克林霉素磷酸酯胶囊的人体药代动力学与相对生物利用度研究

目的 :研究克林霉素磷酸酯胶囊的人体药代动力学与相对生物利用度。方法 :采用微生物法测定18名男性健康志愿者随机自身交叉单剂量口服克林霉素磷酸酯胶囊和特丽仙C300mg 后的克林霉素的经 -时血药浓度 ,以3p97软件拟合计算两者的药代动力学参数及相对生物利用度 ,应用NDST软件分析两制剂的生物等效性。结果 :克林霉素磷酸酯胶囊和特丽仙C两制剂的血药浓度 -时间曲线符合一级吸收一级消除的一房室动力学模型 ,Tmax 分别为 (0 94±0 51)h、(0 75±0 35)h ;Cmax 分别为 (3 86±0 62) μg/ml、(4 08±0 60) μg/ml ;AUC0～12 分别为 (14 88±3 64) μg/(ml·h)、(16 07±3 68) μg/(ml·h)。双单侧t检验法及等效界值法统计处理结果表明 ,AUC0～12、Cmax 均生物等效检验合格。结论 :克林霉素磷酸酯胶囊对特丽仙C的相对生物利用度为(93 4±14 9) %。克林霉素磷酸酯胶囊和特丽仙C两种制剂具有生物等效性

Pharmacokinetics and Relative Bioavailability of Clindamycin Phosphate Capsules in Healthy Volunteers

OBJECTIVE:To study the pharmacokinetics and relative bioavailability of clindamycin phosphate capsules in healthy volunteers METHODS:A single oral dose of 300mg domestic clindamycin phosphate capsules or imported Dalacin C was given to 18 healthy male volunteers in an open randomized crossover study Clindamycin concentrations in plasma were determined by microbiologic assay The pharmacokinetic parmameters as well as relative bioavailability were calculated with 3p97 software and bioequivalence was analysed with NDST software RESULTS:The concentration-time curves of domestic clindamycin phosphate capsules or imported Dalacin C were well fitted for one-compartment open model The pharmacokinetic parameters of domestic and imported products were:Tmax(0 94±0 51) and(0 75±0 35)h;Cmax(3 86±0 62)μg/ml and (4 08±0 60)μg/ml;AUC0～12(14 88±3 64)μg/(ml·h)and(16 07±3 68)μg/(ml·h)respectively There were no significant differences in AUC0～12 and Cmax between two products CONCLUSION:The relative bioavailability of clindamycin phosphate capsules was(93 4±14 9)% compared with imported Dalacin C The results showed that the two formulations were bioequivalent