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

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:

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. 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
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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 cht trong vin nh c th ngi ta khng trn bt kp m ho dc cht vo t dc dnh lng xt ht hoc bao tng lp ln ht trc khi dp vin. Thi gian trn bt kp nh hng n ng nht ca khi bt, do nh hng n SKD ca vin. V vy cn c nghin cu xc nh c th cho tng cng thc dp vin. C trng hp thi gian trn u ko di qu, dc cht li c xu hng tch lp. Loi my nghin trn v lc trn c nh hng n tnh cht ca vin nn v sau. 2.1.2. To ht Mc ch ca vic to ht l trnh hin tng phn lp ca khi bt trong qu trnh dp vin, ci thin chy ca bt dp vin, tng cng kh nng dnh kt ca bt lm cho vin d m bo chc v gim hin tng dnh ci khi dp vin. d dp vin, ht phi d chy v chu nn tt. Mun vy, ht phi p ng mt s yu cu sau: - C hnh dng thch hp: Tt nht l hnh cu - C kch thc thch hp: kch thc ht nh hng n trn chy v t trng ht To ht t c th thc hin bng cch xt ht qua ry hc bng thit b tng si. - To khi m: Thm t dc dnh lng vo khi bt, trn cho n lc t dc thm u khi bt, to ra s lin kt cc tiu phn bt va to ht. t dc d thm vo khi bt, nn dng t dc nng, nht l vi nhng t dc c nht cao nh dch th gelatin, h tinh bt. Lng t dc v thi gian trn quyt nh n kh nng lin kt ca ht. - Xt ht: Khi m sau khi trn u, n nh trong mt khong thi gian nht nh ri xt qua c ry quy nh. Kiu ry xt ht v cch xt nh hng n hnh dng v mc lin kt ca ht. Nu khi m qu m m lc xt ht li ln th d to thnh cc si di. thu c ht c hnh dng gn vi hnh cu, tt nht l xt ht qua ry c l vi lc xt ht va phi. - Sy ht: ht sau khi xt ti thnh lp mng v sy nhit quy nh. Trc khi sy, c th thong gi cho ht se mt, sau a vo bung sy v nng nhit t t cho ht d kh u. Trong qu trnh sy thnh thong o ht, tch cc cc vn v kim tra nhit sy.
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Ht thng c sy cho n m t 1 7% tu tng loi dc cht. m ht nh hng n trn chy ca ht v mc lin kt tiu phn khi dp vin, cn nhit sy nh hng n n nh ho hc ca dc cht. - Sa ht: Ht sau khi sy xong, phi xt li nh nhng qua c ry quy nh ph v cc cc vn, to ra c khi ht c kch thc ng nht hn. hn ch tc ng ca m v nhit, tit kim mt bng sn xut, hin nay trong sn xut cng nghip, ngi ta thng to ht bng thit b tng si. 2.1.3. Dp vin Ht sau khi sy n m quy nh, a trn thm t dc trn, t dc r ngoi ridp thnh vin. C nhiu loi my dp vin khc nhau hot ng theo nguyn tc: Nn hn hp bt hoc ht gia hai chy trong mt ci c nh. Chu k dp vin trong my tm sai c th chia thnh 3 bc: - Np nguyn liu: Khi np dung tch bung nn phi mc ln nht.Do , chy di phi v tr thp nht, chy trn phi v tr cao nht ph hp vi dung tch bung nn chn. Phu v tr trung tm v np y nguyn liu vo bung nn. - Nn (dp vin): Phu dch ra khi trung tm, chy ng yn, chy trn tin dn xung v tr thp nht t lc nn ti a. Cc tiu phn c nn st li vi nhau hnh thnh vin nn. - Gii nn (y vin ra khi ci): Sau khi nn xong, chy trn gii nn tin v v tr trc khi nn. ng thi chy di tin ln v tr cao nht y vin ra khi ci. Phu tin v v tr trung tm gt vin ra khi mm my v tip tc np nguyn liu cho chu k sau. 2.2. Phng php to ht kh u im: trnh c tc ng ca m v nhit i vi vin, do c dng trong cc vin cha dc cht khng bn vi m v nhit (aspirin, vitamin C). Tit kim c thi gain v mt bng hn to ht m. Nhc im: Dc cht phi c kh nng trn chy v lin kt nht nh v kh phn phi ng u vo tng vin. Ngoi ra, hiu sut to ht khng cao v vin kh m bo bn c hc. Cc cng on to ht kh: - Trn bt kp: trn bt dc cht vi bt t dc dnh kh, t dc r. - Dp vin to - to ht: Bt c dp thnh vin to (c ng knh khong 1,5 2cm). Sau ph v vin to to ht
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- Dp vin: Sau khi c ht kh, tin hnh dp vin c khi lng quy nh nh vi phng php to ht t. 2.3. Phng php dp thng Dp thng: l phng php dp vin khng qua cng on to ht. Do tit kim c mt bng sn xut v thi gian, ng thi trnh c tc ng ca m v nhit ti dc cht. Vin dp thng thng d r, r nhanh nhng bn c hc khng cao v chnh lch hm lng dc cht gia cc vin trong mt l m sn xut nhiu khi l kh ln. 3. Bao vin Mt s loi vin nn sau khi dp xong phi tin hnh bao vin vi nhng mc ch khc nhau: - Che du mi v kh chu ca dc cht. - Trnh kch ng ca dc cht vi nim mc d dy. - Bo v dc cht trnh tc ng ca cc yu t ngoi mi nh m, nh sng, dch v - Khu tr tc dng ca thuc rut. - Ko di tc dng ca thuc - d nhn bit, phn bit cc loi vin. - Lm tng v p ca vin Trn thc t c hai cch bao vin: Bao ng v bao mng 3.1. Bao ng L cch truyn thng, p dng t lu trong vin nn vi ni bao quay trn. Baong gm cc giai on: - Bao nn: Nhm lm trn cc gc cnh ca vin v gim bt dy lp bao. bao nn c nhanh tt nht l vin bao phi c mt li. - Bao nhn: Lm nhn mt vin chun b cho bao mu. - Bao mu: bao vin bng cc lp siro mu c cng mu tng dn. - nh bng: cho vin vo ni nh bng, lm nng vin ri thm cc t dc lm bng: parafin, sp ong dng rn hay dung dch, quay cho n lc mt vin nhn bng. 3.2. Bao mng mng (bao film) Bao ng tn thi gian, v bao chim khi lng ln so vi vin, k thut bao ph thuc vo kinh nghim. Do vy, nhng nm gn y ngi ta thng bao mng mng. Nguyn liu to mng l cc polyme, c ho tan hay phn tn vo mt dung mi hay mi trng phn tn thch hp ri phun vo vin. Sau khi sy cho dung mi hay mi trng phn tn bay hi ht, polyme s bm thnh mng mng xung quang vin. Tu theo mc ch bao m s dng cc loi polyme khc nhau: - Bao mng bo v: dng polyme c kh nng chng m, d tan tring dch v nh HPMC, PEG 600
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- Bao mng tan rut: dng cc polyme khng dch v v tan rut nh Eudragit L, S Ngoi cc polyme to mng, cn dng thm cc cht lm do tng do dai, n hi ca mng nh: PGE, glycerin T dc bao c th c ho tan vo dung mi hu c ri a bao. Tuy nhin dung mi hu c d gy c, nhim mi trng v c th gy chy. Do , hin nay ngi ta c hng bao hn dch. Phn tn t dc bao vo cht dn phn cc (nc, cn) di dng hn dch ri a bao. Cc cht dn ny bay hi chm hn do qu trnh bao ko di nhng an ton v d thc hin hn. III. TIU CHUN CHT LNG VIN NN 1. Tiu chun dc in Theo DVN, yu cu k thut chung ca thuc vin nn bao gm: 1.1. r: DVN quy nh dng thit b ERWEKA hoc cc thit b tng t. Mi ln th 6 vin: khng c cn cn trn mt li ca a y, nu cn cn th ch l mt khi mm khng c nhn kh rn s thy c. Nu vin b dnh vo cc a , th lm li th nghim trn 6 vin khc nhng khng cho vo ng. Mu th t yu cu nu 6 vin r ht. Mi trng th l nc ct 37oC 2 Vin nn khng bao phi r trong vng 15 pht Vin bao bo v r trong vng 30 pht. Vin bao tan trong rut phi chu c mi trng HCL 0,1M trong 2h v phi r trong h m phosphat pH 6,8 trong vng 60 pht. Vin tan trong nc phi r trong vng 3 pht. Vin si bt r trong vng 5 pht. Vin si bt r trong vng 5 pht 1.2. ng u khi lng Th vi 20 vin. lch cho php theo bng sau: Khi lng trung bnh Chnh lch so vi khi lng ca vin trung bnh Ti 80 mg 10 80 250 mg 7,5 >250 mg 5 1.3. ng u hm lng p dng cho vin c hm lng dc cht t hn 2mg hoc t hn 2% khi lng trung bnh. Nu c mt vin nm ngoi gii hn 84 115% hm lng trung bnh. Nu c mt vin nm ngoi gii hn trn nhng nm trong gii hn 75 125% hm lng trung bnh th th li vi 20 vin khc. Thuc t yu cu nu trong 30 vin khng c qu 1 vin nm
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ngoi 85 115% v khng c vin no nm ngoi 75 125% hm lng trung bnh. Vin tan trong nc khng th ng u hm lng 1.4. nh lng Th vi 10- 20 vin theo chuyn lun ring, tnh hm lng hot cht trong mi vin theo khi lng trung bnh ca vin 1.5. Trc nghim ho tan Thit b nh gi l my ho tan, theo USP gm thit b kiu gi quay, kiu cnh khuy v kiu dng chy Trc nghim ho tan p dng cho vin nn cha c cht t tan. Vin th tan khng cn th r. 2. Tiu chun nh sn xut 2.1. mi mn Th theo thit b ERWEKA hoc ccs dng c tng t Thit b bao gm mt trng quay c gn vi mt mot tc nht nh. Cho vin cn chnh xc ti mg vo trng quay (10 20 vin) v quay trong khong thi gian nht nh (100 vng). Ly vin ra, sng sch bt v cn li khi lng. Tnh mi mn (% khi lng vin b mt). Nu khng c quy nh ring mi mn khng c qu 3% 2.2. cng Xc nh bng thit b o cng Nguyn tc: Tc ng 1 lc qua ng knh vin cho n lc vin b v. Xc nh lc gy v vin. Gii hn lc gy v vin tu thuc vo tng loi vin IV. CC YU T NH HNG N SKD VIN NN 1. nh hng ca ng dng cch dng Phn ln vin nn c dng ung, do y chng ta s xem xt nh hng ca ng tiu ho n SKD ca vin. ng dng theo quan nim sinh dc hc, chnh l mi trng gii phng, ho tan v hp th dc cht t vin nn. Mi trng ny thay i rt nhiu trong ng tiu ho tu theo tng vng khc nhau: Khoang ming, rut V. KIM NGHIM THUC VIN NN 5.1. nh ngha Vin nn l dng thuc rn, mi vin l mt n v liu, cha mt hay nhiu hot cht. Thuc c sn xut bng cch nn nhiu khi tiu phn ng u. Cc tiu phn gm mt hay nhiu hot cht, c hoc khng c thm t dc, cc cht mu, cht lm thm theo quy nh. Cc tiu phn ny

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c to thnh c th do xt ht (kh, t) hoc trn u hot cht vi t dc. 5.2. Yu cu k thut v phng php th 5.2.1. Tnh cht Vin nn thng c dng hnh tr dt, hai y phng hoc cong, c th khc ch, k hiu hoc rnh. Cnh v thnh vin lnh ln. Mu sc ng nht. Cch th: bng cm quan 5.2.2. r Nu khng c quy nh ring th tin hnh th v nh gi theo Php th r vin nn v vin nang 5.2.3. ng u khi lng Cn chnh xc 20 vin bt k v xc nh khi lng trung bnh ca vin. Cn ring khi lng tng vin v so snh khi lng trung bnh t tnh ra khong gii hn ca gi tr trung bnh. Khng c qu 2 vin c khi lng chnh lch qu khong gii hn ca khi lng trung bnh v khng c c vin no c chnh lch qu gp i lch tnh theo t l phn trm. Nu c yu cu th ng u hm lng th khng phi th ng u khi lng. 5.2.4. ng u hm lng Nghin mn ring tng vin v tin hnh th v nh gi nh i vi thuc bt. 5.2.5. ho tan Ch thc hin khi c yu cu c ch dn trong chuyn lun ring. Nu khng c trong chuyn lun ring th th v nh gi thao Php th tc ho tan ca vin nn v vin tan 5.2.6. nh tnh Tin hnh nh tnh theo cc phng php c quy nh trong tiu chun, vin nn phi cho cc phn ng ca cc hot cht c trong ch phm 5.2.7. nh lng Cn 20 vin, xc nh khi lng trung bnh vin. Nghin mn. Tin hnh nh lng theo cc phng php c quy nh trong tiu chun, hm lng ca nhng hot cht trong ch phm phi nm trong gii hn cho php. 5.2.8. Tp cht (nu c) Khi c yu cu s ch dn trong chuyn lun ring 5.3. Cc loi vin nn 5.3.1. Vin nn khng bao
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Gm cc vin nn c bo ch bng cch nn cc ht gm dc cht, t dc. Vin nn loi ny khng cha mt thnh phn no thay i s gii phng hot cht trong ng tiu ho. Khi b gy vin nn mt lp v quan st bng knh lp th thy ng nht, khng c lp bao ngoi. 5.3.2. Vin bao Vin bao c b mt nhn, thng c mu, c nh bng. Ly mt phn vin b gy, quan st di knh lp, thy r nhn c bao bng mt lp hay nhiu lp. 5.3.3. Vin bao bn vi dch v d dy Vin c bao bng lp bao bn vi dch v d dy nhng li tan c trong dch rut do s dng cc cht bao l cellacephate v cc polymer 5.3.4. Vin nn si bt L vin nn khng bao c cha cc acid v carbonat hoc hydrocarbonat, chng phn ng vi nhau rt nhanh khi c mt ca nc v gii phng CO2, ng thi ho tan hay phn tn hot cht trong nc trc khi dng. 5.3.5. Vin ngm Vin ngm thng l vin nn khng bao c iu ch cc thnh phn v hot cht gii phng dn v tc dng ti ch, gii phng v hp th di li hoc cc phn khc trong ming. 5.3.6. Vin nn tan trong nc Vin nn tan trong nc l vin nn khng bao, ho tan trong nc. Dung dch to thnh c th hi c nh. 5.3.7. Vin nn phn tn trong nc Vin nn phn tn trong nc l vin nn khng bao phn tn trong nc thnh cc tiu phn 5.3.8. Vin nn thay i gii phng hot cht Thng l vin bao hoc khng bo, c iu ch bng cch thm cc t dc c bit hoc iu ch theo phng php c bit nhm thay i tc gii phng hoc v tr gii phng ca thuc. Vin nn thay i gii phng hot cht thng khng yu cu th r m phi th tc ho tan. V d: vin nn acid ascorbic DVN trang 6 Vin bao ibuprofen DVN trang 141

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