加替沙星胶囊的药代动力学及生物等效性评价

Pharmacokinetics and bioequivalence evaluation of Gatifloxacin Capsules

目的:评价加替沙星胶囊在健康男性体内的药代动力学和生物等效性。方法:40例健康男性试验者随机平分为两组,分别口服国产与进口加替沙星胶囊试验制剂或参比制剂,采用高效液相色谱法测定血浆中加替沙星的浓度,计算主要药代动力学参数,评价两制剂的生物等效性。结果:口服国产和进口加替沙星后两组的半衰期、峰时间、峰浓度和滞后时间相比无显著性差异。同时生物等效性相比也无显著性差异,可认为两种制剂具有生物等效性。结论:国产与进口加替沙星胶囊试验制剂或参比制剂在健康志愿者体内具有生物等效性和类似的药代动力学。

Objective：To evaluate the pharmacokinetics and bioequivalence of Gatifloxacin Capsules in the healthy male.Methods：40 healthy male were randomly divided into two groups,there were respectively given domestic and imported oral Gatifloxacin Capsules,used the high performance liquid chromatography method for detected the Gatifloxacin concentrations in plasma,and analyzed the major drug pharmacokinetic parameters and evaluated the bioequivalence of two formulations.Results：The oral administration of domestic and imported in the two groups after gatifloxacin′s half-life,peak time,peak concentration and the lag time had not significant different.Bioequivalence compared with the same time had no significant difference,so we thought that the two formulations were bioequivalent.Conclusion：Domestic and imported Gatifloxacin Capsules preparation or reference test preparation in healthy volunteers are bioequivalent and similar pharmacokinetics.