盐酸环丙沙星胶囊的人体药物动力学和相对生物利用度研究

Pharmacokinetics and relative bioavailability of Ciprofloxacin Hydrochloride Capsules in healthy volunteers

目的 比较国产盐酸环丙沙星胶囊与进口盐酸环丙沙星片在健康人体内的药物动力学和生物利用度。方法 1 0名男性健康志愿者随机交叉口服单剂量 ( 75 0 mg)国产盐酸环丙沙星胶囊 (江苏海慈药业有限责任公司生产 )和进口盐酸环丙沙星片后 ,采用 HPLC-荧光检测法测定血浆中盐酸环丙沙星的血药浓度 ,并计算出药物动力学参数 ,以进口片为标准 ,对国产胶囊的生物利用度和生物等效性进行评价。结果 国产胶囊和进口片的平均 Cmax分别为 4.5 8和 4.66μg/ ml,Tmax为 1 .2 7h和 1 .2 9h;以进口片为标准 ,国产胶囊的相对生物利用度为 94.62± 5 .1 6%。

Objective To compare the pharmacokinetics and relative bioavailability of domestis Ciprofloxacin Hydrochloride capsules with imported tablets in healthy volunteers Methods A single oral dose of 750mg Ciprofloxacin Hydrochloride Capsules was given to 10 healthy male volunteers in an open randomized crossover study.Drug concentration was determined by HPLC FL method and the pharmacokinetic parameters were estimated.The relative bioavailability and bioequivalence of domestic Ciprofloxacin Hydrochloride Capsules(Jiangsu Yangtze River Pharmacy Group Co.,China)as test capsules were determined by comparing with imported tablets as reference Results The experiment data showed that the pharmacokinetic parameters of domestic capsules and imported tablets were Cmax:4 58μg/ml and 4 66μg/ml;Tmax:1 27h and 1 29h.The relative bioavailability of domestic capsules comparing with imported tablets was 94 62±5 16% Conclusions The result of statistical analysis showed that the domestic capsules and the imported tablets were bioequivalent