法莫替丁两种剂型的生物等效性评价

Bioequivalent study of two Famotidine preparations

本实验采用反相高效液相色谱法测定10名志愿受试者单剂量口服40mg供试品法莫替丁分散片与市售法莫替丁片照试验后,法莫替丁血药浓度变化情况,经3P 87药动学程序处理,药时曲线下面积分别是:1075.37±226.07ng/ml×h1113.87±269.87ng/ml×h,达峰时间分别为:2.35±0.24h与2.45±0.16h,峰浓度分别是:186.13±48.34ng/ml与164.7435.00ng/ml.双单侧t检验结果表明:二者药时曲线下面积、峰浓度及达峰时间均无显著性差异(P＞0.05),法莫替丁分散片试品与法莫替丁片为生物等效制剂.以法莫替丁片为标准参比制剂计算法莫替丁分散片的相对生物利用度为:97.49%9.40%.

The pharmacokinetics and relative bioavailability of two Famotidine preparations - dispersible tablet and tablet were studied. Famotidine was determined after a single oral dose of two Famotidine preparations were given respectively to 10 volunteers in an open randomized cross - over test. Famotidine concentration in serum was assayed by RP - HPLC method. After taking a single oral dose 40mg two Famotidine Preparations, the AUC0→∞ of Famotidine dispersible tablet and tablet were 4. 35 ± 1. 07μg/ml × h and 4. 14 ± 1. 24μg/ ml × h ;Tmax were 1. 85± 0. 34h and 1. 90 ± 0. 66h; Cmax were 0. 94 ± 0. 19μg/ml and 0. 88 ± 0. 21μg/ml respectively. The result of statistical analysis showed that there were no significant difference of the AUC0→∞、 Tmax and Cmax of Famotidine between the two formations (p> 0. 05) and the two Famotidine preparations were bioequivalent.