阿奇霉素片人体药动学研究及生物等效性评价

Pharmacokinetics and relative bioavailability of azithromycin tablets in healthy volunteers

目的：研究单剂量口服阿奇霉素片后的血药浓度经时过程,并进行生物等效性评价。方法：20名健康受试者自身交叉单剂量口服阿奇霉素受试制剂和参比制剂各500 mg,用微生物法测定血药浓度。结果：受试制剂与参比制剂的血药浓度-时间曲线基本一致,主要药动学参数cmax分别为（468.54±136.53）和（473.37±131.51）ng/mL;tmax分别为（1.98±0.72）和（2.00±0.74）h;t1/2分别为（39.35±8.08）和（41.23±7.94）h;AUC0-144分别为（4 525.84±1 002.73）和（4 723.06±1 018.60）ng.h.mL-1。结论：统计分析结果表明,两种制剂具有生物等效性,受试制剂的相对生物利用度为（96.27±10.22）%。

Objective：To investigate the concentration-time profile and the relative bioavailability of test azithromycin tablets.Methods：A single oral dose of 500 mg azithromycin was given in a randomized,cross-over study in 20 healthy volunteers.Serum concentrations of azithromycin were determined by microbiological assay.Results：Concentration-time profile of the test tablet was well fitted to that of the reference tablets.The main pharmacokinetic parameters of the test and reference tablet were as follows：cmax（468.54±136.53） and（473.37±131.51） ng/mL,tmax（1.98±0.72） and（2.00±0.74） h,t1/2（39.35±8.08） and（41.23±7.94） h,AUC0～144（4 525.84±1 002.73） and（4 723.06±1 018.60） ng·h·mL^-1.Conclusion：The results of statistical analysis showed that two formulations were bioequivalent.The relative bioavailability of test tablet is（96.27±10.22）%.