National Institutes for Food and Drug Control, Beijing 100050, China; National Key Laboratory of Medicine Regulatory Science, China.
Chinese Pharmacopeia Commission, Beijing 100061, China; National Key Laboratory of Medicine Regulatory Science, China.
Pharmacol Res. 2024 Oct;208:107388. doi: 10.1016/j.phrs.2024.107388. Epub 2024 Sep 5.
Scientific risk assessment of exogenous and endogenous toxic substances in traditional Chinese medicine (TCM) is of great significance. The present review comprises a comprehensive summary of progress in the health risk assessment of harmful exogenous substances in TCMs. Such substances include heavy metals, pesticide residues, biotoxins, and endogenous toxic components involving pyrrolizidine alkaloids. The review also discusses the strengths and weaknesses of various bioaccessibility and bioavailability models, and their applications in risk assessment. Future avenues of risk assessment research are highlighted, including further exploration of risk assessment parameters, innovation of bioaccessibility and bioavailability techniques, enhancement of probabilistic risk assessment combined with bioavailability, improvement of cumulative risk assessment strategies, and formulation of strategies for reducing relative bioavailability (RBA) values in TCMs. Such efforts represent an attempt to develop a risk assessment system that is capable of evaluating the exogenous and endogenous toxic substances in TCMs to ensure its safe use in clinics, and to promote the sustainable development of the TCM industry.
科学评估中药（TCM）中外源和内源性有毒物质具有重要意义。本综述全面总结了 TCM 中有害外源物质健康风险评估的研究进展。这些物质包括重金属、农药残留、生物毒素和内源性有毒成分，如吡咯里西啶生物碱。本文还讨论了各种生物利用度和生物可及性模型的优缺点及其在风险评估中的应用。此外，还强调了风险评估研究的未来方向，包括进一步探索风险评估参数、创新生物利用度和生物可及性技术、增强结合生物利用度的概率风险评估、改进累积风险评估策略以及制定降低 TCM 中相对生物利用度（RBA）值的策略。这些努力旨在开发一种风险评估系统，能够评估 TCM 中的外源和内源性有毒物质，以确保其在临床中的安全使用，并促进 TCM 产业的可持续发展。
