阿卡波糖片人体生物等效性研究现状  

Current status of bioequivalence of acarbose tablets

作　　者：刘文禹 黄洁[1,3] 裴奇 杨双[1] 阳国平[1,2,3] LIU Wen-yu;HUANG Jie;PEI Qi;YANG Shuang;YANG Guo-ping(Center of Clinical Pharmacology,the Third Xiangya Hospital of Central South University,Changsha 410013;Xiangya School of Pharmaceutical Sciences,Central South University,Changsha 410013;Hunan Engineering Research Center for Optimization of drug formulation and early,Changsha 410013,China)

机构地区：[1]中南大学湘雅三医院临床药理中心,长沙410013 [2]中南大学湘雅药学院,长沙410013 [3]湖南省药物制剂优化与早期临床评价工程技术研究中心,长沙410013

出　　处：《中国临床药理学杂志》2018年第16期2015-2017,2021,共4页The Chinese Journal of Clinical Pharmacology

基　　金：湖南省科技计划基金资助项目(2015TP2005)

摘　　要：阿卡波糖片是治疗Ⅱ型糖尿病的常用药物,因其血药浓度与其临床主要疗效无直接关系,同时作用机制也比较特殊,所以传统的以药动学参数为终点评价指标进行人体生物等效性试验无法评判其等效性,应该以药效动力学指标进行人体生物等效性研究。本文主要介绍了阿卡波糖片人体生物等效性研究的的相关指南及国内外研究现状,为其等效性评价提供参考。Acarbose is commonly used to treat type Ⅱ diabetes. Because its blood concentration is not directly related to the clinical efficacy,and the mechanism of action is also very special,the traditional bioequivalence trail with pharmacokinetic parameters as endpoints is not available. FDA recommends that bioequivalence should be established by conducting a study with pharmacodynamic endpoints. This review summarizes the guidance and current status of bioequivalence of acarbose,and hopes to provide a reference for its bioequivalence evaluation.

关 键 词：阿卡波糖片 生物等效性 药效学评价 

分 类 号：R97[医药卫生—药品]