Bao Che 1 On Thi Tot Nghiep 2013 PDF

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Tng hp l thuyt Bo ch I _ n thi TN 2013
MC LC
CHNG I: I CNG V BO CH & SINH DC HC ------------------------------ 3

BI 1: I CNG BO CH HC --------------------------------------------------------------------------- 3
BI 2: SINH DC HC------------------------------------------------------------------------------------------ 4
1. KHI NIM SINH KH DNG (Bioability) --------------------------------------------------------------- 4
2. CC KHI NIM TNG NG ------------------------------------------------------------------------ 4
3. TH NNG THUC TRONG MU THEO THI GIAN---------------------------------------- 5
CHNG II: DUNG DCH THUC ----------------------------------------------------------------- 6

BI 1: I CNG V HA TAN & K THUT HA TAN HON TON ------------------------- 6
1. CC KHI NIM ----------------------------------------------------------------------------------------------- 6
2. TNG TC DUNG MI CHT TAN ------------------------------------------------------------------- 7
2.1. c tnh dung mi ------------------------------------------------------------------------------------------ 7
2.2. Tng tc dung mi cht tan ---------------------------------------------------------------------------- 7
3. TAN ---------------------------------------------------------------------------------------------------------- 8
4. TC HA TAN--------------------------------------------------------------------------------------------- 9
5. CC PHNG PHP HA TAN C BIT -------------------------------------------------------------10
BI 2: K THUT LC ------------------------------------------------------------------------------------------ 11
BI 6: NC THM ---------------------------------------------------------------------------------------------- 11
BI 3: DUNG DCH THUC UNG V THUC DNG NGOI --------------------------------------12
BI 4: SIRO THUC ---------------------------------------------------------------------------------------------- 16
1. SIRO N-------------------------------------------------------------------------------------------------------16
2. SIRO THUC ---------------------------------------------------------------------------------------------------17
CHNG III: THUC TIM------------------------------------------------------------------------ 18

1. I CNG THUC TIM ---------------------------------------------------------------------------------18
2. YU CU CHT LNG -----------------------------------------------------------------------------------19
3. CC THNH PHN CA THUC TIM -----------------------------------------------------------------21
4. QUI TRINH BO CH THUC TIM ---------------------------------------------------------------------23
4.1. Thuc tim dung dch -------------------------------------------------------------------------------------23
4.2. Thuc tim hn dch -------------------------------------------------------------------------------------- 25
4.3. Thuc tim nh tng ------------------------------------------------------------------------------------ 26
4.4. Thuc tim truyn -----------------------------------------------------------------------------------------27
5. XNG SN XUT, PHNG PHA CH THUC TIM ----------------------------------------------28
5.1. Khng kh trong xng sn xut thuc tim -----------------------------------------------------------28
5.2. S b tr mt bng trong sn xut thuc tim (dng lng) ---------------------------------------- 28
6. BAO B NG THUC TIM ------------------------------------------------------------------------------29
7. CC PHNG PHP TIT KHUN ---------------------------------------------------------------------- 29
7.1. Cc nh ngha v phm vi p dng ---------------------------------------------------------------------29
7.2. Phn loi cc pp tit trng -------------------------------------------------------------------------------- 29
1
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Son: T oan _ D08
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CHNG IV: THUC NH MT------------------------------------------------------------------ 30

1. YU CU CHT LNG THUC NH MT ---------------------------------------------------------- 30
CHNG 5: CC DNG THUC BO CH BNG PP HTCX----------------------------- 32

BI 1: I CNG HTCX -------------------------------------------------------------------------------------- 32
BI 2: CC PHNG PHP HTCX ---------------------------------------------------------------------------35
1. CC PHNG PHP NGM -------------------------------------------------------------------------------35
2. CC PHNG PHP NGM KIT NGM NH GIT (Percolatio) ------------------------------37
2.1. Ngm kit c in -----------------------------------------------------------------------------------------37
2.2. Cc phng php ngm kit ci tin --------------------------------------------------------------------39
BAI 4: CAO THUC & DCH CHIT M C ---------------------------------------------------------- 40
1.TNG QUAN CAO THUC & DCH CHIT M C ----------------------------------------------- 40
CC GIAI ON IU CH CAO THUC -----------------------------------------------------------------41
BI 5: CN THUC RU THUC -----------------------------------------------------------------------42
1. CN THUC --------------------------------------------------------------------------------------------------- 42
2. RU THUC -------------------------------------------------------------------------------------------------43
Son: T oan _ D08
BI 1: I CNG BO CH HC
Tm tt qu trnh nghin cu v sn xut mt thuc mi
Nghie n cu
S qu
trnh
nghin cu
Thuoc chuan goc
Mc ch ca
giai on
Th nghie m nghin cu?
la m sa ng
Tm ra 1 cng thc bo ch tt
nht, t i n bo ch mt
l thuc chun gc (prototype)
tht xc nh th lm sng.
Nu t kt qu tt s tin hnh
lm h s ng k sn xut
thuc.
Ho s a ng k
Sa n xuat
Mc ch ca
giai on sn
xut?
Sn xut ra quy m cng

nghip cc thuc c cht lng
ging y nh cht lng ca l
thuc chun gc dng th
lm sng v ng k thuc.
- Xy dng tiu chun cht
lng ca sn phm m mnh s
ng k.
Vai tr ca
GMP &
mi quan
h gia giai
on
nghin cu
v giai on
sn xut
Mc ch ca
GMP?
TIU CHUN
(nghin cu)
- Sn xut l thuc c cht

lng ph hp vi cht lng
lc ng k
CNG THC H S
- Xy dng cng thc v lm h

s ng k thuc
S PH HP V
CHT LNG
(Sn xut)
GMP hnh
lm?
Th no l
thuc c cht
lng xc
nh?
- ngha: GMP gii quyt vn

N NH (sn xut n nh
so vi tiu chun ng k)
- Ging vi cht lng ng k.

- Ging nhau trong cng l.
- Ging nhau gia l vi l.
Son: T oan _ D08
BI 2: SINH DC HC
1. KHI NIM SINH KH DNG (Bioability)
nh ngha
SKD ca thuc l c tnh ca dng thuc phn nh tc v mc m thnh phn c hot tnh
hoc nhm hot tnh sn sng ni tc ng.
Liu kh
dng?
L phn liu thuc c hp thu nguyn vn
Cc thng
s DH xc
nh SKD
ca thuc
Phn loi
Tng ng thi im c s hp thu v thi tr tng ng

Phn nh tc v mc hp thu
nh gi cng tc ng
AUC: Din tch di ng cong Phn nh mc hp thu
tmax: Th.gian n thuc t ti a
Phn nh tc hp thu
N L t l thuc nguyn vn so vi liu dng c hp thu.
F: SKD tuyt i (%)
(
)
(AUCT)abs , (AUCT)IV: Din tch di ng cong
=
(
)
SKD
ton th ca dng th, dng IV
tuyt i
CT Nu dng khc liu:
DIV, Dabs: Liu ca dng IV & dng th
(
)
c s dng t mt ng hp thu
=
khc.
(
)
Khi dc cht khng th s/d ng IV, ta dng SKD tng i
L t l gia dng th so vi dng chun thng l 1 dd nc c bit l hp
N thu tt hoc so vi mt ch phm thng mi (trng hp SKD so snh) c hiu
qu lm sng tt c tn nhim.
F: SKD tng i (%)
SKD
(
)
(AUCT)test , (AUCT)standard Din tch di
tng i
=
100
ng
cong ton th ca dng th, dng
(
)
(SKD so
lm
chun.
snh)
CT
Nu dng khc liu:
Dstandard, Dtest: Liu ca dng chun
(
)
& dng th
=
100
(
)
Cmax: N ti a ca thuc /ht
2. CC KHI NIM TNG NG

2 ch phm: Cng dng bo ch, hm lng, loi dc cht, ng s dng, c sx theo
GMp v t cc tiu chun cht lng qui nh; C th khc nhau v t dc, hnh dng,
tui th, c ch phng thch, nhn, ...
2 ch phm c gc hot tnh ging nhau, c th khc nhau :
Dng mui, ester, phc, ... Vd: tetracyclin clorhydrat, tetracyclin phosphate
Dng thuc. Vd: Vin nang, vin nn
Th phm bo ch
Hm lng. Vd: Vin paracetamol 325 v 500
H thng. Vd: Dng phng thch ko di & dng phng thch tc thi
2 ch phm (t dc phm / th phm bo ch) c SKD ging nhau. Nh vy l:
2 ch phm c t max, Cmax, AUC khng khc nhau c ngha thng k (mc khc bit c
T sinh hc
chp nhn khng qu 20%)
Hoc c mc hp thu (AUC, Cmax) khng khc nhau, s khc nhau v tmax do c .
Cc ch phm cha cng loi hot cht, cng hm lng, cho KQ tr liu v c p ph
tim n nh nhau theo iu kin c ghi trn nhn, c th khc nhau v mu, mi, hnh
T tr liu
dng, tui th, nhn, ...
** so snh tng ng tr liu, 2 ch phm phi tng ng sinh hc.
T dc phm
(T bo ch)
Thay th tr liu
Cc ch phm cha cc hot cht khc nhau c ch nh cho mc tiu tr liu v lm

sng ging nhau.
Vd: Ibuprofen v Aspirin (cng nhm dc l)
Son: T oan _ D08
3. TH NNG THUC TRONG MU THEO THI GIAN

Nng
(a)
MTC
Cmax
Khong tr liu
Cng tc ng
MEC
(b)
Khong tc ng
t1
tmax
t2
Thi gian (h)
o thi nong o thuoc trong ma u tie u bieu sau khi du ng 1 lieu thuoc duy nhat
(a) Trng hp tie m tnh ma ch
(b) Trng hp du ng thuoc t 1 ng hap thu
MEC (mininum effective concentration): Nng ti

thiu c hiu lc
MTC (mininum toxic concentration): Nng ti thiu
gy c
Khong tr liu (therapeutic range): Khong cch gia
MEC v MTC. Thuc c hiu qu tr liu v an ton khi
t nng trong khong ny.
Cng tc ng (intensity): Khong cch gia MEC

v Cmax
Khong tc ng t2 t1
t1: Lc bt u c tc dng tr liu
t1: Lc kt thc tc dng
tmax : Thi im t nng ti a
AUC: Din tch di ng cong, phn nh mc hp
thu dc cht.
Hnh lm GMP
Bi tp: tnh SKD tuyt i, SKD tng i (Xem sch trang 29)
Thuc v hiu cc nh ngha SKD, cc nh ngha tng ng.
V v gii thch c th nng theo thi gian
Son: T oan _ D08
BI 1: I CNG V HA TAN & K THUT HA TAN HON TON

Ni dung:
Cc khi nim
Tng tc dung mi cht tan
tan v cc yu t nh hng tan
Tc ha tan v cc yu t nh hng
Cc pp ha tan c bit
1. CC KHI NIM
N ha tan
N
Phn
loi
L qu trnh phn tn n mc phn t hoc ion cht tan trong dung mi to thnh
hn hp mt tng lng duy nht v ng nht gi l dung dch
L sn phm ca qt ha tan, l hn hp ng nht v l ha ca 2 hay nhiu thnh phn
hay ni cch khc l h phn tn mc phn t.
Dd tht
Nu cht b phn tn mc phn t hoc ion
Dd keo (dd gi)
Nu cht b phn tn l cht cao phn t hoc s ha tan to ra cc

micelle (tp hp phn t)
Lng cht tan c trong 100 phn dung dch.
Nng phn trm
Cch thng th thng dng:
Nng phn t
(mol/l)
Khi lng /th tch (g /100ml)

Th tch /th tch (ml /100ml)
=
S phn t cht tan trong 1 lt dd:
N ng lng l s ng lng gam cht tan trong 1 lt dd.
CT:
Dung
dch
.
.
= .
ng lng l g?
Nng
dd
ng lng gam l g?
- Khi lng tnh bng gam ca cht c th thay th hay phn
ng va vi 1g nguyn t hidro (H) hoc 1g nguyn t oxi (O).
Nng ng
lng (mEq/l; Eq/l)
- 1 mEq l lng tnh bng miligam tng ng vi trng lng

phn t hay trng lng ion chia n.
n c tnh ty theo bn cht ca phn ng ha h c
Phn ng
Tr s n
P acid
baz
S proton hot tnh

S proton hot tnh cn trung ha baz
P OXH-K
S electron cho / nhn trong qu trnh p
P ta &
phc cht
Nu l cation: n = S in tch cation

Nu l anion: n = S ng lng ca
cation tng ng to hoc phc cht.
Son: T oan _ D08
2. TNG TC DUNG MI CHT TAN

2.1. c tnh dung mi
Cu to ha
hc
Tnh cht
ca dm
Ph thuc
cc yu t
no?
Phn loi
dung mi
Da vo
tnh cht
cu to &
bn cht s
lk pht
Lc tng tc c th l:
Lc tnh in do pht lng cc: L lk mnh xy ra
khi trong oht c s pc. Vd: HCl, ...
Bn cht s
Lin kt do s phn cc cm ng: L lc lk yu xy ra
tng tc gia
gia cc pht ko pc
cc pht dm
Lc lin kt qua cu hydro: l lc hp dn xy ra gia
2 pht pc, 1 pht c hidro v pht kia c cc ngt nh
flo, oxy, nit
L dm hnh thnh t cc pht pc mnh & c cu ni
hydro
Dm phn cc
Vd: Nc, cn, ...
L dm hnh thnh t cc pht pc mnh nhng ko c cu
Dm bn phn
ni hydro.
cc
Vd: aceton, pentanol, ...
L dm hnh thnh t cc pht ko pc hoc pc yu.
Dm ko phn cc
Vd: benzen, du thc vt, du khong, ...
2.2. Tng tc dung mi cht tan

iu kin cn mt cht
tan c trong dm
Hin tng solvat ha
Lc tng tc dm-ct
Quy tc chung nhn

nh tnh ha tan ca cc
cht
Lc ht gia cc phn t dm-ct > lc ht gia cc pht cng loi (dm-dm, ctct)
L s tng tc gia cc pht hoc ion ct vi pht dm. (L hydrat
L g?
ha nu dm l nc)
To thnh nhng tp hp pht (solvat) trong cc ion hoc pht
Kt qu? ct c bao bc bi 1 lp v cc pht dm. Cc solcat to thnh s
khuch tn vo dm.
Lc tnh in: Do in tch ca cc pht hoc ion ct vi pht mang
in tch ca dm.
Hoc Tng tc qua cu ni hydro
- Cc cht c tnh cht tng t th tan nhau.
- Cu trc cng tng t s ha tan cng ln.
Dm ko pc ha tan c cc cht ko pc khc v cc cht ny cng c ni pht yu, lc
lk thng do s pc cm ng.
Dm ko pc khng th ha tan cc cht pc v dmkpc c hng s in mi nh, ko th
ph v lk ion hoc cng ha tr ca cht tan pc.
Son: T oan _ D08
3. TAN
TAN
L lng (s ml) dm ti thiu cn thit ha tan mt n v cht (1g) iu kin chun

(20oC, 1 atm)
Vd: Ghi tan ca NaCl trong nc l 1: 2,786 ngha l cn ti thiu 2,786 ml nc ha tan
hon ton 1g NaCl
CC YU T NH HNG N TAN:
Ghi nh
Vd
Chn dm ph hp
Bn cht ha
hc ca ct &
dm
Phng
Thay dc cht
php
bng dn cht d tan
Quinin clorhydrat quinin diclorhydrat c tan cao

hn.
Calcium gluconat calcium glucoheptonat
Camphor khng tan /nc Camphor sulfonat natri
tan /nc
Khi tng to, tan ca:
Nhit
Tng nhit c th lm cho

tan tng, gim hoc khng
i
Lu : 1 cht c tan tng

theo nhit th khi ngui s
ta tr li.
NaCl: Gn nh khng i
Calcium glycerophosphat: Gim (Tan trong 20
phn nc to thng nhng hon ton khng tan
trong nc si)
Na2SO4.10H2O: tng n 32,4oC ri gim v
dng hydrat chuyn thnh dng khan Na2SO4
(ng cong ca tan theo nhit khng
lin tc)
Alkaloid d tan trong nc acid

Quan trng khi s ha tan lin
quan n s ion ha.
Phenol d tan trong nc kim ha.

Cht lng tnh (protein, aa, ...) b ta pH ng in
pH
Cn cn nhc s hi ha gia:
pH bn Hot tnh
S a hnh
(Tnh cht kt
tinh)
Cu trc v nh hnh d tan

hn Dng kt tinh
Chloramphenicol: Pht huy tc dng / mt acid, /mt

kim tan nhng d b phn hy.
Calcium gluconat d tan /mt kim nhng dng thuc
tim ch cho php iu chnh n pH 8,3
Novobiocin, griseofulvin, cortison acetat,
chloramphenicol
Dang tinh th t n nh: d

tan hn
Cht trung gian lin kt ct & Natrisalicylat, natri benzoat: lm tan ca NaCl
dm Tng tan
Antipyrin, uretan: lm tan ca quinin /nc
S hin din
ca cht khc
NaCl: lm tan ca tinh du /nc
Hin tng ha mui

gim tan
ng: lm tan ca ether /nc.
Hn hp dung mi Tng
hoc gim tan
Son: T oan _ D08
4. TC HA TAN
Tc ha
tan
L tc ca dc cht i vo trong dung mi.
V: Tc ha tan (Khi V=0 ngha l tc

khng thay i)
Cng thc
biu th
tht
CT Noyes
v Whitney
S: Din tch tip xc gia cht lng & cht rn

CS: Nng bo ha ca cht tan
Ct: Nng ca dd thi gian t
K: Hng s tc ha tan
CT Nerst
Bruner
) D: H s khuch tn ca ct trong dm
h: B dy lp khuch tn
CC YU T NH HNG TC HA TAN
Lu
Din tch tip
xc
Nhit &
nht ca mt
phn tn
Nghin mn gim kch thc tiu phn

Tng din tch tip xc Tng V
Trong ha tan chit xut khng nghin

dc liu n mn
- Nhit tng nht gim gia

tng s khuch tn ca dc cht tng
V
- Nhit tng tan tng tng tm
thi hiu s (CS Ct)
Khuy trn ph v lp dd bo ha trn
b mt cht tan, i mi lp cht lng
mt phn gii rn lng tng tc
phn tn & ng nht ha dd tng ng
k tc ha tan.
Khuy trn
Mt s cht (Cht keo, hp cht cao phn

t) cng khuy trn li cng kh tan.
Trng hp ny dng phng php ha
tan per descensum.
Per descensum
Nguyn tc: Khuch tn t nhin t ni c nng cao n ni c nng thp m
khng cn s khuy trn.
Khi lp dm bao quanh b mt ct b bo ha s lng xung pha di (do c t trng
cao hn) ng thi y lp dm mi ln tip xc vi b mt ct, do pp ny cn c
tn gi l Ha tan t trn xung. Qu trnh c lin tc xy ra nn b mt ct lun
c xo trn , mc d khng c s khuy trn tc ng t bn ngoi.
tan
tan cng ln CS cng ln V cng

tng.
Coi chng nhm ln gia cc yu t nh hng n tan v tc ha tan. V d Thy c c th hi Nghin mn l

thay i tc ha tan hay thay i tan?
tan ca saccarose l 1:0,5 l tan khng i nhng tc ha tan c th thay i bi cc yu t.
Son: T oan _ D08
5. CC PHNG PHP HA TAN C BIT

iu ch dd thuc vi n cao hn n bo ha bng cch s dng cc tc nhn lm tng tan
Nguyn
tc
Dng cc cht c kh nng to phc d tan /dm vi iu kin phc cht to

thnh vn duy tr nguyn vn tc dng sinh hc ca dc cht ban u.
I2
To dn
cht d tan
ng
dng
iu ch dd
Lugol
KI
KI3
I2 Kh tan /nc & cn thp

KI3 D tan
iu ch thy
ngn diiodid
HgI2
2KI
K2[HgI4]
Mc ch Ha tan trong nc cc cht kh tan

Dng cht
trung gian
thn nc
Dng h
hp dung
mi
Nguyn
tc
Cc cht ny lm trung gian lin kt dung mi v cht tan. Chng thng c

nhm thn nc nh COOH, -OH, -NH2, -SO3H, ..., phn cn li thn du.
V d
Xem cc yu t a/h tan \s hin din cht khc
Nhc
im
Lng cht trung gian ha tan s dng kh ln i khi gy bt li trong iu tr.
Nguyn
tc
Hn hp dung mi lm thay i tan ca dc cht do lm thay i phn

cc, bin dung mi bn phn cc thnh hn hp phn cc mnh, ...
V d
Hn hp dung mi glycerin cn 90 ha tan bromoform

Hn hp [nc cn 90 glycerin] ha tan Digitalin
Nng cht din hot c s dng phi cao hn nng micelle ti hn
hnh thnh cc cu trc micelle c th thu ht cht kh tan, phn tn vo dung
mi v to thnh dd gi.
(CDH c 2 phn: thn nc, thn du. n thp, cc CDH c phn tn di
dng phn t dd tht. Khi n n mt gii hn no cc phn t din hot
s tp hp li to thnh cc micelle dd gi. N ny c gi l n micelle ti
hn. Trong cu trc micelle, cc pht CDH c th xp thnh cc lp song song,
hnh tr hoc hnh cu)
Dng cht
din hot
iu
kin 1
cht l
cht din
hot
M hnh cht
din hot
Cu trc micelle
Thn du
Thn nc
thm nhp ty thuc tnh

phn cc ca dc cht
Tiu phn dc cht kh tan
Vd
Dng Tween 20 ha tan tinh du vo nc
Lin h phng php ha tan dng cht din hot vi bi Nc thm.

10
Son: T oan _ D08
BI 2: K THUT LC
Tc lc (Lu lng lc) c xc nh bng cng thc:
Cng thc
=
Cc bin php gia tng tc lc?
( )
S: Din tch b mt lc
r: Bn knh trung bnh l xp
P p: Hiu s p sut gia 2 mt ca lc
: nht dch lc
l: dy ca mng lc
- Thay i S, r, l: La chn lc c kch thc ph hp

- Gim : Lc nng
- Gim p hoc tng P: Lc di p sut gim hoc p sut cao
(Hiu qu nht)
BI 6: NC THM
Ch phm cha cc cht d bay hi c mi thm nh tinh du, cc acid bay hi (a.acetic,
cyanhydric, ...), cc hp cht ca amoniac
N
Thu c bng cch ct ko DL hoc ha tan tinh du trong nc
Dng lm dm hoc cht dn cho 1 s dc cht c mi v kh chu.
Nguyn tc: Trong q.tr ct ko tdu, nc bc hi mang theo tdu, khi ngng t, mt lng
nh tdu ha tan trong nc mc bo ha. Gn phn tdu ko tan thu nc thm.
CT T DL
Ct ko theo hi nc
C TINH DU
Nhc im: N tinh du ha tan thp
2 pp
Ct ko trc tip
K THUT IU CH
Dng cn lm
trung gian ha
tan
HA TAN
TINH DU
/NC
3 pp
Dng bt talc
lm cht phn
tn tinh du
trong nc
Dng cht
din hot lm
trung gian ha
tan
Tinh du 1g
Cn 90 v 100g
Tinh du /cn 3g
Nc ct
97g
- Tinh du c ha tan theo 2 giai on:

Ha tan /cn
Pha /nc
Hm lng tdu trong nc thm: 0,03%
Tinh du
Nc ct v
Bt talc
1g
1000g
10g
- M t:
Nghin bt talc vi tdu, thm nc khuy lc k.
yn 24 gi thnh thong khuy
Lc dd qua giy lc thm nc.
- H s tan ca tdu /nc l 0,05 tng ng vi n 0,5 g/l
- Lu :
Cn dng 1 lng tha tdu v talc hp ph 60-70% tdu.
Tinh du
Tween 20
Cn 90
Nc ct
2g
20g
300g
678g
- C ch: Hnh thnh cu trc micelle. Xem Cc pp ha tan c

bit [bi 1, mc 5]
- Vai tr ca cc cht:
Tween 20: L CDH phn tn tdu vo hn hp cn-nc
Cn 90: ???
- u im: Mi mnh, n tdu xc nh, bo qun lu hn.
- Nhc im: v ng do CDH.
11
Son: T oan _ D08
BI 3: DUNG DCH THUC UNG V THUC DNG NGOI

Cu hi
L g?
SKD
S
phng
thch v
hp thu
dc
cht
Nhc
Dung
dch
thuc
Phn
loi
Cc giai
on
pha ch
Dung
mi
iu ch
S bin
cht &
Cch n
nh dd
thuc
Tm tt
Ghi ch
L cc ch phm c iu ch bng cch ha tan mt

hoc nhiu dc cht trong dung mi hoc hn hp
dung mi.
Cao hn cu trc hn dch v nh tng
- Dc cht trng thi sn sng hp thu
DD
nhanh, c th hon ton
nc
- S kt ta & ha tan li lm s hp thu
Tc & mc hp thu thp hn v dc
DD du
cht phi khuch tn t du vo nc
Dc cht phng thch ko hon ton & chm
DD gi
v cu trc micelle hoc s to phc vi cc
cht cao phn t
SKD cao hn dng rn
dng dd, 1 s dc cht gim kch ng
D s dng cho tr, i tng kh nut
Cu trc bn vng v mt nhit ng, pp bch n gin
Dng lng (b MT nc): D hng do puhh, d nhim
VSV, nm mc
Kh phn liu chnh xc /v ch phm a liu
DD thuc nc
DD du
Theo bn cht dm
DD ethanol
DD glycerin
DD c dng
Theo cng thc
DD pha ch theo n
Theo tnh cht, ng
s dng, cch dng
Cn ong dc cht & dung mi
Ha tan & phi hp cc thnh phn
Lc
ng gi, trnh by thnh phm.
Nc ct
Nc
Nc kh khong
Nc thm thu ngc
Ethanol
Glycerin
Du thc vt
S kt ta
Cc bin i v
ng vn cht keo
mt vt l
H.tg bin mu hoc c mu
p/u oxh kh
Cc bin i v
p/u thy phn
mt ha hc
p/u racemic ha
p/u to phc
S nhim & pht
trin ca VSV
12
Yu t q: H s phn
b du nc
NaBr, cloral hydrat
Ch pha ch lng
dng trong 1 4 ngy!
Ha tan & Lc l hai

k thut c trng
trong iu ch dd
thuc
Tc nhn,
Bn cht qtrinh phn
hy,
Cch khc phc.
Son: T oan _ D08
Cu hi
Nc
Nc
ct
Nc
kh
khong
Nc
thm
thu
ngc
Ethanol
Vai tr
Hh Ethanol nc
S dng
Du cn dng trong TH cn ko di s phng thch dc cht
Tnh
tan
(nh
cellulos
eacetat)
Ethanol l cht dn tt, gip hp thu nhanh & hon ton dc cht
Bo qun, st trng (xem trn)
Dung mi chit xut DL
Dung mi iu ch dd thuc
Kh nng ha tan cao hon /v mt s dc cht
Ha tan
Glycerin c
im
Du
thc vt
Ghi ch
Dit khun C > 20%

- Glycerin khan d ht m & gy kch ng da nim mc, v vy
glycerin dc dng cha 3% nc.
- Thng dng trong hn hp dm vi nc & ethanol c bit trong
cc dng thuc dng ngoi v glycerin gip gi m & bm dnh tt.
Ko tan / nc
t tan / ethanol. (Du Thu du tan / ethanol)
Tan / cloroform, ether, ether du ha
Salol, long no, menthol, tinh du, alkaloid base, vtm A D E K
Td Dly
Tm tt
- Cc acid, base
- Cc ng c nhm phn cc
- Cc phenol, aldehyd, ceton, amin, aminoacid, glicozid, gm, tannin,
Ha tan
polypeptid, enzym,
- Nc acid ha ha tan alkaloid base
- Nc kim ha ha tan cc acid, cht lng tnh, saponin.
Ko htan Nha, cht bo, alkaloid base
tng k MT nc dc cht d b thy phn, VSV & nm mc d pht trin
Khng
Td Dly
c
iu ch: Lm bc hi & lm ngng t tr li
im
t tiu chun tinh khit v mt ha hc & vi sinh
Cc dng thuc nc
S/d iu
Ty dng thuc c th c tiu chun ring /v nc ct (Nc ct pha
ch
tim / nc ct 2 ln, nc ct thng / nc ct 1 ln)
Cho nc thng i qua cc ct nha trao i ion.
c
Tinh khit v mt ha hc.
im
Ko m bo cc tiu chun v vi sih & cht hu c
S/d iu Cc dng thuc thng thng (thuc ung, thuc dng ngoi )
ch
Dng lm thuc ra phc v pha ch thuc.
c tinh ch loi mui ha tan bng cch nn nc qua mng bn
c
thm p sut cao
im
Kh tinh khit (Loi 80 98 % cc ion ha tan, loi hon ton cc
VSV & ch nhit t)
S/d c
- Acid, kim hu c
Ha tan - Cc alkaloid & mui ca chng
- Mt s glycoziid, nha, tinh du, mt s lipid, phm mu,
Pectin, gm, protid (albumin), enzym, (nhm keo thn nc)
Khng
ha tan Ethanol lm ng vn chng
tng k Mt s dc cht bn vng trong ethanol cao hn nc
L cht bo qun khng khun C > 10%
T/d dl
St trng C 60 90%
ring
D bay hi, d chy, d b oxy ha
sinh hc
13
Son: T oan _ D08
B HA
HC
TC NHN XC TC
pH
pH kim xc tc qt kh
Nhit
Thc y mnh qt oxh
Bc x
Xtc p oxh mnh nht
Ion KL
nng
Thng c trong nc
ct, dng c KL, ng.liu
Kh nng xt gim dn
theo th t: Cu, Mn, Ni,
Fe, Co
S c mt
ca oxy
trong kh quyn, dung

mi, cc cht c tnh oxy
ha mnh trong thnh
phn dd.
P/u oxh
kh
P/u thy
phn
KHC PHC
iu chnh bng acid, kim, h m.
Nu bo qun 0 5oC, tc oxy ha c th
gim t nht l 1/2
Bo qun trong chai l trnh nh sng
To phc vi ion KL bng nattri hoc dinatri ca
EDTA, dihydroethylalycine, acid citric, acid
tartric.
Vd: Dng dinatri ca EDTA n nh dd acdi
ascorbic, oxytetracyclin, PNC, epinephrine,
prednisolon
un si dm; Sc kh tr (N2, CO2) khi ng gi
Dng cht chng oxy ha trc tip:
L cc cht c th oxh kh < dc cht, chng
s chu tc ng trc ca tc nhn oxh hoc c
tc ng ngn chui p ca cc gc t do.
Dng cho mt nc
Dng cho mt du
Ascorbyl palmitat
Natri sulfit Na2SO3
BHT = butyl hydroxy
Natri metabisulfit
toluen
(Na2S2O5)
Natri bisulfit NaHSO3 BHA = butyl
Acid ascorbic
hydroxy anison
-tocopherol
Cc cu trc d b thy phn:

Ester: atropin, novocain
Ether: glycozid, streptomycin
Amid: chloramphenicol,
barbituric
Thay i cu trc nhng hot tnh vn khng i

(Dng cc dn cht bn, t tan lm gim
tan v tc thy phn )
pH
iu chnh pH ph hp:
Ether bn MT kim
Ester bn MT acid
** Cn c s hi ha gia bn & hot tnh
s.hc
To tng 10oC th tc
thy phn tng gp 2 -3
Nhit
ln.
Nng long ca dd
Thay nc bng dm khan (khi c th)
Vd: Barbiturat n nh to thng trong hh
propylen glycol nc hn l ch dng nc.
Lng nc trong dd
P/u
racemic
ha
P/u to
phc
Bn cht ha hc ca cht quang hot

H+, OH-, X-, acetat, CO32-, mt s hp
cht amin,
Cht cao phn t
Vd: alcol polivinylic, metyl
cellulose, natri carnoxy metylcellulose
Bao b bng cht do
Vd: PVP (polyvinylpyrolidon)
to phc vi sulffamid, phenobarbital
chm hp thu.
14
iu chnh pH ph hp khi pha ch.
Cn nghin cu k v chn la cc t dc cao

phn t trc khi a vo cc dng thuc.
Son: T oan _ D08
B VT
L
Kt ta
dc cht
7
ng vn
cht keo
NGUYN NHN
KHC PHC
Dung mi d bay hi. Vd: Iod trong

cn
S ha mui : Khi thm cht d tan vo
dd ca cht kh tan. Vd: Papaverin
clohydrat b ta bi cc bromid kim
P/u trao i ion to cht kh tan (do
cht ingia, pH, do tp cht t bao
b, )
Bn cht & nng cht keo
Cc tc nhn thc y: cht in gii,
pH, do bao b nh ra
Hin tng gi ha cc keo trong cn
thuc, cao thuc
Bin mu,
c mu
Dung dch l MT thun li
Nhim
VSV,
nm mc
Hm lng nc
Ngun cht dinh dng, kh.kh, nhit
Ch v sinh v trng
Dng cht bo qun dit khun:
Cho thuc ung: Nipagin, nipasol, acid
benzoic, ethanol C > 10%
Cho thuc nh mt, thuc tim:
Phenol & cc dn cht (tricresol,
metacresol,...)
Cc dn cht thy ngn hy c:
nitrat phenyl mercuric
Cc dn cht ammonium bc 4:
banzalkonium clorid.
Phn Bin i ha hc, nht l p oxy ha kh (k c ng.nhn v cc cch khc phc), lin h vi bi thuc tim.
K cc bin php chng oxy ha cho dung dch thuc nc (c bit l thuc tim)
H m: l g, vai tr, u, nhc im, c ch, k tn vi h m.
EDTA l g? Ethylendiamin tetrcetic acid
Phn dung mi:
Dung mi Ha tan v khg ha tan c cht no?

C tng k vi dc cht no khng
C tc dng dc l ring khng?
Cc c im khc lu trong qui trnh sn xut nh: d chy n, bay hi, ...
Phn nc:
Loi nc c c im g? N c dng cho sn xut loi thuc no?
Hin tng racemic l g? (Khi ha tan thnh dd trong mt s iu kin nht nh c th xy ra qu trnh sp xp li cu
trc ha hc ni phn t lm chuyn dng i cc, lc hp cht dn dn chuyn thnh hn hp racemic)
Dng thuc c tc dng t trin hay hu trin?
Cc dd thuc thng dng (tr.63)
15
Son: T oan _ D08
BI 4: SIRO THUC
1. SIRO N
CC GIAI ON PHA CH
1. HA TAN
NG
u im
Nhc im
Ha tan
ngui
Cng thc
ng saccarose
180g
Nc ct
100g
T trng 20oC = 1,32
Ha tan
nng
Cng thc
ng saccarose
165g
Nc ct
100g
Nu khng y np bnh pha ch
T trng 105oC = 1,26
Sau khi ngui: d ca siro l 1,32
u im
Ha ta , lc
nhanh, hn ch
c nguy c
nhim kh n
Nhc im
ng c th b
caramen ha
Ch phm c mu
Lu : Nu pha ch khng y np bnh th khng th tnh nng siro n bng phng

php nng.
o t trng
Dng c: T trng k hoc ph k Baum
Cc
(Dng nhiu)
phng
1000ml siro n c n 64% nng 1260g 105oC v 1314g
php o
Cn
20oC
nng
Da vo nhit
ng
si
2. O & IU
CHNH
NNG
NG
Cc
phng
php iu
chnh
Lc
3. LC &
LM TRONG
Nu dng t
trng k
X: Lng nc cn thm (g)

) d1: t trng ca siro cn pha long
=
( ) d: T trng cn t n
d 2: T trng dung mi pha long (d2 =
1 nu l nc)
(d2 < d < d1)
a: Lng siro cn pha long (g)
Nu dng ph
k
E = 0,033 SD
Lm
trong
E: Lng nc cn pha long (g)

S: Khi lng siro (g)
E: S Baum vt qu 35o
Dng ti vi hoc giy lc c l xp

u: Khng a cht l vo siro
Dng bt giy lc
PP: Cho vo siro ang nng, un si trong vi pht
1g/1000g siro
sau lc
PP: Cho 1 lng trng trng vo 10 lt siro ngui, trn
u. un siro n si, khng khuy trn, sau lc.
Dng Albumin
C ch: nhit cao, albumin b ng vn to ta
v ko theo tp cht.
Nhc: C th li tp cht do albumin b thy phn
PP: Cho than hot vo siro, un si, lc qua giy lc.
Dng than hot 3Lu : Khng dng than hot kh mu siro thuc
5%
v than hot cng ng thi hp ph dc cht.
4. NG
CHAI BO
QUN
16
Son: T oan _ D08

2. SIRO THUC
2 CCH IU CH SIRO THUC
1. HA TAN
NG VO
DD DC
CHT
2. TRN
SIRO N
VI DD
DC CHT
c im
Trong phng php ny, ng l 1 thnh phn ca cng thc c ha

tan cng lc vi dc cht. C th thu c siro vi nng ti a.
V d
Siro iodotanic
Iod
Tanin
Nc ct
Saccarose dc dng
2g
4g
400g
600g
ng dng Khi dd dc cht cha qu nhiu nc nh: dch chit DL, dch hm, cao rau
m, ...
khi no?
Phng php ny cho siro thuc c n thuc thp hnv phi dng thm
c im
dung mi ha tan dc cht
V d
Xem trang 69
ng dng PP ny ph hp iu ch siro thuc vi dc liu bng cch dng dch

chit m c hoc cao c c dc liu phi hp vi siro n.
khi no?
Nng ng ca siro thuc trong khong? Tng ng vi t trng bao nhiu? 54 64%, 1,26
1,32
tan ca saccarose trong nc l 1:0,5, n bo ha 6,66% tng ng t trng 1,32, do siro
c n gn bo ha
Pha siro thuc, khi no th cho ng vo dd dc cht, khi no th trn siro n vo dc cht
Bi tp: Cho tan saccarose, tnh n bo ha. T n siro n suy ra n siro???
17
Son: T oan _ D08

1. I CNG THUC TIM
CH
Gi tr li
3 chnh:
- Dc phm v trng
- Dng di dng lng
- Theo ng qua da hoc nim mc bng y c thch hp.
Theo dung mi
hoc cht dn
Theo th tch
ng gi
Thuc tim nc
Thuc tim du
TT th tch nh (S.V.P)
TT th tch ln (L.V.P)
Thuc cha trong mi n v ng gi < 100 ml, thng

gp dng ng 1, 2, 5 ml
Cha t 100 ml 1000 ml mi n v ng gi, hay gp
dng chai 500, 1000 ml
2 Trng thi
Phn loi
Rn
6 Cu trc
Theo trng thi

cu trc v hnh
thc phn phi
Dung dch
Dng rn pha dd
Hn dch tim
Cc ch phm c kha cnh

ging TT
Bt, khi rn pha hd

tim
Nh tng tim
ng tim
Lng
- Dung dch
- Nh tng
- Hn dch
c im
Hot cht n nh /dm
D ha tan, km n nh /dm
Dng mi pha.
Nng hd tim thng nh: 0,5 5 %
Phn tn u /cht dn v lc k trc khi tim.
Hot cht khng tan & km n nh /cht dn
- Bt
- Khi xp
- Vin
Hot cht dng lng khng tan, phn tn thnh ht min

trong dm nc hoc du v khng c tch lp.
Thng gp D/N.
- Ging: ng gi v trng, dng ng tim
- Khc: Cch sn xut, cch s/d
Ch phm sinh
Vaccin BCG, vaccin phng HBV, cc gii c t anatoxin, ...
hc
vd
Mu v cc ch phm t mu (albumin, hng cu, huyt tng, ...)
Khng nguyn chn on giang mai
- Ging: ng gi v trng, cha liu thuc nht nh
- Khc: c cy di da bng 1 kim c bit.
Dng cy di
- p dng cho nhng hot cht cn c tc dng ko di
da
- Vd: Cc hormon
- Ging: c tnh ton thnh lp cng thc v bo ch nh thuc tim truyn.
Cc ch phm v - Khc: S/d theo nhng ch nh c bit ngoi ng tim
- Cc dd thm phn mng bng, chy thn nhn to.
trng khc
vd
- Cc dd ngm ra, Bq m, c quan trong qt cy ghp.
- Thuc tim ng trng: C th dng cho tt c cc ng tim (SC, IM, IV, IC, tim ty sng)
- Thuc tim u trng, nhc trng, thuc tim c Calci clorid: Ch c
IV tht chm v cn thn v thuc tro ra s lm hot t vng tip xc.
Hoc ha long vo dd ng trng tim truyn.
- IV ch c php tim thuc tim nc (dung dch, keo, nh tng kiu D/N)
- IV v SC khng c tim thuc tim du (dd du, nh tng N/D), hn dch (tr insullin) tim IM.
- Tim ty sng: Ch c tim tt ng trng v 10ml
18
Son: T oan _ D08

2. YU CU CHT LNG
1. Chnh xc v n, hm lng
2. V khun
3. Khng c ch nhit t hay c t vk
4. pH
5. ng trng
6. trong & mu sc
7. T trng (ko bt buc)
1. NNG & HM LNG PHI CHNH XC

ngha
Lm th no
B p hao ht
V thuc hp thu hon ton, tc dng nhanh nn nu c sai st vt liu ch nh c th dn n

tai bin trm trng, kh khc phc nht l /v thuc c mnh.
Cn thn trong c pha ch v s dng
B p s hao ht do dnh thuc v bao b ng, bm tim, dy truyn dch. Lng thuc d
thm vo ph thuc th tch ca thnh phm & th cht ca dung mi.
2. V KHUN (y l y/c c trng nht)

ngha
Th no l v
khun
Mc ch
Lm th no?
Da & nim mc l hng ro bo v chng li s xm nhp ca vi trng & tc nhn c hi khc b v

hiu ha khi tim Tt phi tuyt i v khun & ko c mang cc tc nhn c hi c lin quan.
Trong tng n v ng gi (chai, l, ng, ...thuc) u t trng thi ko cha vi sv sng dng sinh
dng hoc bo t.
Lm cho c.phm ko c
Gi cho c.phm n nh (VK, nm mc nhim vo thuc lm hao ht hm lng, c, ta thuc.)
Phi v trng
NPL, dm
Ko kh phng pha ch, dng c thit b: Phi x l v khun hoc t sch
C s, k sx
khun nht nh; c bin php gim thiu s nhim cho gia cc khu
sx
Tun th ch v sinh
Nhvin sn xut
Thng l nhit cao.
Nu hot cht chu c to cao: Ta pha ch v trng, ri chn k
La chn pp thch
thut tit trng ph hp cho bn thnh phm sau khi ng gi kn.
hp tit trng
Nu hot cht ko chu nhit cao: Ta pha ch v trng, kt hp lc v
sp ng gi kn
khun & ng gi thuc trong chu trnh kn, tuyt i v khun.
Clorocresol 0,2 %
/v thuc tim
Phenyl mercuric nitrat 0,001 % - 0,002 %
nc
Cc nipaeste 0,005 % - 0,18 %
/v thuc tim Phenol 0,5 %
du
Cresol 0,3 %
Cht st trng bo
Ch dng cho thuc tim n liu hoc a liu nhng khi
qun
dng vi lng nh
Ko dng cho thuc tim c liu dng > 15 ml hoc IV,
Lu
tim ty sng, tim vo tim, tim vo mt,
a s u c tnh ph huyt t nhiu
(ch c nipaester l an ton)
3. KO C CH NHIT T HAY C T VK
Pyrogene l g?
Ngun gc ch nhit t
Nguyn tc ngn nga
cht gy st
Cc pp phng & loi tr
ch nhit t?
p ng GMP c tm
quan trng nht v tiu
chun no trong sx Tt?
(Cht gy st hay ch nhit t) L nhng cht nhim vo thuc, sau khi tim, ch yu
bng ng tim truyn IV, gy cn st c trng trn ngi bnh.
- Hu ht do c t do VK gram (-)
- T bo hoc sp t mu, t bch cu ca ngi.
- Cht ha hc: Natri nucleat, hn dch mn calci phosphat, pepton, cht chit t t cao
su lu ha c vt ion km
- Phng nga, khng ch nhit t nhim vo thuc v tng ng vi vic ko
nhim vi sv vo nguyn liu dng pha ch, bao b ng, ...
Phng nga nhim khun (ngliu, bao b, dm, mi trung pha ch) v lc (dd thuc)
qua mng siu lc 0,1m.
Bo m cht lng thuc nht l ch tiu v trng v t gii hn ch nhit t, c t
endotoxin
19
Son: T oan _ D08

4. pH PH HP
Mc ch
Bin php
- Ph hp sinh l ca c th (nht l /v hng cu) thuc d dung np, t gy au nhc khi tim
- Gip hot cht ha tan n nh trong dung mi gi c hot tnh
/v Tt du Du pha tim phi c trung tnh ha & kh nc
- p dng cho nhng thuc tim c n nh khong pH rng.
iu chnh
- Dng 1 acid (citric, lactic, HCl 10%, ) hoc base (NaHCO3 , NaOH
pH
10%, ) a v vng pH cn thit
/v Tt
- p dng cho nhng thuc tim nc c n nh khong pH hp.
nc
- Cc h m thng dng:
m pH
acid citric natri citrat pH 3-6
natri hydrophosphat dinatri phosphat pH 5,4-8
natri hidrocarbonat dinatri carbonat pH 9,2-10,8
trnh au nhc khi tim thuc c hot cht n nh pH ko thuc vung pH sinh l ca c th, c
th dng thm cht gim au vo cng thc
5. NG TRNG
Lm cn c tnh lng nc, cht in gii v nhng cht khc cn
tim truyn nhm lp li tr s n thm thu bnh thng cho ng bnh.
V mt an ton Gim au nhc ti ch tim
trong s dng
Gip c th dung np d dng.
Cc thuc tim nc nht l TT th tch ln, truyn tnh mch nn ng trng vi
huyt tng v dch tb hay c cng p sut thm thu (ptt) vi dch m tb d dung
np.
Cc thuc tim dm du ko c hin tng to ptt nn ko t ra vn ng trng.
V mt iu tr
ngha
Loi thuc tim no

cn?
V sao thuc tim u,
nhc trng ch c
tim TM
Cc thng s chng t 1
dd l ng trng
Biu hin ng nht ca
1 Tt ng trng?
Cch tnh lng cht
ng trng ha
V khi tnh ko ph hp v trng lc thm thu s nhanh c khc phc do thuc

phn tn, ha tan vo lng mu ln ca ng tim.
ptt = 7,4 atm; t = -0,52,
nng ng trng: C = 290 mmol/L
C kh nng gi cho hng cu nguyn vn trong th nghim qui nh.
xem bi thuc nh mt
6. TRONG & MU SC
Bao b
Ngun gc &
hng khc phc
Kk phng pha ch
dd thuc tim
- Nt cao su khi hp tit trng

thuc, than hot khi lc ty
mu, thuc b chy khi hn
ng ht bi c mu
- ng (sx ko t sch, qt ct
hn ng), mng lc thy tinh,
dc thy tinh v m, lc
thy tinh (thy tinh km cht
lng b n mn ha hc
ht bi c thy tinh.
Kk khng c lc sch
- Do thuc khng n nh
c, ta
- Chn vt liu tt
- Chai, l, ng: phi ra sch trc
khi ng thuc hoc c hn kn
sau khi sn xut.
- Thit k kiu ng tim c c t b
c nha dnh vt b trnh c mnh
thy tinh.
Lc v x l sch bui
Lc bng thit b thch hp. Dch lc
c thu trong bnh trung gian kn,
sch v ng trc tip vo bao b
x l sch kh v trng.
7. T TRNG
ngha
c t ra v thuc tim gy t tim vo dch ty sng nh bupicain

Dch no ty c t trng 1,0059 thn nhit 37oC, nu thuc c t trng cao hn, khi tim
vo ty sng, khi bnh nhn ang nm dc chn xung, thuc kh lu thng hn l thuc c
t trng tng t dch no ty, ....
20
Son: T oan _ D08

3. CC THNH PHN CA THUC TIM

3.1. Hot cht
- Yu cu chung:
Tinh khit dc dng
V trng
Khng cha ch nhit t hoc gii hn c t vk nu cn.
3.2. Dung mi & cht dn

- Yu cu chung:
3 yu cu chung ca hot cht
Ph hp vi hot cht v dng bo ch c lc chn: Khng tng k vi hot cht, gip hot cht n nh,
gii phng hot cht theo ng yu cu.
Khng c hot tnh ring lm thay i hiu lc iu tr ca thuc, khng c hoc rt t c, c c th dung
np, d thi tr.
- C bao nhiu nhm dung mi dn cht? 2
K tn
Tiu chun chung
Tinh khit dc dng
V trng
Nc ct pha tim
Dm thn nc
t tiu chun ch nhit t hoc gii hn endotoxin
Ethanol, Glycol, Prolylen glycol
Du lc tinh ch, du u nnh,
Tinh khit, v khun, gii hn c t alfatoxin
Dm thn du
vng, hng dng, olive
- Cc loi nc dng trong qui trnh sn xut thuc tim:
Tiu chun cht lng
KL nng
Vi sv
Mui ha tan
ch nhit t
Nc ung
c
Nc kh
khong
Nc thm
thu (RO)
Nc siu
lc (UF)
Gii hn
Kh ton phn hoc
kh cc cation
(Ca2+, Mg2+)
Cn 10mg/l
RO: Loi c 8098% ion
UF khng loi c
mui ha tan
Cng dng
- Ra dng c, bao b
- Nuyn liu sn xut cc loi nc
tinh khit (nc ct, nc kh
khong, ...)
- Ra chai, l, ng ng thuc tim
- Dng ct nc
- Dng pha ch nhiu dng thuc
tr thuc tim
Gii hn
RO & UF loi hon

ton
Ch thay th nc ct khi sc ra
cui cng trong khu ra bao b
ng thuc tim.
Pha ch Tt khng tit trng c
nhit cao.
Nc ct v
khun *
Tinh khit, v trng
Nc ct
pha tim *
Loi hon ton, c

th loi c kh ha
tan CO2, O2
Tinh khit, t gii

hn vsv < 10
CFU/100ml
Nc tinh
khit *
Gii hn tp ha tan
Tiu chun pH
Gii hn vk hiu kh
Gii hn c tt vk
Nc v
khun
tim *
L thnh phm ng gi kn (ng, chai, l)

v tit trng nhit cao, ko c ni c t
vk
Nc ct ko
cha CO2
hoc O2
- Pha ch thuc tim c tit trng

nhit cao
- Dung mi hay cht dn, pha long
thuc tim m c, cp km thuc
tim dng bt.
- Ra dng c, bao b
- Dng ct nc pha tim
- Pha ch dd thm tch, chy thn
nhn to
- Pha long 1 s thuc tim m
c
- hoc dng lm dm, cht dn cho
cc thuc tim bt
- Dng cho hot cht d b ta hoc
khng bn khi CO2 trong nc pha
tim. Vd: natri amylobacbiton, calci
clorid, aminophylin, ...
- Cc thuc nhy cm vi O2 ha
tan. (acid ascorbic, clorpheniramin,.
21
Nguyn tc iu ch
X l t nc thin nhin
(s 3.1 tr114)
Pp ha hc hoc trao i
ion
Nn nc i qua mng
bn thm
Nn nc i qua mng
siu lc
Chng ct t nc sinh
hot hoc nc tinh
khit mc cn thit
H thng lin hon
Lm tinh khit t nc
ung c bng pp ct,
trao i ion, siu lc,
thm thu.
Son: T oan _ D08

- Du pha tim:
u im
Du parafin,
ethyl oleat
Khng c
Nhc im
Chuyn ha chm, gy au ti ni tim
T DNG
- c nht, rt dnh v ng v bm tim.
Du thc vt
tinh ch
D dung np,
chuyn ha
- d b ng c khi nhit mt h qu
thp, d b oxy ha, tr mi i kht v b
trng hp ha, ...
Khc phc nhc im
Thm 1 lng nh ether ethylic hoc

phi hp cc du t nht hn.
Thm cht bo qun trnh i kht:
acid citric, , BHT, BHA, n 0,030,05%, ...
3.3. Cc cht ph
Lu nhm chng oxy ha
C ch
Cht
chng
oxy ha
Kh tr
Cht chng oxh trc

tip
Cht chng oxh gin
tip
Sc kh tr vo nc
ct lm g?
2 kh tr thng
dng?
Cho vd vi thuc tim
cn kh tr khi sn
xut?
Kh oxy v cc gc oxy ha gip bo

v hot cht trong thuc
To phc vi cc ion kim loi (Cu2+,
Pb2+, Zn2+, Hg2+) vn l cc cht xc
tc p oxh lm hng hot cht.
ui oxy hoc ng vo u ng
trc khi hn kn
Cht thng dng

- v thuc tim nc: Natri sulfit,
natri meta bisulfit, natri bisulfit,
thioure (rt thch hp cho vtm C)
- v thuc du: propylgalat, ...
EDTA; cc mui di, tri natri, calci ca
EDTA (cc mui edetat)
Acid citric, dimercaprol
CO2, N2
Adrenalin, vtm C, B12, apomorphin
22
Son: T oan _ D08

4. QUI TRINH BO CH THUC TIM

4.1. Thuc tim dung dch
CN, ONG nguyn ph liu, dung
mi
PHA CH
Ha tan, chnh pH, chnh th ch
Kim tra nng hot cht, pH,
nht
LC TRONG (mng lc 0,45m)
(Dd thuc phi trong sut)
Kim tra trong
NG NG, CHAI, L
iu chnh, kim tra th tch thuc
TIT TRNG
121oC/15-30 pht
SOI KIM TRA TRONG

(Kim tra tng n v chai, l, ng
bng mt thng)
Kim tra hnh thc trnh by
IN (DN) NHN
NG HP, THNG, BO QUN
Kim nghim thnh phm
Cng thc Thuc tim vitamin C 5%, ng 5ml (chuyn lun DVN)
Cht n nh NaHCO3 + acid ascorbic to natri ascorbat bn hn.
Cht chnh pH 5-7: NaHCO3
Cht chng oxy ha: Natri bisulfit, kh tro CO2, hn ch dng nhit cao trong pha ch.
Xem chuyn lun D: th t pha ch.
23
Son: T oan _ D08

Ch :
PHA CH
V TRNG
Khi no pha ch v
trng?
Thuc tim dung dch c hot cht km bn vi nhit ko tit trng c bng
nhit cao
Thuc tim hn dch, nh tng.
c im ng gi
trong bao b v
khun?
Chu trnh kn, lin tc

Vd: Thuc tim diazepam, ergostamin, vtm C, ...
Tiu chun v
trong v thuc tim
dung dch?
LC
C my giai on lc
thuc?
Vt liu lc
Gm nhng thao tc
no?
Qui trnh ng gi?
- Trong tuyt i vi mt thng

- Khng cha ht > 25m
- Gii hn cc tiu phn 2-25m trong 1 ml thuc
**Tiu chun ny ch yu p dng cho thuc tim truyn th tch ln, t 100ml tr
ln, v ni lng cho thuc tim th tch nh.
- Lc trong
- Lc v khun
- Lc thy tinh xp G3, G4, G5
- Mng lc hu c c mn thch hp nh mng xp Milipore dn cht cellulose
- ng thuc
- Hn kn (ng) hoc ng nt (chai, l, ti)
- KN, lin kt vi khu lc trong trnh nhim nht l sau khi lc v trng.
- Tuyt i V KHUN, v tin hnh trong thi gian NGN NHT trnh nguy
c nhim khun tr li.
ng bng my
chn khng
NG GI
Cc pp ng thuc?
p dng?
ng bng kim
bm
ng gi c np
kh tr hoc chn
khng
p dng
Nhc im
ng u nhn
- Kh ng u
th tch
- D nhim khun
ng ming loe
hoc chai, l
** khc phc
nhc im trn
Lu
Phi ra u ng
thuc tim sau khi
ng thuc.
Mc ch ca vic a kh tr hoc carbonic vo? n nh ch phm.

Thuc trng thi chn khng s n nh hn, nht l v vi sinh v ch nhit t.
TIT
TRNG
KIM TRA
CM QUAN
p dng
To , thi gian
ng tim du
Tit khun ng, chai l, dng c chu 145-160oC /1Pp sy nhit kh
nhit, cng nh dm du (du lc, du 2h
vng)
Pp hp nhit m vi ni Hu ht cc thuc tim chu nhit 121oC /15-30
C my pp tit trng?
hp (autoclave)
cao
pht
p dng?
S dng Pp Tyndall cho thuc chu nhit tng i (<
85oC) (lidocain, vtm C, albumin, ...)
Thuc tim khng chu nhit, th tch
Pp lc v trng kt hp < 5ml, v dng thn trng vi thuc
cht st khun
tim n 15ml.
Dung mi trc khi pha ch.
Autoclave: Ni hp hi nc p sut cao.
Mc ch nhng vo dd xanh methylen
- Pht hin ng h
0,01% sau khi tit trng to cao?
- Lm ngui thuc nhanh
kn v hnh thc m quan
Kim nhng ch tiu
trong
no?
sch ca v bao b
Soi ktra trong
- Mc tiu chnh: Pht hin, loi ng/chai b bi.
nhm cc mc tiu g? - 3 mc tiu ph: Pht hin ng/chai h, khng t th tch thuc, khng t m thut
K thut
iu ch
24
Son: T oan _ D08

4.2. Thuc tim hn dch

CN, ONG nguyn ph liu, dung mi
PHA CH TRONG IU KIN V KHUN

Lm mn hot cht.
Phi hp hot cht vi cht ph (gy thm, n nh, ...).
Ha tan cc cht ph vo dm thnh dd, lc trong v v khun.
Phn tn hot cht vo dd.
Chnh pH (nu cn).
Chnh th ch
Kim tra nng hot cht, pH,
mn, c, ...
LC KIM SOT MN
(mng lc 15-50m)
(Dd thuc phi trong sut)
Kim tra mn
NG NG (L)
Hn dch thuc phi khuy lin tc trong sut qu
trnh ng vo bao b
iu chnh th tch ng gi
SOI KIM TRA LOI MU B H
IN (DN) NHN
NG HP, THNG, BO QUN
25
Kim nghim thnh phm
Son: T oan _ D08

4.3. Thuc tim nh tng

CN, ONG nguyn ph liu, dung mi
Kim tra chng nhm ln, sai s
cn ong
PHA CH TRONG IU KIN V KHUN
Phi hp hot cht (Du) vi cht ph (cht nh ha n
nh, ...)
Ha tan cc cht ph vo dm thnh dd
Chnh pH (nu cn)
Lc trong v v khun
Nh ha hot cht vo dd, chnh th ch.
Kim tra nng hot cht, pH, mn
ca ht nh 5m, c, nht ...
NG CHAI
iu chnh, kim tra th tch
SOI KIM TRA LOI MU B H
IN (DN) NHN
Kim tra hnh thc trnh by
NG HP, THNG, BO QUN
Ch :
Cho vd v thuc tim nh tng
kiu D/N?
K thut iu ch
Cht nh
ha
iu kin?
CNH thng dng

nht?
Bao b ng thuc tim nh
tng dng loi no?
im khc nhau gia pha ch

thuc tim dung dch vi hn
dch v nh tng?
Kim nghim thnh phm
Thuc tim du vtm K

Thuc tim cung cp cht bo lipid tinh ch t u nnh
Keo kh; keo t; phi hp
Khng c tnh
Khng nh hng ti CT mu (p ly huyt, ph huyt)
Phi d dung np chuyn ha trong c th
Leucithin (tinh ch t u nnh, trng g)
Phi dng chai thy tinh hoc tt hn nu c trng silicon
** khng dng chai nha v d nh tp vo thuc hoc thuc d dnh bao b
- Thuc tim dung dch: C th pha ch vi quy trnh n gin (khi hot cht
chu c nhit c cao) hoc pha ch v trng (khi hot cht km bn vi
nhit)
- Thuc tim hn dch, nh tng:
Thao tc pha ch phc tp hn (nghin mn, nh tng hoa)
Phi pha ch v trng v dng cht dit khun nu c php. (Cu trc hd, nt
hnh thnh sau khi pha ch s khng tit trng bng nhit c v to cao ph v
cu trc nh tng hoc gy tch lp lm hng hd)
26
Son: T oan _ D08

4.4. Thuc tim truyn

N
Bao b cho Tttr?
B dy truyn
dch gm?
Theo cu
trc
Phn
loi
Theo tc
dng
dc l
Yu cu?
Thuc tim truyn (Tttr) L thuc tim dung mi nc, c sn xut, ng gi v s

dng vi s lng ln t hng trm n hng ngn ml, qua ng tnh mch, nhm
mc ch tr bnh, dinh dng, ...
Chai, ti
- Kim tim bng hp kim ko r
- ng dn thuc bng cht do
- Kha chnh tc truyn thuc.
Dung dch (tht, keo)
Nh tng D/N
Dng rn xp
- Ti lp cn bng toan kim: arginin, nabica, ...
- Khng sinh, tr k sinh trng, ...
- Cht keo duy tr p sut thm thu: Gelatin, albumin, dextran, ...
- Mu & ch phm t mu: plasma, globulin, mu nhn to, ...
- Dung dch sinh l ra xoang
Pha ch v trng
So snh cc c im ca tt th tch nh v tt truyn:

c im
1
Hot cht
2 Dung mi,
cht dn
3
Cht ph
4
5
Cu trc
Th tch
ng gi
Ni dung
nhn
Cht liu
bao b
8 Yu cu
cht lng
9
Kim
nghim
TT th tch nh
Tt c cc loi, gm nhiu hot cht c
mnh: adrenalin, strychnin, atropin,
novocain,
Nc, du
TT th tch ln
Ch yu hot cht thng, t hot cht
c: lidocain, ...
Nc (duy nht)
Nhiu loi: m pH, ng trng, cht st

trng (cn nhc vi Tt < 15ml, khng
dng cho TT > 15ml, thuc IS, IV)
Bt, vin, khi xp.
Dung dch, nh tng, hn dch
Nh: 0,5 1, 2, 5, 10ml, c khi 30, 50ml.
ng kh tr, chn khng nu cn.
Thng in trn ng (ni sx, tn thuc, l
sx)
Ch yu thy tinh
t khi cht do
Kiu dng c trng (ng, l)
Theo quy nh chung
Theo quy nh.
Tt < 15ml nu t v trng, khng cn
th ch nhit t cho tng l m.
27
Ch yu l cht ng trng, iu chnh

pH, m pH. Khng dng cht st trng.
Dd, dd keo, nh tng D/N. Bt, khi
xp.
Ln: 100, 250, 500, 1000ml.
Nn ng chn khng vi Tttr trong chai
thy tinh.
Dn trn chai, ti (tr s p sut thm thu,
pH, s mEq cht in gii, s Kcalo, cht
ph, ...)
Vt liu tng t.
Kiu dng: chai, ti.
ng ln (him)
Cht ch hn, vi trong & ni c t
Endotoxin
Phi kim ch nhit t cho tng l m.
Son: T oan _ D08

5. XNG SN XUT, PHNG PHA CH THUC TIM

5.1. Khng kh trong xng sn xut thuc tim
Cp sch
Cng vic v thao tc
T pha ch v trng LAFU trong khu vc cp B
A
Pha ch thuc khng tit trng c bng nhit.
(v trng)
Lc, ng hn kn thuc tit trng c bng nhit.
Pha thuc tim tit trng c bng nhit cao
B
X l, ra chai, l, ng
C
Ct nc, sy, hp tit trng chai l.
Kho .... Phng hnh chnh, phng kim nghim
D
5.2. S b tr mt bng trong sn xut thuc tim (dng lng)
HNH LANG
Kho nguyn
liu
Phng ktra
ngliu
Pha ch
Airlock
Ct & cp
nc
Kho bao b
Ra ng (chai), dng c
Kho thnh
phm
In (dn) nhn, ng bao b
KHU KHO
KHU CHUN B BAO B,

DUNG C, NC CT
Lc
ng hn ng
(chai)
Sy kh tit
trng cahi ng
Hp tit khun
(autoclave)
Kim nghim
bn thnh
phm
Chn loi mu
h, soi ktra
trong
KHU SN XUT
Cu hi:
2 tiu chun c bn phi t?
Kh sch?
c x l theo cch no?

Nhit , m?
My cp sch? Tng ng vi
hot ng g?
Cc bin php t tiu chun SCH cho

phng pha tim
Nguyn tc sp xp dy chuyn, thit b?
V sao b mt nh xng phi nhn, bng,
gc phng xy hnh cnh cung?
2 phng php chng nhim cho gia cc
khu?
So snh 2 kiu hnh lang?
- Sch sinh hc Gii hn s lng vi sv sngs /1m3 kk

- Sch c hc: Gii hn kch thc & s lng ht bi /1m3 kk
Lc vi thit b lc c mng lc cui cng ph hp vi mc vs phi t.
20-25oC, 45-55% (v thuc tim bt m phi thp hn)
(Xem bng trn)
- Lc khng kh (bin php chnh): HEPA Filter, LAFU
- Tit trng kk vi bc x UV
- Xng/phun ethylen oxid hoc formol
- Cc ch v sinh v trng vi nhn vin pha ch, v sinh ty u dng c,
mt bng nh xng, ...
Lin tc mt chiu
Trnh bm bi
D lau chi
- Cch c in: Xy Airlock ngn cch gia cc khu, c 2 cnh ca la i
din nhau.
- Cch hin i: Airlock c s dng thm yu t nn kh to ra p sut chnh
lch gia cc khu, kt hp qu trnh lc kh. C 2 kiu: HL sch v HL d.
HL sch
HL d
Chnh lch p sut

PHL > Pkhu cp I
(p sut dng)
1,3-1,5mmHg
hay 10-20 Pa
PHL < Pkhu cp I
(p sut m)
28
Chiu khng kh
HL khu cp 4 3
2 1 (lc tr li)
Son: T oan _ D08

6. BAO B NG THUC TIM

Yu cu cht lng chung
Bao b trc khi ng thuc?
Cc vt liu sx bao b?
V sinh bb?
(tr.126)
ng, l thy tinh

Chai thy tinh ng
Tt th.tch ln
Chai, ti nha
Cc dng bao b ng thuc tim?

Kiu ng thuc tng ng?
Cc pp nh gi bn ha hc ca
ng (chai, l) thy tinh?
ng u nhn
ng
ng ming
loe y bng
(c bng)
- Bn, ko nh tp vo thuc
- Kn (m bo v trng trong thi gian bo qun)
3 tiu chun b mt: Sch Kh V khun
- Thy tinh trung tnh (cp I, cp II, cp III): Chai, l ng
- Nha (PE, PP, PVC, ...): Chai (PE,PP), ti (PVC,PVA), ng, b dy truyn dch
(PVC)
- Cao su, nha: nt
- Nhm, nha: np
Sy kh tit trng
Sy kh tit trng
Hoc tit trng t
bn vi nc ca mt trong
bn vi nc ca ton khi
lc
Vt liu sn xut ng: thy tinh y t, nha do
ng thuc bng chn khng. Vic hn u ng kh d.
ng u nhn phi ra u ng sau khi ng thuc.
- ng thuc bng kim phun: Vic hn ng kh khn hn v phi loi b phn thy tinh
tha pha trn ming ng khi hn
- My chuyn dng t ng hn ng:u im:
ng thuc t ng, chnh xc
Khi ng thuc ko b dnh vo u ng nn ko cn ra u ng trc khi hn
Thuc ko b ng u ng khi lc u trc khi ly thuc.
Vt liu sx: Thy tinh trung tnh
u im: d ng thuc tim dng bt; dng ha tr nn lc thuc d dng gip ha tan
& phn tn u; bao b kn nn trnh nguy c nhim khun (do c th ng thuc
tim a liu < 30ml hn ch s ln ly thuc)
Vt liu sx: Thy tinh y t, nha do
Chai
Ti
ng hnh tr v n
Bm tim ng sn thuc
PE: poly ethylen
PP: poly propylen
PVC: poly vinyl clorid
PVA: poly vinyl acetat
7. CC PHNG PHP TIT KHUN

7.1. Cc nh ngha v phm vi p dng
N
V
TRNG
THANH
TRNG
TY U
Mt ch phm hoc mt i tng v khun hay c tit trng

phi t c trng thi khng c vi sv sng dng sinh dng hoc
bo t.
- t gii hn vi sv
- Khng cha vk c, gy bnh: S.aureus, E.coli, ...
- Gii hn s vk, nm mc /ml/gam
Lm v sinh b mt vt, nh, xng, ... loi vi sv c, gy
bnh vi cch thc ph hp.
Phm vi p dng
Thuc tim
Thuc chuyn khoa mt
Thuc dng trn vt thng bng
X l kh trong sn xut sch
Thuc ung
Thc phm
7.2. Phn loi cc pp tit trng
Tit khun bng nhit
Bng nhit kh 160 180oC /30-120 pht

Pp luc
Bng nhit m
Pp hp hi p sut thng
Pp hp hi p sut cao
Pp Pasteur, Pp Tyndall
Tit khun bng tia bc x

Tit khun bng pp lc
(Lc v khun)
Mng lc thy tinh xp (G4, G5), ng knh l xp 0,15m

Mng lc milipiore (dn cht cellulose, ng knh l xp 0,45m
Tit khun bng ha cht
Cc cht st trng bo qun (xem mc 2. Yu cu cht lng V khun)
29
Son: T oan _ D08

1. YU CU CHT LNG THUC NH MT

Lu :
Loi ngm nc kt tnh, loi khan nc hoc loi d ht m
- Hot cht, t dc: phi l loi dc dng hoc co tinh khit cao
- Dung mi: Thng l nc ct pha tim. Nu dm l du thc vt (du liu,
Tinh khit
du u phng) th phi c trung tnh ha, khng b i kht, c tit khun
135-140oC
Cc vt liu lc thng dng: giy lc dy, phu thy tinh xp G3, mng lc
Trong
millipore, ... phi khng hp ph cc hot cht.
sut
** Khng c lc thuc nh mt dng hn dch
Cn m bo s v khun trong sut thi gian s dng bng cht
Yu cu
bo qun.
TNM mc du cha cc cht khng khun, khng sinh, khng
nm, ... nhng cc vi khun nm mc vn c th xm nhp vo. c
Ti sao?
v TNM
bit lu l trc khun m xanh (TNM Na fluorescein thng nhim
dng
trc khun ny)
nhiu ln
C tc dng mnh n thp (phn trm, phn nghn).
Yu cu
Dit khun nhanh.
ca cht
Ph khng khun, khng nm rng, b phi dit c TKMX.
bo
Khng c, khng gy kch ng, d ng v mt.
qun
Tan c trong dung mi (thng l nc).
Yu cu Phi pha ch v trng, khng cn cht bo qun
Tit khun bng nhit m 100oC/30 pht, hoc hp 120oC/20
v TNM
2 pp pha pht
dng 1
Hoc Tit khun Tyndall 70oC/1 gi/3 ngy lin tip
ch v
ln
trng
Lc v khun, siu lc: s dng mng lc c kch thc l xp 0,2
m
Gim tnh kch ng
ngha
n nh hot cht
Gip hot cht d hp thu
- Phi c pH ph hp vi nc mt bng cch dng h mj thch hp
pH nc mt thay i t 6,3 8,6. Trung bnh 7,4
D Php q: pH nn t 6,4 7,8
- Gii quyt c 3 vn : tnh kch ng bn kh nng hp thu
Vd: pH 3,8 Atropin sulfat n nh nhng km hp thu & gy kch
Yu cu
ng mt.
Gii quyt: Pha pH 6,8 (dng h m thch hp). pH ny, thuc
c hp thu tt li khng gy kch ng, tuy nhin thuc khng bn
pH ny do khng dng nhit cao khi pha ch hoc tit
khun, khng sn xut hng lot, ch pha ch khi dng.
H m Gifford (acid boric natri carbonat)
H m Palitzsch (acid boric borax):
Cc h m
Lu h ny khng dng cho thuc tim v acid boric i qua
thng dng
c mng tb hng cu, gy v hc.
cho TNM
Ngoi tdng m, cn c td st khun v kh thch ng vi
nim mc mt.
H m Acid boric natri propionat
Chnh xc
1.
Chnh xc
Tinh khit
Trong sut
2. v
khun
3. pH ph
hp
30
Son: T oan _ D08

ngha
Cht ng
trng ha
Nc mt ng trng vi dung dch NaCl 0,9% c h bng im: t = 0,52oC n 0,56oC.

Mt bnh thng chu c dung dch NaCl t 0,5 1 ,8%.
Nu thuc khng ng trng th mt s b kch ng, nc mt tit ra nhiu
v y thuc ra ngoi.
Thng dng NaCl v rt tan /nc, r tin, d kim, v l thnh phn ca
nc mt. C trng hp cn thay NaCl bng:
Na2SO4, NaNO3, KNO3, ... v NaCl d to ta vi cc dd bc nitrat.
Hoc Cc cht khng c tnh in gii nh glucose, lactose v NaCl
& cc cht in gii khc to ta vi dd bc keo argyrol,
protargol, ...
Nguyn tc:
Trong dd c nhiu cht tan, mi ct u tham gia vo h
bng im, ngha l h bng im ca dd bng tng s
h bng im ca cc ct c trong dd .
Cng thc LUMIRE CHEVROTIER:
Dng h
bng im
0,52 [ ]
[ ]
X (g): Lng cht t ha cn cho vo 100ml dd nh.trng

t1: h bng im ca dd nhc trng (c bng)
t2: h bng im ca dd 1% ca cht dng t ha.
Nu dng NaCl th [t2] = 0,58oC
4. ng
trng
Xem vd trong sch trang203, 204
Cc pp ng
trng ha
Dng
ng
lng NaCl
Tr s
Sprowls
(USP)
ng lng NaCl: l lng NaCl to 1 dd c h bng

im t, hoc p sut thm thu tng ng vi 1 n v
khi lng (1g) hot cht khi ta ha tan vo cng mt th tch
dung mi.
ng lng NaCl khng t l vi n dd, m ty thuc vo
s phn ly ca cc ion.
Xem vd trong sch trang205
**Lu :
Nu CT c nhiu dc cht, ta tnh tng s ng
lng NaCl cn cho cc dc cht, v tnh nh trn.
Khi dng l NaCl, cc hot cht hoc cht t ha c
th biu th bng n v khi lng hoc bng t l.
Tr s Sprowls: l s ml nc c thm vo 1g hot cht
to mt dd ng trng.
T tr s SProwls lng nc cn ha tan lng hot
cht c trong cng thc TNM, lng ny thng < lng ghi
trong cng thc lng dung mi d s c ng trng
ha bng cht t thch hp.
Xem vd trong sch trang206
5. Cc cht
khc
Cht lm tng nht

Cht chng oxh
Cht din hot
Xem iu ch TNM km sulfat, chloramphenicol (thc hnh bo ch),thy s hi.
31
Son: T oan _ D08

BI 1: I CNG HTCX
CU HI
L g?
1 HTCX
Mc tiu
Phn loi
2 Dchchit
Thnh phn
Nguyn liu
iu ch
Cch x l dc liu
3
trc khi chit xut?
Yu cu chung v dm
Nhng dung mi thng
dng trong HTCX?
Nc no?
Nc ct, nc kh khong, nc mm
Kh nng ha
tan
Ha tan
Ko ha tan
4. Dung mi
u im
Nhc im
u im
Cn
Nhc im
Dung mi no?
Vai tr
GHI CH
- Xng, sng, da
2.2.1./223
Thng s dng hn
hp cn nc
Nuc mm trnh to
cc dng mui Ca,
Mg a/h qt HTCX
Protein, pectin, enzym

Nha, tinh du, cht bo
D thm vo dc liu tho mc
Nc
Dm
hu
c
GI
L qt ha tan ko hon ton. L qt k thut
dng dm ha tan & tch cc ct ra khi DL.
Dm cha ct thu c gi l dch chit, phn
DL sau khi chit ly dch gi l b.
- Chit c ti da hot cht trong dch chit
- Gi li ti a tp cht b
- Tm iu kin kinh t nht (tit kim nht)
3 cch phn loi:
- Theo dung mi,
- Theo pp iu ch,
- Theo dng thuc
Hot cht + Cht h tr + Tp cht
- Dc liu tho mc
- Dc liu c ngun gc t ng vt
- Dit men (nu cn)
- Lm kh
D thm, ha tan chn lc, tr
- Nc
- Ethanol
- Dung mi hu c
- Du thc vt
Nc nng ha tan nhanh cc cht trong tb,

loi albumin khi dch chit
- Khng ha tan chn lc, nhiu tp
- Mi trng thy phn
- Mi trng cho VSV pht trin
- Ha tan c nhiu loi hp cht , c th thay
i nng ethanol t hiu sut cao
- C > 20%: bo qun
- C tos thp hn nc nn dch chit d c c
- Ethanol c tc dng dc l ring
- Nng cao kh thm bo dc liu
- D chy, n
Ether, aceton, cloroform, DCM, n-hexan,
benzen, toluen,
Do c nht & sc
cng b mt nh
Nc nng c th ph
hy cc t ch tb t.vt;
lm ng vn albumin
Thy phn glycosid,
alkaloid
Tinh du, nha, acid
hu c
- L dm trung gian tinh ch hot cht

- Loi tp trc khi chit
32
Son: T oan _ D08

GI
1. Thm thu: Thm dm vo mng tb DL
Qt HTCX xy ra qua my 2. Ha tan cc cht trong tbao
5
giai on?
Kh.tn ni (S thm tch)
3. Khuch tn
Kh.tn ngoi (kh.tn t do)
- Kch thc v chiu di mao qun
Thi gian thm thu ph - p lc mao dn
- p lc khng kh trong ng mao qun
thuc vo ?
- Bn cht dung mi
Ngm kit di chn khng
Lm chn khng cc mao qun v tb DL ko kh b rt i d ha tan dm
Nhng phng php
Ngm kit di p lc cao ( p lc cht lng)
thc y s thm thu
Thay kk trong mao qun v tb DL bng 1 cht kh d ha tan trong dung
mi nh CO2, NH3.
Vai tr ca cht din
Tng kh nng thm ca dm vo DL & cht tan do gim sc cng b mt.
hot trong HTCX
5.1. Thm thu
CU HI
5.2. Ha tan
- Th hin Tc ha tan cc
cht trong tb DL
inh lut Fick th hin
g?
Nhng phng php

thc y s ha tan?
5.3. Khuch tn
* Cng thc:
S khuch tn ni?
( thm tch; S khuch
tn phn t)
L g?
Mng
thm
C tc dng g?
tch
Hiu qu
Ti sao ni HTCX c
tnh chn lc?
Phng trnh biu th
lng cht khuch tn?
S
khuch
tn
ngoi?
L g?
c im
Tng din tch

tip xc
G: Kh.lng cht ha tan thi im t

F: Din tch b mt tiu phn cht rn
CS: N bo ha
Ct: n tc thi
x: B dy lp khuch tn
D: h s kh.tn ca ct trong cht lng.
PP: Nghin mn
**Nghim mn mc cho php hn ch tp do s
khuch tn ngoi
Gim b dy lp
PP: Khuy trn bng siu m
khuch tn
Qt vn chuyn ct t nhng tb nguyn vn qua mng tb
L g?
Chnh lch nng cht tan ca dung dch 2 bn mng
ng lc?
c dim
C s tham gia ca mng tb
Mng tb DL nguyn vn
Cho ct dng pht (thng l hot cht) i qua
Ko cho nhng phtu ln (gm, pectin, cht nhy) i qua
HTCX c tnh chn lc
Do tc dng ca mng thm tch
Vo H s tc vn chuyn
W = Vo A C A
Din tch mng
C
Gradient nng
Qt vn chuyn cht tan trn b mt ca tiu phn DL vo lp dung mi
bao quanh v t dn cc dung mi xa hn
Khng c mng t bo tham gia nhiu tp /dch chit
H s khuch tn ngoi >> h s kh/t ni Tc kh/t nhanh
33
Son: T oan _ D08

CU HI
Dc liu
Dung mi
GI
Non, mng manh nhanh
C.trc DL
Gi, rn chc chm
mn & cch phn chia DL
Mc
phi ph hp vi tng loi DL,
phn chia
pp chit, dm, ...
( mn)
Dm pc ha tan cc cht pc nh
mui alka, acid hu c, ng
Bn cht dm
Dm t pc ha tan cht t pc nh
alka baz, tinh du, ...
Khi tng lng dm, c th:
Chit c nhiu hot cht
T l dm &
Hoc lm tng lng tp
DL
cht.
Acid ha dm chit alka
tng hiu sut chit
Vd: Dng acid clohydric chit
alka ca v canhkina; Dng
acid tatric chit alka ca cc
la mch.
pH dm **
Kim ha dm chit
saponin tng hiu sut
chit; hoc a/h tt n qt
chit cc cht nhy /DL (vd
/v r Thc Qu, dm nc vi
5% NaHCO3 chit 1 lng cht
nhy > mt trung tnh)
tng hiu sut chit
Cht din
Vd: Chit alka thng dng
hot trong
Tween 20, Tween 80
dm
- Gim nht ca dm
tng tc tan v tc
khuch tn.
- Ph hy cc t chc tbDL
A/h ca
Nhit
- Dch chit cha nhiu tp
- C th pha hy 1 s cht
- Lm hao ht dm trong
trng hp dm c tos thp
GHI CH
trnh dp nt tbDL,
nn phn chia nh DL
theo nguyn l ct.
Cn tm t l dm/DL
ph hp t: hiu
sut chit, cht lng
dch chit & kinh t.
T l acid: 0,25 1%
so vi DL.
Cn chn acid ph hp
mui alka tng ng
c tan max trong
dm.
T l kim: 5 10% so
vi DL.
T l CDH: 0,2 0,5%
Nhc
Nhng
yu t
6
a/h qt
HTCX?
K thut
chit xut
Thi gian
chit xut
- Chit cng lu, lng cht

kh.yn cng nhiu ng thi
cng tng nhiu tp v nguy c
thy phn hot cht.
- Phi chn c thi

im ngng chit, da
vo: mn DL, PP
chit, Bn cht dung
mi, Nhit chit, ...
tng tc tan v kh.tn ct

vo dch chit.
S khuy
trn
C hc
Ch tc ng bn
ngoi tb
Siu
m
Xy ra c trong v
ngoi tb thi gian
chit ngn m hiu
sut cao.
34
Son: T oan _ D08

BI 2: CC PHNG PHP HTCX

Ngm lnh
Hm (Digestio)
Hm (Infusio)
Sc (Decoctio)
C in
Ngm
Tng quan
nhng pp
HTCX
Ci tin
(nhng pp iu
ch dch chit)
Ngm kit
(Ngm nh
git
Percolatio)
C in
Ngm kit c in
Ci tin
Ngm kit phn on

(Ti ngm kit)
Ngm kit ngc dng
Ngm kit dng p sut
Ngm kit dng siu m
Khng khuy
1. CC PHNG PHP NGM

CU HI
Nhit ngm
S ln ngm
PP
Ngm
Thi gian ngm
1
Nhc
PP
Ngm
ci tin
Thit b
Nhc im
M t?
Ngm
2 lnh l
g?
c im phn
bit
u im
Nhc im
TM TT
Mi pp ngm c nhit khc nhau
Ngm 1 ln vi tng lng dm
Hoc ngm phn on vi lng dm chia ra nhiu phn
Ph thuc loi dm
v nc: < 48 h v d nhim VSV
v cn: c th > 7 ngy
- Dch chit qu long
- Khng chit kit hot cht
- Tn nhin liu & thi gian c c
My khuy tc ln c cnh khuy lm vn DL.
Kh tch b khi dch chit
Tc khuy ln nhit tng dm bay hi.
** Khc phc bng my khuy trn siu m
Cho DL + dm vo bnh kn, tip xc mt thi gian nht nh
nhit thng v c khuy trn. Ht thi gian ngm, gn thu dch
chit v p b thu dch p, trn vi dch gn trn. lng,gn lc ly
dch trong.
Nhit thng
C khuy trn
iu kin
Thi gian ko di
Thi gian
ngm lnh
Bnh kn
D.c, Th.b
Dm d bay hi (cn, ether, cloroform, dm, ru
Dung mi
vang )
Khng c cu trc tbao (nha thuc
Dc liu
phin, l hi ..)
D tan / nhit thng
p dng
Hot cht
Khng bn nhit cao
Tp cht
D tan nhit cao
n gin, d thc hin
Tn thi gian & dung mi
Khng chit kit c hot cht.
35
Son: T oan _ D08

CU HI
M t?
3 Hm
c im phn
bit
TM TT
dm ang si vo DL c phn chia nh trong thit b kn t
dn nhit ri cho ngui dn, thnh thong c khuy trn, sau
gn v p b thu dch chit.
iu kin
Thi gian
d.c, th.b
~ 30 pht
Thit b kn, t dn nhit
Nc
(Khng s/d cho dm bay hi)
- DL mng manh
- Hot cht tan /nhit cao trong thi gian ngn
Dung mi
p dng
u im
n gin
Dch chit gi c hng v DL ban u
M t?
Ngm DL chia nh vi dm trong thit b kn nhit di im

si ca dm nhng cao hn nhit thng v gi nhit trong
mt thi gian nht nh, thnh thong c khuy trn.
tothng < thm < im si dm
thnh thong khuy trn
C th ko di hng gi
iu kin
Thi gian
4 Hm
Thit b kn
C thm b phn gia nhit
C sinh hn hi lu (/v dm d bay hi)
Thng l nc, du
- DL rn chc
- Hot cht
t tan / nhit thng
Khng bn / nhit qu cao
(Vd: Nha toluen, nha cnh kin trng)
d.c, th.b
c im phn
bit
Dung mi
p dng
M t?
un si nh nhng DL vi dm nc trong mt thit b c np y, sau

mt thi gian nht nh, gn & p b thu c dch chit
iu kin
5 Sc
c im phn
bit
60-90 pht ty DL v ty s ln sc
*Ln 1: Lng dm nhiu hn v sc lu hn.
C np y
Nc
Thuc thang
Thi gian
d.c, th.b
Dung mi
p dng
36
Son: T oan _ D08

2. CC PHNG PHP NGM KIT NGM NH GIT (Percolatio)

2.1. Ngm kit c in
- Cho khi bt DL vo bnh ngm kit, gia cc tiu phn trong khi DL c
nhng khe h hay cn gi l khong khng c tnh mao dn.
- dm ln khi bt ny, dm chy lun vo cc khong khng nh trng
lc (P1), i nghch lc mao dn & nht ca dm (P2).
C s l thuyt
- Khi P1 = P2, dm ngng chy xung, cc qt HTCX din ra (ha tan, khch
tn, thm tch, thm thu, ...)
6. Tng quan: Ngm kit c in
- Tip tc thm dm mi lm cho qt cn bng b ph v, dm mi s chim

ch & y dch chit xung di
c im ca qu
trnh
Ngm kit l 1 qu trnh:

Ngm phn on (DL ko tip xc 1 ln vi tng lng dm)
Ngm t ng (Dm mi thay th dch chit do trng lc)
Ngm lin tc (Ko phn bit tng giai on)
M t
Bnh ngm kit
hnh nn ct lt
ngc
u
Nhc
Thit b ngm kit

u
Bnh ngm kit
hnh tr
Nhc
Cc bc tin hnh
u
Nhc
7. Lm m DL
ng dng
Ti sao phi lm m
DL?
- Thao tc d dng
- t b tt khi DL trng n
- Dm d chy thnh lung khuy ng
- Phn trn rng nn d bay hi.
- Dm chy iu ha hn ch to thnh
lung khuy ng cc lp dch chit t b
xo ng
- Dm c xu hng chy vo gia nhng
DL gc ko chit kit
- Kh tho b.
Lm m DL
Np DL vo bnh & ngm lnh
Rt dch chit
Kt thc ngm kit
Chit kit hot cht hn pp ngm (cng lng dm)
Dch chit u m c c th ring, khng cn c hoc c t.
Khng p dng /v:
+ Dm nc (d nhim vi sv), kh.
+ DL cha nhiu cht nhy, tinh bt, gm, (y l cc tp lm nght bnh)
iu ch: Cn thuc, cao thuc (tr 235)
DL trng n to nhng khe h u nhau trnh s nn cht trong bnh
chit dch chit & dm ko b xo trn To cho dm ngm nhanh & u
vo tng tiu phn DL.
** Nu ko lm m th khi np DL vo bnh:
+ Nn cht Tt bnh
+ Khng nn Dm ko thm c DL
Trng hp no
khng cn lm m?
- DL khng c cu trc tb. (DL no?)

- Dm khng pc
Lng dm lm m?
Thng 2030% lng DL, c khi 50100% (ty thuc bn cht DL & dm)
Thi gian lm m
Khong 2-4h, y kn
37
Son: T oan _ D08

9. Rt dch chit
8. Np DL
M t
Ngm lnh
Lng DL np vo
binh?
Lng dm?
Tc rt dch
chit?
10. Kt thc ngm kit
Ch g? Ti sao?
Thi im kt thc
ngm kit?
Cch xc nh
thi im kt thc?
Cho DL lm m vo bnh, san bng mt, khng nn cht

Gip DL thm u dm
Mc ch
thi gian cn thit cho qt ha tan & khuch tn.
Dch chit u thu c m c hn.
Thi gian
Khong 12 24 gi
Khng qu 2/3 th tch bnh.
DVN quy nh: 1 3ml /pht
Ty s lng DL (ch yu) & loi DL.
Vd: Lng DL 200g (t!) th tc 1 ml/pht
X
S git /pht
Cng thc tnh:
K
H s ph thuc lng DL
=
C
Lng DL chit (g)
Khi rt dch chit, phi thm dm lun to 1 lp dm trn b mt khi DL
V: B mt DL ko c dm s c thay th bng khng kh to nn nhng khe h, lc
ny ta mi dm vo th khng kh s y ngc dm tr ln lm xo trn cc lp DL
bn di hng c bnh.
Lng hot cht ti u

Thi gian ngn nht
(Trong sn xut: do vn kinh t, khng tn lng ln dm m dch chit
ra ch cn rt t. Trong nghin cu th khc)
- Cm quan: mu sc, th v
- Puhh: Thuc th c bit cho tng nhm hot cht
Th trn sc vt
- D Thy S qui nh cn kh trong 10ml dch chit cui cng phi < 0,02g
**Thng lng dm gp 6 7 ln lng DL
Bnh ngm kit hnh nn ct lt ngc

y trn D
Gc vt to bi trc v
cnh hnh nn khong 3o
y di d
ng thot c kha
* iu chnh tc chy ca dch chit
38
Son: T oan _ D08

2.2. Cc phng php ngm kit ci tin

:
Bnh 1
Bnh 2
500g
Bnh 3
300 g
200g
500 ml x 3
Ngm kit phn

on
(ti ngm kit)
200ml
200 ml x 3
300 ml
500ml
1000 ml
Ngm kit ngc

dng
Ngm kit dng

p sut
Vd: Tin hnh chit xut theo phng php ti ngm kit vi lng DL 1000g, chia
ra 3 phn khng bng nhau, s bnh ngm kit phn on l 3.
T Bnh 1 chit c 200ml DC u ring, 1500ml DC sau (chit 3 ln, mi ln
500ml) lm m v chit DL Bnh 2.
T Bnh 2 chit c 300ml DC u ring, 600ml DC sau lm m v chit DL
Bnh 3.
T Bnh 3 chit c 500ml DC. Gp c DC u ca c 3 bnh li l: 200 + 300 +
500 = 1000ml (t l DC thu c so vi DL l 1/1 = 1000g DC / 1000ml DL).
Nguyn tc:
Chiu ca DM v chiu ca DL ngc dng.
DL c chit vi nhng DC c nng hot cht gim dn.
DM th ln lt chit xut cc nguyn liu c t l hot cht tng dn.
Phn loi:
Ngm kit ngc dng gin on:
S ln DC: n ln.
S bnh ngm kit: n + 1.
Ngm kit ngc dng lin tc: o
DL chuyn ng ngc chiu vi dm. o
Thu c DC mt u. B c y ra u kia.
p dng trong sn xut ln. Khng tn nhiu cng sc.
Dng p sut cao:
Dng p lc kh y dm qua khi DL.
DL cha trong nhng bnh hnh tr di, ng knh nh.
Dng p sut gim: Dng bm chn khng.
Ngm kit dng

siu m
C bi tnh ton:
cho dc liu, yu cu xut lng dm
Qt ngm kit phi xc nh tng lng dm dng, ngm bao nhiu, dch chit u?, Chit c bao nhiu th ngng? C
bao nhiu? Cha li bao nhiu?
Cc pp ngm kit ci tin ch hc nguyn tc.
Phn bit c cc pp ngm.
39
Son: T oan _ D08

BAI 4: CAO THUC & DCH CHIT M C

1.TNG QUAN CAO THUC & DCH CHIT M C
L g?
c im
Phn loi
Tngquan
Cao thuc
Cc giai on
iu ch
L g?
Tng
u im
quan Dch
chit m
T l dch chit
c
v ch phm
Cc giai on
iu ch
Dch chit m c pha
siro 1/10
Dch chit m c pha

nc tr thuc
Nhng ch phm c iu ch bng cch c n m c nht nh

cc dch chit thu c t cc DL (Xem s 5.12/247)
- c loi tp cht (1 phn hay hon ton)
- T l hot cht / cao thng t l hot cht / DL
- Ch phm trung gian iu ch cc dng thuc khc
Cao kh
Khi bt. Rt d ht m. m phi 5%.
Theo th
cht cao
Khi c qunh. Hm lng dm dng CX
Cao c
cn li trong cao 20%.
(c trng
Khi lng hi snh. Mi v c trng ca DL
nht)
Cao lng
**Nu ko c ch dn khc, qui c: 1ml cao
lng tng ng 1g DL dng ch cao
Cao nc
Theo dm
Cao cn
Cao ether
Cao c theo pp ngm lnh (vd cao thuc phin)
Theo pp
HTCX
Cao c theo pp ngm kit (vd cao m tin)
iu ch dch chit (Xem li bai 2)
C c Lm kh: a dch chit n th tch nht nh
Loi tp (Nu cn)
Qt loi tp thng gn lin vi c c.
Hiu chnh hm lng hot cht trong cao
(Tiu chun ha cao thuc): ng nht hm lng ng nht
tdng tr liu.
Dng bo ch trung gian c pha ch sn & bo qun trong phng pha
ch
- iu ch ch phm nhanh chng m khng cn phi bo qun DL
phng pha ch
- ng nht v mt cht lng
1/10
4 giai on nh cao thuc
Nc (v hot cht khng bay hi. Vd: cam tho, vin ch,
lc tin, )
dm chit
Nccn (v tinh du hoc cht bay hi. Vd: nhn trn, trn
b, cnh kin trnagws, khuynh dip, )
L nhng cao lng
iu ch bng pp ngm kit hoc ngm lnh
Dung mi chit l cn thp (25 30%)
Khi dng, pha 1 phn dch vi 9 phn nc
Ch dng trong 12h sau khi pha thnh tr thu
40
Son: T oan _ D08
1. ch dch
chit
CC GIAI ON IU CH CAO THUC

La chn dung mi
chit da vo u?
Cho vd?
2. loi tp
Loi tp tan nc
hoc cn thp
Loi tp tan /cn cao
hoc dm hu c
3. c c lm kh
Loi tp bng pp thay

i pH?
Khi c c cn tun
theo nguyn tc no?
C cch
thy
Cc pp
c c
C chn
khng
4. hiu chnh
hm lng
Cc pp lm kh
Tiu chun ha cao

thuc
- Bn cht hot cht & tp cht

- PP chit
a/d cho cc pp ngm (a s)
Nc
Nc acid ha hoc nc nng: trong pp ngm kit
Vd: Cao lng canhkina; cao lng cam tho (USP XVIII)
Ethanol
a/d cho pp ngm kit, ngm lnh
Tp
Gm, nhy, pectin, tinh bt,
PP loi
Tp
- Nhit , Cn cao (do lm ng vn cc tp trn)

Nha, bo,
- Nc nng
PP loi
- Nc acid ha
- Parafin rn
Tp trong dch chit t DL cha Flavonoid. Alkaloid.
Tp
(2.2.3./249)
- Nhit c c cng thp cng tt
- Thi gian c c cng nhanh cng tt
- Thu hi dm
Mc ch: m bo hot cht ko b ph hy v t hiu qu kinh t.
- Dng c: c b mt bc hi rng
- Khuy trn: trnh to vng b mt, cn tr s bay hi.
Ch :
1 s dch chit trong bnh c th si bt mnh thm vo dch chit
b ca cao, parafin, hoc du thc vt ngn s to bt.
C nhanh!
Xem bi 3
Khi hm lng Phi trn vi cao c HL ln hn (/v cao kh, cao c)
< hn q
C bt dung mi (/v cao lng)
Glycerin, cao ru ng, cao cam tho, cao
Khi hm
men bia (/v cao c)
Dng cht
lng > hn
n
Tinh bt, lactose, glucose, magnesi oxyd,
q
b DL nghin mn (/v cao kh)
41
Son: T oan _ D08
BI 5: CN THUC RU THUC
1. CN THUC
Nhng ch phm lng
c iu ch bng pp
chit xut DL (ngm lnh, ngm kit)
L g?
hoc ha tan cao thuc, dc cht, tinh du
theo t l qui nh ethanol nhng nng khc nhau
Cn thuc n: c t 1 ng.liu
Theo thnh
Cn thuc kp: c t nhiu ng.liu khc nhau (vd cn
Tng quan
phn ng.liu
opi-benzoic)
Cn thuc
Phn loi
Cn thuc tho mc
Theo ngun
gc DL
Cn thuc ng vt
Ngm lnh, ngm kit, ha tan
Theo pp c
Lu :
Tiu chun m (v a/h n cn)
Nguyn liu
mn thch hp (ty bn cht DL v dm)
Vd: cn thp th phn chia th, cn cao th phn chia mn)
Etanol 60% Thng DL khng cha tinh du
Etanol
DL c (cha alka, glycozid)
La chn
70 80%
DL cha tinh du (cn v qut)
ty vo bn
DL cha hot cht d b phn hy (cn u)
cht DL
DL cha tinh du
Etanol 90%
DL cha cht ch tan trong cn cao (cn
Ethanol dc
cnh kin trng, cn gng)
Dung mi
dng c nng
Dng c
Cn k bch phn (trang 258)
iu ch
Xc nh
thch hp
nng
cn tht: cn 15 oC
2
khi
nim
cn
cn biu kin
Bng tra cn Gay Lussac (Khi C > 56%)
Chuyn cn biu kin Cng thc tnh cn tht
sang cn thc: 2pp
X = C + 0,4 (15 t)
(Khi 25%<C<56%)
/v DL thng
1 : 5 (nu ko c qui nh hm lng hot cht)
T l DL & thnh phm
/v DL c
1 : 10
p dng cho DL ko cha hot cht c mnh, v cha t tp tan trong cn
Ngm lnh
Vd: cn ti, cn i hong, cn v qut, cn gng,
DL c hot cht c mnh hoc DL thng & ko cha tp tan /cn
3 PP iu
Ngm kit
Vd: Aconitin
ch cn
p dng cho DL c nhiu tp tan (nha, bo) trong cn
thuc
Ha tan
Vd: thuc phin, m tin
Cn kp
Kt hp ccpp ni trn
Mu, mi, v
Cm quan
0,87 0,98
T trng
Bng pp ct cn o t trng ca cn thu c
Hm lng ethanol /
Kim sot
Hoc pp GC
ch phm
cht lng,
L s ml nc cho vo 10 ml cn thuc xut hin ta c
H s vn c
bo qun
Cn sau khi bay hi
nh lng hot cht
(/v cn thuc c)
PP ha hc; Th hot tnh sih hc; PP Debreuille (pp cp tc

xc nh gii hn t l alkaloid trong cn thuc)
42
Son: T oan _ D08
2. RU THUC
Cu hi
L g?
c im
Phn loi
Tng quan
Ru thuc
Thnh phn
1. iu ch
dch chit
Cc giai
on iu
ch ru
thuc
2. Pha ru
Tm tt
Dng thuc lng c mi thm v v ngt
iu ch: ngm DL t.vt hoc .vt ( ch bin) trong ru hoc ethanol
long
Hm lng ethanol / ru thuc 45%
c dng trc tip cha bnh, b (khc vi cn thuc)
Ru n
Ru kp (Vd: ru h ct)
Nguyn liu
Dung mi
Saccarose
- V ngt
iu v
- To nht n nh ru thuc, hn ch
bay hi ru, lng cn, oxh hot cht
Hng DL
iu
Vd: trn b, qu, tiu hi
Cht ph
hng
Tinh du thm
Mu do chnh DL
VdL huyt gic
To
mu
Cht mu thc phm
Caramen
- Thng dng pp ngm lnh, ngm phn on
- Khi ngm phi y kn, ch mt hoc ngm h th
Pp chit
- ngm nng t s dng v ru d bay hi, phi c thit b
un hi lu
iu chnh thnh phm c ru v mi v thch hp
Mc ch
ru khi chit xut l 40 50% nhng ru thnh
chnh
phm thng khong 20 30%
Tr ngi
Ta & Bin mu
Phi hp t t cc dch chit c thnh phn, cn gn
ging nhau trc ng thi phi hp vi cc cht n nh,
cht trung gian ha tan.
Nguyn tc
Phi hp siro n vi dch chit th nht
Thm t t dch chit th hai v cc dch chit ring
Pha long t t vi nc n ru qui nh (Nc dng
pha ru nn l nc ct un si ngui)
Cc bn nh xem cc cng thc iu ch cn thuc, cao thuc (Mc 4 tr.252, mc 5 tr.261)
43
Son: T oan _ D08
B sung:
HTCX
Dc lie u
Dung mi
DCH CHIT
Pha n la p
Tng hoa t chat
Ba
X ly
CC DNG CH PHM
Ti liu tham kho:

Gio trnh Bo ch v Sinh dc hc Tp 1
Cp nht phn thy Ha n thi TN
cng (Nguyn Ngc L _ DCT 2007)
Mt s t vit tt
ct = cht tan
dm = dung mi
t = ng trng
DL = dc liu
pc = phn cc
kpc = khng phn cc
tb = t bo
a/h = nh hng
qt = qu trnh
v = i vi
mt = mi trng
CDH = cht din hot
TNM = thuc nh mt
pp = phng php
s/d = s dng
Tt = Thuc tim
Tttr = Thuc tim truyn
CX = chit xut
c = iu ch
dd = dung dch
Cui mi bi mnh c ghi li nhng cu thy dn thm.

Bi son kh trnh khi sai st, mong cc bn ng gp v b sung! Chc lp mnh thi tht tt!
44
Son: T oan _ D08

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Tng hp l thuyt Bo ch I _ n thi TN 2013

CHNG I: I CNG V BO CH & SINH DC HC ------------------------------ 3

CHNG II: DUNG DCH THUC ----------------------------------------------------------------- 6

CHNG III: THUC TIM------------------------------------------------------------------------ 18

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Tng hp l thuyt Bo ch I _ n thi TN 2013

CHNG IV: THUC NH MT------------------------------------------------------------------ 30

CHNG 5: CC DNG THUC BO CH BNG PP HTCX----------------------------- 32

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Tng hp l thuyt Bo ch I _ n thi TN 2013

Thuoc chuan goc

Sn xut ra quy m cng

- Sn xut l thuc c cht

- Xy dng cng thc v lm h

- ngha: GMP gii quyt vn

- Ging vi cht lng ng k.

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Tng hp l thuyt Bo ch I _ n thi TN 2013

L phn liu thuc c hp thu nguyn vn

Tng ng thi im c s hp thu v thi tr tng ng

Cmax: N ti a ca thuc /ht

2. CC KHI NIM TNG NG

Cc ch phm cha cc hot cht khc nhau c ch nh cho mc tiu tr liu v lm

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Tng hp l thuyt Bo ch I _ n thi TN 2013

3. TH NNG THUC TRONG MU THEO THI GIAN

Thi gian (h)

(b) Trng hp du ng thuoc t 1 ng hap thu

MEC (mininum effective concentration): Nng ti

Cng tc ng (intensity): Khong cch gia MEC

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Tng hp l thuyt Bo ch I _ n thi TN 2013

BI 1: I CNG V HA TAN & K THUT HA TAN HON TON

Nu cht b phn tn mc phn t hoc ion

Dd keo (dd gi)

Nu cht b phn tn l cht cao phn t hoc s ha tan to ra cc

Nng phn trm

Cch thng th thng dng:

Khi lng /th tch (g /100ml)

S phn t cht tan trong 1 lt dd:

N ng lng l s ng lng gam cht tan trong 1 lt dd.

- 1 mEq l lng tnh bng miligam tng ng vi trng lng

S proton hot tnh

S electron cho / nhn trong qu trnh p

Nu l cation: n = S in tch cation

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Tng hp l thuyt Bo ch I _ n thi TN 2013

2. TNG TC DUNG MI CHT TAN

2.2. Tng tc dung mi cht tan

Hin tng solvat ha