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  • Title: [Study on bioequivalence of new Wubei fast-release tablet].
    Author: Chen H, Gao SB, Li LJ, Yan R, Ji Y.
    Journal: Zhongguo Zhong Yao Za Zhi; 2013 Aug; 38(16):2728-32. PubMed ID: 24228594.
    Abstract:
    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. METHOD: 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. RESULT: 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. CONCLUSION: 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.
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