药用辅料对CYP3A活性的影响及其对仿制药质量和疗效一致性评价的指导作用  

Effects of pharmaceutical excipients on CYP3A activity and its guiding effects on quality and efficacy consistency evaluation of generic drugs

作　　者：陈思雨 陈露露 王欣桐 李晓晖 余鹏 欧阳冬生 CHEN Siyu;CHEN Lulu;WANG Xintong;LI Xiaohui;YU Peng;OUYANG Dongsheng(Changsha DUXACT Co.,Ltd.,Changsha 410000,Hunan,China;Hunan Key Laboratory for Bioanalysis of Complex Matrix Samples,Changsha,410000,Hunan,China;Department of Clinical Pharmacology,Xiangya Hospital,Central South University,Changsha 410000,Hunan,China)

机构地区：[1]长沙都正生物科技有限责任公司,湖南长沙410000 [2]复杂基质样本生物分析湖南省重点实验室,湖南长沙410000 [3]中南大学湘雅医院临床药理研究所,湖南长沙410000

出　　处：《中国临床药理学与治疗学》2020年第4期460-466,共7页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：国家科技重大专项基于药物基因组学的示范性新药临床评价技术平台建设(2017ZX090361);复杂基质样本生物分析湖南省重点实验室(2017TP1037);药物临床评价关键技术创新及应用示范(2019SK2241);基于信息化平台与智能计算的药物评价创新技术开发与应用(2019GK5020);湖南省复杂基质样本生物分析国际科技创新合作基地(2019CB1014)。

摘　　要：药物制剂的处方和工艺是保证药物质量和疗效的基础,药用辅料是药物制剂处方的重要组成部分。部分药用辅料可影响CYP3A的活性,继而可能影响其底物在体内的代谢和生物利用度。在中国和美国,相对生物利用度是仿制药研究的关键内容。我国正在推进仿制药质量和疗效一致性评价。因此,了解药用辅料对CYP3A的影响及其对一致性评价的指导作用具有十分重要的现实意义。The prescription and technology of pharmaceutical preparations are the basis for ensuring the quality and efficacy of medicines.Pharmaceutical excipients are important part of pharmaceutical preparations.As it’s known to all that some pharmaceutical excipients can affect the activity of CYP3A,and then may influence the metabolism and bioavailability of its substrates in vivo.Relative bioavailability is a key element of generic drug research in China and the United States.Our country is advancing the quality and efficacy consistency evaluation of generic drugs.Therefore,it is of great practical significance to understand the impact of pharmaceutical excipients on CYP3A and its guiding role in consistency evaluation.

关 键 词：药用辅料 CYP3A 一致性评价 

分 类 号：R969[医药卫生—药理学]