【摘要】 目的研究阿奇霉素胶囊及片剂在正常人体内的药动学及相对生物利用度。方法采用3×3拉丁方试验设计,将24名男性健康志愿受试者随机分为3组,分别单次口服阿奇霉素供试制剂与参比制剂。采用HPLC法测定经时血药浓度。用DAS药动学程序处理试验数据,并对试验结果进行方差分析和双单侧t检验。结果阿奇霉素胶囊及片剂的相对生物利用度为:104.1%±10.2%和99.9%±9.8%;阿奇霉素胶囊及片剂供试品和参比品的药时曲线下面积(AUC0→T)分别为:23.27±4.52μg·h·ml-1、23.33±5.76μg·h·ml-1、23.31±7.70μg·h·ml-1;AUC0→∞分别是31.25±5.13μg·h·ml-1、30.59±6.54μg·h·ml-1、29.78±8.15μg·h·ml-1;达峰时间(Tmax)分别为:2.17±0.38h、2.03±0.55h、2.21±0.48h;达峰浓度(Cmax)分别是:1.260±0.109μg·ml-1、1.310±0.138μg·ml-1、1.298±0.087μg·ml-1。结论经统计学分析,制剂间药动学参数差异无显著性意义,阿奇霉素胶囊及片剂与参比制剂具有生物等效性。更多还原

【Abstract】 Objective To investigate the pharmacokinetics and bioequivalence of azithromycin capsules and tablets in healthy volunteers. Methods Using 3×3 Latin design,24 healthy male volunteers were randomly divided into 3 groups.a single oral dose of either test or reference preparation was administered to each volunteer. Azithromycin concentration in plasma was detected by HPLC. The experiment data was calculated with DAS program. The results were analyzed by ANOVA and two one-side test.Results The relative bioavailability of azithromycin capsules and tablets in the test was 104.1 % ±10.2 % and 99.9 %±9.8 % respectively;AUC0-T of azithromycin of tests and reference preparations were 23.27±4.52 μg·h·ml-1?23.33±5.76 μg·h·ml-1?23.31±7.70 μg·h·ml-1;AUC0→∞ were 31.25±5.13 μg·h·ml-1?30.59±6.54 μg·h·ml-1?29.78±8.15 μg·h·ml-1;Tmax were2.17±0.38 h?2.03±0.55 h?2.21±0.48 h; Cmax were1.260±0.109 μg·ml-1?1.310±0.138 μg·ml-1?1.298±0.087 μg·ml-1. Conclusion The statistic analysis shows that the main pharmacokinetics parameters of the 3 formulas are not significantly different.Azithromycin of tests and reference preparations are bioequivalent.更多还原