中药定量药理学的研究实践与思考  

Research practice and thinking of pharmacometrics of traditional Chinese medicine

作　　者：褚扬 王相阳 乔淼 付爽 莫红梅 王根辈 马晓慧 CHU Yang;WANG Xiangyang;QIAO Miao;FU Shuang;MO Hongmei;WANG Genbei;MA Xiaohui(Tasly Pharmaceutical Group Co.,Ltd.,Tianjin 300410,China;National Key Laboratory of Chinese Medicine Modernization,Tianjin 300193,China)

机构地区：[1]天士力医药集团股份有限公司,天津300410 [2]现代中药创制全国重点实验室,天津300193

出　　处：《中草药》2024年第13期4287-4298,共12页Chinese Traditional and Herbal Drugs

基　　金：国家重点研发计划“中医药现代化”重点专项资助项目(2022YFC3502000)。

摘　　要：定量药理学是一门运用数理统计方法定量表征药理作用规律的交叉学科,可通过建模与模拟技术预测药物的药动学、药效学及疾病机制和实验进程等,在化学药/生物药的创新研发中已体现出良好的应用价值。近年来,国内外研究者对于定量药理技术在中药领域的应用也做了有益的尝试,但由于成分复杂、物质基础不明确等原因,中药定量药理学的技术难度较大,仍处于实验探索阶段。通过结合近年来定量药理技术在中药研发中的研究实践,论述了相关模型的特点和适用场景,同时根据中药多组分、多靶点、协同起效、多相代谢等固有特征,认为基于“药代成分群-生物标志物群相关性”的多维整合研究思路是符合中医药特色的研发模式,有助于实现中药的量-时-毒/效数智化创新。为认识定量药理技术在中药研发中的价值,理解中药定量药理研究的特点提供依据,同时为中药新药研发技术指南的制定提供参考。Quantitative pharmacology is an interdisciplinary that uses mathematical statistics to quantitatively characterize pharmacological effects.It can predict the pharmacokinetics,pharmacodynamics,disease mechanism and clinical trial process of drugs through modeling and simulation technology,and has shown good application value in the innovative research and development(R&D)of chemical drugs and biological drugs.In recent years,domestic and foreign scholars have made beneficial attempts on the application of quantitative pharmacological technology in the field of traditional Chinese medicine(TCM).However,due to the complex composition and unclear material basis,the technical difficulty of pharmacometrics of TCM is relatively large,and it is still in the stage of experimental exploration.Based on the research practice of quantitative pharmacological technology in TCM R&D over recent years,the characteristics and application scenarios of relevant models were discussed in this paper.At the same time,according to the inherent characteristics of TCM such as multi-component,multi-target,synergistic effect and multiphase metabolism,the author considers that the multi-dimensional integration research idea based on the correlation between pharmacokinetic component group and biomarker group is a R&D model that conforms to the characteristics of TCM,and is helpful to realize the digital&intelligent innovation of dose-time-toxicity/efficacy of TCM.It provides a basis for understanding the value of quantitative pharmacological technology in the R&D of TCM,understanding the characteristics of quantitative pharmacological research of TCM,and provides reference for the formulation of technical guidelines for the research and development of new TCM.

关 键 词：定量药理学 建模与模拟 中药药动学 中药数智化 药代成分群-生物标志物群相关性 

分 类 号：R285[医药卫生—中药学]