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目的 比较国产与进口富马酸比索洛尔片剂的人体药代动力学及两药的相对生物利用度。方法 受试者自身交叉口服同等剂量的国产与进口富马酸比索洛尔片剂 ,HPLC内标定量方法测定血药浓度 ,3P87计算机程序处理药代数据。结果 两种片剂的体内过程均符合一级吸收二室模型 ,国产片剂的主要药代动力学参数 T1/ 2α、T1/ 2 β、Cmax、Tmax和AUC0 -36分别为 1.32h、7.42h、49.6 0ng·ml-1、2 .5 4h和 489.49ng·ml-1·h-1;进口片剂的主要药代动力学参数T1/ 2α、T1/ 2 β、Cmax、Tmax和AUC0 -36分别为 1.31h、7.94h、48.5 3ng·ml-1、2 .5 7h和 5 2 0 .82ng·ml-1·h-1。结论 相对生物利用度为 95 .31%。经统计学分析两种片剂具有生物等效性
Objective To compare the pharmacokinetics of domestic and imported bisoprolol fumarate tablets and the relative bioavailability of the two drugs. Methods Subjects self-cross oral administration of the same dose of domestic and imported bisoprolol fumarate tablets, HPLC quantitative internal standard method for the determination of plasma concentration, 3P87 computer program processing pharmacokinetic data. Results The in vivo process of the two tablets were in accordance with the first-order absorption two-compartment model. The main pharmacokinetic parameters T1 / 2α, T1 / 2 β, Cmax, Tmax and AUC0 -36 of domestic tablets were 1.32h and 7.42h , 49.60ng · ml-1,2.54h and 489.49ng · ml-1 · h-1 respectively. The main pharmacokinetic parameters T1 / 2α, T1 / 2β, Cmax, Tmax and AUC0 -36 Respectively, 1.31h, 7.94h, 48.5 3ng · ml-1,2.57h and 520.082ng · ml-1 · h-1. Conclusion The relative bioavailability was 95.31%. The two tablets were statistically bioequivalent