc sn xut.
Thi quen v sinh: cm khng c n, ung, nhai ko cao su ht thuc, chi
tc... trong khu vc sn xut. Phi ra tay sau khi i v sinh, trc khi vo khu
vc sn xut v sau khi cm vt liu.
Quy trnh thao tc chun v sinh c nhn, v d: thay trang phc, giy dp, ra
tay...) c p dng vi tt c cc i tng l nhn vin sn xut, nhn vin k
thut, hp ng, khch thm quan, cn b thanh tra v qun l.

Trang phc cho nhn vin lm vic cc cp sch khc nhau:

Mc D: tc, ru cn che kn bng khn hoc m. Qun o bo h chung.
Mc C: tc, ru cn che kn. Qun o 1 hoc 2 mnh, tay o di, ci kn, c cao.
Giy hoc ng ph hp. Trang phc khng gy nhim bi.
Mc B: tc, ru cn che kn. i khn chm u, gp np vo trong c o. eo
mt n trnh nhim do nc bt. Gng tay cao su v khun, khng xoa bt.
i giy v khun ng qun b vo trong giy, ng tay o b vo trong gng. Mt
n, gng tay phi c thay sau mi ca lm vic.
Mc A: nh mc B. Ngoi ra, khng c cm cc vt dng,ngoi khu vc ny.
V sinh nh xng:
Trong cc phng sn xut thuc v khun, ni chung khng nn t bn ra
troh nhim. Trng hp c bit phi cung cp nc sch ra (t tiu
chun nc ung).
Khng cc loi thuc dit cn trng, chut b trong khu vc sn xut trnh
nhim nguyn liu, thit b, sn phm trung gian v thnh phm.
GMP-WHO quy nh: khng nn dng n t ngoai thay th cho phng php
kh khun bng ho cht do hiu qu st khun km.
Nhm m bo mc sch cho cc khu vc sn xut v kim tra cht lng,
GMP-WHO quy nh v mc nhim tiu phn trong khng kh (bng 17.1) v
gii hn mc nhim vi sinh vt (bng 17-2).

V sinh thit b:
Sau khi lm v sinh theo cc SOP, phi c cn b kim tra, k
tn, ghi h s v treo bin thit b lm sch.
Khi lm v sinh, nn s dng my ht bi v khn t trnh
gy nhim.
Cn c mt khu vc ring trong dy chuyn sn xut lm v
sinh i vi cc thit b c th tho ri hoc di chuyn c.
Ch : Khch thm quan, nhn vin cha qua o to v GMP
tt nht l khng nn cho vo khu vc sn xut v kim tra cht
lng. Trng hp bt buc phi cho vo, cn trang b qun o,
m, khu trang v phi gim st cht ch.

7. Thm nh (validation)
7.1 Khi nim
Thm nh l phng php thch hp chng minh rng nguyn liu, cng
thc bo ch, quy trnh sn xut, quy trnh thao tc chun, nh xng, thit b,
h thng h tr c s dng ttong qu trnh sn xut v kim tra cht lng
lun lun t c kt qu.
7.2 Ni dung thm nh
Thm nh thit k hay DQ - design qualification: thm inh nh xng, khu
vc ph tr, trang thit b v quy trnh c c thit k theo ng yu cu ca
GMP hay khng.
Thm nh lp t hay IQ - installation qualification: thm nh nh xng, khu
vc ph tr v trang thit b c xy dng v lp t theo ng tiu chun
thit k ban u hay khng.
Thm nh vn hnh hay OQ - operatioia qualification: thm nh nh xng,
khu vc ph tr v trang thit b hot ng theo ng tiu chun thit k ban
u.
Thm nh hiu nng hay PQ - perfomance qualification: thm nh mt thit b
hoc mt quy trnh (sn xutt v sinh hay kim nghim) c p ng tiu chun
v c tnh cht lng nh do thit b hay quy trnh p ng hoc sn xut.

8. Sn xut
8.1 Nguyn tc
Mi thao tc trong qu trnh sn xut phi theo ng quy trnh nh, ng vi
giy php sn xut v lu hnh.
8.2 Quy nh chung
Vic x l nguyn vt liu v sn phm, v d nh tip nhn v bit tr, ly
mu, bo qun, dn nhn, cp pht, pha ch, ng gi v phn phi u phi
thc hin ng cc quy trnh thao tc chun.
Trnh thc hin sai lch so vi quy trnh thao tc chun. Nu c sai lch hoc
iu chnh, cn c vn bn ph duyt ca ngi c trch nhim, ca b phn
m bo cht lng.
-Khi sn xut cc sn phm khc nhau, khng nn tin hnh ng thi hoc lin
tip trong cng mt phng tr khi chng minh rng khng c kh nng nhm
ln v nhim cho.
-Trong sut qu trnh sn xut, tt c nguyn liu, bao b ng bn thnh phm,
my mc, thit b chnh u phi n nhn ghi r tn sn phm, s l. Trong
mt s trng hp, cn ghi li tn ca sn phm sn xut trc .
- Vic ra, vo xng sn xut nn hn ch, ch c nhn vin c thm quyn mi
c ra vo.
Nhng sn phm khng phi thuc khng c sn xut cng khu vc hoc
trn cng my mc, thit b dng sn xut dc phm.

 phng nhim cho v nhim khun trong qu trnh sn xut

Ch khi thao tc vi nguyn vt liu, sn phm kh v c kh nng to
thnh v pht tn bi. Cn c thit b v bin php kim sot khng kh thch
hp.
Hn ch ti a kh nng nhim v nhim cho nguyn liu, bn thnh phm,
thnh phm trong qu trnh sn xut do con ngi mi trng, thit b. c
bit ch khi sn xut cc ch phm v khun, ch phm c ngun gc sinh
hc, nguyn liu c hi, cht c t bo...
Trnh nhim cho bng mt s bin php nh:
+Sn xut tng sn phm, thc hin cc cng on trong khu vc ring, khp
ki v ring bit nu cn. V d: ch phm beta-lactam, vaccin, sinh phm...
+ Tin hnh sn xut tng loi sn phm theo chin dch, sau lm v sinh
ty u nh xng.
+ Lp t cht gi ph hp, chnh lch p sut, h thng cp v thi khng
kh.
+ Hn ch ti a nguy c tp nhim do ti tun hon khng kh khng qua x
l.

9. Kim tra cht lng

9.1 Vai tr
Kim tra cht lng l mt phn ca GMP, lin quan ti ly mu, xy dng
v thm nh tiu chun v phng php kim nghim nguyn liu, bn
thnh phm, thnh phm. Kim tta cht lng khng ch gii hn trong
phng th nghim m bao gm tt c nhng vn lin quan ti cht lng
sn phm.
9.2 Nhng yu cu c bn
Kim tra cht lng phi c lp vi sn xut.
C s dng kim tra cht lng phi t cc nguyn tc Thc hnh tt
phng th nghim - GLP).
9.3. Ni dung chnh
Kim tra nguyn liu ban u, sn phm trung gian, bn thnh phm v thnh
phm.
Xem xt h s l sn xut.
Nghin cu n nh ca bn thnh phm, thnh phm, sn phm pha li
(hn dch, bt pha tim...) v c nguyn liu khi cn thit

10. T thanh tra

10.1 Nguyn tc
Mc ch ca t thanh tra l nh gi vic chp hnh ca nh
sn xut theo nguyn tc GMP trong mi lnh vc sn xut v
kim tra cht lng.
10.2. Ni dung
C s sn xut cn t ra chng trnh t thanh tra theo nguyn
tc GMP nhng vn sau: nhn s, nh xng, bo dng nh
xng thit b, bo qun nguyn liu ban u v thnh phm,
my mc thit b dng trong sn xut v kim tra cht lng, sn
xut v kim tra trong qu trnh sn xut, kim tra cht ing, h
s ti liu, v sinh, chng trnh thm nh, chun ho thit b,
quy trnh thu hi sn phm, x l khiu ni, kim sot nhn, bin
php khc phc ln t thanh tra trc.

11. Khiu ni
11.1 Nguyn tc
Tt c khiu ni v cc thng tin khc Hn quan n sn phm c
kh nng b sai, hng u c xem xt theo cc quy trnh thao
tc chun v phi c bin php khc phc.
11.2 Thc hin
Cn c cn b chu trch nhim x l khiu ni v quyt nh bin
php x l
C y quy trnh thao tc chun v bin php x l khiu ni,
thu hi sn phm.
Ch trng c bit ti sn phm khiu ni b gi mo.
Thit lp y h s v sn phm khiu ni.
Tin hnh thu hi sn phm nu cn.
Thng bo cho c quan qun l bit bin php x l cc trng
hp do li ca nh sn xut, sn phm km phm cht hoc b lm
gi.

12. Thu hi sn phm

12.1 Nguyn tc
Cn c mt h thng thu hi nhanh chng v c hiu qu sn
phm c bit hoc nghi ng c sai, hng trn th trng.
12.2. Thc hin
Cn c cn b chu trch nhim thu hi sn phm.
C quy trnh thao tc chun v bin php, bo qun sn
phm thu hi.
Thit lp y h s v sn phm thu hi.
Thng bo cho c quan qun l tt c mi ni phn phi
sn phm bit v d nh thu hi sn phm.

13. Sn xut v kim nghim theo hp ng

13.1 Nguyn tc
Vic sn xut v kim nghim theo hp ng cn c xc nh r
rng, c thng nht v c kim sot.
13.2 Quy nh chung
Tt c k hoch sn xut v kim nghim theo hp ng u phi
theo ng giy php lu hnh ca sn phm.
Hp ng phi cho php bn hp ng c kim tra c s sn xut
ca bn nhn hp ng.
13.3 Bn hp ng
Chu trch nhim nh gi nng lc ca bn nhn hp ng, c bit
l vic thc hin ng nguyn tc GMP.
Cung cp cho bn nhn hp ng tt c thng tin cn thit lin quan
ti sn xut v kim tra cht lng sn phm.

13.4 Bn nhn hp ng
C iu kin sn xut v kim tra cht lng sn phm, c
giy php sn xut.
Khng c chuyn cho bn th ba cng vic nhn khi cha
c bn hp ng nh gi v cho php.
13.5 Bn hp ng
Cn xy dng bn hp ng gia bn hp ng v bn nhn
hp ng, trong nu r trch nhim ca mi bn.
Ni dung k thut ca hp ng phi c son tho bi nhng
ngi c thm quyn, nm vng kin thc v cng ngh dc,
kim nghim dc phm v GMP.
-H s sn xut v kim nghim theo hp ng phi c thit
lp, bo qun theo ng quy nh ca GMP.

14. H s, ti liu
14.1. Nguyn tc
H s ti liu l mt phn thit yu ca h thng m bo cht
lng v v vy cn phi thit lp cho mi vn c lin quan
ti GMP.
14.2 Mc ch
Xc nh cc tiu chun v quy trnh thao tc chun cho tt c
nguyn vt liu phng php sn xut cng nh kim tra cht
lng. H s ti liu m bo cho ton th nhn vin c lin
quan ti sn xut v kim a cht lng hiu bit ni dung,
cng vic cn thao tc, hnh ng. Cng c th dng a cu
lch s ca sn xut hoc nghin cu s liu, nhm hon thin
sn phm. i khi dng cung cp thng tin cho c quan iu
tra hoc c quan qun l.

14.3 Quy nh chung

H s ti liu cn c xy dng, son tho, r sot v phn pht
mt cch thn trng. Cn tun theo nhng ni ung ghi trong giy
php sn xut v lu hnh.
Phi c ngi c thm quyn ph duyt, k v ghi ngy thng.
Ni ung r rng, trnh by c trt t, d hiu, d thc hin.
Thng xuyn r sot, cp nht.
S liu v h s cn lu gi c th c ghi li bng h thng x
l s liu in t hoc cc phng tin ng tin cy khc. H s
lu trong my tnh phi c bo mt v bo v bng cch sao li
sang bng, a t, vi phim hoc in ra giy.

14.4 Cc loi h s ti liu

Nhn: nguyn liu, thit b, bao b, bn thnh phm, thnh
phm, ho cht cht chun, thuc th dng cho sn xut v kim
tra cht lng.
Tiu chun v quy trnh kim nghim.
Tiu chun nguyn liu ban u v bao b.
Tiu chun sn phm trung gian v bn thnh phm.
Tiu chun thnh phm.
Cng thc gc.
Hng dn ng gi.
H s pha ch l.
H s ng gi l.
Cc quy trnh thao tc chun (SOP) dng trong sn xut v kim
tra cht lng.

Ph lc 1
NI DUNG THC HNH TT PHNG TH NGHIM (GOOD
LABORATORY PRACTICE - GLP)
1. T chc nhn s v o to
- Tng t nh GMP: hun luyn, s lng v cht lng, chc nng nhim v.
2. H thng cht lng
- Chnh sch cht lng.
- S tay cht lng.
- Ngi chuyn trch v cht lng.
3. C s vt cht, mi trng
- Din tch ph hp.
- C cc phng kim nghim ring bit: ho hc, phn tch dng c, vi sinh...
- H thng cung cp kh cho tng khu vc, kh lc sch cho phng kim nghim
vi sinh.
- H thng x l cht thi rn, lng, kh.
- Cc khu vc bo qun ng mi, ho cht.
- Phng lu mu ng cc iu kin quy nh.
- Thit k chng nh hng ti kt qu ca cc php o (nh: nhit , m,
khng kh, rungrnhiu t, bi...). - Sp xp gn gng, ngn np, v sinh.

4. Thit b
- Ph hp vi ni dung chuyn mn.
- Thm nh, chun ho (chng trnh, quy trnh).
- H s, ti liu thit b.
- Nhn cho thit b.
X l, loi b, ring thit b hng, khng t tiu chun.
5. Thuc th v cht chun, chng v sinh vt v sc vt th
- Tiu chun ca thuc th v cht chun, chng vi sinh vt v sc vt th.
- Ghi v lu h s khi pha thuc th v nhn cht chun.
- Ghi nhn ng cho thuc th sau khi pha.
- Theo di nhit khi cn bo qun lnh mt s ho cht v thuc th.
- Kim tra nh k cc dung dch chun v dung dch ion gc.
- Kim tra nh k nc kh khong, nc ct dng cho phng th nghim.
- Pht hnh cht chun theo nguyn tc ng gi cho mt ln s dng.
- Thc n cho sc vt th nghim phi tiu chun ho...
6. Tiu chun cht lng v phng php phn tch
- Tiu chun cht lng phi c ban hnh chnh thc bng vn bn, ng
vi h s ng k vi B Y t.
- H s thm nh tiu chun cht lng (TCCL).

7. Mu th
- Quy trnh ly mu, x l mu v bo qun mu.
- Ly mu khng c gy nhim hoc lm thay i tnh cht ca
nguyn liu, thnh phm. - H s mu th.
8. Th Dghm v nh gi kt qu phn tch
- Tin hnh phn tch ngay sau khi ly mu.
- Kt qu inh ng c ly trung bnh sau t nht 2 ln tin
hnh.
- Thay i kim nghim vin khi kt qu khng t.
- H s.
9. H s, ti liu
- Thit b. - Quy trnh thao tc chun (SOP).
- S tay kim nghim vin ng quy nh.
- H s kim nghim l, m phi c ng ring v bo qun
ng ch .
- Lu tr h s ng thi gian quy nh.

10. Theo di tui th

- C quy trnh theo di tui th trong iu kin bnh thng.
-C quy trnh theo di tui th trong iu kin lo ho cp tc
(cng bc).
-Phng tin, trang thit b dng thao di tui th thuc.
11. An ton phng th nghim
- Cc quy nh chung v an ton.
- Trang thit b, bo h lao ng trong phng th nghim.
- Hun luyn nhn vin v an toan lao ng.
- H thng x l cht thi (rn, lng, kh).
- Thm nh thng k h thng x l cht thi.
12. T thanh tra
- Quy trnh t thanh tra v nh k.
- K hoch v bin php khc phc sau khi t thanh a.

Ph lc 2
NI DUNG THC HNH TT BO QUN THUC
(GOOD SORAGE PRACTtCE - GSP)
1. T chc nhn s v o to
Tng t nh GMP: hun luyn, s lng v cht lng, chc nng, nhim
v...Th kho thuc c, thuc gy nghin v thuc hng thn phi l DSH.
2. Nh kho v trang thit b
V tr xy dng: m bo phng chng l, lt, ngp nc, m t.
Thun tin cho cng vic xut, nhp, vn chuyn v bo v.
Din tch hp l, c cc khu vc ring ph hp vi mc tiu bo qun.
B tr ng i cho nguyn liu hp l, c ca thot him, h thng bo chy
v phng, cha chy, chng n.
H thng trao i, iu ho khng kh, thng thong trong kho.
Nn: chng m, chng thm, chu lc, phng, nhn.
nh sng: y , ph hp vi tng khu vc.
Kho c trang b ph hp vi yu cu bo qun c bit nh: mt, lnh, ng
lnh, trnh nh sng, chng m, cht c, cht c hot tnh cao, cht nguy
him... C khu vc ly mu, cp pht ring trnh nhim, nhim cho.

3. V sinh
- Quy trnh, bin php v sinh.
- Quy trnh th gom v x l cht thi.
- Bin php, qu trnh dit tr cn trng, chut b trong kho.
- Kim a sc kho nh k cho nhn vin.
- Ni ra tay cho nhn vin, mang gng tay khi tip xc vi
nguyn liu.
4. Cc quy trnh bo qun
- Nguyn tc nhp trc, xut trc (FIFO: First in - first out).
- Bit tr, nguyn liu khng t tiu chun phi loi b.
- nh gi nh k cht lng hng ho.
- H thng quy trnh thao tc chun (SOP), h s, s sch.
- Nhn, bao b ng, m bo cht lng.
- Ni ly mu, cp pht v cc quy trnh thao tc chun (SOP).

5. Hng tr li
- C khu vc bo qun ring.
- nh gi li cht lng.
6. Xut kho
- m bo cc iu kin bo qun nguyn liu, thnh phm
trong qu trnh vn chuyn (nhit , m, nh sng...)
- Ti liu, h s km theo.
7. H thng h s, ti liu
- Cc quy trinh thao tc chun (SOP) c vit bng vn bn,
c xt duyt.
- H thng s sch, th kho theo di nhp., xut hng.
- H s nhp, xut thuc c, nghin, hng thn.
- Bin php an ton lao ng.