阿奇霉素分散片人体生物等效性评价

Pharmacokinetics and bioequivalent of azithromycin dispersible tablets in healthy volunteers

摘要: 目的:评价阿奇霉素分散片的人体生物等效性。方法:20名男性健康志愿者随机交叉口服阿奇霉素分散片受试制剂和参比制剂各500 mg,采用高效液相色谱-质谱法(LC-MS)测定血药浓度。以DAS 2.0软件计算其药动学参数,考察其生物等效性。结果:阿奇霉素分散片受试制剂和参比制剂的差异均无统计学意义(P>0.05)。以AUC_0-120h计算,受试阿奇霉素分散片相对生物利用度为(119.6±52.9)%。结论:阿奇霉素分散片受试制剂和参比制剂具有生物等效性。

Abstract: Objective: To evaluate the bioequivalence of two domestic preparations of azithromycin in healthy volunteers.Methods: A single oral dose of 500 mg test or reference formulations were given to 20 male healthy volunteers in a randomized cross-over design.The serum concentration of azithromycin was determined by liquid chromatography-tandem mass spectrometry method.Pharmacokinetic parameters and relative bioavailability were calculated by DAS program.Results: Pharmacokinetic parameters of test and reference were not statistically different(P>0.05).The relative bioavailability of test was(119.6±52.9)%.Conclusions: The test and reference formulations were bioequivalent.