中药上市后人体群体药代动力学试验设计要点  

Key elements of design about PPK of Chinese medicine after marketing

作　　者：王建农[1] 姜俊杰[2] 谢雁鸣[2] 

机构地区：[1]中国中医科学院西苑医院,北京100091 [2]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中国中药杂志》2011年第20期2871-2873,共3页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2009ZX09502-030);中国中医科学院自主选题研究项目(Z0133)

摘　　要：中药人体群体药代动力学(population pharmacokinetics,PPK)是定量考察患者群体中药物浓度决定因素的一门学科。进行合理的中药PPK试验设计可为临床用药提供真实客观的数据,进而促进临床个体化用药方案的制订。该文参考历年文献,并结合实际工作经验,针对中药人体PPK试验设计的要点进行总结,主要包括研究对象的选择、指标的选取、样本采集方案设计、血液样本分析方案设计、数据分析方案设计。PPK is a discipline that quantitative investigates the determinants of drug concentration in patient groups. Developing reasonable PPK design of experiment can provides the real objective data for clinical medicationand then promotes the formulating of clinical individualized medication regimens. This paper referenced over all years literatures, and combined with practical work experience. Summarizes of the main points of PPK design of experiment focused on traditional Chinese medicine. The content mainly included choosing research objects, selecting items, designing sample collection steps, blood sample analysis experiments and data analysis schemes.

关 键 词：中药人体群体药代动力学 试验设计 

分 类 号：R285[医药卫生—中药学]