Potential Toxicity of Traditional Chinese Medicine and Its Scientific Regulation
10.13422/j.cnki.syfjx.20251629
- VernacularTitle:中药潜在毒性研究及其科学监管探讨
- Author:
Ting WANG
1
;
Can TU
1
;
Lin ZHANG
1
;
Zhaojuan GUO
1
Author Information
1. Beijing Research Institute of Chinese Medicine，National Medical Products Administration Key Laboratory Research and Evaluation of Traditional Chinese Medicine，Beijing International Science and Technology Cooperation Base for Traditional Chinese Medicine Hepatotoxicity and New Drug Research and Development，Beijing University of Chinese Medicine，Beijing 102401，China
- Publication Type:Journal Article
- Keywords:
potential toxicity of traditional Chinese medicine;
risk factor;
disease-syndrome combination animal model;
interspecies difference;
scientific regulation
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(3):1-9
- CountryChina
- Language:Chinese
-
Abstract:
In recent years， with the extensive application of traditional Chinese medicine （TCM） both domestically and internationally， safety concerns associated with TCM have been frequently reported. Notably， some TCM substances traditionally regarded as ''non-toxic'' have exhibited significant adverse reactions during clinical use， drawing substantial attention to TCM safety. This study first analyzed the risk factors contributing to the potential toxicity of TCM from perspectives such as drug properties， individual constitution， and clinical medication practices. Subsequently， it proposed research strategies and methodologies for investigating potential TCM toxicity： ① conduct studies under the guidance of TCM theory， adhering to the principle of diversity and unity. ② adopt an integrated research paradigm of ''originating from clinical practice-syndrome-based foundation-returning to clinical practice-serving supervision''. ③ implement a three-tier technical system of ''Mathematical modeling-high-throughput screening via liquid chromatography-mass spectrometry （LC-MS）-systems biology'' to systematically elucidate the causes， material basis， and mechanisms of toxicity. Finally， scientific regulatory recommendations for potential TCM toxicity are proposed： ① establish a multidimensional prevention and control system addressing drug properties， physical constitution factors， and clinical medication practices. ② address the impact of modern processing techniques on the safety of new TCM drugs. ③ strengthen the revision of standards for Chinese medicinal materials to ensure their safety. ④ account for disease-syndrome combination animal models and interspecies differences in safety assessment outcomes. This study aims to overcome critical challenges in TCM regulation by advancing evaluation through research and driving research through evaluation. By establishing a high-level scientific regulatory framework， it seeks to not only safeguard clinical medication safety but also propel the high-quality development of the TCM industry， thereby providing scientific support for the inheritance and innovative evolution of TCM.
