国产吗氯贝胺在健康志愿者体内生物利用度研究  

Study on the relative bioavailability of moclobemide tablets in healthy volunteers

作　　者：孙培红[1] 李荣[1] 崔一民[1] 孙忠民[1] 

机构地区：[1]北京医科大学第一临床医院

出　　处：《中国药学杂志》1998年第6期354-356,共3页Chinese Pharmaceutical Journal

摘　　要：目的：研究国产吗氯贝胺片剂与进口同种产品的生物利用度及其药动学特征。方法：健康志愿者１２人，随机、交叉、单剂量ｐｏ３００ｍｇ吗氯贝胺片剂，采用反相高效液相色谱法，测定不同时间血药浓度，用３Ｐ８７程序处理数据。结果：国产药品的ｃｍａｘ，ｔ１／２和ＡＵＣ分别为（１．４９９±０．４５３）μｇ·ｍｌ－１，（３．３５９±１．３１５）ｈ，（９．４６０±２．４９２）ｈ·μｇ·ｍｌ－１。结论：国产品与进口品比较，高峰血药浓度，达峰时间虽有显著性差异（Ｐ＜０．０５），但曲线下面积经统计学分析无显著性差异（Ｐ＞０．０５），其相对生物利用度为９２．０７％。ｐｏ该药２４ｈ尿排出原型药物为给药量的１．１９％。OBJECTIVE: Pharmacokinetics and bioavailability of domestic and imported moclobemide tablets were compared in 12 healthy volunteers after single dose oral administration. METHOD: The blood levels of moclobemide were determined by RP HPLC. The 3P87 program was used for the calculation of pharmacokinetic parameters. RESULTS: The c max , t 1/2 , and AUC of the domestic product was (1.499±0.453)μg·ml -1 , (3.359±1.315)h, and (9.460± 2.492 )h·μ·ml -1 , respectively. CONCLUSIONS: The statistical analyss for the AUC showed that there was no significant difference (P>0.05) between the two products. The relative bioavailability of domestic moclobemide tablet was 92.07% . The urine cumulative excretion of the domestic product was 1.19%.

关 键 词：吗氯贝胺 生物利用度 高效液相色谱 

分 类 号：R969.1[医药卫生—药理学]