Pharmacokinetics of two components in felodipine-enalapril sustained-release tablets in Chinese healthy volunteers  

非洛地平-依那普利缓释片在健康中国人中的药代动力学研究（英文）

作　　者：吕伊莎 冉黎灵[1] 吴蔚[1] 李三望 周瑞[1] 唐芳[1] 余鹏[1] 牟玲丽[2] 程泽能[1] 

机构地区：[1]中南大学药学院,湖南长沙410013 [2]湖南师范大学医学院,湖南长沙410006

出　　处：《Journal of Chinese Pharmaceutical Sciences》2015年第7期427-432,共6页中国药学（英文版）

基　　金：National Natural Science Foundation of China(Grant No.81102499);supported by Hunan Science and Technology Project(Grant No.2011SK3261,Changsha,China)

摘　　要：To compare the pharmacokinetics properties of enalapril-felodipine sustained-release tablet with enalapril and felodipine in the two reference formulations in Chinese healthy volunteers, the study was designed to a randomized, open label, crossover and two treatment pharmacokinetic study using enalapril-felodipine sustatined-release tablet as the test formulation. A total of 12 individuals were randomly assigned to 2 gorups （6 individuals in each group）. The wash-out period was 14 d. Compared with the reference formulations, felodipine in the sustained-release tablet showed significantly sustained-release characteristics, while the pharmacokinetics processes of enalapril and its active metabolite enalaprilat were basically similar in Chinese healthy volunteers.本文通过比较国产复方非洛地平缓释片试验制剂与同时服用非洛地平片和马来酸依那普利片两种参比制剂的药代动力学特征,采用开放、随机、自身交叉试验设计,筛选12位健康男性受试者,随机分为2组,每组6人,周期间的洗脱期为14天。我们发现与普通片剂相比,复方非洛地平缓释片中非洛地平成分具有明显的缓释特征,而另一成分依那普利及其活性代谢产物依那普利拉则无缓释效果。

关 键 词：FELODIPINE ENALAPRIL ENALAPRILAT PHARMACOKINETICS 

分 类 号：R969.1[医药卫生—药理学]