中药新药的药代研究

Pharmacokinetic Research on Investigational Chinese Herbal Medicines

开展中药药代研究是实现中药现代化的需要,国家药政管理部门积极鼓励在中药新药研发中开展药代研究,然而如何结合注册要求和中药特点开展中药新药的药代研究尚需在技术上进一步细化。本文从三个方面讨论中药新药的药代研究:(1)中药注册申报要求及药物研究技术指导原则涉及的中药药代研究;(2)中药药代动力学方法及研究实例;(3)对中药新药药代研究的思考。当前中药药代动力学在理论、方法、技术、应用上已取得长足发展,基本解决了对中药这类复杂混合物药物开展药代研究的技术难题,为开展中药新药(特别是含多种活性成分的复方中药新药)的药代研究打下基础。围绕中药新药研发需求,迫切需要加紧制定专门针对中药新药的药代动力学研究技术指导原则及药物相互作用研究技术指导原则,这将进一步提升我国中药新药研发的技术水平,并向人用药品注册技术要求国际协调会(ICH)贡献中国标准。

Pharmacokinetic research plays a crucial role in advancing the modernization of Chinese herbal medicines.The Chinese National 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 medicines,as well as the unique characteristics of these medicines.In this Review,we explore the field of pharmacokinetics research on investigational 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,accompanied by relevant study examples.Lastly,we discuss how to conduct pharmacokinetic research in a rational manner during the development of new herbal medicines.Significant progress has been made in the theory,methodologies,techniques,and applications of pharmacokinetics for Chinese herbal medicines.The progress made in resolving the technical challenges associated with conducting pharmacokinetic 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 research 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 Requirements for Pharmaceuticals for Human Use(ICH).