国产阿奇霉素分散片人体生物等效性研究

Bioequivalence of azithromycin dispersant in healthy volunteers

目的:比较2种阿奇霉素分散片的人体生物等效性。方法:采用双制剂双周期自身交叉对照的方法,将22例健康男性受试音随机分为两组,口服阿奇霉案分散片受试制剂或参比制剂各1g。用HPLC-电化学检测法测定血浆中的阿奇霉素浓度,用DAS软件计算药动学参数,进行生物等效性评价。结果:阿奇霉素分散片受试制剂与参比制剂AUC_(0→132h)分别为(24,25±6．25)和(25．02±6．29)μg·h·mL^(-1);AUC_(0→∞)分别为(29．62±5．91)和(31．35±9．02)μg·h·mL^(-1);C_(max)分别为(1．18±0．17)和(1．18±0．21)μg·mL^(-1);T_(max)分别为(2．27±0．26)和(2．16±0．28)h;t_(1/2)分别为(39,89±9．36)和(42．27±9．62)h。与参比制剂比较,受试制剂相对生物利用度为(97．4±9．8)%。结论:口服阿奇霉素量试制剂和参比制剂生物等效。

Objective：To assess the bioequivalence of two azithromycin dispersants. Methods： 22 healthy male volunteers were randomly assigned to one of two treatment groups. Each volunteer orally received a single dose of either test or reference azithromycin 1 gram and were then crossed-over. The plasma concentration of azithromycin was determined by HPLC with electrochemical detection. The pharmacokinetic parameters were assessed by DAS program. Results：The pharmacokinetic data of test and reference samples were as follows： AUC0-123h（24.25 ±6.25） vs. （25.02 ±6.29） μg·h·mL^-1; AUC0→∞ （29.62±5.91） vs. （31.35 ±9.02） μg·h·mL^-1; Cmax（1.18 ±0.17） vs. （1.18 ±0.21） μg·mL^-1; Tmax （2.27 ± 0. 26） vs. （2.16± 0. 28 ） h and t1/z （39.89 ± 9.36） vs. （42.27 ± 9.96） h. The relative bioavailability of the test sample was （97.4 ± 9.8） %. Conclusion ： The test azithromycin dispersants were bioequivalent to the reference azithromycin.