K THUT BO CH THUC VIN V PHNG PHP KIM

NGHIM

I.I CNG

1.Khi nim v qu trnh pht trin ca vin nn

Vin nn (tabellae) l dng thuc rn, c iu ch bng cch nn
mt hay nhiu loi dc cht (c thm hoc khng thm t dc), thng c
hnh tr dt, mi vin l mt n v liu.
Quy trnh sn xut vin nn c m t chnh thc vo nm 1843
bng pht minh ca Thomas Brockedon. n nm 1874 my dp vin nn ra
i. Tuy vy, vic sn xut vin nn vn pht trin rt chm. Cho n 1932
trong Dc in Anh (B.P) mi ch c mt chuyn vin nn. Nguyn nhn
ca s pht trin chm ca vin nn l do thiu phng php nh gi cht
lng dng thuc.
u nhng nm 50, Higuchi v cng s nghin cu phng php
o lc dp vin, lm c s i su nghin cu v vin nn. Tip l s
pht trin ca SDH bo ch. Hng lot cng trnh nghin cu v vin nn ra
i, thc y mnh m s pht trin ca dng thuc. 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 pht trin rng ri
nht, ph bin nht hin nay.

2. u - nhc im ca vin nn
u im
- c chia liu 1 ln tng i chnh xc
- Th tch gn nh, d vn chuyn, mang theo ngi.
- D che du 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 hay hn dch.
- Ngi bnh d s dng: Phn ln vin nn dng ung, trn vin nn
thng c ch d nhn bit tn thuc.
Nhc im:
- Khng phi tt c cc dc cht u ch thnh c vin nn

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 Sau khi dp thnh vin, din tch BMTX ca dc cht vi mi trng
ho tan b gim rt nhiu, do vi dc cht t tan nu bo ch vin
nn khng tt, SKD ca thuc c th b gim kh nhiu.
SKD vin nn thay i tht thng do trong qu trnh bo ch, c rt
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

II.K THUT BO CH VIN NN

1.La chn t dc xy dng cng thc dp vin

Ch c mt s dc cht c cu trc tinh th u n c th dp thnh
vin nn. a s dc cht cn li, mun dp thnh vin nn, th phi cho
thm t dc. Vic la chn t dc l mt khu quan trng do t dc c
nh hng trc tip n SKH ca vin.
Khi la chn t dc, cn xem xt cc yu t:
- Mc ch s dng ca vin: ung, ngm Cc loi vin khc nhau, t
dc cng khc nhau.
- Tnh cht ca dc cht: tan, n nh ho hc, trn chy
- Tnh cht ca t dc: trn chy, kh nng chu nn, nhng tng
tc vi dc cht c th xy ra
- Phng php dp vin: Mi phng php dp vin c cch dng t
dc khc nhau.
Yu cu ca t dc: m bo bn c hc ca vin, n nh ho hc
ca dc cht, gii phng ti a dc cht ti vng hp thu, khng c tc
dng dc l ring, khng c, d dp vin v gi c hp l.
Mt s nhm t dc hay dng:

1.1.T dc n
Cn gi l t dc pha long, c thm vo vin m bo khi
lng cn thit ca vin hoc ci thin tnh cht c l ca dc cht,lm
cho qu trnh dp vin c d dng hn.

1.1.1. Nhm tan trong nc

Lactose:
l t dc n c dng kh ph bin trong vin nn.Lactose d tan trong
nc, v d chu, trung tnh, t ht m, d phi hp vi nhiu loi dc cht.
lactose tn ti di hai dng:
Dng khan (ch yu l lactase)
Dng ngm nc (ch yu l lactose.H2O)

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 Bt ng (Saccazose)
D tan v ngt, do thng dng lm t dc n v dnh kh trong vin
ho tan, vin nhai, vin ngm. Khi dng lm t dc n, c th to ht m
vi hn hp nc - cn. Bt ng lm cho vin d m bo bn c hc
nhng kh r, khi dp vin d gy dnh chy, do thng kt hp vi t
dc n khng tan tng cng cng cho vin.
Hin nay trn th trng c mt s loi t dc, bt ng dng dp thng
nh:
* Dipac: l sn phm ng thi kt tinh ca 97% ng v 3% dextrin di
dng ht nh, trn chy tt. Khi dp vin, vin khng b bin mu nhng
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, c KTTP phn b tng i rng,
trn chy tt.
Glucose:
D tan trong nc, v ngt trong lactose, do hay c dng cho vin ho
tan nh vi ng bt. Glucose trn chy km, d ht m, d 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
dc cht kim v amin hu c trong qu trnh bo qun ging nh lactose
Manitol:
D tan trong nc, v hi ngt, li cm gic mt d chu trong ming khi
ngm, do rt hay c dng trong vin ngm, vin nhai. Manitol t ht
m, ht to ra khng chc nh bt ng v glucose
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. Cng nh
manitol, sorbitol c nhiu dng kt tinh v v nh hnh khc nhau. Cho nn
nhiu khi cc loi t dc sorbitol do cc nh sn xut khc nhau cung cp,
c s khc nhau v trm chy, kh nng chu nn n nh
Sorbitol cng 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
nh hn 50%.

1.1.2. Nhm khng tan trong nc

Hay dng cc loi tinh bt, dn cht celullose v bt mn v c.
Tinh bt:

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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 phi phi hp
khong 30% bt ng m bo vng chc ca vin.
Tinh bt bin tnh:
L tinh bt qua s l bng cc phng php l ha thch hp nhm thu
phn v thay th tng phn ri to ht. Tinh bt bin tnh nn v trn chy
tt hn tinh bt, ho tan tng phn trong nc tu theo mc thu phn.
Trn th trng c nhiu tinh bt bin tnh vi cc tn thng mi khc
nhau: Starch 1500, lycatab
Cellulose vi tinh th
L t dc c dng ngy cng nhiu, nht l trong vin nn dp thng, do
c nhiu u im: chu nn tt, trn chy tt, lm cho vin d gin. Trn th
trng c nhiu loi khc nhau : Avicel, Emcocel
Vin dp vi Avicel d m bo bn c hc, mi mn thp, khng cn
dng lc nn cao. Avicel d to ht, ht d sy kh, dc cht dng liu
thp v cht mu d phn b u trong ht v trong vin.
Avicel gi thnh cao nn cha c dng nhiu nc ta.
* Calci dibasic photphat:
l t dc v c, bn v l ho, khng ht m, trn chy tt. Trn th trng
t dc dp thng cha Dicalci photphat c bn di tn thng mi l
Emcompress hoc ditab. Vin dp vi Dicalci photphat c bn c hc
cao, r chm v vy khng nn dng t l cao vi dc cht t tan.
* Calci carbonat, magnesi carbonat:
l nhng t dc c kh nng ht, cho 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
1.2. T dc dnh
L tc nhn lin kt cc tiu phn to hnh vin, m bo chc ca
vin.
1.2.1. Nhm t dc dnh lng:
T dc dnh lng dng trong phng php xt ht t. C nhiu loi t
dc dnh lng c mc kt dnh khc nhau:

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 - Cn
- H tinh bt
- Dch th gelatin
- Dch gm arabic
- Dch th PVP
- Siro
- Dn cht cellulose
1.2.2. Nhm t dc dnh th rn
Thng dng cho vin xt ht kh v dp thng. Dng cho cc loi
bt ng, tinh bt bin tnh, dn cht cellilose, Avicel Cc t dc dnh
rn tan c trong nc v cn c th xt ht t vi hn hp nc - cn
cc t l khc nhau.
T dc dnh nh hng trc tip n kh nng r, gii phng dc
cht ca vin nn. Do nn thn trng khi la chn t dc dnh, m bo
ng loi t dc v lng t dc cho tng cng thc, trnh lm dng t
dc dnh.
1.3. T dc r
R l giai on khi u cho qu trnh SDH ca vin nn sau khi
ung. T dc r lm cho vin r nhanh v mn, gii phng ti a b mt
tip xc ban u ca tiu phn dc cht vi mi trng ho tan, to iu
kin cho qu trnh hp thu dc cht v sau. Trong SDH bo ch, hin nay
ngi ta rt quan tm n ng hc ca qu trnh gii phong ca dc cht
trong c th, trong t dc r ng vai tr quan trng. Theo Wagner, qu
trnh gii phng dc cht ca vin nn c biu th nh sau:
Cc loi t dc r hay dng:
- Tinh bt
- Tinh bt bin tnh
- Avicel
- Bt cellulose
- Acid alginic
1.4. T dc trn
T dc trn l nhm t dc gn nh lun phi dng n trong cng
thc vin nn v t dc trn c nhiu tc dng trong qu trnh dp vin:

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 - Chng ma st
- Chng dnh
- iu ho s chy
- Lm cho mt vin bng p
Cc loi t dc trn hay dng:
- Acid stearic v mui
- Talc
- Aerosil
- Tinh bt
1.5. T dc bao
Tu mc ch bao m chn bao thch hp.
Cc loi t dc bao hay dng trong bao mng mng:
- Dn xut cellulose: Hin nay c s dng kh rng ri:
* HPMC (hydroxy propyl methyl cellulose): L t dc bao s dng nhiu
trong bao bo v. u im: bn vi cc yu t ngoi mi, khng c mi v
ring, d phi hp vi cc cht nhun mu.
* HPMC (hydroxy propyl cellulose): Tan trong nc v dung mi hu c
phn cc, thng phi hp vi cht bao khc tng bn ca mng.
* EC (ethyl cellulose): Khng tan trong nc, tan trong dung mi hu c,
bn vi ngoi mi. Thng dng lm t dc bao cho vin tc dng ko di.
* CAP (cellulose acetat phthalat): D tan trong rut do dng bao tan
rt. Khi bao thng phi cho thm cht lm do.
* HPMCP: l este ca HPMC vi acid phthalic, dng bao tan rut. Thng
dng hn dch nc.
- Shellac: l nha cnh kin tinh ch. Shellac tan c trong mi trng
kim nn c th dng bao tan rut.
- Nha methcrylat l sn phm trng hp ca acid methacrylic.
* Eudragit E tan trong dch v, dng bao bo v.
* Eudragit L v S: khng tan trong dch v, dng bao tan rut.
- Ngoi ra cn nhiu t dc khc phi hp trong thanh phn mng bao
nh PEG, PVP, cht dit hot
1.6. T dc mu
Mc ch: thm vo vin nhn bit, phn bit mt s loi vin, lm
cho vin p hoc kim sot s phn tn ca mt s dc cht dng
liu thp trong vin.

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 Nhc im: lm cho qu trnh bo ch v bo qun vin thm phc
tp nh mt so chaats mu tng k vi dc cht, lm thay i tan
ca dc cht, gy phn ng ph, khng bn, lm cho vin b bin mu
trong qu trnh bo qun
Cht mu dng cho vin phi l cht mu thc phm, khng c, ch
cn dng t l nh v c mu n nh.
Mt s cht mu c dng trong bao vin:
- Erythrosine (Red 3)
- Ponceau 4R
- Carmin (Naturel red 4)
- Allura red AC (red 40)
- Tartrazin (yellow 5)
- Sunset yellow (yellow 6)
- Riboflavin
- Brilliant blue (blue 1)
- Indigotine (blue 2)
- Fast Green (Green 3)
Cc cht mu trn th trng c th dng n cht hoc c hp
ph trn mt cht mang tr khng tan, khi dng c th pha long gn
vi t dc tr nh tinh bt, bt ng c hn hp mu ng
nht.
2. La chn phng php to ht - dp vin
2.1. Phng php to ht t
y l phng php thng dng nht hin nay
u im: d bo m bn c hc ca vin
Dc cht d phn phi vo tng vin
Quy trnh v thit b n gin, d thc hin
Nhc im: Chu tc ng ca m v nhit (khi sy ht), c th lm
gim n nh ca dc cht
Quy trnh ko di tri qua nhiu cng on, tn mt bng v
thi gian s dng.
Phng php to ht t bao gm cc cng on:
2.1.1. Trn bt kp
Vin nn thng l hn hp ca nhiu bt n. KTTP bt nh hng
n trn chy, t trn biu kin, n kh nng chu nn, n mc trn
u ca khi bt. Vi dc cht t tan, KTTP cn nh hng trc tip n
SKD ca vin. Do trc khi trn bt kp cn ch n vic phn chia
nguyn liu n mc 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