中药质量标志物（quality markers，Q-Marker）的提出推动了中药质量控制从“化学表征”向“功能表征”的转变。附子Aconiti Lateralis Radix Praeparata为临床常用有毒中药，《中国药典》2025年版对其采用双酯型生物碱限量检查与单酯型生物碱含量测定相结合的质量控制模式，在保障临床安全用药方面发挥了重要作用，但在毒性指标覆盖范围与药效指标完整性方面仍有优化空间。以《中药质量标志物研究技术指南》为指导，系统梳理了附子的毒效物质基础与质量标准研究进展，从药效、毒性及药代动力学特征3个角度对附子潜在Q-Marker进行了总结，为附子质量标准的优化及临床安全有效用药提供参考。

The introduction of quality markers (Q-Marker) of traditional Chinese medicine has driven the shift of quality control of traditional Chinese medicine from “chemical characterization” to “functional characterization.” Aconiti Lateralis Radix Praeparata, a commonly used toxic herb, is quality-controlled by a model combining the limit test of diester-type alkaloids with the content determination of monoester-type alkaloids in the Chinese Pharmacopoeia (2025 edition). This model has played a significant role in ensuring clinical medication safety, while the coverage of toxicity indicators and the completeness of efficacy indicators remain to be improved. Guided by the Technical Guide for Research on Quality Markers of Traditional Chinese Medicine, this paper systematically reviews the toxic-effect material basis and quality standard research progress of Aconiti Lateralis Radix Praeparata, and summarizes the potential Q-Markers from the three perspectives of efficacy, toxicity, and pharmacokinetic characteristics, aiming to provide a reference for the optimization of Aconiti Lateralis Radix Praeparata quality standards and its safe and effective clinical application.

R282.6

国家重点研发计划“中医药现代化”重点专项（2023YFC3502803）；广州市重点研发计划项目（2024B03J1281）；中医药广东省实验室自主科技项目（HQCML-B-2024003，HQL2024PZ008）