中国药物警戒 ›› 2026, Vol. 23 ›› Issue (2): 174-180.
DOI: 10.19803/j.1672-8629.20250907

• 安全与合理用药 • 上一篇    下一篇

中药中元素形态价态研究关键技术探讨

李耀磊1,2, 程显隆1,2, 林永强1,2, 刘静1,2#, 魏锋1,2,*   

  1. 1中国食品药品检定研究院中药民族药检定所,北京 102629;
    2药品监管科学全国重点实验室,北京 102629
  • 收稿日期:2025-12-15 出版日期:2026-02-15 发布日期:2026-02-13
  • 通讯作者: *魏锋,男,博士,研究员,中药整体质量评价研究。E-mail: weifeng@nifdc.org.cn; #为共同通信作者。
  • 作者简介:李耀磊,男,博士,助理研究员,中药整体质量评价研究。
  • 基金资助:
    国家自然科学基金资助项目(82404856); 药品监管科学全国重点实验室课题(2025SKLDRS0343)

Key Technologies for Research on Speciation and Valence of Elements in Traditional Chinese Medicine

LI Yaolei1,2, CHENG Xianlong1,2, LIN Yongqiang1,2, LIU Jing1,2#, WEI Feng1,2,*   

  1. 1Institute for Control of Chinese Traditional Medicine and Ethnic Medicine, National Institutes for Food and Drug Control, Beijing 102629, China;
    2State Key Laboratory of Drug Regulatory Science, Beijing 102629, China
  • Received:2025-12-15 Online:2026-02-15 Published:2026-02-13

摘要: 目的 探讨中药中元素形态价态分析的关键技术,为中药外源性有害物质的风险评估与监管提供理论依据与方法参考。方法 结合本课题组及国内外相关研究,以高污染中药品种为切入点,剖析砷、汞、硒等元素形态价态的提取、分离、检测等关键流程的技术要点,并探讨未知结合形态表征策略及该领域面临的方法学挑战。结果 形态价态分析是准确评估中药元素安全性与生物有效性的关键。矿物、植物、动物、菌类中部分高风险中药的元素形态价态暴露研究备受关注,现有研究已建立符合砷、汞、硒等元素特性的酸提、酶提、溶剂萃取等多种提取方法,可有效降低形态转化。通过高效液相色谱/离子色谱与电感耦合等离子体质谱等联用技术,实现对元素无机态、有机态的高灵敏度同步分析;在未知结合态方面,高分辨质谱等技术助力元素与中药有机组分结合形态鉴定。复杂基质干扰、体内外生物有效性关联较弱、标准制定与实践转化不足等问题仍是当前主要挑战。结论 中药中有害元素形态价态研究技术的探索与应用,为中药无机污染物风险防控与科学监管提供新技术、新方法与新工具。

关键词: 中药, 有害元素, 形态价态, 电感耦合等离子体质谱, 高效液相色谱, 仿生提取

Abstract: Objective To explore the key technologies for speciation and valence analysis of elements in traditional Chinese medicine (TCM) in order to provide data for risk assessment and regulation of exogenous harmful substances in TCM. Methods Based on research by our group and related studies worldwide, this study focused on TCM varieties with high risks of pollution. Key technologies for such processes as extraction, separation, and detection related to the speciation and valence of such elements as arsenic, mercury, and selenium were summarized. Strategies for characterizing unknown binding forms and methodological challenges to this field were also discussed. Results Speciation and valence analysis was critical to accurate evaluation of the safety and biological effectiveness of elements in TCM. Studies on the exposure of element speciation and valence in high-risk TCM categories, such as minerals, plants, animals, and fungi, attracted much attention. There were various extraction methods available, including acid extraction, enzyme extraction, and solvent extraction, tailored to the matrix characteristics of arsenic, mercury, and selenium, which could effectively minimize species transformation. The combination of high-performance liquid chromatography/ion chromatography with inductively coupled plasma mass spectrometry enabled highly sensitive and simultaneous analysis of inorganic and organic forms of elements. For unknown binding forms, high-resolution mass spectrometry and other technologies could help identify the binding forms of elements with organic components in TCM. However, challenges persisted, including interference from complex matrices, weak correlations between in vitro and in vivo bioavailability, and insufficient standardization and practical applications. Conclusion The exploration and application of technologies for studying the speciation and valence of harmful elements in TCM can inspire new technologies, methods and tools for risk prevention and control, and for effective regulation of inorganic pollutants in TCM.

Key words: Traditional Chinese Medicine, Harmful Elements, Speciation and Valence, Inductively Coupled Plasma Mass Spectrometry, High-performance Liquid Chromatography, Biomimetic Extraction

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