中国药物评价2023，Vol.40Issue(6)：457-469,13.
中药新药的药代研究
Pharmacokinetic Research on Investigational Chinese Herbal Medicines
摘要
Abstract
Pharmacokinetic research plays a crucial role in advancing the modernization of Chinese herbal medicines.The Chinese Na-tional Medical Products Administration(NMPA)actively promotes the integration of pharmacokinetics research in the development of new herbal medicines.However,in order to effectively conduct pharmacokinetic research on investigational herbal medicines,further technical refinements are needed.These refinements must take into consideration the specific Chinese registration requirements for herbal medi-cines,as well as the unique characteristics of these medicines.In this Review,we explore the field of pharmacokinetics research on inves-tigational herbal medicines from three perspectives.Firstly,we examine the Chinese registration requirements for herbal medicines,as well as herbal-medicine-related recommendations that are outlined in the NMPA's pharmacokinetic and drug-drug interaction research guidelines.Secondly,we provide a description of the methodologies used to conduct pharmacokinetic research on herbal medicines,ac-companied by relevant study examples.Lastly,we discuss how to conduct pharmacokinetic research in a rational manner during the devel-opment of new herbal medicines.Significant progress has been made in the theory,methodologies,techniques,and applications of phar-macokinetics for Chinese herbal medicines.The progress made in resolving the technical challenges associated with conducting pharmaco-kinetic research on complex herbal medicines has established a solid foundation for pharmacokinetic research that supports the development of new herbal medicines,particularly those prepared from combinations of multiple herbs.In order to expedite the development of new herbal medicines,there is an urgent need to formulate comprehensive guidelines for pharmacokinetic research and drug interaction re-search that are specifically applicable to investigational herbal medicines.This will greatly improve the technical standards in development of new herbal medicines and enable Chinese standards to contribute to the International Council for Harmonisation of Technical Require-ments for Pharmaceuticals for Human Use(ICH).关键词
药代动力学/药代性质药物相互作用/中药新药/中药注册Key words
Pharmacokinetics/Pharmacokinetic drug-drug interaction/Investigational Chinese herbal medicines/Registration of Chi-nese herbal medicines分类
医药卫生引用本文复制引用
李川,杨军令,程晨,贾伟伟..中药新药的药代研究[J].中国药物评价,2023,40(6):457-469,13.基金项目
国家自然科学基金资助项目(82192912) （82192912）
中医药创新团队及人才支持计划项目(ZYYCXTD-C-202009) （ZYYCXTD-C-202009）
