国产和进口阿奇霉素片在人体内的生物等效性研究

目的:研究国产和进口阿奇霉素片在健康人体内的生物等效性。方法:采用高效液相色谱-紫外检测法测定12名健康志愿者单剂量交叉口服国产和进口阿奇霉素片500mg后的经-时血药浓度。采用F检验法结合赤池信息准则法判别房室模型,利用DAS软件计算药动学参数。结果:最佳房室模型为二室模型,国产和进口阿奇霉素片的Cmax分别为(437.4670±51.5670)、(442.9670±61.5030)μg/L,t1/2β分别为(44.7450±13.1750)h、(49.2670±15.1740)h,tmax分别为(2.5830±0.5150)h、(2.5830±0.5150)h,AUC0～144分别为(13.2799±2.9827)、(12.1953±2.9140)(mg.h)/L,国产阿奇霉素片的相对生物利用度为(101.7±0.1)%。结论:国产与进口阿奇霉素片具有生物等效性。

Determination of Bioequiavailability of Azithromycin Tablets Both Home and Abroad in Healthy Human Body

OBJECTIVE:To study the bioequiavailability of both the domestic and the imported azithromycin tablets in healthy human body.METHODS:The serum concentrations in 12 healthy volunteers was determined by HPLC-UV after administration of a single oral dose of 500mg azithromycin tablets by a cross-over design.The compartment model was discriminated by F-test and AIC method and the pharmacokinetic parameters were calculated by DAS program.RESULTS:The optimal compartment model fitted to two-compartment model.The main pharmacokinetics parameters of the domestic azithromycin tablets vs.the imported ones were the following:Cmax was(437.4 670± 51.5 670),(442.9 670± 61.5 030)μ g/L;t1/2β was(44.7 450± 13.1 750),(49.2 670± 15.1 740)h;tmax was(2.5 830± 0.5 150),(2.5 830± 0.5 150)h;AUC0～ 144 was(13.2 799± 2.9 827),(12.1 953± 2.9 140)(mg· h)/L.The relative bioavailability of the domestic azithromycin tablets was(101.7± 0.1)%.CONCLUSION:The domestic azithromycin tablets and the imported ones were bioequivalent.