Study on bioequivalence of new Wubei fast-release tablet.
- Author:
Hu CHEN
1
;
Sheng-Bin GAO
;
Li-Juan LI
;
Rui YAN
;
Yue JI
Author Information
- Publication Type:Journal Article
- MeSH: Animals; Dogs; Drug Delivery Systems; Drug Stability; Drugs, Chinese Herbal; chemistry; metabolism; pharmacokinetics; Female; Humans; Sodium Bicarbonate; chemistry; Tablets; Therapeutic Equivalency
- From: China Journal of Chinese Materia Medica 2013;38(16):2728-2732
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo 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.
METHODWubei 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.
RESULTThe 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.
CONCLUSIONThe 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.
