中药含有的内源性有毒成分和外源性有害残留物已经成为威胁人体健康安全的危险因素，其严重制约了中药产业的可持续发展。风险评估是控制中药质量、保障用药安全的有效科学手段。通过具体剖析中药毒害物风险评估研究现状及问题，以解决关键性问题为切入点，总结国内外风险评估相关文献，提出了生理药代动力学（ physiologically based pharmacokinetic，PBPK）模型的实用性，重点阐述其在风险评估研究中用于组织内剂量预测、跨物种种间剂量外推、不同暴露途径及剂量药动学预测以及不同生命阶段或疾病人群药动学预测的功能优势和局限性，探讨PBPK模型在中药毒害物风险评估研究中的潜在利用价值，以期为中药安全性评价和限量标准制定提供技术参考及新策略。

Traditional Chinese medicine (TCM) containing endogenous toxic components and exogenous harmful residues has become a risk factor to threaten human health, which has seriously restricted the sustainable development of TCM industry. Risk assessment is an effective scientific method to prevent and control the quality of TCM, so as to ensure the safety of the medication. In this paper, through a specific analysis of research situations and problems of risk assessment of harmful substances in TCM, relevant research literature on risk assessment at home and abroad are summarized to solve the key issues and put forward the practicability of physiologically based pharmacokinetic (PBPK) model. It focuses on functional advantages and limitations in risk assessment studies, including prediction of tissue dosimetry and interspecific dosimetry extrapolation, pharmacokinetic prediction of different exposure routes and duration, as well as pharmacokinetic prediction in different life stages or pathological populations. Finally, the potential value of the PBPK model in the risk evaluation of toxic substances in TCM was briefly discussed, in order to provide technical reference and new strategies for the safety evaluation and the establishment of limited standards in TCM.

R285.61

国家自然科学基金面上项目(81873194);国家中医药管理局青年歧黄学者支持项目