法莫替丁缓释片的生物利用度研究

Study on bioavailability of famotidine sustainedrelease tablets in healthy volunteers

目的：研究评价法莫替丁缓释片在健康人体内的生物利用度。方法：以高效液相色谱法测定血药浓度，用３Ｐ８７程序处理数据。结果：单剂量给药，本品的达峰时间为（７．１２±０．４０）ｈ，峰浓度为（５８．６９±４．３６）ｎｇ·ｍｌ－１，相对生物利用度为（１１７．０±８．９）％；多剂量给药达稳态后，本品的峰浓度为（７０．７２±４．６１）ｎｇ·ｍｌ－１，血药浓度波动度为（１２１．６±１１．４）％，相对生物利用度为（１１７．９±２３．４６）％。结论：法莫替丁缓释片与市售普通片基本生物等效。

OBJECTIVE: The bioavailability of famotidine sustainedrelease tablets was studied in 16 healthy volunteers. METHODS:BZThe famotidine plasma levels were determined by HPLC method,and the plasma leveltime data were proessed by 3P87 pharmacokinetics procedure. RESULTS: The results showed that the peak plasma level occurring at(7.120.40)h was (58.694.30)ngml-1,and its relative bioavailability was (117.08.9)% after a single dose oral administration;The peak pasma level was (70.724.61)ngml-1,the fluctuating degree (FD) was (121.611.4)%,and its relative bioavailability was (117.923.46)% at steady state after multiple dose oral administration. CONCLUSION: The effect of the sustainedrelease tablets is basically equivalent to that of the normal tablets on marketing.