摘要
目的 :评价法莫替丁分散片的生物等效性。方法 :采用反相高效液相色谱法 (RP HPLC)测定 1 0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后 ,血药浓度变化情况。结果 :经 3p87药动学程序处理 ,药时曲线下面积分别为 (1 0 75 .37± 2 2 6 .0 7)ng·h·ml 1 与 (1 1 1 3 .87± 2 69.87)ng·h·ml 1 ,达峰时间分别为 (2 .35± 0 .2 4 )h与 (2 .45± 0 .1 6)h ,峰浓度分别为 (1 86 .1 3± 48.34)ng·ml 1 与 (1 64 .74± 35 .0 0 )ng·ml 1 。结论 :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 .0 5) ,法莫替丁分散片供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该分散片的相对生物利用度为 97.49%±9.40 %
OBJECTIVE:The pharmacokinetics and relative bioavailability of two Famotidine preparations—dispersible tablet and reference tablet were studied. METHODS:Famotidine concentrations in 10 volunteers plasma were determined after a single oral dose of two famotidine preparations were given respectively to 10 volunteers in an open randomized cross over test. Famotidine concentrations in plasma were assayed by RP HPLC method. RESULTS: After taking a single oral dose of 40 mg two famotidine preparations,the AUC 0→∞ of famotidine dispersible tablet and tablet were (1075.37±226.07)ng·h·ml -1 and (1113.87±269.87)ng·h·ml -1 ; T max were (2.35±0.24)h and (2.45±0.16)h;C max were (186.13±48.34)ng·ml -1 and (164.74±35.00)ng·ml 1 respectively. CONCLUSION:The result of statistics analysis showed that there were no significant difference of the AUC 0→∞ 、T max and C max of famotidine between the two formations(P>0.05) and the two famotidine preparations were bioequivalent
出处
《华西药学杂志》
CAS
CSCD
北大核心
2000年第4期262-264,共3页
West China Journal of Pharmaceutical Sciences
关键词
法莫替丁
分散片
药动学
生物等效性
Famotidine
Dispersible tablet, Pharmacokinetics,Bioequivalent
