由于中药成分的复杂性和药效物质基础的不确定性，其给药剂量和用药次数的确定仍缺乏验证性指导，中药成分之间相互作用机制和中药制剂一致性评价的阐释也进展缓慢。目前，中药药动学的研究不作为中药新药研发和临床实施给药方案的必备项，导致方剂中药效物质在体内的运行规律未能得到全面阐释，整体与单一成分的血药浓度变化规律与其产生不良反应之间的关联性也缺乏科学的揭示，更是中药缓控释制剂和靶向制剂等新型制剂没有取得突破的直接原因。为了说明中药及其方剂药动学的重要性和迫切性，通过“中国知网”“PubMed”“国家自然科学基金委员会”等平台搜索“中药方剂”“药动学”“毒代动力学”等关键词，对国内外中药及其方剂药动学的发展历程进行综述和展望，揭示其发展规律，期望为中药药动学学科的快速发展和合理应用奠定良好基础。

Due to the complexity of traditional Chinese medicine (TCM) components and the uncertainty of their pharmacodynamic substance basis, there is still a lack of validated guidelines for determining dosages and administration frequencies. The understanding of interaction mechanisms between TCM components and the consistency evaluation of TCM formulations have also progressed slowly. Currently, pharmacokinetics studies of TCM are not considered essential for the development of new TCM drugs and the implementation of clinical dosing regimens. This has led to an incomplete understanding of the in vivo behavior of pharmacologically active substances in TCM prescriptions, as well as a lack of scientific elucidation on the correlation between blood concentration changes of whole formulations versus individual components and their adverse effects. It is also a direct reason why advanced formulations like sustained-release and targeted delivery systems have not made breakthroughs. To illustrate the importance and urgency of TCM pharmacokinetics, this paper conducts a review and outlook through platforms like “China National Knowledge Infrastructure” “PubMed” and “National Natural Science Foundation of China” by searching keywords such as “traditional Chinese medicine formula”, “pharmacokinetics” and “toxickinetics”. The aim is to reveal the development patterns of TCM and its prescription pharmacokinetics both domestically and internationally, thereby laying a solid foundation for the rapid development and rational application of the discipline.

R28

福建省高校产学合作项目（2021Y4016）；技术创新重点攻关及产业化项目（2023XQ014）