中药复方新药研发中的药代动力学研究方法学  

Pharmacokinetic study methodology in compound Chinese drug development

作　　者：毕京峰[1] 阎博华[2] 段锋[1] 魏振满[1] 许文涛[1] 谭钧元[1] 朱珍真[1] 陈本超[1] 

机构地区：[1]中国人民解放军第302医院新药临床试验中心,北京100039 [2]四川省中医医院国家药物临床试验机构,成都610075

出　　处：《中国临床药理学杂志》2015年第16期1671-1673,1691,共4页The Chinese Journal of Clinical Pharmacology

基　　金：国家"十二五"科技重大专项课题基金资助项目(2010ZX100510-002-002)

摘　　要：本文结合药代动力学的研究目标对当前中药复方药代动力学研究方法进行了论证,发现基于少数有效成分的经典药代动力学研究方法往往不能代表复方中药的真实效应,而药物累积法、药理效应法、血清药理法及基于权重的多效应成分分类整合法均是基于药效学研究进行药代动力学反推,可能无法反应体内真实的药代动力学过程。应用药效学标示物进行药效学研究,其结果将更有临床应用价值。This study discussed whether the current pharmacokinetic study method of compound Chinese medicine could meet its research objectives in drug development process. The conclusion were that,firstly,because the single or multiple active ingredient often do not represent the true effect of compound Chinese medicine,its findings may be biased.Secondly,drug accumulation method,pharmacological effect method,serum pharmacological method and integration of multi- effect component classifier method often draw pharmacokinetic results by pharmacodynamic study with thrust reversers method,but these methods can not accurately reflect the true pharmacokinetics in vivo. It might be more clinical value to make pharmacodynamic studies with pharmacodynamic markers.

关 键 词：药代动力学 复方中药 再评价 

分 类 号：R969.1[医药卫生—药理学] R932[医药卫生—药学]