TRNG I HC Y - DC THI NGUYN B MN BO CH - CNG NGHIP DC

Bi Tiu Lun: Thnh phn, vai tr ca t dc trong vin nn cha Ibuprofen.

H v tn: Phm Duy Lp: Dc K4B.

Cnh.

Thi nguyn 2011

A Ibuprofen.
Ibuprofen l mt thuc chng vim gim au khng steroid c tc dng chng vim, gim au v h nhit (NSAID). Liu thp c tc dng gim au, liu cao c tc dng chng vim. Thuc t tc dng ph (nht l ng tiu ha) hn aspirin, indometacin v pyrazolon, v vy c dng nhiu trong vim khp mn tnh. Ibuprofen l dn cht ca acid aryl propionic: C13H18O2
O

OH

*) Tnh cht lin quan n bo ch: - Ibuprofen l mt bt kt tinh trng hoc tinh th khng mu, c mi nh v kh bn vng vi nhit v m nn c th iu ch vin nn bng phng php xt ht t. - Ibuprofen c tnh acid yu vi pKa = 5,2, nn tan trong cc dung dch hydroxyd v carbonat kim. - Ibuprofen rt t tan trong nc nn thng c vn v sinh kh dng (SKD), v th cn phi th tan ca vin. - chy t 750C n 780C. *) Dc ng lc hc: - Hiu lc sinh hc 49 - 73% . Lin kt protein 99%. - Chuyn ha qua Gan. Bn r 1,8 - 2h. - Bi tit qua Thn. - Ibuprofen dng theo ng ung gy kch ng nim mc d dy, c th gy u x v chy mu d dy. hn ch tc dng ph ny ca ibuprofen, vin nn ibuprofen thng c bao mng tan rut.

B - Mt s bit dc dng vin nn cha Ibuprofen.

I) Ibuprofen 200mg (Vin nn bao phim) Cng ty c phn dc phm TW 2 Dopharma. Trnh by: Hp 10 v x 10 vin nn bao phim mu xanh Cng thc: Ibuprofen............................................................................200mg Tinh bt, lactose, CMC, PVP, Magnesi stearat Paten AE, ospray v......1 vin *) Phn tch thnh phn: - Ibuprofen: Hot cht chnh. - Tinh bt, lactose va lm t dc n, va lm tng tnh chu nn ca vin, ci thin tnh cht c l ca dc cht, ng thi lm cho vin r nhanh, r mn v gii phng hot cht (t dc r). - CMC vai tr l t dc dnh, lin kt cc tiu phn to hnh vin, m bo chc ca vin. - PVP l t dc dnh t. Ci thin tnh thm v tan ca dc cht. - Magnesi stearat l t dc trn c tc dng iu ho s chy ca ht v chng dnh, lm vin bng p, trong bo ch thng dng hn hp talc Magie stearat. Tuy nhin nu cho lng qu mc s lm cn tr qu trnh gii phng dc cht ra khi vin. - Do ibuprofen gy kch ng nim mc d dy nn phi bao mng tan rut. Dng Eudragit L100 l mt polyme to mng bao tan rut, do trong phn t c nhm carboxyl nn khng tan trong mi trng acid nhng li tan tt trong mi trng trung tnh hay kim yu, nn mng ch bao tan v gii phng dc cht khi vin ti rut non. II) Hagifen Cng ty c phn dc Hu Giang. Trnh by: Hp 10 v x 10 vin nn bao phim. Cng thc: Ibuprofen ............................... 400 mg T dc va ......................1 vin (Tinh bt sn, avicel, lactose, PVP, bt talc, magnesi stearat, aerosil, sodium starch glycolate, HPMC, PVA, PEG 6000, titan dioxyd, mu ponceau)

*) Phn tch thnh phn: - Ibuprofen: Hot cht chnh. - Tinh bt, lactose c vai tr l t dc n, ci thin tnh cht c l ca dc cht. Tinh bt v Avicel (l mt Cellulose vi tinh th) thm vo cng thc va c tc dng lm tng kh nng chu nn ca vin, lm cho vin chc, ng thi c tc dng lm r vin v gii phng hot cht trong ng tiu ho. - Dch th PVP l t dc dnh, m bo chc ca vin, to hnh vin. Ci thin tnh thm, tan ca dc cht. - Bt talc v Magie stearat l cc t dc trn c tc dng iu ho s chy ca ht, chng dnh v lm cho vin bng p hn, nhng ch cho 1 lng thch hp. - Aerosil c vai tr l t dc trn iu ho s chy, t nh hng n kh nng gii phng dc cht ca vin. - Sodium starch glycolate l t dc siu r, cu to bi tinh bt c gn lin kt cho natri carboxymethyl. SSG c dng hnh cu nn trn chy tt, kh nng trng n rt nhanh v mnh. - HPMC, PVA, PEG 6000 l nhng t dc bao, s dng lm bao bo v (bao phim) c kh nng chng m, d tan trong dch v. - Tital dioxyd l cht chng dnh dng trong bao mng. Ngoi ra n cn c tc dng chn tia t ngoi. - Mu ponceau l t dc mu, lm p vin v kim sot s phn tn ca dc cht trong vin. III) Nabufen Tablet - Sn xut ti n . Trnh by: Hp cha 10 v, mi v c 10 vin. Cng thc: Ibuprofen bp 400 mg T dc: Cellulose vi tinh th, lactose, natri starch glycolat, natri lauryl sulphat, silic keo khan, povidon (pvp k-30), croscarmellose natri, talc v khun, magnesi stearat, HPMC, titan dioxyd, propylene glycol, diethyl phthalat, oxyd st , oxyd st vng. *) Phn tch thnh phn: - Ibuprofen: Hot cht chnh. - Cellulose vi tinh th, lactose va l t dc n, ci thin tnh cht c l ca dc cht, m bo khi lng vin. Va l t dc r, Cellulose vi tinh th thm vo cng thc c tc dng lm tng kh nng chu nn ca vin, lm cho vin chc,ng thi c tc dng lm r vin. - Natri starch glycolat l t dc siu r, trn chy tt. - Natri lauryl sulphat l cht din hot ion ho, cht gy thm, c tc dng nh ho (t dc trn tan trong nc), iu ho s chy, ci thin tan dc cht.

- Silic keo khan c vai tr trong qu trnh trn to ht, lin kt d dng hn. - Povidon (PVP K30) l t dc dnh, ci thin tnh thm v tan ca dc cht. - Croscarmellose natri: T dc siu r,lm vin r nhanh,mn, gip cho vic gii phng hot cht. - Talc v Magie stearat l t dc trn,c tc dng iu ho s chy ca ht, chng dnh v lm cho vin bng p hn, nhng ch cho 1 lng thch hp. - HPMC l t dc bao, dn cht ca cellulose, c kh nng chng m cho vin, tan trong dch v. - Tital dioxyd l cht chng dnh dng trong bao mng. Ngoi ra n cn c tc dng chn tia t ngoi. - Propylene glycol, diethyl phthalat l nhng cht lm do, c tc dng lm tng do dai, n hi ca mng bao. - Oxyd st , oxyd st vng l nhng t dc mu, lm p vin v kim sot s phn tn ca dc cht trong vin. IV) Dibulaxan Cng ty c phn dc Danapha. Trnh by: Vin nn. Thuc p trong v bm 20 vin, hp 5 v, c km theo t hng dn s dng. Cng thc: Paracetamol.325,0 mg Ibuprofen.. 200,0 mg T dc va 1 vin. (Eragel, Tinh bt m, Talc, Povidon K 30, Aerosil, Mu Erythrosin lake, Mu Tartrazin lake) *) Phn tch thnh phn: - Paracetamol v Ibuprofen: Hot cht chnh, kt hp tc dng gim au v khng vim ca ibuprofen v tnh cht gim au, h nhit ca paracetamol.Ch nh gam au, khng vim trong au c khp do chn thng, thp khp, vim thn kinh, iu tr cm st, nhc u, au rng, au bng kinh. y l nhng dc cht t tan trong nc, kh bn vng vi nhit v m nn c th bo ch bng phng php xt ht t. - Eragel l mt tinh bt bin tnh, c vai tr l t dc n, r. - Tinh bt m va c vai tr l t dc n, ci thin tnh cht c l ca dc cht. Va c tc dng lm t dc r, gip vin r nhanh, mn. - Bt talc l t dc trn, c tc dng iu ho s chy ca ht, chng dnh v lm cho vin bng p hn. - Povidon K 30 l t dc dnh, ci thin tnh thm v tan ca dc cht.

- Aerosil c vai tr l t dc trn iu ho s chy, t nh hng n kh nng gii phng dc cht ca vin. - Mu Erythrosin lake, Mu Tartrazin lake l nhng t dc mu. Lm p vin v kim sot s phn tn ca dc cht trong vin. V) Dimitalgil F Cng ty c phn dc Hu Giang. Trnh by: Hp 10 v x 10 vin nn. Cng thc: Paracetamol .................. 500 mg Ibuprofen ....................... 200 mg Cafein............................... 20 mg T dc va ............. 1 vin (Tinh bt bin tnh, PVP, talc, magnesi stearat, sodium starch glycolate). *) Phn tch thnh phn: - Paracetamol v Ibuprofen: Hot cht chnh. - Cafein: Hot cht, gip hn ch tc dng ph ca paracetamol v ibuprofen, kch thch hot ng ca tim, nng ngng chu au. - Tinh bt bin tnh c vai tr l t dc n, t dc r. - PVP l t dc dnh t, ci thin tnh thm v tan ca dc cht, lin kt cc tiu phn to hnh vin, m bo chc ca vin. - Bt talc v Magie stearat l cc t dc trn c tc dng iu ho s chy ca ht,chng dnh v lm cho vin bng p hn, nhng ch cho 1 lng thch hp. - Sodium starch glycolate l t dc siu r, lm cho vin r nhanh, r mn. VI) Glotasic Cng ty c phn dc phm Glomed. Trnh by: Hp 5 v x 20 vin nn. Hp 10 v x 12 vin nn. Cng thc: Paracetamol.325 mg Ibuprofen200 mg Cafein25 mg T dc va ...1 vin. (Povidon K30, pregelatinized starch, natri starch glycolat, Sunset yellow(FD& C yellow 6), silic dioxyd th keo, talc, magnesi stearat). *) Phn tch cng thc: - Paracetamol, Ibuprofen v Cafein: Hot cht.

- Povidon K30 l t dc dnh, to hnh vin v m bo chc ca vin. Ci thin tnh thm v tan ca dc cht. - Pregelatinized starch l mt tinh bt bin tnh, c vai tr l t dc n, t dc r, lm vin r nhanh, mn do kh nng trng n mnh trong nc. - Natri starch glycolat l t dc siu r, trn chy tt. - Sunset yellow(FD& C yellow 6) l t dc mu. Lm p vin v kim sot s phn tn ca dc cht trong vin. - Silic dioxyd th keo c vai tr trong qu trnh trn to ht, lin kt d dng hn. - Talc v Magie stearat l t dc trn,c tc dng iu ho s chy ca ht, chng dnh v lm cho vin bng p hn. VII) Doaxan Cng ty TNHH dc phm Bnh Chu. Trnh by: Hp 5 v x 20 vin nn. Cng thc: Paracetamol..325 mg Ibuprofen...200 mg T dc va ..1 vin. (Lactose, Avicel PH101, Povidon, Mu sunset yellow, Sodium starch glycolat, Natri lauryl sulfat, Magnesi stearat, Aerosil) *) Phn tch cng thc: - Lactose l t dc n, ci thin tnh cht c l ca dc cht. - Avicel PH101(l mt Cellulose vi tinh th) lm t dc n, thm vo cng thc va c tc dng lm tng kh nng chu nn ca vin, lm cho vin chc, ng thi c tc dng lm r vin (t dc r), gii phng hot cht trong ng tiu ho. - Povidon l t dc dnh, to hnh vin v m bo chc ca vin. Ci thin tnh thm v tan ca dc cht. - Sodium starch glycolat l t dc siu r, trn chy tt. - Natri lauryl sulphat l cht din hot ion ho, cht gy thm, c tc dng nh ho (t dc trn tan trong nc), iu ho s chy, ci thin tan dc cht. - Magnesi stearat, Aerosil l nhng t dc trn iu ho s chy, lm vin bng p, chng dnh. - Mu sunset yellow l t dc mu. Lm p vin v kim sot s phn tn ca dc cht trong vin.

VIII) Hapacol Cng ty c phn dc Hu Giang. Trnh by: Hp 10 v x 5 vin nn. Cng thc: Paracetamol .................... 325 mg Ibuprofen ......................... 200 mg T dc va ..................1 vin (Tinh bt m, lactose, PVP, magnesi stearat, bt talc, aerosil, sodium starch glycolate, mu orange lake). *) Phn tch thnh phn: - Paracetamol v Ibuprofen: Hot cht chnh. - Tinh bt m, lactose va lm t dc n, lm tng tnh chu nn ca vin, ci thin tnh cht c l ca dc cht, ng thi lm cho vin r nhanh, r mn v gii phng hot cht (t dc r). - PVP l t dc dnh, ci thin tnh thm v tan ca dc cht. - Talc v Magie stearat l t dc trn,c tc dng iu ho s chy ca ht, chng dnh v lm cho vin bng p hn. - Aerosil c vai tr l t dc trn iu ho s chy, t nh hng n kh nng gii phng dc cht ca vin. - Sodium starch glycolate l t dc siu r, trn chy tt. - Mu orange lake l t dc mu. IX) Qbilacxan Cng ty c phn dc phm Qung Bnh Quapharco. Trnh by: Hp 10 v x 10 vin nn. Cng thc: Paracetamol...........................325mg Ibuprofen................................200mg T dc va .......................1 vin (Tinh bt m, Lactose, Eragel, Polyvinyl pyrolidon (PVP), Magnesi stearat, Talc, Ethanol 96%,Nc ct, Mu sunset yellow) *) Phn tch thnh phn: - Paracetamol v Ibuprofen: Hot cht chnh. - Tinh bt m, lactose va lm t dc n, lm tng tnh chu nn ca vin, ci thin tnh cht c l ca dc cht, ng thi lm cho vin r nhanh, r mn v gii phng hot cht (t dc r).

- Eragel l mt tinh bt bin tnh, c vai tr l t dc n, r. - Talc v Magie stearat l t dc trn,c tc dng iu ho s chy ca ht, chng dnh v lm cho vin bng p hn. - Polyvinyl pyrolidon (PVP) l t dc dnh, m bo chc ca vin, to hnh vin. Ci thin tnh thm, tan ca dc cht. - Ethanol 96% c vai tr ho tan PVP dn n c kh nng dnh. - Mu sunset yellow l t dc mu. X) Lopenca Cng ty c phn dc Hu Giang. Trnh by: Hp 5 v x 20 vin nn. Cng thc: Ibuprofen.............................. 200 mg Acetaminophen......................325 mg T dc va .......................1 vin (Tinh bt m, tinh bt sn, PVP, magnesi stearat, bt talc, sodium starch glycolat, mu orange lake) *) Phn tch thnh phn: - Tinh bt m, tinh bt sn l t dc n, t dc r. - PVP l t dc dnh, m bo chc ca vin, to hnh vin. Ci thin tnh thm, tan ca dc cht. - Talc v Magie stearat l t dc trn,c tc dng iu ho s chy ca ht, chng dnh v lm cho vin bng p hn. - Sodium starch glycolate l t dc siu r, trn chy tt. - Mu orange lake l t dc mu. Lm p vin v kim sot s phn tn ca dc cht trong vin.

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