Chinese Journal of Pharmacovigilance ›› 2026, Vol. 23 ›› Issue (2): 174-180.
DOI: 10.19803/j.1672-8629.20250907

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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

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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