中药的毒性与四气五味、升降浮沉、归经同属药性理论范畴，共同构成指导中医临床用药的基本原则。然而，大毒药材成分复杂，其毒性成分与作用机制难以完全阐明；加之临床用药方案多样及个体差异显著，亦为相关研究带来诸多挑战。基于大毒药材的特性，系统梳理了《中国药典》2025年版所收录的大毒药材。通过本草典籍溯源与现代药理研究相结合的研究路径，从共性毒性成分与通路、毒-效双向规律及减毒存效策略等多维度进行深入分析，综述了现代分析检测技术在大毒药材质量控制中的应用现状，并对其可能存在的其他有毒物质及其风险管控策略进行了阐述，为促进大毒药材临床安全合理应用及加强毒性风险防控提供参考依据。

The toxicity of traditional Chinese medicines (TCMs), along with the four natures and five flavors, ascending, descending, floating, and sinking, and channel tropism, belongs to the category of pharmacological theory and together constitutes the fundamental principles guiding clinical TCM practices. However, the complex composition of highly toxic medicinal materials makes it difficult to fully elucidate their toxic components and mechanisms of action. Additionally, the diversity of clinical medication regimens and significant individual differences pose considerable challenges to related research. Based on the characteristics of highly toxic medicinal materials, this study systematically reviews the highly toxic medicinal materials included in the 2025 edition of the Chinese Pharmacopoeia. By integrating herbal textual research with modern pharmacological studies, this paper provides an in-depth analysis from multiple perspectives, including common toxic components and pathways, the bidirectional relationship between toxicity and efficacy, and strategies for reducing toxicity while preserving efficacy.Furthermore, it reviews the current application of modern analytical detection techniques in the quality control of these medicinal materials and discusses other potentially toxic substances in TCMs along with risk management strategies. This review aims to serve as a reference for promoting safe and rational clinical use of highly toxic medicinal materials and strengthening the prevention and control of toxicity risks.

R285

四川省中医药管理局科学技术专项（2024zd033）；四川省中医药管理局中医药科研专项（25ZDAZX012）