K thut bao vin

Mc tiu bi hc:
1. Nu c yu cu ca lp v bao v tiu chun vin
nn bao.
2. Trnh by c cc giai on trong bao ng,
nhng kh khn khi bao ng v cch khc phc.
3. Nu c nguyn liu dng trong bao phim..
4. Trnh by c cu to c bn ca thit b dng
bao phim (k tn mt s loi thit b).
5. Trnh by c qu trnh bao phim.
6. Nu c cc tiu chun cht lng ca vin bao v
phng php kim tra.

Ti liu hc tp
1-B mn Cng nghip Dc (1999), K thut bao vin,
Sn xut thuc I, tr.58-74.
Ti liu tham kho:
1-B mn Bo ch (2004), k thut bao, Mt s
chuyn bo ch hin i, tr.94-123.
2-DVN III (2002), ph lc.1.15 (PL19-20)
3- Banker G.S.,C.T. Rhodes, Modern Pharmaceutics,
third Ed., Marcel Dekker Inc., 1995
4-Lachman L. The theory and practice of industrial
pharmacy, third Ed., Philadenphia, 1986.

i cng

Yu cu
ca lp
v bao

Tchun
vn em
bao

Cc PP
bao vin

Yu cu ca lp v bao
1. Tng v p cho sn phm (b mt nhn,
mu u)
2. bn c hc thch hp (khng v, nt)
3. t c yu cu v mc ch ca vin bao (bao
bo v, tan rut, kim sot gii phng)
4. Che du mi v kh chu ca DC
5. Lp bao cng mng cng tt.
Tiu chun ca VN em bao
1. Mt vin phi li, cnh vin mng
2. Vin c bn c hc tt: cng >6,0kg;
mi mn thp: <1,8%.
3. DC v TD khng tc dng ho hc vi kim loi ca
ni bao v TD dng bao.

Cc PP bao vin
1. Bao ng
2. Bao phim
3. Dng my dp vin bao vin

Bao ng

Cc g
trong B

u nhc
im
/B

Nhng
kh khn/
B

my B, bao phim t
ng

ni bao ng c
in

Khthi

Cp kh
nng
Khnn
Dch bao
Thnh ni

c l

M hnh ni bao phim, bao

ng t ng c thnh ni c l

Cc giai on trong bao ng

Giai on
Bao
cch ly

Mc ch

Nguyn liu

Bo v
nhn

Polymer: shellac, zein,

HPMC, CAP

Ph kn
cnh vin

T dc dnh + bt rc
Hn dch bao

Bao
nhn

Lm nhn
b mt

Siro + titan dioxid

Bao
mu

Lp mu
ng nht

Siro + cht mu

Bao
bng

Lm bng
mt vin

Sp carnauba,
sp ong

Bao
nn

Cc giai on trong bao ng

Cc giai NL s dng,
on
dng dng.

K thut lm

Bao
cch ly

Shellac, zein, HPMC,

PVAP, CAP.
Thng pha dd 1530%/cn

-Bao trong ni bao vin c

in, t ng.
-Khi vin cho vo phi sy
nng, chuyn ng trong ni
bao.
-Rt hoc phun dd bao vo
khi vin, thi gi nng sy
kh, c lm nh vy n khi lp
bao t yu cu.

Bao
nn
dng
bt rc

-Bt rc: bt ng,

CaCO3, MgCO3, tinh
bt, talc, kaolin,
dextrose.
-T dc dnh: siro 5060% (c th thm MC,
gm, gelatin)

-Cho nhn vo ni bao (c

in), cho ni quay o vin.
-Cho mt lng TDD vo o
u.
-Rc mt lp bt rc, o
nh, cho vin quay t do cho
bm chc vo nhn. thi gi

Cc giai on trong bao ng

Cc giai
on

NL s dng, dng
dng.

K thut lm

Bao nn
dng hn
dch bao

- Hn dch bao: CT phi

hp gia TDD v bt
rc.

-Cho nhn vo ni bao, cho ni

quay o vin.
-Sy nng vin, cho tng lng
hn dch bao, o vin
phn tn u, thi gi nng.
C lm nh vy khi lp bao t
yu cu

( c th
AD/bao t
ng)

Bao nhn Thng dng siro 3/1

Bao mu
PP bao
mu tan
trong nc

hm nng.
i khi c th thm 15% TiO2 lm cht cn
sng.

-Cho vin bao nn v sy

kh vo ni bao, cho ni quay. T
i tng lp siro 3/1 hm nng
vp vin, quay t do 5-10
pht v thi kh nng35-40 0C
lm kh. C lm nh vy cho
n khi lp bao t yu cu

-Dng siro 3/1 c mu

tng t nht n m
bao.
-Siro mu thng c

-Cho vin bao nhn vo ni

bao, cho ni quay. Ti hoc
phun tng lp siro mu, cho ni
quay t do/3-4pht, thi gi

Cc giai on trong bao ng

Cc giai
on

NL s dng, dng
dng.

- Dng siro 3/1 c mu

Bao mu
(ch dng mt loi siro
PP bao
mu)
mu
khng tan

Bao bng

Thng dng cc loi sp:

sp ong, carnauba,
candelilla.Dng di dng
bt mn, dd/dung mi
hu c, bt
nho/ethanol

K thut lm
-K thut cng lm nh trn. Nh
ng nhanh t c lp mu ng
nht hn.
-BM xong vin c sy kh n
m qui inh.
- Cho vin sy kh cn nng
vo ni bao, cho ni quay, cho
cht lm bng vo, cho quay
n khi vin t bng th
xc vin ra.

Ch : B t ng/ thit b bao t ng ?

Cc yu t nh hng n s ng nht lp bao

Qu trnh bao gm:
1. Cp dch
2. Vin xo trn nh chuyn ng ca ni bao
3. Thi gi nng (sy)
lp bao c ng nht th
-

Lp dch bao phi lng cho n khi lan trn b

mt nhn bao

Dch bao phi thm t tt c cc vin, tng dn l

ng dch khi kt vin tng ln

Ni bao phi o vin tt.

u nhc im trong bao ng

1. u im: d lm, nguyn liu d kim r
tin
2. Nhc im:
- Nhiu cng on, mt thi gian
-

Khng ghi c k hiu trn vin

V bao dy ah n r ca vin

V bao d v, nt, kh bo qun.

Nhng kh khn trong bao ng v cch khc

phc
1/ Vin b gy v khi bao
php:.......

nguyn nhn v gii

2/ V bao b st m
3/ V bao b rn nt
4/ Vin bao kh sy kh
5/ Dnh vin
6/ Mu khng u
7/ Vin b m v m hi
8/ Vin lm m

So snh mt s c im gia
bao ng bao phim
Bao ng

Bao phim

Tnh
cht
mng
bao

V bao dy (50-100%)
Gin, d v
Khng gi c k hiu
khc trn vin

Mng (2-4% kl nhn, c

th <10% kl sp)
Mm do, bao c nhiu
dng thuc
Gi c k hiu

Qu
trnh
bao

phc tp, ko di,

kh t ng ho

n gin, nhanh,
d t ng ho

Thit b n gin

chuyn dng

Nguyn d kim, r tin

liu bao

La chn linh hot

Nhn
em

Vin trn, vin nn

Vin nn, cm, ht,

pellet...

Bao phim

Nguyn
liu /BP

K thut
BP

1 s Nguyn
nhn gy
hng mng

Nguyn liu dng trong bao phim

1.Polymer (cht to mng)
2.Cht do ho
3.Cht mu
4.Dung mi.

1. Polymer
V d
Polymer
bao mng
qui c
Polymer
bao mng
tan rut
Polymer
bao mng
gii phng
ko di

Cellulose (HPMC, HPC, MC, EC)

Vinyl (PVP)
Glycol (PEG)
Polymethacrylat (Eudragit E, NE)

CAP
CAT
PVAP

pH
6.0
5.5
5.0

HPMCAS
EUDR. L100
HPMCP

pH
5.0-6.5
6.0
5.0-5.5

Cht bo v sp (sp ong, carnauba, alcol

cetylic, alcol cetostearylic).
Shellac, Zein, Ethyl cellulose
Ester ca cellulose (v d acetate)
Silicon th n hi
Polymethacrylat (Eudragit RL, RS)

2. Cht do ho
nh hng cht do ho i vi tnh cht mng
Tnh cht
mng

Xu hng nh hng

Nhit
CHTT

Gim

bm dnh

Tng

Tnh thm

Tng hoc gim

2. Cht do ho
Nhm ho
cht

V d

Alcol a chc

Glycerin, Propylen glycol

PEG 200-6000

Ester hu c

Diethyl phthalat (DEP), Dibutyl

phthalat (DBP), Triethyl citrat (TEC),
Acetyl triethyl citrat (ATEC), Acetyl
tributyl citrat (ATC)

Cc loi du v Du thu du
glycerid
Monoglycerid acetyl ho
Du da ct phn on

3. Cht mu
Nhm ho cht

V d

Cc phm mu
tan trong nc

sunset yellow, quinoline yellow,

tatrazine, erythrosine

Cc cht nhum
mu dng lake

sunset yellow lake

quinoline yellow lake

Cc cht mu
v c

titan dioxid, talc, st oxid.

Cc cht mu
t nhin

riboflavin, carmin, anthocyanin,

chlorophyll

4. Dung mi
Nhm dung mi V d
Nc

Alcol

Methanol, Ethanol,
Isopropanol

Ester

Ethyl acetat, Ethyl lactat

Ceton

Aceton, Methylethyl ceton

Dn xut chloro
ca hydrocarbon

Methylen chlorid, Trichloethan

K thut bao phim

1. Chun b cho bao phim
- Thit lp CT cho dd bao
- Pha ch dch bao
- Chun b vin bao
2.Thit b bao phim
3. Tin hnh bao vin

Cc g trong bao phim:

Cc giai
on

Ni dung

K thut lm (cch
tnh)

Thit lp -la chn polyme

CT cho dd ph hp v cc TD
bao
khc.
-Tnh ton dy
phim.

- loi polyme, cht do ho,

cht mu, cht chng dnh.
-Tnh din tch b mt
vin.
-s mg cht rn to thnh/1
cm2 b mt
-KL cht rn to phim cho 1
m sx n vin.

Pha ch
dch bao

-Thng pha hn
dch (tng lng
cht to mng: 515% so vi tng l
ng dch)

-Ngm polyme trong dung

mi cho trng n.
-Cht rn c phn tn/dm
=my khuy tc cao.
- Dch bao c lc qua ry
0,25mm v khuy lin tc
trong khi bao.

Chun b
vin bao

-Vin phi t TC ca
vin em bao
-Vin sy nng trc khi

Cc g trong bao phim:

Cc giai
Ni dung , k thut lm
on
Tin hnh
bao
Tin hnh
bao trong ni
bao

-Cho vin vo ni bao, cho ni quay, ht bui.

-Thi gi nng sy vin.
-Phun dch bao vo vin vi tc sao cho vin c
sy kh lin tc.
-Cui cng c th bao bng = dd PEG 10%.
-Sy vin n m qui nh

Tin hnh
bao
Tin hnh
bao trong
thit b tng
si

-Cho nhn vo bung lm vic ca my.

-Thi kh nng vo theo chiu t di ln v p lc sao
cho nhn chuyn ng thnh dng trong bung lm
vic, nhn bao ln lt qua vi phun dch bao.
-Phun dch bao qua vi phun.
-Nhn c sy kh ngay trong dng ko kh nng.

Cch tnh khi lng nguyn liu rn to phim

*Gi A: din tch b mt vin (mm2), d: ng knh vin
(mm), h: b dy vin
Din tch b mt vin:
-Vin nn trn: A=(d.h+1/2d2) (mm2)
-Vin nang, vin nn di: A= d.h (mm2)
-Vin trn: A=d2 (mm2)
*Gi L l s mg cht rn to thnh trn 1 cm2 b mt.
Mng bao bo v thn nc: L=2-4mg/ cm2
Mng bao bo v s nc: L=1-2mg/ cm2
Mng bao tan rut: L=3-5mg/ cm2
Hoc trong qu trnh nghin cu tm ra L
*Khi lng cht rn Q to phim cho m sn xut n vin:
Q=L (mg/cm2).A (mm2).10-2.n
Ch : b lng h hao trong qu trnh bao t 5-10%.

Thit b bao phim

Gm c 4 b phn
1/ B phn cha vin v lm chuyn ng vin
2/H thng phun dch bao:
- Phun cao p
-Phun dng kh nn
-Phun siu m
3/ B phn cung cp kh nng, sy kh vin trong qu trnh
bao.
4/ B phn ht bi v dung mi ra khi ni bao.
Mt s loi thit b bao phim
1/Ni bao ng c in
2/Ni Pellegrini
3/Ni Strunck
4/ Ni bao c l: Ni Accela Cota;Ni Hi-coater; Ni

Qu trnh bao
Khthi

Cp kh
nng
Khnn
Dch bao
Thnh ni

c l

Gm 3 qu trnh:
1. Qu trnh phun dch bao
2. Qu trnh sy
3. Qu trnh o vin

C ch hnh thnh mng bao

T o git phun

Thm t

Git phun di chuyn

Lan rng

Va ch m vo nhn bao

H p nht thnh mng

H
nh 2. Qu tr
nh h
nh thnh mng bao

Cc khuyt tt mng bao

1. Mng b nt v bong
Nguyn nhn: ng sut
Ba loi ng sut:
- ng sut co ngt: co th tch khi dung mi bay hi.
- ng sut nhit: chnh lch h s gin n nhit.
- ng sut th tch: thay i th tch nhn bao.
ng sut > bn ko nt mng
ng sut > lc bm dnh bong mng
2. Dnh vin v thng mng
Nguyn nhn: qu t
- Tc phun dch cao, di phun hp
- Hnh dng vin khng thch hp
- Ni bao o vin km

3. Mt vin th rp
Nguyn nhn: hin tng sy phun.
- Tc phun dch qu chm
- Nng polymer hoc t l cht rn qu cao
- Nhit v lu lng khng kh sy qu cao
- p sut kh phun qu thp
- Khong cch t sng phun n khi vin qu xa.
4. Cnh vin b mi mn
Nguyn nhn:
- Nhn bao c mi mn ln
- Cnh vin c g (bavia)
- Mng bao qu gin
- Kch thc vin to, khi lng m bao ln

Bao bng my dp vin:

Dng my dp vin quay trn bao vin

Ni dung , k thut lm
Tin hnh
bao dng
my kp

-Cht bao, c lm di dng ht, bao trn.

-Nhn bao c lm my th nht, vin lm xong
chuyn theo mng sang my th hai bao

Tin hnh
bao dng
my n

1.
2.
3.
4.
5.
6.

Vin lm nhn phi dp ring sau a vo my

dp vin bao.
Qu trnh bao vin gm 6 bc.
Chy di h xung, phu np ht bao na lp di.
Chy di ha tip xung, nhn bao c a vo
ci.
Chy trn h xung nn ci.
Chy trn i ln, chy di tip tc h xung,
phu phn phi ht bao na lp trn vo ci.
Chy trn h xung, bao hon thin v bao.
Chy trn, chy di i ln, v y vin ra

u im ca PP bao vin bng my dp vin

-Ton b QT u kh (cht d b hng bi m v
nhit. VD: peniclin, vitamin C)
-Khi lng ca vin bao u nhau
-Vin r nhanh hn
-C th t ng ho ton b qu trnh.
-C th in ch, k hiu trn vin.

Mt s v d cng thc bao phim

1. Cng thc c polymer l dn xut ca

cellulose
% w/w
Vai tr
HPMC
7.5
Polymer
PEG 400
0.8
Cht do ho
St oxid (vng)0.6 Cht mu/cn sng
Titan dioxid 3.1
Cht mu/cn sng
N
88.0
mi cao
2.cCng thc
c Dung
cn sng
% w/w
HPMC
6.9
PEG 400
0.7
St oxid (vng)4.4
Nc
88.0

Vai tr
Polymer
Cht do ho
Cht mu/cn sng
Dung mi

3. Cng thc c cha

% w/w
HPMC
6.5
PEG 400
0.7
St oxid (vng) 0.5
Talc
4.3
Nc
88.0

bt talc
Vai tr
Polymer
Cht do ho
Cht mu/cn sng
Chng dnh
Dung mi

4. Cng thc c polymer acrylic dng phn tn

% w/w
Eudragit RL30D (h phn tn 30%) 5.5
Hn dch mu 30%
16.4
Citroflex 2
1.1
Nc
77.0
Hn dch mu 30%
Talc
Titan dioxid
Quinolin yellow lake
Nh tng kh bt
PEG 6000
Nc

%w/w
15.0
8.0
4.0
0.1
3.0
69.9

Kim
cht lng mng bao
1.
Vintra
bao
- Tnh cht: b mt nhn, thng c mu, c nh
bng. Ly mt phn vin b gy, em quan st d
i thu knh, thy r nhn c bao bng 1 lp hay
nhiu lp
- tan r: phi p ng yu cu th r ca vin
nn v vin nang (tr vin nang)
Vin bao phim phi r trong vng 30 pht. Cc vin
bao khc phi r trong vng 60 pht. i vi vin bao
khc vin bao phim, nu c vin no khng tan r
th th li vi 6 vin khc, thay nc bng dd HCl 0,1
M.
Ch phm t nu c 6 vin u r ht.
- ng u khi lng (theo qui nh ca thuc
vin nn v chuyn lun ring)
- nh lng v cc yu cu k thut khc(theo qui
nh ca thuc vin nn v chuyn lun ring)

Kim tra
mng
2.Vin
nncht
bnlng
vi d
dy bao
(vin bao tan trong rut)
- Tnh cht
- r: -mi trng th: dd HCl 0,1N trong 2h khng
c hin tng hng mng. Sau thay mi trng
th bng dd m phosphat pH 6,8/ 1h, yu cu
c 6 vin r ht.
- ng u hm lng, nh lng, v cc yu
cu khc (theo qui nh ca thuc vin nn v
chuyn lun ring)
3. Vin nn thay i gii phng hot cht:
( theo qui nh chung ca thuc vin nn v
chuyn lun ring)
ng gi bo qun v nhn thuc vin
-Hnh thc ng gi
-Nhn ca ng thuc phi ghi: ngoi qui
nh chung phi ghi r: vin bao tan rut hay
vin bao phim.

Bi kim tra
H tn sinh vin:.......................................
M sinh vin:............................................
T ...........Lp.................Kho................

p n bi kim tra
1--S

4--S

2--S

5--S

3--S

6--S

7-A-B-C
8-A-B-C

9.............................
10.................................
...................................

....................................

Cu hi lng gi
Chn cu tr li ng () hoc sai (S) sau y:
1. Vin em bao phi c bn c hc tt.
/S
2. Bao ng c lp v bao dy hn bao phim.

/S

3. Bao phim thng ko di thi gian, v tn cng hn bao

ng. /S
4. Giai on bao cch ly/B vi mc ch ph kn cnh ca vin.
/S
5. Khi bao nn trong bao ng ngi ta ch dng PP dng hn
dch bao.
/S
6. Khi bao phim nhn bao khng cn phi sy nng trc khi
bao. /S

Cu hi lng gi
La chn mt p n ng nht trong cc cu hi sau y:
7. Nhc im trong bao ng:
A- Nhiu cng on mt nhiu thi gian
B- Nguyn liu kh kim, t tin
C-C A v B
8. Nguyn nhn gy dnh vin v thng mng/bao phim
A-Tc phun dch cao, di phun hp
B- Ni bao o vin km
C- C A v B

Cu hi lng gi
in t thch hp vo ch trng:
9. Qu trnh bao ng gm:
A- ................................................
B- Qu trnh sy
C-..................................................
10. Thit b dng bao phim gm:
A- B phn cha vin v lm chuyn ng vin
B- ..........................................................
C- ..........................................................

D-B phn ht bi v dung mi ra khi ni bao.