国产麦迪霉素胃溶片的药代动力学和生物利用度研究  

A PHARMACOKINETICS AND BIOAVAILABILITY STUDY OF MEDECAMYCIN IN HEALTHY VOLUNTEERS

作　　者：周文[1] 邹雄[1] 傅善基[1] 徐成伟[1] 

机构地区：[1]山东医科大学附属医院

出　　处：《山东医科大学学报》1998年第2期176-178,共3页Acta Academiae Medicinae Shandong

摘　　要：对国产和进口麦迪霉素的生物利用度进行了比较研究。１０名健康志愿者交叉口服单剂量国产和进口麦迪霉素胃溶片６００ｍｇ，应用ＨＰＬＣ法测定其血药浓度，并采用３Ｐ８７程序处理实验数据。结果表明，麦迪霉素口服吸收表现为一室开放模型；口服国产与进口麦迪霉素胃溶片的Ｃｍａｘ分别为０．１１９和０．１３９ｍｇ／Ｌ，Ｔｍａｘ分别为０．５０±０．４５和０．４５±０．３４ｈ，ＡＵＣ分别为０．２０１５和０．２０２１ｍｇ／（ｈ·Ｌ），经统计学处理，两者无显著差异（Ｐ＞０．０５），国产麦迪霉素胃溶片相对生物利用度为９８．７２％。A single oral dose of 600mg Medecamycin controlled and domestics were given to 10 healthy male volunteers in a randomized cross over study.The Medecamycin concentrations in serum were determined by high performance liquid chromatography.The data obtained were treated with 3P87 practical pharmacokinetical program.The results showed that the serum concentration time curves of the two tablets were fitted to a one compartment model with first order absorption.Pharmacokinetics parameters of domestics and controlled Medecamycin:Cmax are 0.119 and 0.139g/L,Tmax are 0.5±0.45 and 0.45 ±0.34h,AUC are 0.2015 and 0.2021 mg/(L·h) respectively.The relative bioavailability of Medecamycin domestics to controlled was 98.72%.The results suggested that both tablets of Medecamycin have bioequivalance.

关 键 词：麦迪霉素 药代动力学 生物利用度 胃溶片 HPLC 

分 类 号：R978.15[医药卫生—药品]