两种罗红霉素片人体生物等效性的研究

Study on relative bioavailability of two kinds of roxithromycin tablets in healthy volunteers

目的评价重庆科瑞制药有限责任公司研制的罗红霉素片（简称科瑞片）与桂林南药股份有限公司生产的罗红霉素片（简称南药片）的人体相对生物等效性。方法20名健康受试者随机分为两组，交叉设计，服用科瑞片和南药片。通过微生物杯碟法测定血清中罗红霉素浓度，经3p97程序对数据进行拟舍和计算药动学参数。结果科瑞片和南药片体内药时曲线均为二室模型，药动学参数分别如下：t1/2β为（7．96±3．46）h和（10．46±5．10）h；Cmax为（7．67±2．18）μg／ml和（7．15±2．74）μg／ml；Tmax为（1．82±1．00）h和（2．10±1．22）h；AUC（0～T）为（66．36±45．35）μg·h^-1·ml^-1和（67．65±43．60）μg·h^-1·ml^-1，科瑞片和南药片相对生物利用度为（98、09±11．90）％。结论经方差分析和单双侧t检验，两种片剂具有生物等效性。

Objective To evaluate the bioavailability of two kinds of roxithromycin tablets in healthy volunteers. Methods A randomized crossover design was performed in 20 healthy volunteers, 150mg of roxithromycin tablets and preparation tablets were given respectively. The serum concentration of roxithromycin tablets were determined by microbial plate assay. The pharmacokinetics were calculated by program of 3p97. Results The concentration-time curves of tablets both fitted to two-compartment open models. The main pharmacokinetic parameters were as follows： t1/2β were （7.96 ± 3.46） h and （ 10.46± 5.10） h, Cmax were （7.67±2.18）μg/ml and （7.15±2.74）μg/ml, Tmax were （1.82±1.00）h and （2.10±1.22）h;AUC（0-T） were （66.36±45.35）μg · h^-1 · ml^-1 and （67.65±43. 60）μg· h^-1· ml^-1 , respectively. Conclusion Both roxithromycin tablets were bioequivalent. The relative bioavailability of test roxithromycin tablets was （98. 09±11.90） %.