比索洛尔胶囊与片剂的生物等效性研究

Study on the Bioequivalence of Bisoprolol Capsules and Tablets in Healthy Volunteers

本研究对比观察比索洛尔胶囊（A）和片剂（B）在10名中国男性健康志愿者体内的相对生物利用度及其有关主要参数均值，以判定两者是否生物等效。采用二期交叉设计，血药浓度用HPLC法测定。结果表明A／B的平均相对生物利用度为100．1±18．7％，采用方差及双单侧t检验进行统计学分析，两者的AUC，Tmax；Cmax均无显著性差异（P＞0．05），故上述两种制剂具有生物等效性。结果也提示不同个体对比索洛尔的吸收存在较大的个体差异。关键词##4比索洛尔;;高效液相色谱法;;生物等效性;;

The bioequivalence of bisoprolol capsules and tablets was studied in 10 Chinese healthy volunteers. A randomized two-way crossover study design was adopted in the study. Bisoprolol concentrations in plasma were detected by HPLC. The results showed that the relative bioavailability of tested bisoprolol was 100,1 ±18. 7 %. The relult of statistical analysis showed that the two products were bioequivalent. The study also indicated that an inter-subject varlability for absorption of the drug exists.