【摘要】 目的:评价国产盐酸雷尼替丁胶囊与进口盐酸雷尼替丁片的人体生物等效性。方法:采用反相高效液相色谱法,测定20名健康志愿者随机分组、自身对照单次口服盐酸雷尼替丁胶囊或盐酸雷尼替丁片300mg后不同时刻的血药浓度,计算药动学参数,并进行方差分析和双单侧t检验。结果:盐酸雷尼替丁片与盐酸雷尼替丁胶囊的Cmax分别为(1247.1±547.5)、(1294.8±613.2)μg/L;tmax分别为(2.98±0.73)、(2.73±0.80)h;t1/2分别为(3.17±0.36)、(3.33±0.42)h;AUC0～t分别为(5805.9±1403.5)、(5941.2±1526.3)(μg·h)/L;AUC0～∞分别为(6163.8±1456.4)、(6351.8±1652.7)(μg·h)/L;盐酸雷尼替丁胶囊相对于盐酸雷尼替丁片的生物利用度为(104.3±24.3)%。结论:2种制剂具有生物等效性。更多还原

【Abstract】 OBJECTIVE:To study the pharmacokinetics and bioequivalence of both domestic ranitidine hydrochloride capsules and imported ranitidine hydrochloride tablets.METHODS:20healthy volunteers were randomized into groups,whose plasma concentrations of ranitidine were determined at different time after single oral dose of300mg ranitidine hydrochloride capsule or ranitidine hydrochloride tablets300mg by own control by a RP-HPLC method,the pharmacokinetic parameters were computed and which were experienced variance analysis and two-way t-tests and one-way t-tests.RESULTS:The respective pharmacokinetic parameters of ranitidine hydrochloride tablets and ranitidine hydrochloride capsuless were as folˉlows,the C max were(1247.1±547.5)μg/L and(1294.8±613.2)μg/L;t max were(2.98±0.73)h and(2.73±0.80)h;t 1/2 were(3.17±0.36)h and(3.33±0.42)h;AUC 0～t were(5805.9±1403.5)(μg·h)/L and(5941.2±1526.3)(μg·h)/L;AUC 0～∞ were(6163.8±1456.4)(μg·h)/L and(6351.8±1652.7)(μg·h)/L;The relative bioavailability of the ranitidine hydrochloride capsules to ranitidine hydrochloride tablets was(104.3±24.3)%.CONCLUSION:Ranitidine hydrochloride capsules and the ranitidine hydrochloride tablets were bioequivalent.更多还原