中医药在人类健康中发挥重要的作用，然而，近年来中药不良反应事件时有发生，如何科学的回答中药安全性问题需要一套有效的研究方案。基于数学模型和定量药理学研究思路，提出中药风险评估的新策略，即中药定量毒理学。中药定量毒理学基于风险评估、风险控制以及毒理学实验方法与定量药理学研究方法之间的相似性，对致毒关键要素、毒性物质及毒性机制进行系统评价，建立数学模型，为药品监管及临床应用提供可推广、可复制的中药质量评控体系及安全用药方案。中药定量毒理学基于现代中药毒性认知，将为中药安全性和风险防控对策提供重要的理论指导，为中医药健康可持续发展提供科学护航。

Traditional Chinese medicine (TCM) plays an important role in human health. However, the frequent occurrence of adverse reactions in TCM in recent years has often made it difficult to give scientific answers to the safety issues of TCM and requires an effective research program. In this paper, a new strategy for risk assessment of TCM was proposed based on mathematical models and quantitative pharmacology research ideas, namely quantitative toxicology of TCM. Quantitative toxicology of TCM is based on risk assessment, risk control and the similarity between toxicology test methods and quantitative pharmacology research methods, and the systematic evaluation of key elements of toxicity, toxic substances and toxicity mechanisms, and the establishment of mathematical models to provide a generalizable and replicable TCM for drug regulation and clinical application. The quality assessment and control system and safe drug use program can be replicated for drug regulation and clinical application. The quantitative toxicology of TCM is based on the modern toxicity cognition of TCM, which will provide important theoretical guidance for the safety and risk prevention and control measures of TCM, and provide scientific escort for the healthy and sustainable development of TCM.

R285.53

国家自然科学基金资助项目(81873194)；国家中医药管理局青年歧黄学者支持项目；中国科学院大学宁波生命与健康产业研究院合作项目(2020YJY0224)