Professional Documents
Culture Documents
KIM NGHIM THUC VIN NN - NANG VIN NN Vin nn khng bao (uncoated tablets)
Vin si bt
Vin bao Vin bao tan trong rut Vin ngm Vin nn phn tn trong nc Vin nn tc dng ko di VIN NANG
(effervescent tablets)
(coated tablets) (enteric coated tablets) (lozenge)
Yu cu k thut
1. Tnh cht 2. tan r (Disintegration) 3. ng u khi lng (Uniformity of weight/mass)
Phng phap th
1. Tnh cht: Vin nn + Vin rn, hai mt nhn, trn mt c th c rnh, ch hoc k hiu, cnh v thnh vin lnh ln. Vin khng b
Phng phap th
1. Tnh cht: Vin nang (capsules) C nang 00 0 1 2 3 4 5 Dung tch (ml) 0,95 0,67 0,48 0,38 0,38 0,21 0,13
Dng bo ch
Dng bo ch
Vin nang
Dng vin Nn khng bao Sui bt Vin bao Bao phim Bao khc
Mi trng Nc Nc
KIM NGHIM THUC VIN NN (NANG) 4. PHP TH HO TAN - Xc nh t l ha tan hot cht ca vin trong nhng iu
kin ch nh.
- Ging tan r, ho tan oan chc rng thuc c ho tan ging nh cc l ban u c tc dng lm sng.
Nh SX A ng u khi lng t tan ra (pht) 10 ha tan (%) 23,74
B
C
t
t
10
14
67,14
95,32
ca thuc.
Mc ich: nh gi tc dng sinh dc hc ch khng phi nhm mc ich nh gi v an ton cng nh hiu qu ca thuc. nh gi tc dng v an ton ca thuc phi tin hnh th nghim in vivo v nh gi lm sng.
7. NG U HM LNG NH GI KT Qu
Ln Lng mu Kt qu chp nhn
10
Nu 1 vin c gi tr hm lng nm ngoi gii hn 85% - 115% nhng trong gii hn 75% - 125% ca HLTB th tin hnh th li vi 20 vin khc. 2 20 Khng qu 1/30 c hm lng nm ngoi khong 85 115% HLTB nhng trong khong 75 125% HLTB
C GNG HC TT!