[Study on bioequivalence of new Wubei fast-release tablet].
OBJECTIVE
To prepare a new Wubei fast-release tablet and study the pharmacokinetics and bioequivalence of self-prepared Wubei fast-release tablet and Wubei powder in Beagle dogs.


METHODS
Wubei fast-release tablet was prepared with direct powder compression. Six Beagle dogs were randomly devided into two groups. They were orally administered with Wubei fast-release tablet and Wubei powder, respectively. Peimine concentrations in human plasma were determined by HPLC-MS/MS after administration. The pharmacokinetic parameters were calculated by DAS 2.0 using a non-compartmental analysis. The bioequivalence of fast-release tablet and powder was evaluated.


RESULTS
The main pharmacokinetic parameters of peimine in Wubei fast-release tablet as follows: Cmax (7.4 +/- 2.3) microg x L(-1), AUC(0-t) (59.13 +/- 15.25) microg x L(-1) x h(-1), Tmax (1.5 +/- 0.0) h. The main pharmacokinetic parameters of peimine in Wubei powder as follows: Cmax (8.0 +/- 1.7) microg x L(-1), AUC(0-t) (68.78 +/- 16.27) microg x L(-1) x h(-1), Tmax (1.5 +/- 0.0) h. The 90% confidence interval of InAUC(0-t), and lnCmax of peimine in Wubei fast-release tablet were 95.4% - 104.6%, 90.9% - 109.1% of corresponding parameters of Wubei powder, respectively.


CONCLUSIONS
The self-prepared Wubei fast-release tablet and Wubei powder were bioequivalent. And the self-prepared Wubei fast-release tablet had simple production process, easy administration.
Department of Pharmacy, Hebei Chemical and Pharmaceutical College, Shijiazhuang 050026, China. chenhuisjz@126.com
Hu
H
Chen
Sheng-Bin
SB
Gao
Li-Juan
LJ
Li
Rui
R
Yan
Yue
Y
Ji
D000818:Animals; D004285:Dogs; D016503:Drug Delivery Systems; D004355:Drug Stability; D004365:Drugs, Chinese Herbal / Q000737:chemistry / Q000378:metabolism / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D017693:Sodium Bicarbonate / Q000737:chemistry; D013607:Tablets; D013810:Therapeutic Equivalency
D004365:Drugs, Chinese Herbal; D013607:Tablets; D017693:Sodium Bicarbonate