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目的:评价两种替硝唑片剂人体生物等效性。方法:采用单剂量双交叉实验设计,用HPLC法测定20名健康受试者口服两种替硝唑片1000mg后的血药浓度。结果:受试制剂和参比制剂药-时曲线均符合一室模型,t1/2分别为(15.56±1.12)h和(15.49±1.12)h,tmax为(1.8±0.5)h和(1.7±0.3)h,Cmax为(12.55±2.64)mg／L和(12.32±2.90)mg／L,AUC为(227.44±24.65)mg·h·L-1和(225.98±34.42)mg·h·L-1,受试制剂的相对生物利用度为(101.5±6.9)％。结论:经统计学分析,两种替硝唑片具有生物等效性。
PURPOSE: To evaluate the bioequivalence of two tinidazole tablets in humans. Methods: The single-dose double-crossover design was used to determine the plasma concentrations of two tinidazole tablets (1000 mg) after oral administration to 20 healthy subjects by HPLC. RESULTS: The drug-time curves of the test and reference preparations were in accordance with the one-compartment model with t1 / 2 of (15.56 ± 1.12) h and (15.49 ± 1.12) h and tmax of (1.8 ± 0.5) h and (1.7 ± 0.3) h, Cmax was (12.55 ± 2.64) mg / L and (12.32 ± 2.90) mg / L respectively and AUC was (227.44 ± 24.65) mg · h · L-1 and (225.98 ± 34.42) mg · h · L- 1, the relative bioavailability of the test preparation was (101.5 ± 6.9)%. Conclusion: The two tinidazole tablets have bioequivalence after statistical analysis.