Dc IN VIT NAM

CNG HA X HI CH NGHA VIT NAMB Y T

D C inVIT NAMm

Ln xut bn th t

H NI-2009

Hi ng Dc in Vit Nam, Trung tm Dc in - Dc th Vit Nam gi bn quyn Dc in Vit Nam ln xut bn th t

Trung tm Dc in - Dc th Vit Nam 48 Hai B Trng, Hon Kim , H Ni in thoi : (84-4) 38256905 Fax: :(84-4) 39 343547E-m ail; hdddvn@hn.vnn.vn

PHARMACOPOEIAVIETNAMICA

EDITIO IV

B Y T CNG HO X HI CH NGHA VIT NAMc lp - T do - Hnh ph

S: 3195/Q-BYTH Ni, ngy 01 thng 9 nm 2009

QUYTNH v vic ban hnh Dc in Vit Nam ln xut bn th t

B TRNG B Y T

Cn e Ngh nh s 188/2007/N-CP ngy 27/12/2007 ca Chnh ph quy nh chc nng, nhim v, quyn hn v c cu t chc ca B Y t;

Cn c Lut Dc ngy 14/6/2005;

Cn c Lut Tiu chun v Quy chun k thut ngy 29/6/2006;

Cn c Lut Cht lng sn phm, hng ha ngy 21/11/2007;

Cn c Ngh nh s 79/2006/N-CP ngy 09/8/2006 ca Chnh ph quy nh chi tit thi hnh mt s iu ca Lut Dc;

Cn c Ngh nh s 127/2007/N-CP ngy 01/8/2007 ca Chnh ph quy nh chi tit thi hnh mt s iu ca Lut Tiu chun v Quy chun k thut;

Cn c Ngh nh s 132/2008/N-CP ngy 31/12/2008 ca Chnh ph quy nh chi tit thi hnh mt s iu ca Lut Cht lTig sn phm, hng ha;

Cn c Thng t lin tch s 11/2008/TTLT/BYT-BKHCN ngy 29/12/2008 ca Lin B Khoa hc v Cng ngh v B Y t v Hng dn xy dng, thm nh, cng b B tiu chun quc gia v thuc v ban hnh, xut bn Dc in Vit Nam

Cn c Quyt nh s 1281/Q-BKHCN ngy 16/7/2009 ca B Khoa hc v Cng ngh v vic cng b B tiu chun quc gia v tiuc;

Xt ngh ca ng Cc trng Cc Qun l dc,

QUYT NH:

i 1. Ban hnh Dc in Vit Nam ln xut bn th t, gm cc Tiu chun quc gia v thuc:

1 - Tiu chun v nguyn liu h dG v thnh phm ha dc;

2 - Tiu chth v dc liu v thuc t dc liu;

3 - Tiu chun v ch phm vc xin v sinh phm y t;

4 - Tiu chun v phuQfng php kim nghim chung cho thuc v nguyn liu lm thuc dng cho ngi.

iu 2. Dc in Vit Nam ln xut bn th t c hiu lc t ngy 01/01/2010. Bi b cc quy nh tiDc in Vit Nam ln xut bn th nht, Dc in Vit Nam ln xut bn th hai v Dc in Vit Nam ln xut bn th ba.

iu 3. Cc ng/B: trng V Khoa hc v o to, Cc trng Cc Qun l dc, Ch tch Hi ng Dc in Vit Nam, Gim c Trung tm Dc in - Dc th Vit Nam c trch nhim hng dn vic p dng Dc in Vit Nam ln xut bn th t.

iu 4. Cc ng/B: Chnh Vn phng B Y t, V trng V Khoa hc v o to, Cc trng Cc Qun l dc, Th trng cc V/Cc, Tng Cc v cc on v trc thuc B Y t, Gim c S Y t cc tnh, thnh ph trc thuc Trung ng, Th trng Y t cc ngnh, Ch tch Hi ng Dc in Vit Nam v Gim c Trung tm Dc in - Dc th Vit Nam chu trch nhim thi hnh Quyt nh ny.

B TRNG

Nguyn Quc Triu

TrangL i gii thiu xi

L i i i u xiii

L ch s Dc in nc C ng ha x hi ch gM a V it N am XV

H i ng Dc in V i N am IV xix

C c cig tc vin xxi

C c c qiian v i v tham gia x y dg Dc ie V it N am IV xxiii

Danh mc cc chuyn lui XXV

Danh mc chiiyii lun m i so vi D V N I I xxxiv

D aiih mc cc chuyn lun ca D V N I I I khg a vo D V N IV xxx x

Qui ih chiing xli

C c chiyi lun

Nguyn liu ho dc v thnh phm ho dc 1

Vc xin v sinh phm y t 641

Dc liu 679

Thuc t dc liu 9 3 9

Ph hig ngoi P-1

C c ph lc P L - 1

M c lc tra cii theo t V it N am ' M L-1

M c lc tra cis theo tn L atin M L-35

Hi ng Dc in Vit Nam c thnh lp t nm 1963, t chc cng tc xy dng Dc in Vit Nam v tiu chun ha thuc. Trong hn 45 nm qua, Hi ng Dc in Vit Nam khng ngng c cng c, pht trin, v bin son, trnh B Y t ban hnh 4 B Dc in Vit Nam. B Dc in Vit Nam ln xut bn th nht (I) nm 1971, B Dc in Vit Nam ln xut bn th hai (II) nm 1990, B Dc in Vit Nam ln xut bn th ba (III) nm 2002, v nay l B Dc in Vit Nam ln xut bn th t (IV) nm 2009.

Dc in Vit Nam l B tiu chun quc gia v thuc, quy nh v tiu chun cht lng thuc v cc phoTig php chung v kim nghim thuc, l vn bn quy phm k thut quan trng ca ngnh Y t trong cng tc kim tra, gim st, qun l, m bo v nng cao cht lng thuc phc v s nghip chm sc v bo v sc khe nhn dn.

tng bc trin khai thc hin Chnh sch thuc quc gia, Chin lc pht trin ngnh Dc, trong thi gian qua (2004 - 2009), B Y t, Hi ng Dc in Vit Nam, cc n v t trung ng ti a phng, cc chuyn gia trong v ngoi nghnh Y t tp trung nghin cu xy dtig, bin son, thm nh v hon chnh B Tiu chun Quc gia v thuc - Dc in Vit Nam ln xut bn th t (IV) theo quy nh ca Lut Tiu chun v Quy chun k thut v c ban hnh theo quy nh ti Lut dc.

Dc in Vit Nam IV c t chc bin son mt cch khoa hc, cng phu, theo mt quy trnh thng nht, xem xt sa i cc tiu chun ban hnh v b sung nhiu tiu chun thuc mi. Cc tiu chun ca Dc in Vit Nam IV m bo s k tha truyn thng ca cc Dc in Vit Nam trc y, ng thi cp nht nhiu tin b khoa hc k thut tin tin, a vo nhiu mc cht lng cao tng ng vi cc nc trong khu vc v th gii, m bo tnh thc thi p dng i vi cc c s sn xut, kinh doanh trong nc, ph hp vi thng l quc t v hi ha vi cc Dc in tin tin trn th gii.

B Y t Ban hnh Dc in Vit Nam IV lm c s php l cho cc c quan qun l, k thut, cc n v, doanh nghip, c nhn hot ng trong lnh vc dc tng cTig cng tc tiu chun ha cht lng thuc, m bo thuc c cht lng ngy cng cao phc v cho nhu cu trong nc v xut khu. Dc in Vit Nam l ti liu k thut lm cn c qun l, kim tra, nh gi cht lng thuc lu hnh Vit Nam.

B TRNG B Y T

TS. Nguyn Quc Triu

Dc in Vit Nam lt xut bn th ba (DVN III) c B Y t ban hnh v c hiu lc t 01/7/2002. T ngy ban hnh, Dc in tr thnh vti bn quy phm k thut quan trng v tiu chun ha v kim nghim cht lng thuc tt c cc c s sn xut v kim tra cht lng d'c phm trn c nc. DVN III l mt vn bn k thut chun mc ca B Y t v c tham chiu trong mi hot ng o to, nghin cu khoa hc lin quan n thuc cc n v trong ton ngnh y t, Dc in gp phn tch cc vo vic pht trin, hin i ha ngnh Dc, m bo v nng cao cht lng thuc phc v s nghip chm sc v bo v sc khe nhn dn.Ngy 30/6/203, ti Quyt nh s 2471/BYT-Q, B trng B Y t thnh lp Ban Thng trc Hi ng Dc in Vit Nam IV v giao cho Hi ng vic xy dng DVN IVj ng thi hng dn trin khai thc hin DVN III va c ban hnh. Qua hn 5 nm trin khai thc hin, n nay Hi ng hon thnh vic xy dng B tiu chun Quc gia v thuc - Dc in Vit Nam v c B trng B Khoa hc cng ngh cng b ln xut bn th nht ngy 16/07/2009. Ngy 01/09/2009 B trng B Y t k quyt nh ban hnh DVN IV v c hiu lc thi hnh t 01/01/2010.DVN IV c 1157 chuyn luti (tiu chun), bao gm 356 chuyn lun nguyn liu ha dc; 260 chuyn lun thnh phm ha dc; 314 chuyn lun dc liu v thuc t dc liu; 25 chuyn lun vc xin v sinh phm y t; 154 ph hng ngoi chun; 202 chuyn lun v phng php kim nghim thuc v quy nh chung vi trn500 ha cht, thuc th diig trong kim nghim.DVN IV a vo nhiu chuyn lun thuc thnh phm cc dng bo ch khc nhau ph hp vi tnh hnh pht trin cng nghip dc hin nay nc ta. Cc chuyn lun ha dc, dc liu v vc xin cng c s thay i cp nht ph hp vi tinh hnh hin nay. Bn cnh nhng phng php kim nghim phn tch kinh in, nhiu phong php, k thut phn tch hin i c b sung v Dc in nh sc k lng hiu nng cao, sc k kh, in di mao qun, quang ph nguyn t pht x v hp th, phn tch acid-amin, phn tch ha cht bo v thc vt tn d trong dc liu v.v... Nhiu chuyn lun thuc mi, nhiu mc cht lng cao trong tiu chun ca nguyn liu v thnh phm thuc tng otig vi trnh tin tin ca cc nc trong khu vc v trn th gii c a vo Dc in. Nhng thay i ny l hon ton ph hp trong bi cnh Vit Nam l thnh viii chnh thc ca T chc Thng mi Th gii (WTO) vi nn kinh t ang pht trin nng ng v hi nhp vi th gii.DVN IV c xy dng v bin son mt cch khoa hc, cng phu, theo mt quy trnh thng nht, c tham kho nhng Dc in nc ngoi mi nht, i chiu vi thc t sn xut v kim nghim thuc Vit Nam hin nay. Nhm m bo kh nng trin khai p dng trong the t, phn ln k thut kim nghim trong cc chuyn lun u c thm nh ti cc c s kim nghini thuc (Vin Kim nghim thuc Trung ng, Vin Kim nghim thuc TP. H Ch Minh, Vin Kim nh quc gia vc xin v sinh phm y t, cc trng i hc Dc, mt s Trung tm Kim nghim dc phm - m phm v mt s doanh nghip Dc..DVN IV l b tiu chun quc gia v thuc c xc nh ti Lut Dc v Lut Tiu chun v Quy chun k thut. iu ny khng nh tnh quy phm k thut ca Tiu chun Dc in. V vy, vic trin khai p dng DVN IV l yu cu cn thit trong sn xut kinh doanh v kim tra cht lng dc phm nhm gp phn vo vic m bo cht lng thuc.Nhn dp hon thnh v xut bn Dc in Vit Nam IV, Hi ng Dc in Vit Nam xin trn trng cm 011 Lnh o B Y t, B Khoa hc v Cng ngh, cc V, Cc chc nng ch o trc tip v c hiu qu i vi cng tc xy dng Dc in. Hi ng nh gi cao s ng gp tr tu v cng sc ca nhiu chuyn gia, cn b trong v ngoi ngnh, c bit l PGS.TS. Trnh Vn Qu, nguyn ch tch Hi ng Dc in Vit Nam v cc y vin, cng tc vin ca Hi ng, cc c quan, n v, doanh nghip dc... gp phn vo cng tc xy dng Dc in, Nh xut bn Y hc thc hin vic n hnh cun Dc in Vit Nam IV ng v ni dung v p v hnh thc. Hi ng Dc in Vit Nam xin trn trng cm n s cng tc v ng gp qu bu .Mc d Dc in Vit Nam IV c xy dng theo mt quy trinh cht ch, cng phu nhng chc chn kh trnh khi mt s thiu st. Hi ng Dc in mong nhn c nhng gp , ph binh tip tasa i, b sung nhm lm cho Dc in ngy cng hon thin, p ng yu cu thc tin v tiu chun ha v kim tra cht lng thuc, gp phn m bo v nng cao cht lig thuc phc v s nghip chm sc v bo v sc khe nhn dn.

HI NG DC IN VIT NAM CHU TCH

TS. Nguyn Vn Tu

LCH S C IN NC CNG H X HI CH NGHA VIT NAM

Nc Vit Nam Dn ch Cng ho c thnh lp t ngy 02 thng 9 nm 1945, nay l nc Cng ho X hi ch ngha Vit Nam. Trong thi k Php thuc v thi k khng chin chng Php, Ngnh Dc Vit Nam da vo De in Php qun l cht lng thuc. Nm 1954, sau khi ha bnh c lp li Min Bc, vic xy dng mt b Dc in Vit Nam ph hp vi tnh hnh sn xut v s dng thuc tr nn cn thit; c bit cng tc tiu chun ha thuc l lnh vc c Chnh ph ht sc quan tm. Ngy 28 thng 3 nm 1963, Chnh ph ban hnh Ngh nh s 123/CP v cng tc tiu chun ha. thc hin Ngh nh 123/CP ca Chnh ph, ti Thng t s 19-BYT/TT ngy 19 thng 7 nm 1963 B Y t giao cho Th trng, Dc s V Cng Thuyt, chu trch nhim ch o vic t chc Hi ng Dc in Vit Nam (HD VN). DS. V Cng Thuyt ngh B Y t c Gio s Tin s dc khoa Trng Cng Quyn, mt trong nm gio s u tin ca Ngnh Y t Vit Nam do Ch tch H Ch Minh k quyt nh, trc tip t chc hot ng ca HD VN. Ngy 27/02/1964, B trng B Y t, bc s Phm Ngc Thch, k Quyt nh s 183/BYT-Q v c cu t chc HD VN I gm c Ch tch Hi ng do GS.TS. Trng Cng Quyn m nhim; 4 Ph Ch tch l DS. V Cng Thuyt, DS. Trn Vn Lun, BS. Nguyn Ngc Don v BS. Nguyn Vn Hng. Ban th k gm c DS. Ng Gia Trc, Trng ban v DS. Nguyn Hu By, Ph ban. Cc u vin ca HD VN gm 16 ngi, trong c 12 dc s v 4 bc s. Hi ng Dc in Vit Nam I thi k 1963 - 1984 c 6 ban: Ha dc, Bo ch, Dc liu, vc xin - huyt thanh v Phng php kim nghim chung. Tng s ngi tham gia xy dng DVN I, tp 1 l 92 ngi, trong ch c 2 bin ch vn phng, cn li l cc cn b kim nhim t cc n v trong ngnh.Ln u tin xy dng Dc in Vit Nam, B Y t ra cc phng chm ch o trong qu trnh son tho l:

Phi xut pht t tnh hnh thc t ca Vit Nam;Dc in phi c tc dng thc y, nng cao trnh k thut ca ngnh ln mt bc;Phi th hin c phng chm kt hp ng ty y ng mc.

Ban Thng trc HD VN t chc mt s cuc hi tho ti H Ni bn v nguyn tc la chn, lp danh mc thuc a vo DVN. Hi ng Dc in thng nht s a vo DVN cc thuc ang c dng ph bin trong nc, c gi tr phng v cha bnh c xc nh, c trin vng c s dng trong khong thi gian t 5 n 10 nm ti. c bit ch n cc nguyn liu v thnh phm sn xut trong nc, thuc dc liu v thuc y hc c truyn, sau l cc thuc nc ngoi c mt ti Vit Nam.Nguyn tc la chn v xy dng cc phng php kim nghim l phi ph hp vi kh nng trang thit b ca cc c quan kim nghim Trung ng, nhng c ch n tnh hnh trang thit b ca cc c quan kim nghim tuyn tnh. Phng php kim nghim trong Dc in c tnh php ch v l phng php trng ti. Sau 6 nm son tho DVN I trong iu kin chin tranh c lit Min Bc, ngy 20-11-1970, B Y t c Quyt nh s 1008/BYT- Q ban hnh Dc in Vit Nam I, tp 1, bao gm 572 chuyn lun v thuc trong c 269 ho dc, 120 dc liu, 167 ch phm bo ch v 16 sn phm sinh hc cng vi cc phng php kim nghim, cc cht ch th, cc cht i chiu, cht chun v thuc th p dng trong sn xut, phn phi, kim nghim v s dng thuc.Thng 3-1977 B Y t k Quyt nh ban hnh Bn b sung DVN I, tp 1, gtri phn nh chnh v b sung lin quan ti 36 tiu chun Vit Nam (TCVN) v phng php kim nghim thuc v dng thuc, 7 ch tiu v ha cht, thuc th v 2 bng liu thuc c A, B. ng thi ban hnh thm 44 tiu chun v thuc v nguyn liu dng lm thuc.T sau ngy gii phng Min Nam, B Y t cho in li 4 000 cun DVN I c kt hp sa cha v b sung theo ni dung ca bn b sung nm 1977, p ng u cu cng tc tiu chun ha v m bo cht lng

; thi k chin tranh gii phng v bo v gia ca Vit Nam v thuc v cc photig

php kim nghim thuc, c tc dng thc y cng tc qun l cht lng thuc phc v cho nhim v ca ngnh trong sn xut cung ng thuc, chm lo sc khe nhn dn trong chin tranh bo v T quc cng nh trong thi k xy dng kinh t sau khi t nc ha bnh thng nht.

Trc thc t V it Nam c nn y hc c truyn dn tc lu i, thc hin phng chm ca ng v N h nc v k tha, pht huy, pht trin y hc c truyn, kt hp y hc c truyn vi y hc hin i v hin i ha y hc c truyn, thuc t dc liu v thuc y hc c truyn cng c s dng ngy cng nhiu v rng ri. thng nht tiu chun trong ton ngnh, nng cao cht lng thc c truyn, vic tin hnh xy dng cun D VN I, tp 2, phn ng dc l mt yu cu bc thit. B Y t c Quyt nh ngy 16 thng 9 nm 1968 thnh lp Ban ng dc ca HD V N do G S .T S . Trng Cng Quyn, Gh tch Hi ng D VN kim Trng ban vi 4 Ph ban: G S .T SK H . Tt Li; B S . Lng y L Vn Li; Lng y L Vn Qunh v Lng y Ph c Thnh. Ban ng dc c 3 tiu ban: Dc liu, Y l ng y v B o ch. s thnh vn tham gia xy dng cun Dc din V it Nam I, tp 2 (phn ng dc) gm 5 cn b chuyn trch trong tng s 8 cn b thuc bin ch Vn phng HD V N lc , cng 23 y vin, 1 1 cng tc vin v 7 c quan.Vic xy dng DVN I, tp 2 (phn ng dc) c tin hnh qua cc bc:1. X y dng v xut bn cun Dc liu Vit Nam (1969 - 19 72) gm 34 1 dc liu trng nc, 74 dc liu nhp ngoi, 3 chuyn lun chung v trng cy thuc, ch bin, bo ch, bo qun thuc c truyn dn tc. Trong bc ny thng nht chn tn chnh, tn khoa hc, tn khc ca cy thuc hoc b phn dng lm thuc, m t, hnh v b phn dng ca dc liu, tnh v, cng dng, liu dng, cch dng... Nh tp hp c cc lng y v cc dc s c nhiu kinh nghim, Ban ng c tho lun v i n thng nht quan im v cc vn chuyn mn. Cun Dc liu V it Nam c xut bn 2 ln, ln th nht l 5.000 cun v ln th hai l 1 2 . 0 0 0 cun.2. D kin danh mc, thng nht ni dung, b cc cc chuyn lun v bin son d tho DVN I (phn ng dc) (1970 - 1975). Yu cu v ni dung ca cun Dc in Vit Nam I, tp 2 (phn ng dc) cao hn cc chuyn lun trong cun Dc iiu Vit Nam. Ngoi phng php kim nghim nh tnh, th tinh khit, nh lng cn c thm mc ch bin, bo qun v nhng vn cn thit cho cc lng y nh: Tnh v, quy kinh, cng nng, ch tr, cch dng, liu lng v king k.3. In cc d tho, gi ti cc c s thu thp kin ng gp (1975 - 1980).4. Chnh l bn d tho, trnh B Y t duyt v cho php xut bn. Thng 4 -1983 cun Dc in Vit Nam in ln th nht tp 2 (Thuc Dn tc) c ban hnh vi 244 chuyn lun, s lng 4000 cun. Nh vy n 1983, B D VN I c hon chnh c v tn dc v ng dc.T gia thp k 80, t nc bt u qu trnh thc hin ng li v chnh sch i mi ca ng v Nh nc. Yu cu v cht lng thuc ngy cng cao trong qu trnh hi nhp quc t ngy cng gia tng thc y cng nghip dc trong nc bt u pht trin. Thi k ny Hi ng cng c thm nhiu Dc in mi ca cc nc tham kho. Trinh cn b dc c nng ln, Ngnh Dc c thm nhiu gio s, tin s, dc s chuyn khoa. H thng kim nghim thuc ca Nh nc v cc doanh nghip tng bc c hin i ha theo yu cu ca qun l cht lng v yu cu phc v cho cng tc sn xut-kinh doanh dc phm. n lc ny ni dung D V N I c nhiu im khng cn ph hp. V ic son tho Dc in Vit Nam ln th 2 (DVN II) tr thnh mt yu cu thc t. Ngy 12/5/1984 B Y t ban hnh Quyt nh 328/B Y T -Q b sung v kin ton t chc H D V N bin son D V N II. B an thng trc H D V N II gm: Ch tch Hi ng G S. Trng Cng Quyn, 4 ph Ch tch: G S .T S . Nguyn Vn n; PG S. N g G ia Trc; G S. Nguyn K im Hng v PG S. Trn Th Hong Ba. Ban th k gm Trng ban: PG S. Don Huy Khc vi 3 Ph ban: D SC K II. Phan Vn Tn, T S. Nguyn B Hip v T S. Nguyn Vn Th. Vn phng Hi ng Dc in Vit Nam l mt n v hnh chnh chuyn mn, trong bin ch Vin Kim nghim, gip vic cho Ban Thng trc v Ban Th k. Tng s cn b tham gia xy dng D V N II l 2 2 1 ngi gm cc gio s, tin s, dc s chuyn khoa, trong c 5 bc s y khoa, 4 lng y v 9 cn b ngnh khc.Dc in Vit Nam II gm 3 tp. Tp 1 v Tn dc c 89 chuyn lun xut bn nm 1990 gm 39 ho dc, 12 bo ch, 8 dc liu, 29 phng php kim nghim chung, 1 quy nh chung, pht hnh 1500 cun. Tp 2 (thuc ng dc), xut bn nm 19 9 1, gm 63 chuyn lun dc liu v mt chuyn lun chung v phng php ch bin dc liu c truyn. Tp 3 xut bn thng 12 -19 9 4 gm 84 ha dc, 70 thnh phm bo ch, 70 dc liu, 62 phng php kim nghim chung, 90 ph hng ngoi. D V N II, tp 3 c nhiu chuyn lun mi v cc chuyn iun khc c sot xt, nng cao, cng nh a vo mt s phong php kim nghim chung hin i nh sc k kh, sc k lng.

Sau 10 nm i mi, tnh hnh ngnh Dc trong nc c nhiu chuyn bin tch cc ng k. Vo gia thp nin 90, th trng thuc V it Nam tng gp 6 ln nhng nm cui thp k 80. Cng nghip dc trong nc c bc pht trin mi, sn xut gn 5 000 dc phm. Khong 200 cng ty dc phm nc ngoi

XV i

c cp giy php hot ng Vit Nam. Khong 4 000 dc phm nc ngoi thuc cc khu vc trn th gii c cp s ng k Vit Nam. Cng tc tiu chun ha v m bo cht lng thuc trong nc, thuc nc ngoi ngy cng c nng cao. Nm 1995, Vit Nam tr thnh thnh vin th mi ca Hip hi cc quc gia ng Nam (khi ASEAN) v tng bc ch ng tham gia tin trnh hi nhp quc t. Vic son tho v ban hnh Dc in Vit Nam ln th 3 l mt bin php quan trng bo m hiu lc cho cng tc qun l nh nc v cht lTig thuc trong tnh hnh t nc v bi cnh quc t mi.Ngy 25-7-1994, trong Quyt nh s 519/BYT-Q B trTig B Y t cng b danh sch Ban thng trc HD VN III gm 11 thnh vin do GS.TS. Trng Cng Quyn Ch tch Hi ng, 7 ph ch tch: PGS.TS. L Vn Truyn, PGS. Don Huy Khc (kim Trng ban th k), GS.TS. Nguyn Vn n, GS.TSKH. ng c Trch, PGS. V Khnh, PGS. Ng Gia Trc v PGS. Trn Th Hong Ba. Cc Ph trng ban th k gm: TS. Nguyn Vi Ninh, PGS.TS. Trnh Vn Qu v TS. Nguyn Vn Th. Cui nm 1997, trong Quyt nh s 2678/1997/BYT-Q ngy 23-12-1997, B tmng B Y t b nhim PGS.TS. L Vn Truyn - Th trng BY t gi chc v Ch tch Hi ng Dc in Vit Nam III, tip ni nhim v Ch tch HD Vit Nam m GS.TS. Trng Cng Quyn m nhim trong hn 3 thp k. Cc Ban ca Hi ng ni chung vn gir nguyn v t chc, ring ban phng php kim nghim chung tch thnh 2 ban: Ban phng php phn tch thuc th v cht i chiu v Ban phng php sinh hc. Cc cn b tham gia xy dng DVN III gm: 4 cn b chuyn trch thuc bin ch Vn phng Hi ng Dc in Vit Nam, 176 y vin v cc cng tc vin, nhiu c quan trong ngnh Y t.Trong 5 nm (1995 - 2000), Hi ng Dc in Vit Nam hon thnh vic bin son Dc in Vit NamIII v in hai tp D tho. D tho Dc in Vit Nam III (Thuc c truyn) gm 154 chuyn lun in vo nm 1998. D tho Dc in Vit Nam III (Tn dc v Dc liu) in vo nm 2000. Hai bn D tho Dc in Vit Nam III c gi ti cc n v trong ton ngnh ly kin ng gp. Nm 2001, sau khi thu thp cc kin ng gp, Hi ng t chc thm nh, nghin cu b sung v hon thin cc chuyn lun Dc in Vit Nam III c in chnh thc u nm 2002. So vi ln xut bn trc, Dc in Vit Nam III a thm nhiu chuyn lun thuc mi, b sung nhng k thut v phng php tin tin, hin i trong kim nghim thuc, nng cao tiu chun cht lng ca nguyn liu lm thuc v thnh phm tng ng vi trnh tin tin trong khu vc v trn th gii, p ng vi u cu thc t ca Vit Nam v yu cu hi nhp quc t. Nhn thc c tm quan trng ca cng tc Dc in trong thi k t nc hi nhp vo nn kinh t ton cu, B Y t ch trng cng c HD VN hng dn vic trin khai p dng DVN III v tip tc xy dng Dc in, tin ti ban hnh DVN IV. Ngy 28/02/2003, ti Quyt nh s 689/BYT-Q, B trng BY t b nhim PGS.TS. Trnh Vn Qu, Vin trTig Vin Kim nghim lm Ch tch HD VN, thay PGS.TS. L Vn Truyn. Sau , Ban Thng trc Hi ng c cng c li vi cc Ph ch tch l nhng cn b ang gi chc v qun l ca Cc qun l Dc, Vin Kim nghim thuc, Vin Kim nh vc xin v Sinh phm y t v V Khoa hc v o to B Y t, Nh vy, Ban Thng trc HD VN IV gm 9 thnh vin do PGS.TS. Trnh Vn Qu lm Ch tch Hi ng; 6 Ph ch tch: GS.TS. Phm Thanh K, TS. Trn Cng K, PGS.TS. Trnh Vn Lu, TS. Cao Minh Quang, GS.TS. Nguyn nh Bng v TS. Phm Quc Bo. Do nhng thay i cn b gi chc v lnh o cc c quan, n v qun l dc v kim nghim nn n nm 2007, danh sch 6 Ph ch tch Hi ng l GS.TS. Phm Thanh K, TS. Trong Quc Cng, PGS.TS. Trnh Vn Lu, DS. Nguyn Vn M, PGS.TS. L Vn Phng v TS. Phm Quc Bo. Trng Ban th k l Vin trng Vin Kim nghim thuc Trung ng (hin l PGS.TS. Trnh Vn Lu), cc Ph trng Ban th k l ThS. Cao Th Mai Pho'ng (Chnh Vn phng Hi ng Dc in Vit Nam) v DS. Nguyn Vn Vin (chuyn vin Cc Qun l Dc - B Y t). Ngy 31/3/2008, B trng B Y t b nhim TS. Nguyn Vn Tu, Ph vin trng Vin Kim nghim thuc Trung ng, lm Ch tch Hi ng Dc in Vit Nam thay PGS.TS. Trnh Vn Qu ngh ch hu tr, tip tc iu hnh cc cng vic ca Hi ng Dc in Vit Nam. Tip theo , ngy 2 thng 1 nm 2009, B Trng B Y t k Quyt nh s 08/Q-BYT thnh lp Trung tm Dc in - Dc th Vit Nam trn c s ca Vn phng Hi ng Dc in Vit Nam, i mt n v s nghip c thu trc thuc Vin Kim nghim thuc Trung ng, c t cch php nhn, c con du v ti khon ring. Trung tm Dc in - Dc th Vit Nam l c quan thng trc ca Hi ng Dc in Vit Nam.Sau khi cng c Ban Thng trc Hi ng, cc Ban chuyn mn cng u c t chc li theo hng gim u mi, trong Ban Dc liu v Ban Thuc c truyn nhp thnh Ban Dc jjtfg13flg,4uc; Ban Phng php phn tch, thuc th v cht i chiu v Ban Phng php sinh hc nh,^^6n"BW::P^ong php kim nghim chung. Cc y vin Ban Thng trc Hi ng c phn cng tr tip ph trcl ckc ban chuyn mn; cc cn b Vn phng HD Vit Nam c c lm Th k ca cc b^chuyn , *

, V ' \ S ''

XVll

ng thi vi vic cng c t chc, Hi ng trin khai ngay cc hot ng chuyn mn. Nm 2003 - 2004, Hi ng tp trung vo vic dch chuyn ng DVN III sang ting Anh v bin tp thnh phin bn ting Anh ca DVN III. Thng 4 nm 2005, phin bn ting Anh DVN III c xut bn v pht hnh, ch yu n cc i tc nc ngoi, cc cng ty xut nhp khu thuc v cc t chc quc t. l ln u tin Dc in Vit Nam c thm phin bn ting Anh, gip cc ng nghip nc ngoi c th tip cn d dng vi b Tiu chun quc gia v thuc ca Vit Nam, mt t nc c ngnh Dc ang pht trin mnh m v hi nhp su rng vi nn kinh t trn th gii.Cng trong cc nm 2004 - 2005 Hi ng tin hnh r sot, chnh sa v b sung DVN III. u nm 2006 Bn b sung DVN III c ban hnh v xut bn. Ni dung ca Bn b sung c chun b nh mt phn ca DVN IV s xut bn sau ny.Cng tc xy dng DVN IV c trin khai vi mt k hoch tng th c B Y t ph duyt. Vo thi k ny, Lut Dc c Quc hi kha XI, k hp th 7 thng qua ngy 14/6/2005. Dc in Vit Nam c xc nh trong Lut Dc l b Tiu chun quc gia v cht lng thuc v cc phng php kim nghim thuc. Lut Tiu chun v Quy chun k thut cng c Quc hi kha XI, k hp th 9 thng qua ngy 29/6/2006 chi phi vic xy dng v ban hnh Dc in, i hi cng tc ny phi tun theo nhng quy trnh, th tc y v cht ch.Ngy 29/12/2008, B Y t v B Khoa hc v Cng ngh k Thng t lin tch s 1 l/2008/TTLT/BYT- BKHCN hng dn xy dng, thm nh, cng b B tiu chun quc gia v thuc v ban hnh, xut bn Dc in Vit Nam. Thng t ny a cng tc tiu chun thuc ln mt bc pht trin mi, m bo vic xy dng cc tiu chun quc gia v thuc - Dc in Vit Nam tun th cc quy nh ca Lut Dc, Lut Tiu chun v Quy chun k thut, ph hp vi c th ca tiu chun quc gia v thuc v thng l quc t; p ng yu cu hi nhp quc t v dc.Thi gian ny, Dc in Vit Nam IV c bn hon thnh v c B Y t nghim thu cp B. p ng cc quy nh ti Thng t 1 l/2008/TTLT/BYT-BKHCN, cc tiu chun quc gia v thuc ca Dc in Vit Nam IV c gi thm tra v chuyn mn ti Cc Qun l Dc v thm nh ti Tng cc Tiu chun - o lng - Cht lng. Ngy 16 thng 7 nm 2009 B trng B Khoa hc v Cng ngh k cng b B Tiu chun quc gia (TCVN I: 2009) xut bn ln 1, bao gm: TCVN I-l: 2009 B tiu chun quc gia v thuc - phn 1: Phng php kim nghim thuc; TCVN 1-2: 2009 B tiu chun quc gia v thuc - phn 2; Nguyn liu ha dc; TCVN 1-3: 2009 B tiu chun quc gia v thuc - phn 3: Thnh phm ha dc; TCVN 1-4: 2009 B tiu chun quc gia v thuc - phn 4: Dc liu v thuc t dc liu; TCVN 1-5: 2009 B tiu chun quc gia v thuc ~ phn 5: v c xin v sinh phm y t. Trn c s cng b B tiu chun quc gia v thuc TCVN I: 2009 ca B trng B Khoa hc v Cng ngh; ngy 24 thng 7 nm 2009 Hi ng Dc in Vit Nam c Cng vn s 40/D-DT ngh B Y t c quyt nh ban hnh Dc in Vit Nam IV v ngy 01 thng 9 nm 2009, B trng B Y t k Quyt nh s 3195/Q-BYT v vic ban hnh Dc in Vit Nam ln xut bn th t, c hiu lc thi hnh t 01/01/2010.Hi ng huy ng khong 200 chuyn gia y v dc t Vin Kim nghim thuc Trung ng, Vin Kim nghim thuc TP. H Ch Minh, Vin Kim nh quc gia vc xin v sinh phm y t, Trng i hc Dc H Ni, Trng i hc Y - Dc TP. H Ch Minh, Vin Dc liu, v nhiu n v sn xut, kim nghim v nghin cu v thuc khc tham gia vo cng tc Dc in. Trong 5 nm t 2003 n 2008, cc chuyn lun DVN IV c xy dng v bin son cng phu theo mt quy trnh khoa hc thng nht; ln lt qua cc bc xy dng danh mc, bin son d tho, kho nghim, ly kin, thm nh, nghim thu trnh cc cp c thm quyn cng b v ban hnh p ng. DVN IV c 1157 chuyn lun, bao gm 356 nguyn liu ha dc, 260 thnh phm ha dc, 314 dc liu v thuc t dc liu, 25 vc xin v sinh phm y t; cn li l cc chuyn lun v phng php kim nghim v quy nh chung. Ni dung ca DVN IV phn nh trinh pht trin hin nay ca ngnh Dc Vit Nam, cp nht nhng tin b khoa hc cng ngh sn xut v kim nghim dc phm trn th gii, p ng yu cu m bo cht lng thuc cho t nc trong bi cnh ton cu ha v hi nhp kinh t th gii.Tri qua 46 nm hot ng, Hi ng Dc in Vit Nam xy dng v xut bn 4 ln DVN, trong DVN III, DVN IV c thm phin bn ting Anh. Dc in Vit Nam thc s gp phn vo vic tiu chun ha cht lng thuc, qun l v nng cao cht lng dc phm sn xut, lu hnh trong nc, ng gp hiu qu vo qu trnh pht trin v tng bc hin i ha ngnh Dc nc nh.

HI NG DC IN VIT NAM IV(Theo Thng t s 19-BYT/TT ngy 19/7/1963, Qut iih s 2471/Q-BYT ngy 30/6/2003,

Quyt nh so 4565/Q-BYT ngy 21/12/2004, Quyt nh s 1766/Q-BYT ngay 18/5/2006 v Quyt nh s 1767/Q-BYT ngay 18/5/2006) va Quyt nh s 1120/Q-BYT ngy 31/3/2008

(2003-2009)

Ch tch Hi ng Dc in Vit Nam IVPGS.TS. Trnh Vn ii (2/2003-3/2008)

TS. Nguyn Vn Tu (t 4/2008)

Cc Ph ch tch Hi ng Dc in Vit Nam IVCc trung Cc Qun l Dc: TS. Trn Cng K (t 6/2003 n 5/2004), TS. Cao Minh Quang (5/2004- 8/2007), TS. Trng Quc Cng (t 8/2007).Vin trTig Vin Kim nghim thuc Trung ng: PGS.TS. Trnh Vn Lu.Vin trng Vin Kim nghim thuc Thnh ph H Ch Minh: TS. Cao Minh Quang (t 6/2003-5/2004), DS. Nguyn Vn M (5/2004 - 11/2008), TS. Nguyn Ngc Vinh (t 11/2008). "Vin trng Vin Kim nh quc gia vc xin v Sinh phm y t: GS.TS. Nguyn inh Bng (6/2003- 5/2006), PGS.TS. L Vn Phng (t 5/2006).Ph Ch tch Hi ng khoa hc - K thut, B Y t, Trng ban Dc v Trang thit b y t: GS.TS. Phm Thanh KLnh o V Khoa hc - o to, B Y t: TS. Phm Quc Bo (T 5/2006).

Bn Thng trc Hi ng Dc in IVGm Ch tch, cc Ph ch tch, Trng ban v Ph trng ban th k.

Ban th kTrng ban: PGS.TS. Trnh Vn Lu.Ph trng ban: ThS. Cao Th Mai Phng,

DS. Nguyn Vn Vin.Cc u vin: ThS. L Thanh Hi, ThS. ng Th Minh Hng, ThS^Lc Th Thu Hng, CN. Thch Th Hin, ThS. Nguyn Th Hng, TS. Nguyn Vn Li, ThS. Nguyn Th Phng Mai, TS. Thy Ngn, DSCKI. Trng Th Nguyt, CN. Ng Quang Ti, CN. H Th Thy.

Ban Danh php quy chTrng ban: TS. Cao Minh Quang (12/2004-8/2007), TS. Trotig Quc Cng (t 8/2007).Ph trng ban: ThS. Nguyn Xun Hnh (12/2004- 5/2006), PGS.TS. Nguyn Quang t (t 5/2006).Th k ban: ThS. ng Th Minh Hng.

Ban Ha dcTrng ban: 'PGS.TS. Trnh Vn Lu.Ph trng ban: ThS. Phan Th Thu Chi,

PGS.TS. Trng Phng.Th k ban: ThS. Nguyn Th Hng.Cc u vin: DS. V Bch Dng, PGS.TS. Trn Thnh o, TS. Vnh nh, ThS. Nguyn Thanh H, Ths. Nguyn Th Thu H, ThS. Trn Thu Hnh, PGS.TS. Trn c Hu, ThS. L Th Hng Hoa,

PGS.TS. V Th Bch Hu, DS. L Th cm Hng, PGS.TS. Nguyn Hi Nam, ThS. Nguyn Hng Qun, TS. on Cao Sn, ThS. Nguyn Th Kim Thanh, PGS.TS. L Minh Tr, PGS.TS. Nguyn c Tun.

Ban Bo chTrng ban: DS. Nguyn Vn M (t 12/2004 - 11/2008), TS. Nguyn Ngc Vinh (t 11/2008).Ph trng ban: GS.TS. V Xun Minh, ThS. Nguyn Th Kim Xun (2004-5/2006), ThS. Bi Th Hoa (t 5/2006).Th k ban: ThS. Cao Th Mai Phng, DSCKl. Th Cm Vn.Cc u vin: PGS.TS. Hong Minh Chu, ThS. Trn Th Qunh Chi, ThS. Lc Th Thu Hng, ThS. H Minh Hin, PGS.TS. Nguyn ng Ho, PGS.TS. Hunh Vn Ho, ThS. L Vn Lng, ThS. Nguyn ng Lm, PGS.TS. Nguyn Vn Long, DSCKl. Nguyn Quang Lun, ThS. Hong Mng, DS. Phm Hng Phng, DSCKI. Bi Vn Thanh.

Ban Dc liu - ng dcTrng ban: GS.TS. Phm Thanh K.Ph trng an; PGS.TS. Chu Quc Trng,

PGS.TS. Trn Hng.Th k ban: ThS. Nguyn Th Phng Mai.Cc u vin: ThS. Vng Vn nh, DS. Nguyn Th Minh Chu, CN. Nguyn Chiu, DS. Nguyn Th Kim Danh, ThS. Phm Th Ging, TS. Nguyn Thu Hng, TS. V Vn Lo, TS. Bi M Linh, TS. Li Quang

Long, t S. Nguyn Thj Nhungl, TS. Quyn, PGS.TS. Phm Xun Sinh, ThS. Nguyn Th Phng Tho, PGS.TS. Nguyn Duy Thun, TS. Nguyn Th Bch Thu, TS. Hunh Ngc Thy, DS. V Th Bch Tuyt, TS. Nguyn Vn Tu, PGS.TS. Nguyn Vit Thn.

Ban Vc xin v Sinh phmTrng ban: GS.TS. Nguyn nh Bng (12/2004- 5/2006), PGS.TS. L Vn Phng (t 5/2006).Ph trng ban, kim th k ban: TS. Th Ngn. Cc u vin-. TS. Hong Th Hng, TS. Nguyn Th Kim Hng, ThS. Hong Quang Huy,PGS.TS. Nguyn Th Hng Linh, PGS.TS. L Th Lun.

Ban Phng php kim nghim chungTrng ban: PGS.TS. Trnh Vn Qu.Ph trng ban: PGS.TS. Thi Phan Qunh Nh, TS. Phng Th Vinh.Th k ban: ThS. Cao Th Mai Phng, ThS. Lc Th Thu Hng.

Cc u vin: PGS.TS. Trn T An, ThS. Nguyn Tun Anh, PGS.TSKH. Trung m, ThS. Bi Th Ha, ThS. ng Trn Phng Hng, TS. Trn Vit Hng, DSCK. Nguyn Duy Khang, ThS. Trng Tli Thu Lan, DS. L Tn Phc, DS. Phm Hng Phng, ThS. Hunh Th Thnh, TS. Nguyn Vn Th, TS. Nguyn Ngc Vinh.

Ban Bin tp - Hiu nhTrng ban: PGS.TS. Trnh Vn Qu.Cc u vin: GS.TS. Phm Thanh K, ThS. Lc Th Thu Hng, ThS. Nguyn Th Hng, ThS. Nguyn Th Phng Mai, TS. Thy Ngn, ThS. Cao Th Mai Phng.

Trung tm Dc in - Dc th Vit NamGim c: ThS. Cao Th Mai Phng.Ph Gim c: ThS. Lc Th Thu Hng.Cn b chuyn trch: DS. L Th Thu Hin, ThS. Nguyr Th Hng, ThS. Nguyn Th PhoTig Mai, CN. H Th Thy.

CC CNG TC VIN

PGS.TS. Nguyn Thi An DS. Phm Hng Anh TS. Trn Th Hng Anh DS. Nguyn Th Vn Anh ThS. Cao Ngc Anh PGS.TS. Nguyn Th Bay DS. Nguyn Th Bch PGS.TS. Ha Bnh PGS.TS. Phng Ha Bnh DSCKI. Nguyn Thanh Bnh PGS.TS. Phm Vn Ca DS. H Th Minh Chu LY. Hong Bo Chu DS. L Th Kim Chi TS. L nh Chi TS. Nguyn Th Minh Chung ThS. Hunh Ngc Di DS. Qu Dim ThS. ng Thu Dung ThS. Phm Th Duyn PGS.TS. V Vn in ThS. Nguyn Vn H DS. Nguyn Vit H DS, Mai Thanh H DS. H Minh Hin ThS. Nguyn Th Hoa ThS. Nguyn Th Vnh Hng CN. Hong Khnh Ha ThS. L Xun Hu GS. Phm Gia Hu ThS. T Mnh Hng ThS. L Th Thin Hong ThS. Hong Th Hng TS. ng Vn Khnh PGS.TS. Trn Cng Khnh TS. Nguyn Vit Knh ThS. Trn Cng Lun

DS. Nguyn Trng LuThS. Ng Th Xun MaiDS. Dng Nguyn Mng MaiDS. Phm Hng MinhDSCKI. Dng Cng MinhKS. Tng Hu NghPGS.TS. L Quan NghimDS. Nguyn Th Trang NhungDS. Th OanhTS. Phm ng PhngThS. Trn Anh PhngThS. Nguyn Th Thanh PhngDS. Trnh Th QuyDSCKII. Trn Th L SungTS. Nguyn Th Minh TmThS. Phm Thanh TmDS. Hong Thanh TmThS. Nguyn Phng ThanhDS. Nguyn Th ThanhThS. Th ThanhThS. Nguyn Nht ThnhDS. Nguyn Hu ThnhThS. L Th Thanh ThoThS. Nguyn Th Thanh ThoThS. Le Th Minh ThoThS. L Th ThuDS. V Th Minh ThuThS. Th Thanh ThyThS. Nguyn c TonThS. Vn TrnGS.TS. Nguyn Thu VnDS. Bi Th VnThS. Lc Th VnThS. Trn Th Bch VnDS. L VinKS. Nguyn B VngDS. Nguyn Th Hng Yn...

CC c QUAN V N V THAM GIA XY DNG Dc IN VIT NAM IV

Cc qun l Dc, B Y t

V Khoa hc v o to, B Y t

Vin Kim nghim thuc Trung ng, B Y t

Vin Kim nghim thuc TP. H Ch Minh, B Y t

X Trng i hc Dc H Ni

Khoa Dc, Trng i hc Y - Dc TP. H Ch Minh

Vin Dc liu, B Y t

Vin Kim nh vc xin v Sinh phm Y t, B Y tBnh vin Y hc c truyn Trung ng, B Y t

Trung tm Kim nghim Dc phm v M phm H Ni

Trung tm Kim nghim Dc phm v M phm TP. Hu

Trung tm Kim nghim Dc phm v M phm TP. H Ch Minh

Trung tm Kim nghim v nghin cu dc, Cc Qun y

Mt s doanh nghip sn xut v kinh doanh Dc...

DANH MC CC CHUYN LUN

11 Tn chuyn lun TT Tn chuyn lun

1 Acetazolamid 52 Bch u khu (Qu)2 Acetylcystein 53 Bch gii t3 Aciclovir 54 Bch hoa x thit tho4 Acid acetylsalicylic 55 Bch tt l (Qu)5 Acid ascorbic 56 Bch thc (R)6 Acid benzoic 57 Bch trut (Thn r)7 Acid boric 58 Ban h (irhn r)8 Acid citric ngm 1 phn t nc 59 Benzalkonium clorid9 Acid folic 60 Benzathin benzylpenicilin

10 Acid hydrocloric 61 Benzylpenicilin kali11 Acid hydrocloric long 62 Benzylpenicilin natri12 Acid mcfenamic 63 Berberin clorid13 Acid nalidixic 64 Betamethason14 Acid nicotinic 65 Betamethason dipropionat15 Acid salicylic 66 Betamethason valerat16 Actis (L) 67 Bm bm bic (Ht)17 Adrenalin 68 Bnh vi18 Adrenalin acid tartrat 69 Biosubtyl19 Albendazol 70 Biotin20 Alimemazin tartrat 71 Bisacodyl21 Alopurinol 72 Bng ht nc22 Alverin citrat 73 Bng ht nc tit khun23 Amikacin 74 B b24 Aminophylin 75 B cng anh25 Amitriptylin hydroclorid 76 B ct ch (Qu)26 Amlodipin besilat 77 Bi mu (Thn hnh)27 Amoni clorid 78 Bt b28 Amoxicilin trihydrat 79 Bt bnh v29 Amphotericin B 80 Bt pha tim Amoxicilin30 Ampicilin 81 Bt pha tim Ampicilin31 Ampicilin natri 82 Bt pha tim Artesunat32 Ampicilin trihydrat 83 Bt pha tim Benzathin benzylpen33 Artemether 84 Bt pha tim Benzylpenicilin34 Artemisinin 85 Bt pha tim Cefazolin35 Artesunat 86 Bt pha tim Cefotaxim36 Aspartam 87 Bt pha tim Ceftriaxon37 Atenolol 88 Bt pha tim Cloramphenicol38 Atropin Sulfat 89 Bt pha tim Streptomycin39 Azithromycin 90 Bt pha tim Vinblastin Sulfat40 Ba kch (Re) 91 Bt pha tim Vincristin Sulfat41 Bacitracin 92 Bt talc42 Bari sulfat 93 Bromhexin hydroclorid43 Bari suifat pha hn dch 94 C c dc (Hoa)44 B t nhn 95 C c dc (L)45 Bc h 96 C nga46 Bc nitrat 97 Cafein47 Bc vitelinat 98 Ci c (Ht)48 Bch b (R) 99 Calci carbonat49 Bch hp (Thn hnh) 100 Calci clorid dihydrat50 Bch cp (Thn r) 101 Calci gluconat51 Bch ch (R) 102 Calci gluconat pha thuc tim

103 Calci glycerophosphat104 Calci hydroxyd105 Calci lactat pentahydrat106 Calci lactat trihydrat107 Calci pantothenat108 Calci phosphat109 Cam tho (R)110 Cam tho nam111 Camphor112 Cnh kin trng113 Cao b phi114 Caocactis115 Cao hy thim116 Cao ch mu117 Cao lng hoc hng chnh kh118 Cao lng t nghch119 Cao tang cc m120 Captopril121 Carbamazepin122 Ct cnh (R)123 Ct sm (R)124 Cau(Ht)125 Cau (V qu)126 Cu ng

' 127 Cu k t128 Cu tch (Thn r)129 Cefaclor13 0 Cefadroxil monohydrat

vl31 Cefazolin natri132 Cefixim133 Cefotaxim natri134 Cefradin13 5 Ceftriaxon natri13 6 Cefuroxim axetil137 Cefuroxim natri138 Cephalexin139 Cetirizin hydroclorid140 Cetostearyl alcol141 Cetyl alcol142 Ch dy (L)143 Ch vng (L)144 Ch thc145 Ch xc146 Chiu liu (V thn)147 Chymotrypsin148 Cinietidin149 Cinarizin 150,, Cineol151 Ciprofloxacin hydroclorid152 Clarithromycin153 Clavulanat kali154 Clindamycin hydroclorid155 Clofazimin

156 Cloral hydrat157 Cloramphenicol ,158 Cloramphenicol palmitat159 Cloramphenicol sucinat natri160 Cloroform161 Cloroquin phosphat162 Clorphenirmin maleat163 Clorpromazin hydroclorid164 Cloimazol165 Cloxacilin nai166 Cocain hydroclorid167 Codein168 Codein phosphat169 Colecalciferol170 Cortison acetat171 C ngt (L)172 C nh ni173 C tranh (Thn r)174 C xc (R)175 Cc mn176 Cc tinh tho177 Ci xay178 Ct kh (R)179 Ct toi b (Thn r)180 Cofmchy(L)181 C chc (Thn r)182 C mi (C)183 C sng184 Cc hoa vng (Cm hoa)185 Cyanocobalamin186 Cyproheptadin hydroclorid187 D cm188 Dnh dnh (Qu)189 Dapson190 Dm dng hoc191 Du (Cnh)192 Du (L)193 Du (Qu)194 u (V r)195 Du m u196 Dy au xong (Thn)197 Dexamethason198 Dexamethason acetat199 Dexamethason natri phosphat200 Dexclorpheniramin maleat201 Dexpanthenol202 Dextromethorphan hydrobromid203 Diazepam204 Dch truyn Ringer-Lactat205 Diclofenac natri206 Dicloxacilin natri207 Din h sch (R c)208 Dip c209 Dip h chu

210 Dip h chu ng211 Diethyl phtalat212 Dimercaprol213 Diphenhydramin hydroclorid214 Domperidon maleat215 Doxycyclin hydroclrid216 Dung dcl ^Clorhexidin gluconat217 Dung dch Formaldehyd218 Dung dch Glyceryl trinitrat219 Dng dch Povidon iod220 Da cn (L).221 Da cn (R)222 i (Ha)223 i hong (Thn r)224 i hi (Qu)225 i ph bnh226 i to (Qu)227 m trc dip228 an sm (R)229 o (Ht) _230 ng sm (R)231 ng sm Vit Nam (R)232 ng sm Vit Nam ch233 ng tm tho234 u en (Ht)235 u vn trng (Ht)236 u xanh (Ht)237 a ct b238 a d u (R )^239 a hong (R)240 a lin (Thn r)241 a long242 inh hng (N hoa)243 inh lng (R)244 trng (V thn)245 c hot (R)246 c hot k sinh thang247 Dongsulfat248 ng sulfat khan249 n l (L)250 ng qui (R)251 oTg quy di thc (R)252 fng trng253 Enalapril maleat254 Ephedrin hydroclorid255 Ergocalciferol256 Erythromycin257 Erythromycin ethyl sucinat258 Erythromycin stearat259 Ei^hrosin260 Ethambutol hydroclorid261 Ethanol262 Ethanol 96%263 (Cc) Ethanol long

264 Ether m265 Ether thng

. 266 Ethinylestradiol267 Eugenol268 Famotidin269 Fenofibrat270 Flucloxacilin nai271 Fluconazol272 Fluocinolon acetonid273 Fluocinolon acetonid dihydrat274 Furosemid275 Gai(Re)276 Gac (o ht)277 Gc (Ht)278 Gelatin279 Gentamicin Sulfat280 Glibenclamid281 Gliclazid282 Globulin min dch ngi283 Glucosamin hydrocorid284 Glucosamin Sulfat kali clorid285 Glucosamin Sulfat natri clorid286 Glucose khan287 Glucose ngm mt phn t nc288 Glycerin289 Glycerol monostearati [40 -55290 Griseofulvin291 Guaifenesin292 Gng (Thn r)293 H th (R) _294 H th trng (R)295 H kh tho (Cm qu)296 Haloperidol297 Halothan298 Hu phc (V)299 H tiu (Qu)300 Hoc hng301 Hon an thai302 Hon bt trn303 Hon bt v304 Hon b ung ch kh305 Hon lc y306 Hon minh mc a hong307 Hon ngn kiu giai c308 Hon nh trn309 Hon ninh khn310 Hon ph nhi ,311 Hon quy t312 Hon sm nhung b thn313 Hon thp ton i b314 Hon thin vng b tm315 Hon tiu dao316 Hong b (V thn)317 Hong cm (R)

318 Hong ng (Thn v r)319 Hong k (R)320 Hong lin (Thn r)321 Hong nn (V thn, v cnh)322 Hong tinh (Thn r)323 Hot thch324 He (N hoa)325 Hng hoa (Hoa)326 Hng chanh (L)327 Huyn sm (R)328 Huyt gic (Li g)329 Huyt thanh khng bch hu330 Huyt thanh khng di331 Huyt thanh khng nc rn332 Huyt thanh khng un vn333 Huyt thanh min dch dng cho ngi334 Hng gia b (V r)335 Hng nhu336 Hng ph (Thn r)337 Hythim338 Hydroclorothiazid339 Hydrocortison acetat340 Hydroxocobalamin acetat341 Hydroxocobalamin elorid342 Hydroxocobalamin Sulfat343 Hydroxyethylceulose344 Hydroxyethylmethylcelulose345 Hydroxypropylceluiose346 Hyoscin butylbromid347 Ibuprofen348 Indomethacin349 Interferon alpha 2350 lod351 Isoniazid352 ch mu353 ch tr (Qu)354 Kali bromid355 Kali clorid356 Kali iodid357 Kali permanganat358 Kaolin nng359 Kaolin nh360 Kaolin nh thin nhin

,361 K u nga (Qu)362 K huyt ng (Thn)363 K ni kim364 Kem Aciclovir365 Kem Clotrimazol366 Kem Fluocinolon367 Kem Ketoconazol v Neomycin368 Kem Ketoconazol369 Km oxyd370 Km Sulfat371 Ketoconazol

372 Ketoprofen373 Kha t (Qu)374 Khim thc (Ht)375 Khn ng hoa376 Kh hnh nhn377 Kh sm (L v cnh)378 Khng hot (Thn r v r)379 Kim anh (Qu)380 Kim ngn (Cung)381 Kim ngn (Hoa)382 Kim tin tho383 Kinh gii384 Lactose385 Lamivudin386 Lanolin khan387 L hen388 L lt389 Lc tin390 Levomepromazin maleat391 Levonogestrel392 Levothyroxin natri393 Lidocain hydroclorid394 Lin kiu (Qu)395 Lincomycin hydroclord396 Long m (R v thn r)397 Long nhn398 Loperamid hydroclori399 L hi (Nha)400 Lc nhung401 Lc (L)402 Lc (R)403 Ma hong404 (Cc) Macrogol405 Magnesi carbonat nng406 Magnesi carbonat nh407 Magnesi clorid408 Magnesi hydroxyd409 Magnesi oxyd nng410 Magnesi oxyd nh411 Magnesi stearat412 Magnesi Sulfat413 Magnesi trisilicat414 Mangiferin415 Manitol416 M (Ht)417 M (L)418 M tin (Ht)419 Mch mn (R)420 Mch nha421 Mai mc422 Mn kinh t423 Mng ct (V qu)424 Mm xi (Qu)425 Mt ong

426 Mau n bi (V r)427 Mu l428 Mebendazol429 Mefloquin hydroclorid430 Meloxicam431 Menthol432 Meprobamat433 Mercurocrom434 Metformin hydroclorid435 DL-Methionin436 Methyl parahydroxybenzoat437 Methylprednisolon438 Methylprednisolon acetat439 Methyl salicylat440 Methyldopa441 Metoclopramid442 Metronidazol443 Miconazol444 Mit gip445 Morphin hydroclorid446 M hoa trng447 M mui448 Mc hng (R)449 Mc qua (Qu)450 Mc hoa trng451 Mc tc452 Mt dc (Gm nha)453 Mung tru (L)454 Nang Acetylcystein455 Nang Alverin456 Nang Amoxicilin457 Nang Ampicilin458 Nang Artemether459 Nang Artemisinin460 Nang Azithromycin461 Nang Cefaclor462 Nang Cefadroxil463 Nang Cefradin464 Nang Cephalexin465 Nang Clarithromycin466 Nang Clindamycin467 Nang Cloramphenicol468 Nang Cloxacilin469 Nang Doxycyclin470 Nang Erythromycin stearat471 Nang Fluconazol472 Nang Indomethacin473 Nang Ketoprofen474 Nang Lincomycin475 Nang Loperamid476 Nang mm Vitamin A477 Nang mm Vitamin A v D478 Nang mm Vitamin E479 Nang mm Progesteron

480 Nang Ofloxacin481 Nang Omeprazol482 Nang Paracetamol483 Nang Piracetam484 Nang Piroxicam485 Nang Rifampicin486 Nang Rifampicin v isoniasid487 Nang Sulpirid488 Nang Tetracyclin hydroclorid489 Naphazolin nitrat490 Natri benzoat491 Natri bromid492 Natri calci edetat493 Natri camphosulfonat494 Natri citrat495 Natri clorid496 Natri hydrocarbonat497 Natri salicylat498 Natri sulfacetamid499 Natri Sulfat500 Natri Sulfat khan501 Natri thiopental v natri carbonat502 Natri thiosulfat503 Neomycin Sulfat504 Nga trut (Thn r)505 Ngi cu506 Ngh (Thn r)507 Ngc trc (Thn r)508 Ng cng509 Ng th du (Qu)510 Ng bi t511 Ng gia b chn chim (V thn, v cnh)512 Ng gia b gai (V r, v thn)513 Ng v t514 Ngu bng (Qu)515 Ngu tt (Re)516 Nha m t517 Nhu (Qu)518 Nhu (R) _519 Nhn sm (R)520 Nhn trn521 Nhn trn ta522 Nhm hydroxyd kh523 Nhm phosphat kh524 Nh hng (Gm nha)525 Nhc u khu (Ht)526 Nhc thung dung (Thn)527 Niclosamid monohydrat528 Nicotinamid529 Nifedipin530 Nikethamid531 Nitrofurantoin532 Norfloxacin533 Nc nc (V thn)

534 Nc ct 588 Propylthiouracil535 Nc pha thuc tim 589 Pyrantel pamoat536 Nc oxy gi m c 590 Pyrazinamid537 Nc oxy gi long 10% 591 Pyridoxin hydroclorid538 Nc oxy gi long 3 % 592 Pyrimethamin539 Nc tinh khit 593 Qua lu (H t)540 Nc v khun tim 594 Qua lu (Qu)541 Nystatin 595 Qu (Cnh)542 Ofloxacin 596 Qu (V thn, v cnh)543 Omeprazol 597 Qui gip v qui bn544 Oresol 598 Quinin bisulfat545 Oxygen 599 Quinin dihydroclorid546 Oxymetazolin hydroclorid 600 Quinin hydroclorid547 Oxytetracyclin dihydrat 601 Quinin sulfat548 u (Re c) 602 Ranitidin hydroclorid549 dc(R) 603 Rau m550 Papaverin hydroclorid 604 Rau sam551 Paracetamol 605 Ru mo552 Pepsin 606 R qut (Thn r)553 Pethidin hydroclorid 607 Retinol tng hp m c dng bt554 Phnobarbital 608 Retinol tng hp m c dng du555 Phenol 609 Riboflavin556 Phenoxymethylpenicilin 610 Riboflavin Hatri phosphat557 Phenoxymethylpenicilin kali 611 Ring (Thn r)558 Phenylpropanolamin hydroclorid 612 Rifampicin559 Phenytoin 613 Rong m560 Phng k 614 Rotundin561 Phng phong (R) 615 Roxithromycin562 Phthalylsulfathiazol 616 Rutin563 Ph t 617 Sa nhn (Qu)564 Phc linh 618 Sa sm (R)565 Phytomenadion 619 Salbutamol566 Pilocarpin nitrat 620 Si t567 Piperazin dipat 621 Si h (R)568 Piperazin citrat 622 Sp ong trng569 Piperazin hydrat 623 Sp ong vng570 Piperazin phosphat 624 Sm b chnh (R)571 Piracetam 625 Sm cau (Thn r)572 Piroxicam 626 Sm i hnh (Thn hnh)573 Polysorbat 20 627 Sm Vit Nam (Thn r v r)574 Polysorbat 60 628 Sn dy (R c)575576

Polysorbat 80 Povidon

629630

St fumarat St oxyd

577578579

Povidon iod Praziquantel Prednisolon

632633

St (II) sulfat St (II) sulfat kh Sen (Ht)

580 Prednison 634 Sen (L)

581 Primaquin diphosphat 635636637638639640641

Sen (Cy mm)Sorbitol Sn th (Qu)Sn a (Qu)Spartein sulfat Spectinomycin hydroclorid Spiramycin

582583584585586

Procain hydroclorid Procainamid hydroclorid ProgesteronPromethazin hydroclorid Propranolol hydroclorid

587 Propyl parahydroxybenzoat

642 Stearyl alcol 696 Thuc bt Sorbitol-643 Streptomycin Sulfat 697 Thuc git Nikethamid644 Strychnin sulfat 698 Thuc m Acid boric 10%645 Sulfadiazin 699 Thuc m Benzosali646 Sulfadimidin 700 Thuc m Hydrocortison acetat647 Sulfadoxin 701 Thuc m Km oxyd648 Sulfaguanidin 702 Thuc m Nystatin649 Sulfamethoxazol 703 Thuc m tra mt Tetracyclin hydroclorid650 Sulfamethoxypyridazin 704 Thuc nh mt Ciprofloxacin651 Sulfathiazol 705 Thuc nh mt Cloramphenicol652 Sulpirid 706 Thuc nh mt Gentamycin653 Tarn tht (Re c) 707 Thuc nh mt Hydrocortison v neomycin654 Tang k sinh 708 Thuc nh mt Km Sulfat655 Tartrazin 709 Thuc nh mt Natri clorid 0,9 %656 To (Ht) 710 Thuc nh mt Neomycin657 Tc k 711 Thuc nh mt Ofloxacin658 Tm vi 712 Thuc nh mi Oxymetazolin659 Tm gi 713 Thuc nh mi Xylometazolin660 Tn giao (R) 714 Thuc tim Acid ascorbic661 Tt bt (Qu) 715 Thuc tim Adrenalin662 Tenoxicam 716 Thuc tim Aminophylin663 Terfenadin 717 Thuc tim Atropin Sulfat664 Terpin hydrat. 718 Thuc tim Cafein v natri benzoat665 Tetracain hydroclorid 719 Thuc tim Calci clorid 10%666 Tetracyclin hydroclorid 720 Thuc tim Calci gluconat667 T tn 721 Thuc tim Clorpromazin hydroclorid668 Thch cao 722 Thuc tim Cyanocobalamin669 Thch hc (Thn) 723 Thuc tim Dexamethason,670 Than hot tnh 724 Thuc tim Diclofenac natri671 Thanh cao hoa vng (L) 725 Thuc tim Ephedrin hydroclorid672 Thanh hao 726 Thuc tim Gentamycin673 Tho qu (Qu) 727 Thuc tim Glucose674 Tho quyt minh (Ht) 728 Thuc tim Hydrocortison acetat675 Thng ma (Thn r ) 729 Thuc tim Hydroxocobalamin676 Theophylin 730 Thuc tim Kali clorid677 Th 731 Thuc tim Lidocain678 Thiamin hydroclorid 732 Thuc tim Lincomycin679 Thiamin nitrat 733 Thuc tim Methylprednisolon acetat680 Thin ma (Thn r) 734 Thuc tim Morphin hydroclorid681 Thin mn ng (R) 735 Thuc tim Natri bicarbonat682 Thin nin kin (Thn r) 736 Thuc tim Natri clorid683 Thin trc hong 737 Thuc tim Procain hydroclorid684 Th ty t 738 Thuc tim Progesteron685 Th hong lin (Thn r) 739 Thuc tim Pyridoxin hydroclorid686 Th phc linh (Thn r) 740 Thuc tim Quinin dihydroclorid687 Thng tho (Li thn) 741 Thuc tim Spartein Sulfat688 Thc a 742 Thuc tim Thiamin hydroclorid689 Thuc bt Acetylcystein 743 Thuc tim truyn Glucose

Thuc tim truyn MetronidazolThuc tim truyn Natri clorid ng trng

690 Thuc bt Aspartam 744691 Thuc bt Azithromycin 745692 Thuc bt Cefadroxil 746 Thuyn thoi693 Thuc bt Cephalexin 747 Thng lc (R c)694 Thuc bt Natri hydrocarbonat 748 Thng trut695 Thuc bt Roxithromycin 749 Ta t (L)

750 Ta t (Qu)751 Tat hn)752 Tin h (R)753 Tiu hi (Qu)754 Timolol maleat755 Tinh bt756 Tinh du Bc h757 Tinh d Bch n758 Tinh du Hi759 Tinh du Hng nhu trng760 Tinh du Long no761 Tinh du Qu762 Tinh du Trm763 Tinidazol764 Titan dioxyd765 Ton yt766 Tobramycin767 All-Rac-Alpha Tocopherol768 All-Rac-Alpha Tocopherol acetat769 Ti (Cn hnh)770 Tolbutamid771 T mc (G)772 Trch t (Thn r)773 Trm (Cnh, l)774 Trc bch dip775 Trn bi ^776 Tri mu (Thn r)777 Trihexyphenidyl hydroclorid778 Trimethoprim779 Tuberculin PPD780 Tc on (R)781 T uyn (R)782 T ba (L)783 T gii (Thn r)784 Uy linh tin (R)785 Vancomycin hydroclorid786 Vaniin787 Vaselin788 Vng ng (Thn)789 Vc xin bch hu hp ph790 Vc xin bch hu, un vn hp ph dng cho

ngi ln v v thnh nin791 Vc xin bch hu-un vn-ho g hp ph (DTwP)792 Vc xin bi lit bt hot (IPV)793 Vc xin bi lit ung794 Vc xin BCG795 Vc xin di t bo dng cho ngi796 (Cc) Vc xin dng cho ngi797 Vc xin si798 Vc xin t ung bt hot799 Vc xin thng hn ung800 Vc xin thng hn Vi polysaccharid801 Vc xin un vn hp ph802 Vc xn vim gan B iu ch ti huyt tuOTig ngi

803 Vc xin vim gan B ti t hp (rDNA)804 Vc xin vim no Nht Bn805 Vin t Nystatin806 Vin t Paracetamol807 Vin nn Acetazolamid808 Vin nn Aciclovir809 Vin nn Acid acetylsalicylic810 Vin nn Acid ascorbic811 Vin nn Acid folic812 Vin nn Acid mefenamic813 Vin nn Acid nalidixic814 Vin nn Albendazol815 Vin nn Alimemazin816 Vin nn Alopurinol817 Vin nn Aminophylin818 Vin nn Amoxicilin819 Vin nn Amoxicilin v acid clavulanic820 Vin nn Artemether821 Vin nn Artemisinin822 Vin nn Artesunat823 Vin nn Atenolol824 Vin nn Atropin Sulfat825 Vin nn Berberin clorid826 Vin nn Betamethason827 Vin nn Biotin828 Vin nn Bisacodyl829 Vin nn Bromhexin hydroclorid830 Vin nn Calci v Vitamin D831 Vin nn Captopril832 Vin nn Carbamazepin833 Vin nn Cefadroxil834 Vin nn Cefixim835 Vin nn Cefuroxim836 Vin nn Cetirizin837 Vin nn Cephalexin838 Vin nn Chymotrypsin839 Vin nn Cimetidin840 Vin nn Cinarizin841 Vin nn Ciprofloxacin842 Vin nn Clarithromycin843 Vin nn Cloramphenicol844 Vin nn Cloroquin phosphat845 Vin nn Clorpheniramin846 Vin nn Clorpromazin hydroclorid847 Vin nn Cotrimoxazol848 Vin nn Cyproheptadin hydroclorid849 Vin nn Dexamethason850 Vin nn Dexclorpheniramin851 Vin nn Dexpanthenol852 Vin nn Dextromethorphan hydrobromid853 Vin nn Diazepam854 Vin nn Diclofenac855 Vin nn Domperidon856 Vin nn t m o Clotrimazol

857 Vin nn Enalapril 907 Vin nn Phthalylsulfathiazol858 Vin nn Ephedrin hydroclorid 908 Vin nn Phytomenadion859 Vin nn Erythromycin 909 Vin nn Piroxicam860 Vin nn Erythromycin stearat 910 Vin nn Praziquantel861 Vin nn Ethambutol 911 Vin nn Prednisolon862 Vin nn Ethambutol hydroclorid v Isoniazid 912 Vin nn Primaquin diphosphat863 Vin nn Famotidin 913 Vin nn Promethazin hydroclorid864 Vin nn Furosemid 914 Vin nn Propranolol865 Vin nn Gliclazid 915 Vin nn Propylthiouracil866 Vin nn Glucosamin 916 Vin nn Pyrantel pamoat867 Vin nn Griseofulvin 917 Vin nn Pyrazinamid868 Vin nn Haloperidol 918 Vin nn Pyridoxin hydroclorid869 Vin nn Hydroclorothiazid 919 Vin nn Quinin sulfat870 Vien nn Ibuprofen 920 Vin nn Ranitidin871 Vin nn Indomethacin 921 Vin nn Riboflavin872 Vin nn Isoniazid 922 Vin nn Rifampicin873 Vin nn Kali clorid 923 Vin nn Rotundin874 Vin nn Ketoconazol 924 Vin nn Roxithromycin875 Vin nn Lamivudin 925 Vin nn Rutin876 Vin nn Levomepromazin 926 Vin nn Rutin v Acid ascorbic877 Vin nn Levonorgestrel 927 Vin nn Salbutamol878 Vin nn Levothyrosin 928 Vin nn st fumarat v Acid folic879 Vin nn Loperamid 929 Vin nn st (II) sulfat880 Vin nn Magnesi - B5 930 Vin nn Spiramycin881 Vin nn Magnesi - Nhm hydroxyd 931 Vin nn Sulfadoxin v Pyrimethamin882 Vin nn Mebendazol 932 Vin nn Sulfaguanidin883 Vin nn Mefloquin 933 Vin nn Sulfamethoxazol884 Vin nn Meloxicam 934 Vin nn Tenoxicam885 Vin nn Metformin 935 Vin nn Tetracyclin hydroclorid886 Vin nn Methionin 936 Vin nn Theophylin887 Vin nn Methyldopa 937 Vin nn Thiamin888 Vin nn Methylprednisolon 938 Vin nn Tinidazol889 Vin nn Metronidazol 939 Vin nn Tolbutamid890 Vin nn Metronidazol v Nystatin 940 Vin nn Trihexyphenidyl891 Vin nn Natri thiosuifat 941 Vin nn Vitamin Bi, B v B12892 Vin nn Niclosamid 942 Vin si Paracetamol893 Vin nn Nicotinamid 943 Vin ch (R)894 Vin nn Nifedipin 944 Vinblastin Sulfat895 Vin nn Norfloxacin 945 Vincristin Sulfat896 Vin nn Nystatin 946 Vng nem (L)897 Vin nn Ofloxacin 947 X sng (Qu)898 Vin nn Papaverin hydroclorid 948 Xch thc (R)899 Vin nn Paracetamol 949 Xuyn khung (Thn r)900 Vin nn Paracetamol v Cafein 950 Xuyn sn gip901 Vin nn Paracetamol v Clorpheniramin 951 Xuyn tiu (Qu)902 Vin nn Paracetamol v Codein phosphat 952 Xng b903 Vin nn Penicilin V 953 Xylometazolin hydroclorid904 Vin nn Penicilin V kali 954 d (Ht)905 Vin nn Phnobarbital 955 Zidovudin906 Vin nn Phenytoin

DANH MC CC CHUYN LUN MI so VI DVN III'1"1' Nguyn liu ho dc TT Nguyn liu ho dc

1 Acetazolamid 47 Dicloxacilin natri2 Acetylcystein 48 Diphenhydramin hydroclorid3 Acid folic 49 Domperidon maleat4 Acid mefenamic 50 Dung dch clorhexidin gluconat5 Acid nalidixic 51 Erythromycin6 Alimemazin tartrat 52 Erythromycin ethyl sucinat7 Alopurinol 53 Erythrosin8 Alverin citrat 54 Ethinylestradiol9 Amikacin 55 Fenofibrat

10 Amitriptylin hydroclorid 56 Flucloxacilin natri11 Amlodipin besiiat 57 Fluconazol12 Amphotericin B 58 Glibenclamid13 Ampiciiin natri 59 Gliclazid14 Artemether 60 Glucosamin hydroclorid15 Aspartam 61 Glucosamin Sulfat kali clorid16 Atenolol 62 Glucosamin Sulfat natri clorid17 Azithromycin 63 Glycerol monostearat 40 -5 018 Bacitracin 64 Guaifenesin19 Benzaikonium clorid 65 Halothan20 Benzathin benzylpenicilin 66 Hydroxyethylcelulose21 Betamethason 67 Hydroxyethylmethylcelulose22 Betamethason dipropionat 68 Hydroxypropylcelulose23 Biotin 69 Hyoscin butylbromid24 Bisacodyl 70 Ketoconazol25 Bromhexin hydroclorid 71 Ketoprofen26 Captopril 72 Lamivudin27 Carbamazepin 73 Levomepromazin maleat28 Cefadroxil monohydrat 74 Levonogestrel29 Cefazolin natri 75 Loperamid hydroclorid30 Cefixim 76 Cc macrogol31 Cefotaxim natri 77 Magiferin32 Cefradin 78 Mefloquin hydroclorid33 Ceftriaxon natri 79 Meloxicam34 Cefuroxim axetil 80 Metformin hydroclorid35 Cefuroxim natri 81 Methyl parahydroxybenzoat36 Cetirizin hydroclorid 82 Methyldopa37 Cetostearyl alcol 83 Methylprednisolon38 Cetyl alcol 84 Methylprednisolon acetat39 Chymotrypsin 85 Metoclopramid40 Cinarizin 86 Miconazol41 Clarithromycin 87 Neomycin sulfat42 Clavulanat kali 88 Niclosamid monohydrat43 Clofazimin 89 Nifedipin44 Clotrimazol 90 Nitrofurantoin45 Cyproheptadin hydroclorid 91 Norfloxacin46 Dexclorpheniramin maleat 92 Ofloxacin

93 Omeprazol 111 Roxithromycin94 Oxymetazolin hydroclorid 112 St oxyd95 Oxytetracyclin dihydrat 113 Spectinomycin hydroclorid96 Phenylpropanolamin hydroclorid 114 Stearyl alcol97 Piracetam 115 Sulpirid98 Polysorbat 20 116 Tartrazin99 Polysorbat 60 117 Tenoxicam

100 Polysorbat 80 118 Terfenadin101 Povidon 119 Timolol maleat102 Povidon iod 120 Tinidazol103 Praziquantel 121 Titan dioxyd104 Prednison 122 Tobramycin105 Propranolol hydroclorid 123 Tolbutamid106 Propyl parahydroxybenzoat 124 Trihexyphenidyl hydroclorid107 Propylthiouracil 125 Vancomycin hydroclorid108 Pyrantel pamoat 126 Xylometazolin hydroclorid109 Quinin dihydroclorid 127 Zidovudin110 Riboflavin natri phosphat

TT Thnh phm ho dc TT Thnh phm ho dc

1 Bt pha tim Benzathin benzylpenicilin 30 Nang mm Vitamin E2 Bt pha tim Cefazolin 31 Nang mm Vitamin A v Vitamin D Bt pha tim Cefotaxim 32 Thuc bt Acetylcystein4 Bt pha tim Ceftriaxon 33 Thuoc bt Aspartam5 Bt pha tim Vinblastin Sulfat 34 Thuc bt Azithromycin6 Bt pha'tim Vincristin Sulfat 35 Thuc bt Bari sulfat pha hn dch7 Dch truyn Ringer - lactat 36 Thuc bt Cefadroxil8 Dung dch Povidon iod 37 Thuc bt Cephalexin9 Kem Aciclovir 38 Thuc bt Natri hydrocarbonat

10 Kem Clotrimazol 39 Thuc bt Roxithromycin11 Kem Fluocinolon 40 Thuc bt Sorbitol12 Kem Ketoconazol 41 Thuc git Nikethamid13 Kem bi da Ketoconazol v Neomycin 42 Thuc m Hydrocortison acetat14 Nang Acetylcystein 43 Thuc m Nystatin15 Nang Artemether 44 Thuc m tra mt Tetracyclin hydroclorid16 Nang Azithromycin 45 Thuc nh mt Ciprofloxacin17 Nang Cefadroxil 46 Thuc nh mt Gentamycin18 Nang Cephradin 47 Thuc nh mt Hydrocortison v Neomycin19 Nang Clarithromycin 48 Thuc nh mt Natri clorid 0,9 %20 Nang Clindamycin 49 Thuc nh mt Neomycin21 Nang Fluconazol 50 Thuc nh mt Ofloxacin22 Nang Ketoprofen 51 Thuc nh mi Oxymetazolin23 Nang Loperamid 52 Thuc nh mii Xylometazolin24 Nang Ofloxacin 53 Thuc tim Aminophylin25 Nang Omeprazol 54 Thuc tim Amoxicilin26 Nang Piracetam 55 Thuc tim Calci gluconat27 Nang Rifampicin v Isoniasid 56 Thuc tim Cloramphenicol28 Nang Sulpirid 57 Thuc tim Diclofenac29 Nang mm Progesteron

XXXV

58 Thuc tim Hydrocortison acetat 104 Vin nn Dexpanthenol59 Thuc tim Hydroxocobalamin 105 Vin nn Domperidon60 Thuc tim Kali clorid 106 Vin nn Enalapril maleat61 Thuc tim Methylprednisolon acetat 107 Vin nn Ethambutol62 Thuc tim Natri clorid 108 Vin nn Gliclazid63 Thuc tim Progesteron 109 Vin nn Glucozamin64 Thuc tim Spartein Sulfat 110 Vin nn Haloperidol

65 Thuc tim Streptomycin 111 Vin nn Hydroclothiazid ,66 Thuc tim truyn Metronidazol 112 Vin nn Kali clorid67 Vin t Nystatin 113 Vin nn Ketoconazol68 Vin t Paracetamol 114 Vin nn Lamivudin69 Vin nn Calci v Vitamin D 115 Vin nn Levomepromazin70 Vin nn Ethambutol v Isoniasid 116 Vin nn Levonogestrel71 Vin nn Paracetamol v Cafein 117 Vin nn Levothyrosin72 Vin nn Paracetamol v Chlopheniramin 118 Vin nn Loperamid73 Vin nn st fumarat v Acid folic 119 Vin nn Magnesi - B74 Vin nn Vitamin B], B vB i2 120 Vin nn Mefloquin75 Vin nn (Alpha) Chymotrypsin 121 Vin nn Meloxicam76 Vin nn Acetazolamid 122 Vin nn Metformin77 Vin nn Aciclovir 123 Vin nn Methyldopa78 Vin nn Acid folic 124 Vin nn Methylprednisolon79 Vin nn Acid mefenamic 125 Vin nn Metronidazol v Nystatin80 Vin nn Acid nalidixic 126 Vin nn Natri thiosulfat81 Vin nn Alimemazin 127 Vin nn Niclosamid82 Vin nn Allopurinol 128 Vin nn Nifedipin83 Vin nn Alverin 129 Vin nn Norfloxacin84 Vin nn Aminophylin 130 Vin nn Ofloxacin85 Vin nn Amoxicilin v Acid clavulanic 131 Vin nn Paracetamol v Codein86 Vin nn Artemether 132 Vin nn Phenytoin87 Vin nn Atenolol 133 Vin nn Phytomenadion88 Vin nn Atropin sulphat 134 Vin nn Praziquantel89 Vin nn Betamethason 135 Vin nn Primaquin90 Vin nn Biotin 136 Vin nn Propranolol91 Vin nn Bisacodyl 137 Vin nn Propylthiouracil92 Vin nn Bromhexin 138 Vin nn Pyrantel pamoat93 Vin nn Carbamazepin 139 Vin nn Ranitidin94 Vin nn Catopril 140 Vin nn Roxithromycin95 Vin nn Cefadroxil 141 Vin nn Rutin v Acid ascobic96 Vin nn Cefixim 142 Vin nn st II Sulfat97 Vin nn Cefuroxim 143 Vin nn Sulfadoxin v Pyrimethamin98 Vin nn Cetirizin 144 Vin nn Tenoxicam99 Vin nn Cinarizin 145 Vin nn Tinidazol

100 Vin nn Clarithromycin 146 Vin nn Tolbutamid101 Vin nn t m o Clotrimazol 147 Vin nn Trihexyphenidyl102 Vin nn Cyproheptadin 148 Vin si Paracetamol103 Vin nn Dexclorpheniramin maleat

TT Vc xin v sinh phm y t TT Vc xin v sinh phm y t

1 Biosubtyl 7 Vc xin bi lit bt hot (IPV)2 Globulin min dch ngi 8 Vc xin di t bo dng cho ngi3 Huyt thanh khng nc rn 9 Vc xin si4 Interferon Alpha 2 10 Vc xin t ung bt hot5 Tiiberculin PPD 11 Vc xin thng hn ung6 Vc xin bch hu, un vn hp ph dng cho 12 Vc xin thng hn Vi Polysaccharid

ngi ln v v thnh nin 13 Vc xin vim gan B ti t hp (rDNA)

TT Dc liu TT Dc liu

1 Bch hoa x thit tho 25 Hong lin (Thn r)2 Bm bm bic (Ht) 26 Hong nn (V thn, v cnh)3 C c dc (L) 27 Hng gia bi (V r)4 Cam tho nam 28 Kh sm (L)5 Cau (Ht) 29 Kim ngn (Cung)6 C ngt (L) 30 L hen7 Cc mn 31 Lc (L)8 Gm chy (R) 32 Mng ct (V qu)9 Ch dy (L) 33 Mm xi (Qu)

10 Ch vng (L) 34 Mc hoa trng11 Chiu liu (V thn) 35 Ng cng12 C chc (Thn r) 36 Nhu (R)13 Du m u 37 Nhu (Qu)14 Dip h chu ng 38 Ncnc(V)15 Da cn (R) 39 Phng phong (R)16 ng sm Vit Nam (R) 40 Qu (Cnh)17 ng sm Vit Nam ch 41 Rau sam18 u en (Ht) 42 Sm cau (Thn r)19 u xanh (Ht) 43 Thanh cao hoa vng (L)20 a long 44 Thng lc (R c)21 inh lng (R) 45 Tm gi22 n i (L) 46 Ton yt23 Gc (o ht) 47 Xuyn sn gip24 H th trng (R)

Cc chuyn lun thay thHng nhu: Thay th Hng nhu trng v Hng nhu ta Xng b: Thay th Thy xng b v Thch xng b Bi mu: Thay th Trit bi mu v Xuyn bi mu

TT12345

Tn ph lcPh lc 1.5 Hn dch thuc Ph ic 1.6 Nh tong thucPh lc 1.9 Thuc dn thm qua da v thuc dn tc dng ti ch. Ph lc 1.16 Thuc nh tai v thuc xt vo tai Ph lc 1.17 Thuc ht

XXXVI1

6 Ph lc7 Ph lc8 Ph lc9 Ph lc

10 Ph lc11 Ph lc12 Ph lc13 Ph ic14 Ph lc15 Ph lc16 Ph lc17 Ph lc18 Ph lc19 Ph lc20 Ph lc21 Ph lc22 Ph lc23 Ph lc

, 24 Ph lc25 Ph lc26 Ph lc27 Ph lc

- 2 8 Ph lc-2 9 Ph lc^30 Ph lc^31 Ph lc^32 Ph lc33 Ph lc34 Ph lc35 Ph lc36 Ph lc37 Ph lc38 Ph lc39 Ph lc40 Ph lc41 Ph lc42 Ph lc43 Ph lc44 Ph lc

DANH MC CC CHUYN LUN CA DVNIII KHNG A VO DVNIV

TT Nguyn liu ha dc

1 Cloramin T2 Emetin hydroelorid3 Levamisol hydroclorid

TT Thnh phm ha dc

1 Dung dch Acid boric 3 %2 Dung dch lod 1 %3 Ch khu phu thut khng tiu

TT Vc xin v Sinh phm

1 Vc xin di

TT

456

Nguyn liu ha dc

OuabainPhytinReserpin

TT Thnh phm ha dc

4 Ch khu phu thut t tiu5 Sir Piperazin

TT Dc liu TT Dc liu

1 A giao 16 Ngu hong2 Bch n (L) 17 Phn t gii3 Bch qu (Ht) 18 Ph bnh4 Ba gc (V r v r) 19 Sn u cn5 B kt (Gai) 20 Tam lng6 B kt (Qu) 21 Thanh b7 i (V thn) 22 Thn khc8 Hu phc (Hoa) 23 Thin hoa phn9 Lo qun tho 24 Thin nam tinh (Thn r)

10 Lc gic 25 Thng s n (R)11 Lc gic giao 26 Tr linh12 Lc gic sng 27 Trm hng (G)13 Mn ti 28 V qu lu14 Minh giao 29 X hng15 Mc thng (Thn)

TT Thuc t dc liu TT Thuc t dc liu

1 Bt cam si 8 Ru b huyt tr phong2 Bt cm cm 9 Ru rn3 Cn xoa bp 10 Ru tc k4 Hon ch thc tiu b 11 T t ging kh thang5 Hon h xa i to 12 Thin ma cu ng thang6 Hon long m t can 13 Vin nn ngn kiu gii c

Huyt ph trc thang

QUINHCHUNG

1. Tn chnh ca cc chuyn lun l tn Vit Nam, sau tn Vit Nam l tn Latin v nhng tn Vit Nam thng dng khc nu c.i vi dc liu: C th dng tn qui c ch tn dc liu, hoc dng tn gc ca cy, con lm v thuc lm tn dc liu. Tn quy c ca dc liu l tn ring ca v thuc c dng trong y hc c fruyen, v d; Ph bnh, Bch gii t... Trong trung hp tn chuyn lun l tn c, con dng lm thuc th tip theo sau tn chuyn lun c thm nhng t' ch b phn dng ca cy, con nhng trong du ngoc n, v d nh (L), (Qu)...Mi chuyn lun ca De in Vit nam IV (chuyn lun ring hay ph lc) l mt tiu chun v cht lTig thuc hoc phng php kim nghim thuc ca Vit Nam.2. Nguyn t lng cc nguyn t trong Dc in Vit Nam IV l cc gi tr c tha nhn ghi trong Bng nguyn t lng tng i 1997 c xy dng trn c s cht ng v carbn '^c = 12 ca Hip hi Quc t v Ha hc thun ty v ng dng (IPAC).3. Cc n v o lng dng trong Dc in Vit Nam IV u tun theo Ngh nh ca Chnh ph s 134/2007/N-CP ngy 15 thng 08 nm 2007 quy nh v n v o lung chnh thc.4. Cc n v o lng c vit tt nh sau:

Mt: m Gi; hD ecim t: dm Pht: minCentimt: cm Giy: sMilimt: mm KilPascan: kPaMicrmt: fxm Pascan: PaNanmt: nm Pascan giy: Pa.sLt: 1 hoc L Ampe: AMililt: ml hoc mL Miliampe: mAMicrlt: p.1 hoc L Vn: VKilgam; kg Milivn: mVGam; g Mol: molMiligam: mg Mol fren lt: mol/1, Mol/L, MCentigam: cg Becren: BqMicrgam: |ig n v quc t: IU hoc vqtNangam: ng Celsius: c

Phn trm: %5. Nu khng c ch dn khc, mi nhit c ghi trong Dc in Vit Nam IV u c biu th bng bch phn Celsius, k hiu l "C".6. Nhit tiu chun c qui nh l 20 c, nhit bnh thng ca phng th nghim (nhit phng) c qui nh l 20 c n 30 c. Nu khng c ch dn g khc, tt c th nghim i vi thuc phi thc hin nhit phng (20 c n 30 C) v nhng nhn xt kt qu phi thc hin ngay sau khi thao tc. Tuy nhin khi nh gi kt qu mt th nghim b nh hung bi nhit th phi thc hin iu kin nhit tiu chun (20 C).Trong th nghim "Mt khi lng do lm kh", nu ch qui nh tin hnh mt nhit no , th gii hn cho php v nhit c hiu l: Nhit qui nh 2 c (v d: 100 c ngha l 100 c 2 C).7. Nhit ne: Nc cch thy l nc c nhit 98 c n 100 c, tr phi c ch n khc; cm t trong cch thy" c ngha l dng c ngm trong nc un si, "trn cch thy" c ngha l dng c ch tip xc vi hi nc un si.Nc nng: 70 c n 80 c.Nc m: 40 c n 50 c.Nc lnh: 2 c n 10 c.Nc : 0 c8. Nhit ni bo qun:Lnh su; Di -10 c.Lnh: 2 c n 10 c.Mt: 10C n20C .Nhit phng: 20 c n 30 c (l nhit ph bin ni lm vic).

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Nhit phng c iu nhit: 20 c n 25 c (l nhit c duy tr bng my iu ha nhit ).N n^ 3^ 5 c n 40 c Rt nng: Trn 40 c.9. p sut c biu th bng s n v kilPascan (kPa).1 kPa = 7,5006 Torr.1 Torr l p sut di ct thy ngn 1 mm.Nu ghi "chn khng" m khng c ch dn g khc th c ngha l p sut khng qu 2,0 kPa (.15 mm thy ngn).10. Khi nim cn chnh xc l cn ti 0,1 mg, 0,01 mg hoc 0,001 mg ty theo nhy ca loi cn phntch dng cn sao cho sai s ca php cn khng qu 0,1%.Khi lng cn c c chnh xc ph hp vi lp li xc nh. lp li tng ng vi +5 hoc -5 on v sau ch s c ngha cui cng cho; v d: Lng cn 0,25 g ngha l lng cn nm trong khong 0,245 g n 0,255 g.Khi nim cn ngha l php cn c thc hin vi sai s di 1 %.Khi nim cn khong l cn ly mt lng khng qu 10 % lng ch nh trong Dc in.Khi nim sy n khi lng khng i v nung n khi lng khng i ngha l hai ln cn lin tip khng khc nhau qu 0,5 mg. Ln cn th hai tin hnh sau mt thi gian sy hoc nung thm (thng 1 gi l thch hp) ty theo tnh cht v lng cn.Khi nim cn trc (i vi chn nung, bnh, vi...) ngha l dng c c x l n khi lng khng i. Nu trong chuyn lun c qui nh phi cn mt cn hay mt ta (sy kh, nung, un bc hi) trong nhng dng c th c ngha l nhng dng c ny c sy hoc nung n khi lng khng i.Khi nim cn khng ng k hay cn khng th cn c l cn khng nng qu 0,5 mg.1 1 . Khi o th tch, nu ch s sau du thp phn l 0 hoc tn cng bng 0 th th tch phi ong, o chnh xc (v d 10,0 ml hoc 0,50 ml). Khi nim ong, o chnh xc ly mt th tch dung dch hay cht lng l phi ong o bng pipet chnh xc, bnh nh mc hay buret chun. Cn ong, o c hiu l dng ng ong hoc nhng phng tin khc thch hp o th tch. Nhng th tch c micrlt c o bng micrpipet hay micrsyringe (bm cht lng siu vi). m git, dng ng m git chun, 20 git nc tinh khit ca ng ny 20 c c khi lng t 0,90 g n 1 , 1 0 g. - ' .

12 . "Nc" c ngha l nc tinh khit. Nc tinh khit c s dng trong tt c cc th nghim thuc nhng khng dng vi nhng ch phm tim.13. Mt dung dch, nu khng ghi r dung mi s dng th c hiu l ung dch trong nc tinh khit hay nc ct.14. Khi nim "ngay" v " ngay lp tc" dng ong th nghim thuc c ngha l thao tc ny phi thc hin trong vng 30 giy sau thao tc trc .15. Th nh tnh l php th cn thit nhn bit mt cht thuc hay nhng thnh phn chnh ca thuc da trn tnh cht vt l hay ha hc c trng.Ph hng ngoi l phng php chun xc nh tnh, v mi mt cht thuc ch cho mt vng "im ch" ca ph, khng trng lp yi ph ca nhng cht khc. Nhng c tnh ca ph hng ngoi c th c dng nh l php th hng u nh tnh. Thng th php th ph hng ngoi t n tin cy v khng cn thm php th no khc. Tuy nhin, khi mt sn phm i mt mui th cn thit th thm "ion c hiu". Nhng php th nh tnh tip theo trong mi chuyn lun l khng nh li v nh tnh ca ph hng ngoi lm trc. Trong trng hp cn thit, cn tin hnh xc nh thm im chy ca thuc; khi im chy khng c s lp li ng nh nhit qui nh th c th dng mt gi tr xp x, gii hn sai s c qui nh trong chuyn lun ring.16. Th tinh khit l tp hp cc php th nhm pht hin nhng tp cht nhim vo thuc. kim tra tinh khit, phi th xc nh s c mt cc tp cht, s lng v gii hn ea chng cng nh nhng yu cu khct . ' . . , : I _________I . . a 4._______ L _______ : li A I X______________ 1 . 2 : ^ I . 1 ' 1 ~ 1 , . 1 . i !

khng chp nhn nhng tp cht khc c trong thuc mc d khng c ghi trong Dc in. Mi khi c s thay th cht ny bng cht khc hoc cho thm mt cht mi ong thc hin qui trnh th phi c thm nhng php th tng ng. Nng ca tp cht c biu th bng phn triu ca khi lng, hoc khi gii hn vt

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qu 500 phn triu th c biu th bng phn trm (%). NhTig gi tr ny ch l khong gi tr ph hp vi nhng yu cu c xc nh da trn s thch hp vi nhng th nghim cho.17. Trong chuyn lun khng sinh, ti mc nh lng c ghi ng thi hai phng php l phng php vi sinh vt v phng php ha hc hay ha l; mi-phng php u c th c s dng. Phng php nh lng vi sinh vt c coi nh phng php c khuyn co p dng, nu dng phng php khc nh lng th phng php khng c km tin cy hn phng php vi sinh vt. Nu kt qu ca hai phng php qu chnh lch thi ly kt qu theo phng php vi sinh vt kt lun (tr khi c ch dn khc).IS.PhoTig php th qui nh trong Dc in Vit Nam c th c thay th bng nhng phng php khc c ng v chnh xc cao hn. Tuy nhin, khi c s chnh lch, nghi ng, th ch kt qu thu c t phng php ghi trong Dc in l c gi tr a ra kt lun cui cng.19.Nu trong chuyn lun c ghi vic xc nh phi tin hnh so snh vi mt cht chun hay cht i chiu (C) th phi dng cc cht ny theo qui nh ca B Y t.20. Khi th nghim hay nh liig (tr chi dn khc) nu qui nh mu th phi so snh vi mu kim tra trng th phi chun b mu ny nh mu th nhng khng cho cht cn th hay cn nh lng v phi tin hnh song song cng iu kin nh mu th. Cng toTg t nh vy khi th nghim c yu cu tin hnh song song vi mu i chiu (chng).21. Cc kt qu nh lng c tnh n mt s l thp phn cn thit nhiu hn yu cu mt ch s ri lm trn ln hay xung nh sau:Nu con s cui cng tnh c l 5 n 9 th con s ng trc n c tng thm 1.Nu con s cui cng tnh c l di 5 th con s ng trc n khng thay i.Cc php tnh khc, th d chun ha cc dung dch chun cng tin hnh tng t.Th d; 8,2758 lm trn s l 8,276.

1,2634 lm trn s l 1,263.22. Hm lng tiu chun: Hm Iiig tiu chun ca mt cht qui nh trong mt chuyn lun c th hin tnh theo cng thc ha hc c th c gii hn trn 100 % ca cht , gii hn trn ny p dng vi kt qu nh lng tnh theo hm lng tng ng ca cng thc ha hc m cht qui nh. V d: Ghi cha khng t hn 98,5 % v khng nhiu hn 102,0 % ca C|2H22Ca0i4.H20 ngha l kt qu nh lng khng c t hn 98,5 % v khng nhiu hn 102,0 % tnh theo hm lng tng ng ca C|2H22Ca0)4.H20.Nu trong chuyn lun ring khng ghi gii hn trn th c ngha l gii hn trn khng qu 101,0 %.23. Trong cc chuyn lun, mc m t hoc tnh cht, thut ng "trng" c ngha l trng hoc gn nh trng; "khng mu" c ngha l khng c mu hoc gn nh khng mu; "khng mi" c ngha l khng c mi hoc thc t khng c mi. Tr khi c cc ch dn khc, cch th mu sc hoc mi c tin hnh nh sau:a) Mu:Cht rn; Ly 1 g cht th cho ln trn mt t giy trng hoc mt knh ng h khng mu t ln trn t giy trng ri quan st.Cht lng: Cho cht th vo trong mt ng nghim khng mu, ng knh bn trong 15 mm, t trc mt nn trng cch ng 30 mm, nhn ngang ng di nh sng ban ngy.b) Mi:Cht rn: Trn mt mt knh ng h, ng knh t 6 cm n 8 cm, ly t 0,5 g n 2,0 g cht th tri thnh lp mng, sau 15 pht, xc nh mi bng cm quan.Cht lng: Ly 2 ml cht th cho vo mt knh ng h nh n ri xc nh mi bng cm quan.24.Trong cch biu th nng dung dch, nu khng c ch dn g khc, nng c biu th l phn trm (%) khi lng trn th tch (kl/tt), tinh theo s gam cht ha tan trong 100 m dung dch, k hiu la % (kl/tt) hoc %.Cc trng hp khc biu th bng cc k hiu v c hiu nh sau:% (kl/kl): S gam cht ha tan trong 100 g dung dch.% (tt/tt): S mililt cht ha tan trong 100 ml dung dch.% (tkl): S mililt cht ha tan trong 100 g dung dch.25. Ethanol khng c ch dn g khc th c ngha l ethanol tuyt i.Khi nim "alcol" khng c ch dn g c ngha l alcol cha khong 96 % (tt/tt) ethanol (C2H6O). Dung dchethanol trong nc nhng nng khc c ch bng t ethanol km theo t l phn trm (tt/tt) hoc 0

26. Ether c ngha l ether ethylic.Cc ether du ha: Khi vit km gii hn v nhit th gii hn ny c hiu l khong si. V d: Ether du ha (30 c n 40 C) ngha l ether du ha c khong si t 30 c n 40 c.27. Hn hp ca cc cht lng c ghi theo k hiu 10 :1 , hoc 50 : 9 ; 1, v.v... c ngha l hn hp cc cht th t theo th tch. Th d: cloroform - methanol - amoniac (50 : 9 : 1) c ngha l iy ln lt 50 ml cloroform trn u vi 9 ml methanol v 1 ml amoniac thnh mt hn hp. Trong chuyn lun, tn cc cht lng trong hn hp c in nghing v khng c ch (TT) i km sau.28. Trong chuyn lun, tn cc ha cht, thuc th, dung dch th, cht ch th, dung dch chun , dung dch mu, dung dch m c trnh by bng ch nghing v c ch (TT) nu c trong Ph lc 2.1. Cc thuc th chung; Ph lc 2.3. Cc dung dch m v Ph lc 2.4. Cc dung dch mu hoc c ch (C) nu c trong Ph lc 2.2. Cc dung dch chun .29. Cc nh ngha v tan nh sau:"Tan" c ngha l cht th ( c tn nh thnh bt nu l cht rn) ha tan c trong dung mi to thnh mt dung dch trong, ng nht, khng cn nhng phn t ca cht th. Xc nh tan bng cch cho lng dung mi vo cht th nhit 25 c 2 c trong 30 pht, c cch 5 pht li lc 30 giy. tan c biu th nh sau:

tan S ml dung mi ha tan 1 g cht thRt tan Di 1D tan T 1 n 10Tan Trn 10 n 30Hi tan Trn 30 n 100Kh tan Trn 100 n 1 000Rt kh tan Trn 1 000 n 10 000Thc t khng tan Trn 10 000

30. acid hay kim ca dung dch, nu khng c ch dn g khc, c xc nh bng giy qu xanh hay . Mun xc nh nhng tnh cht ny chnh xc hn th phi o pH bng pH k.31. Bnh ht m: Cm t "trong bnh ht m" c ngha l dng mt bnh kn c kch thc thch hp, bn trong cha silica gel hoc mt cht lm kh khc gi cho khng kh trong bnh c m thp.Bnh ht m chn khng: L binh ht m cha mt cht lm kh thch hp v c p sut khng qu 2,0 kPa (15 mm thy ngn), nu khng c ch dn khc.32. Danh php thc vt, ng vt ca cy, con lm thuc gm tn chi v tn loi, h thc vt hay ng vt.33. Dc liu c ghi trong Dc in l b phn dng lm thuc c lu hnh trn th trng, khng ln tp cht. Trong Dc in, vic thu thp x l dc liu ti ch ch bao hm ring b phn dng.34. Qui cch c im dc liu c m t da trn dc liu kh ni chung. Cht lng tiu chun ca dc liu ti cng c qui nh nu em dng ti.Phn m t dc liu ch cp n b phn dng lm thuc, khng m t ton b con vt hay ton b cy cung cp dc liu .35. Dc liu c ngun gc khc nhau, c m khc nhau, c m t mt cch tng ng v chi tit, u tin l mt th, loi, sau m t mt s c im ca nhng th, loi khc, gip phn bit chng. Trong mt s trng hp, chng c m t ring r nhng chuyn lun khc nhau.36. Vic lm kh dc liu ti ch, hay lm kh trong qu nh thu hi dc liu c hiu nh sau:a. Thut ng "lm kh", c ngha l c th sy, nng kh, phi di nh sng mt tri hoc phi trong bng rm (phi m can).b. Thut ng phi kh nhit thp c ngha l phi kh nhit khng qu 60 c, c dng cho dc liu khng chu c nhit cao.c. Thut ng "phi m can" c ngha l phi trong bng rm ngoi khng kh, c dng cho dc liu khng sy, nng, khng phi nng c.d. Trong mt s Tig hp, dc liu phi phi kh trong thi gian ngn, thut ng c dng l "phi nhanh di nng to", "phi ng thi gian".37. c im vi phu (thng l c im mt ct ngang dc liu), soi bt dc liu v nhng vi c im khc ca mt dc liu l nhng c im ca vt mu quan st di knh hin vi.38. Cc dc liu, dc cht, t dc v cht ph gia dng trong mt ch phm phi tun theo nhng qui nh ca Dc in. Nhng iu Dc in khng qui nh th phi tun theo qui nh hin hnh ca B Y t.

T dc, cht ph gia em dng khng c phong hi ti tnh an ton v tnh hiu qu ca thuc, cn ch trnh lm cn tr phng php phn tch qui nh trong chuyn lun Dc in.39. Dc liu dng sn xut thuc thnh phm (thuc t dc liu) phi t tiu chun Dc in Vit Nam. Nu c yu cu dng dc liu bo ch th qui trnh bo ch phi c tin hnh theo phng php qui nh trong chuyn lun Dc in. Tr khi c nhng ch nh khc.40. Lng qui nh cho mi thnh phn trong cng thc ca mt ch phm thuc t dc liu c tnh theolng dc liu sch, tn thnh bt hoc c x i.41. Duyc liu s dng theo dng ung thng dng di dng thuc sc, tr khi c nhng ch nh khc.42. Liu lng qui nh dng trong dc in l liu dng thng thng i vi ngi trng thnh. Vic sa i, iu chnh liu lng ty thuc vo tnh trng bnh tt ca tng ngi bnh c th. Liu ti a ca mt thuc l liu cao nht m ngi trng thnh c th chu c v khng c dng qu liu ; tr khi c nhng ch nh khc.43. Nc dng trong bo ch thuc t dc liu l nc sch, nc ung t theo tiu chun v sinh y t.44. Ru dng trong bo ch thuc t dc liu l ethanol 40 % n 45 %.45. Nhng yu cu c bn v bo qun thuc c ghi mc "Bo qun". ng l phng tin bo qun thuc, yu cu ca ng cng bao gm c nhng phn hp thnh nh l nt hay np. Cc ng phi kn, khng c lm nh hng n cht lng thuc ng bn trong, khng cho mi trng bn ngoi tc ng nh hng n cht lng v phi t theo qui nh ca Dc in Vit Nam.v nhit ni bo qun phi thc hin rtg yu cu qui nh.Trnh nh sng" c ngha l cht ng c trong chai l thy tinh mu h phch, hoc chai l thy tinh mu, chai l thy tinh bc bng giy en hoc bt k ng no khong b nh hng bi nh sng."y kn" c ngha l ng c th trnh eho cc cht ng bn trong khng b bi bn v cc cht l bn ngoi nhim vo."Hn kn" c ngha l ng phi kn hi v c th bo v cht ng trong chng c hi m v cc vi khun.46. Nhn thuc phi theo ng quy nh hin hnh.

K HIU CC CH VIT TT

Dc in vit Nam ln xut bn th t.Thuc th.Cht i chiu.Chun (Dung dch).Bacillus Calmette - Gurin.n v ln bng trong 1 mg nitrogen protein.n v ln bng trong 1 mg nitrogen ton phn.Thi gian xut hin hin tung ln bng (tnh theo pht) khi c theo di frong phn Tig ln bng.Lng c t hoc gii c t khi trn vi 1 IU khng c t s xut hin ln bng trong thi gian ngn nht.Lng c t ti thiu khi kt hp vi 1 IU khng c t c th git cht mt con vt ctrng lng xc nh trong bn ngy (Liu L+ ph thuc vo tng loi ng vt th nghim).Lng G t ti thiu khi kt hp vi 0,1 IU khng c t c th git cht mt vt th nghim c tri lng xc nh trong bn ngy.Lng c t toi thiu khi kt hp vi mt lng khng c t c nh (thuOTg l 0,002 ly khng c t) trong th tch 0,2 ml s gy phn ng da ti ch c th nhn thy c (ch i vi bch cu).Lng c t git 50 % Ga mt nhm ng vt trong vng 4 ngy (LD50 khc nhau ty theo tng loi ng vt th nghim)Liu gy cht nh nht, l lng c t c th git cht cc sc vt trong vng 4 ngy (MLD khc nhau ty theo loi ng vt th nghim). Ni chung, MLD c thay th bang LD50. Liu vc xin bo v c 50 % ng vt utrc gy min dch chng li mt liu th thch ca vi khun c hoc c t.n v kt hp khng c t (Antitoxin Binding Value), l gi tr xc nh lng c t thm vo gii c t thnh mt hn hp (xc nh kim tra trn ng vt th nghim).

DVN IV: TT:C:C:BCG:Lf/ mg PN: Lf/ mgN: Kf:

Lf;

L+:

L+/ 10:

Lr:

LD50:

MLD:

ED50:

ABV:

xlv

CPE; Tc ng gy bnh t bo (Cytopathic effect).MEM: Mi trng MEM (Minimum Essential Medium).FCS: Huyt thanh bo thai b (Foetal Calf Sera).CCIDso: Lng virus gy nhim 50% t bo (Cell culture infective dose).NMSL: Nc mui sinh l.EU: n v ni c t (Endotoxin Unit).Nc BET; Nc th ni c t.Me: - CH3 (methyl)Et: - CH2CH3 (ethyl)Pr^ - CH(CH3)2 (o-propyl)Pr": - CH2CH2CH3 (-propyl)Bu: - CH2CH(CH3)2 (-butyl)Bu^ - CH (CH3)CH2CH3 (5ec-butyl)Bu": - CH2CH2CH2CH3 (-butyl)Bu': - C(CH3)3 (ter/-butyl)Ph: - CHs (phenyl)Ac: - COCH3 (acetyl)

xlvi

Cc chuyn lun

NGUYN LIU HA DC V THNH PHM HA DC

ACETAZOLAMIDAcetazolamidiim

o 9\ \ /// s .

H2NHVN -N

C4H6N4O3S2 p.t.l: 222,2

Acetazolamid l N-(5-sulfamoyl-l ,3,4-thiadiazol-2- yl)acetamid, phi cha t 98,5 % n 101,0 % C4H6N4O3S2, tnh theo ch phm lm kh.

Tnh chtBt kt tinh trng hay gn nh trng.Rt kh tan trong nirc, kh tan trong ethanol 96 %, thirc t khng tan trong ether, tan trong cc dung dch hydroxyd kim long.

nh tnhC th chn mt trong hai nhm nh tnh sau: N hm liA , B. 'Nhm II: B, c, D.A, Ph hng ngoi (Ph lc 4.2) ca ch phm phi ph hp vi ph hng ngoi ca acetazolamid chun. Nu ph ca ch phm trng thi rn khng ph hp vi ph ca cht chun, ha tan ring r ch phm v chun trong ethanol 96 % (TT), bc hoi n kh, chun b cc mu o mi di dng a nn v ghi ph.B. Ha tan 30,0 mg ch phm trong dung dch natr hydroxyd 0,01 M v pha long thnh 100,0 m bng cng dung mi. Pha long 10,0 ml dung dch ny thnh 100,0 ml bng dung dch natr hydroxyd 0,0 M (dung dch A). o ph hp th t ngoi (Ph lc 4.1) ca dung dch A trong khong t 230 nm n 260 nm, dung dch c cc i hp th ' 240 nm. hp th ring bc sng cc i phi nm trong khong t 162 n 176.Pha long 25,0 ml dung ch A thnh 100,0 ml bng dung dch natr hydroxyd 0,01 M. o ph hp th t ngoi (Ph lc 4.1) ca dung dch ny trong khong t260 nm n 350 nm, dung dch c cc i hp th 0'292 nm. hp th ring bc sng circ i phi nm trong khong t 570 n 620. c. Ly khong 20 mg ch phm vo mt ng nghim, thm vo 4 ml dimg dch acd hydrocloric long (TT) v 0,2 g km bt (TT). t ngay mt ming giy tm ch acetat (TT) ln ming ng nghim. Ming giy s c mu en nh nu.D. Ha tan khong 25 mg ch phm trong mt hn hp gm 0,1 ml dung dch natr hydroxyd long (TT) v 5 ml nc. Thm 0,1 ml dung dch ng suifat (T^ T). S to thnh mt ta mu xanh nh lc.

trong v mu sc ca dung dchHa tan 1,0 g ch phm trong 10 ml dung dch natri hydroxyd 1 M (TT). Dung dch ny khng c c hn hn dch chun i chiu s II (Ph lc 9,2) v khng c c mu m hn mu mu V5 hoc VN5 (Ph lc 9.3, phng php 2).

Tp cht lin quanKhng c qu 1 %.Phong php sc k lp mng (Ph lc 5.4).Bern mng: Silica gel GF254-H dung mi: Hn hp dung mi mi pha: Amonac - ethyl acetat - sopropanol (20 : 30 : 50).Dng bnh sc k khng c lp giy lt bn trong v cho bnh bo ha dung mi 1 gi trc khi trin khai sc k.Dung dch th: Ha tan 50 mg ch phm trong hn hp ng th tch ca ethanol 96 % (TT) v ethyl acetat (TT) v pha long thnh 10 ml vi cng dung ini.Dung dch i chiu: Pha long 1 m dung dch th thnh 100 ml bng hn hp ng th tch ca ethanol 96 % (T p v ethyl acetat (TT) .Cch tin hnh: Chm ring bit ln bn mng 20 |Lil mi dung dch trn. Trin diai sc k ti khi dung mi i c 15 cm. kh bn mng ngoi khng kh v quan st di nh sng t ngoi bc sng254 nm. Bt k vt ph no trn sc k ca dung dch th ngoi vt chnh khng c m mu hn vt trn sc k ca dng dch i chiu (1 %).

SulfatKhng c qu 0,05 % (Ph lc 9.4.14)Thm 20 ml nc vo 0,4 g ch phm v ha tan bng cch un nng ti si. Lm ngui trong khi vn lc lin tc v lc.Ly 15 ml dch lc tin hnh th.

Kim ioi nngKhng c qu 20 phn triu (Ph lc 9.4.8).Ly 1,0 g ch phm tin hnh th theo phong php 3. Dng 2 ml dung dch ch mu 10 phn triu (TT) chun b mu i chiu.

M t khi lng do lm khKhng c qu 0,5 % (Ph lc 9.6).(1,000 g; 100"Cn 105 "C).

T rosulfatKhng c qu 0,1 % (Ph lc 9.9, phng php 2). Dng 1,0 g ch phm.

nh IngHa tan 0,200 g ch phm trong 25 ml dimethyl- formamid (TT). Chun bng dung dch natri hydroxyd 0,1 M trong ethanol (C). Xc nh im kt thc bng phoi php chun o in th (Ph lc 10.2).

1 ml dung dch natri hydroxyd 0,1 M trong ethanol (C) tng ng vi 22,22 mg C4H6N4O3S2.

Bo qunng trong l nt kn, trnh nh sng.

Loi thucThuc chng glcm.

Ch phmThuc tim, vin nn.

VIN NN ACETAZOLAMID Tabellae cetaiolamidiL vin nn cha acetazolamid.Ch phm phi p ng cc yu cu trong chuyn lun Thuc vin nn (Ph lc 1.20) v cc yu cu sau y :

Hm lng acetazolamid, C4H6N4O3S2, t 95,0 % n 105,0 % so vi lng ghi trn nhn.

Tnh chtVin mu trng.

nh tnhA. Cn mt lng bt vin tng ng vi khong 0,5 g acetazolamid, thm 2 ml dung dch nai hydroxyd 1 M (TT). Lc k, lc, trung tnh dch lc bng acid acetic bng (TT), lc ly ta, sy ta thu c 105 c n kh.Ph hng ngoi (Ph lc 4.2) ca cn thu c phi ph hp vi ph hng ngoi i chiu ca acetazolamid.B. Nghin mt lTig bt vin tng ng vi khong 0,5 g acetazolamid vi hn hp gm 5 ml nc v 1 ml dung dch natri hydroxyd 1 M (TT), cho hn hp thu c vo ng nghim, thm 0,2 g km bt (TT) v 0,5 ml acid hydrocloric (TT), lp tc y mnh giy c tm dung dch ch acetat (TT) ln trn ming ng nghim, trn giy s xut hin mu en nu.c. Cn mt lng bt vin tng ng vi khong 25 mg acetazolamid, thm 5 ml nc, 0,15 ml dung dch natri hydroxyd 1 M (TT), lc, thm 0,1 ml dung dch ng suat 10 % (TT), s xut hin ta hoc mu lam nh lc.

Tp cht lin quanPhng php sc k lp mng (Ph lc 5.4).Bn mng: Silica gel GF254.Dung mi khai trin: Propan-2-ol - ethyl acetat - moniac (50 : 30 ; 20).Dung dch th: Cn chnh xc mt lng bt vin tng ng vi khong 50 mg acetazolamid, thm 10 ml hn hp dung mi ng th tch ethanol 96 % (TT) v ethyl acetat (TT), lc k trong 20 pht, lc. Dung dch i chiu: Ht chnh xc 1 ml dung dch th, pha long vi hn hp dung mi trn va 100 ml.

Cch tin hnh: Chm ring bit ln bn mng 20 |0.1 mi dung dch trn. Trin khai sc k n khi dung mi i c khong 15 cm. Ly bn mng ra v kh ngoi khng kh. Quan st di nh sng t ngoi bc sng 254 nm.Trn sc k , bt k vt ph no trn sc k ca dung dch th cng khng c c mu m hn mu ca vt chnh ca dung dch i chiu (1 %).

nh lngPhng php chun o in th (Ph lc 10.2).Cn 20 vin, tnh khi lng trung bnh vin, nghin thnh bt mn. Cn chnh xc mt lng bt vin tng ng khong 0,4 g acetazolamid, thm 90 ml dimethylformamid (TT). Chun bng dung dch tetrabutylamoni hydroxyd 0,1 M (C). Xc nh im kt thc bng phng php chun o in th.1 ml dung dch tetrabutylamon hydroxyd 0,1 M (C) tng ng vi 22,22 mg C4H6N4O3S2.

Bo qunng ong bao b kn, ni kh mt, trnh nh sng.

Loi thucThuc chng glcm.

Hm lng thng dng125 mg, 250 mg.

ACETYLCYSTEIN Acetylcystein um

HSH NHAc

CODHC5H9NO3S p.t.l: 163,2

Acetylcystein l acid (2R)-2-(acetylamino)-3-sulfanyI- propanoic, phi cha t 98,0 % n 101,0 % C5H9NO3S, tnh theo ch phm lm kh.

Tnh chtBt kt tinh trng hoc tinh th khng mu.D tan ong nc v trong ethanol 96 %, thc t khng tan trong dicloromethan.

nh tnhC th chn mt trong hai nhm nh tnh sau:Nhm I: A, E. 'Nhm II: B, c, D, E.A. Ph hng ngoi (Ph lc 4.2) ca ch phm phi ph hp vi ph hng ngoi ca acetylcystein chun. Chun b cc mu o bng cch phn tn trong kali bromid (TT) di dng a nn.B. im chy (Ph lc 6.7): T 104 c n 110 c.

c. Thm 0,05 ml dung dch natri noprusiat 5 % (TT) v 0,05 ml amoniac m c (TT) vo 0,5 ml dung dch s. S xut hin mu tm thm.D. Kim tra sc k mc php th "Tp cht lin quan". Thi gian lu ca pic chnh trong sc k thu c t dung dch th (2) phi tng r vi pic chnh trong sc k thu c t dung dch i chiu (2).E. Ch phm phi p ng php th Gc quay cc ring.

trong v mu sc ca dung dchDung dch S: Ha tan 1,0 g ch phm trong nc khng c carbon dioxyd (TT) v pha long n 20 ml bng cng dung mi.Dung dch s phi trong (Ph lc 9.2) v khng mu (Ph lc 9.3, phng php 2).

pHThm 8 m! nc khng c carbon dioxyd (TT) vo2 ml dung dch s v lc u. pH ca dung dch ny phi t 2,0 n 2,8 (Ph lc 6.2).

Gc quay cc ringT +21,0 n +27,0, tnh theo ch phm lm kh (Ph lc 6.4).Trn u 1,25 g ch phm vi 1 ml dung dch natri edetat 1 % trong mt binh nh mc 25 ml. Thm7,5 ml dung dch natri hydroxyd 4 % (TT), lc k ha tan. Pha long n 25,0 ml bng dung dch m phosphat pH 7,0 T2).

Tp cht lin quanTien hnh bng phng php sc k lng (Ph lc5.3). Chun b cc dung dch ngay trc khi dng, tr dung dch th (3).Pha ng'. Phi hp 3 th tch acetonitri (TT) v 97 th tch nc\ iu chnh n pH 3,0 bng acid phosphoric (TT).Dung dch th (1): Lc 0,80 g ch phm trong 1 ml dung dch acid hydrocloric 1 M (TT) v pha long thnh 100,0 ml bng nc.Dung dch th (2)\ Pha long 5,0 ml dung dch th (1) thnh 100,0 ml bng nc. Pha long tip 5,0 ml dung dch ny thnh 50,0 ml bng nc.Dung dch th (3)\ Dng dung dch th (1) sau khi pha t nht 1 gi.Dung dch i chiu (1)\ Lc mt hn hp gm4,0 mg acetylcystein chun, 4,0 mg L-cystin (TT), 4,0 mg L-cystein (TT), 4,0 mg tp cht chun c ca acetyl- cystein (N,N'-diacetyl-L-cystin), 4,0 mg tp cht chun D ca acetylcystein (N,S-diacetyl-L-cystein) trong 1 ml dung dch acd hydrocloric 1 M (TT) v pha long thnh 100,0 ml bng nc.Dung dch i chiu (2): Lc 4,0 mg acetylcystein chun trong 1 ml dung dch acid hydrocloric 1 M (TT) v pha long thnh 100,0 ml bng nc.

iu kin sc k-.Ct thp khng g (25 cm X 4 mm) c nhi pha tnh c (5 |am).Detector quang ph t ngoi t bc sng 220 nm. Tc dng: 1,0 ml/mm.Th tch tim: 20 xl.Cch tin hnh:Khi tin hnh sc k theo cc iu kin trn, cc cht s c thi gian lu nh sau: L-cystin khong 2,2 pht; L-cystein khong 2,4 pht; aci 2-methyl-2-thiazoIin- 4-carboxylic [c to thnh trong dung dch th (3)] khong 3,3 pht; acetylcystein khong 6,4 pht; tp cht c khong 12 pht; tp cht D khong 14 pht. Tim dung dch i chiu (1). Php th ch c gi tr khi:Trong sc k thu c ca dung dch i chiu (1), phn gii gia pic L-cystin v pic L-cystein t nht l 1,5; phn gii gia pic tp cht c v pic tp cht D t nht l 2,0.Tim dung dch acd hydrocloric 0,01 M (TT) lm mu trng. Ln lt tim 3 ln dung dch i chiu(1), dung dch i chiu (2) v cc dung dch th. Ghi sc k vi thi gian gp 5 ln thi gian lu ca acetylcystein tc vo khong 30 pht.T sc k thu c ca dung dch th (1), tnh hm lng phn trm ca cc tp cht bit v cha bit theo cc cng thc sau:

, - , - A ,xm -, X100Tap cht bit = --------- =--------

^2 ^ ^1

^ , . . . ' A X X100Tap cht cha bit = --------X OT

Trong :A| l din tch pic ca tng tp cht (L-cystin, L- cystein, tp cht c v tp cht D) trong sc k thu c ca dung dch th (1);A2 l din tch pic ca cc tp cht tng ng (L- cystin, L-cystein, tp cht c v tp cht D) trong sc k thu c ca dung dch i chiu (1);A3 l din tch pic ca tp cht cha bit trong sc k thu c ca dung dch th ( 1 );A4 l din tch pic ca acetylcystein trong sc k thu c ca dung dch i chiu (2 );rtii l khi lng ch phm trong dung dch th (1) ;ITI2 l khi lng ca mi tp cht lin quan c trong dung dch i chiu ( 1 );II3 l khi lng ca acetylcystein trong dung dch i chiu (2).Hm lng phn trm ca mi tp cht bit hoc cha bit khng c qu 0,5 %. Tng hm lng phn trm ca c tp cht bit v cha bit khng

c qu 0,5 %. B qua tt c cc pic ng vi pic ca dung mi, pic xut hin vi thi gian lu khong 3,3 pht (tng ng vi pic ca acid 2-methyl-2- thiazolin-4-carboxylic) v cc pic c din tch pic nh hn 0,1 ln so vi pic chnh trong sc k thu c ca dung dch i chiu (2).

KmKhng c qu 10 phn triu.Xc nh bng phng php quang ph hp th nguyn t (Ph lc 4.4, phng php 2).Dung dch th. Ha tan 1,00 g cli phm trong dung dch acid hydrocloric 0,001 M v pha long n50,0 ml bng cng dung mi.Dung dch i chi. Pha cc dung dch i chiu bng cch dng dung dch km mu 5 mg/ml (TT), pha long vi dung dch acid hydrocloric 0,00 M.o hp th 213,8 nm, dng n cathod rng km lm ngun bc x, ngn la khng kh - acetylen v hiu chnh s hp th khng c hiu.

Kim loi nngKhng c qu 10 phn triu (Ph lc 9.4.8).Ly 2,0 g ch phm tin hnh th theo phng php 3. Dng 2 ml dung dch ch mu 10 phn triu (TT) chun b mu i chiu.

Mt khi lng do lm khKhng c qu 1,0 % (Ph lc 9.6).(1,000 g; sy chn khng; 70 C; 3 h).

Tro sulfatKhng c qu 0,2 % (Ph lc 9.9, phng php 2). Dng 1,0 g ch phm.

nh lngHa tan 0,140 g ch phm trong 60 ml nc v thm 10 m dung dch acid hydrocloric long (TT). Sau khi lm mt trong nc , thm 10 ml dung dch kali iodid (TT) v chun bng dung dch iod 0,1 N fC), dng 1 ml dung dch h tinh bt (TT) lm ch th.1 ml dung dch iod 0,1 N (C) tng ng vi 16,32iigC5H9N03S.

Bo qunBo qun trnh nh sng.

Loi thucThuc gii c qu liu paracetamol, thuc tiu cht nhy.

Ch phmThuc tim, thuc cm.

NANG ACETYLCYSTEIN Capsulae AceylcyseiniL nang cng cha acetylcystein.Ch phm phi p ng cc yu cu trong chuyn lun Thuc nang (Ph lc 1.13) v cc yu cu sau y:

Hm lng acetylcystein, C5H9NO3S, t 95,0 % n105,0 % so vi lng ghi trn nhn.

Tnh chtNang cng, bt thuc trong nang mu trng hay trng ng, mi c bit, c v ngt.

nh tnhA; Trong phn nh lng, trn sc k dung dch th phi cho pic chnh c thi gian lu tng ng vi thi gian lu ca pic acetylcystein trn sc k ca dung dch chun.B. Ha tan mt lng ch phm cha khong 1,0 g acetylcystein trong 20 ml nc. Lc k, lc. Ly 1 mi dch lc, thm 0,1 ml dung dch natri nitroprusiat 5 Vo (TT) v 0,1 ml amonac m c (TT) s xut hin mu tm m.

nh lngPhng php sc k lng (Ph lc 5.3).Pha ng: Ha tan 6,8 g kali dihydrophosphat (TT) trong 1000 ml nc, iu chnh dung dch ti pH 3,0 bng dung dch acidphosphoric m c (TT), lc. Dung dch th: Cn 20 vin, tnh khi lng trung binh ca bt thuc trong nang, nghin thnh bt mn. Cn chnh xc lng bt tng ng khong 0,1 g acetylcystein vo bnh nh mc 100 ml, ha tan v pha long vi dung dch natri metabisulfit 0,05 % n nh mc, lc u, lc. Ht 10 ml dung dch lo vo bnh nh mc 100 ml, pha long vi dung dch natri metabisulfit 0,05 % n nh mc, lc u.D m g dch chun: Cn chnh xc khong 0,1 g acetyl- cystein chun vo bnh nh mc 100 ml, ha tan bng dung dch natri metabisiit 0,05 %, pha long vi cng dung mi n nh mc, lc u. Ht 10 ml dung ch ny vo bnh nh mc 100 ml, pha long vi dung dch natri metabisulfit 0,05 % n nh mc, lc u.iu kin sc k:Ct thp khng g (25 cm X 4 mm) c nhi pha tnh c (5 )0,m).Detector quang ph t ngoi t bc sng 214 nm. Th tch tim: 20 |J,1.Tc dng: 1,5 ml/min.Cch tin hnh :Kim tra kh nng thch hp ca h thng sc k: Tin hnh sc k vi dung dch chun, lch chun tng i ca cc din tch p ng t 6 ln tim lp li khng c ln hn 2,0 %.

Tin hnh sc k ln lt vi dung dch chun v dung dch th.Tnh hm lng acetylcystein, C5H9NO3S, c trong nang da vo din tch pic thu c trn sc k ca dung ch th, dung dch chun v hm lng C5H9NO3S ca acetylcystein chun.

Bo qunng trong l kn, ni mt, trnh nh sng.

Loi thucThuc iu ha s tit dch ca ph qun.

Hm lng thng dngNang 200 mg.

THUC BT ACETYLCYSTEIN Pulveres AcetylcysteinL thuc bt cha acetylcystein.Ch phm phi p ng cc yu cu trong chuyn lun Thuc bt (Ph lc 1.7) v cc yu cu sau y:

Hm lng acetylcystein, C5H9NO3S, t 95,0 % n105,0 % so vi lng ghi trn nhn.

Tnh chtBt mu trng, c v ngt.

nh tnhA. Trong phn nh lng, trn sc k ca ung dch th phi cho pic chnh c thi gian lu tng ng vi thi gian lu ca pic acetylcystein trn sc k ca dung dch chun.B. Ha tan mt lng ch phm cha khong 1,0 g acetylcystein trong 20 ml nc. Lc k, lc. Ly 1 ml dch lc, thm 0,1 ml dung dch natri nitroprusiat 5 % (TT) v 0,1 ml amoniac m c (TT) s xut hin mu tm m.

Mt khi lng do lm khKhng c qu 5,0 % (Ph lc 9.6).(] ,000 g; 75 C; 4 h, trong chn khng).

mnThuc bt phi t yu cu Bt rt mn (Ph lc 3.5).

nh lngPhng php sc k lng (Ph lc 5.3).Pha ng: Ha tan 6,8 g kali dihydrophosphat (TT) trong 1000 ml nc, iu chnh dung dch ti pH 3,0 bng dung dch acid phosphoric m c (TT), lc. Dung dch th: Cn chnh xc mt lng bt thuc nghin mn thu c php th ng u khi lng tng ng khong 0,1 g acetylcystein vo bnh nh mc 100 ml, ha tan v pha long vi dung dch natri metabisulfit 0,05 % n nh mc, lc u, lc. Ht 10 ml dch lc vo bnh nh mc 100 ml, pha

long vi dung dch natri metabisulfit 0,05 % n nh mc, lc u.Dung dch chun: Cn chnh xc khong 0,1 g acetyl- cystein chun vo bnh nh mc 100 ml, ha tan bng dung dch natri metabisulfit 0,05 %, pha long vi cng dung mi n nh mc, lc u. Ht 10 ml dung ch ny vo binh nh mc 100 ml, pha long vi