Li Xiao-Xin, Lu Jun-Qi, Li Qiong-Xia
Yuexiu District Center for Food and Drug Inspecting and Testing Guangzhou 510055, China Yuexiu District Center for Disease Control and Prevention Guangzhou 510055, China.
Zhongguo Zhong Yao Za Zhi. 2024 Sep;49(17):4630-4636. doi: 10.19540/j.cnki.cjcmm.20240701.602.
The pollution of heavy metals and harmful elements in traditional Chinese medicine is one of the main problems that hinder the internationalization of traditional Chinese medicine. At present, major developed countries have incorporated elemental residues into drug risk assessment to ensure drug quality and safety, while China's drug risk assessment system is still in its infancy. In recent years, China has made efforts to improve the risk assessment system of traditional Chinese medicine. Researchers have reported the risk assessment of heavy metals and harmful elements in traditional Chinese medicine, aiming to evaluate the quality and safety of traditional Chinese medicine and promote the integration of traditional Chinese medicine with international standards. This study reviews the research reports in recent years, compares the pharmacopoeia standards of major developed countries, pinpoints the similarities and differences between different drugs in terms of hazard identification, hazard characteristics, and assessment methods, and discusses the possible problems and development directions of the risk assessment system of traditional Chinese medicine. This review is expected to improve the limit standards of traditional Chinese medicine elements and the risk assessment system of traditional Chinese medicine, thus providing support for enhancing the international competitiveness of traditional Chinese medicine products.
中药中重金属和有害元素的污染是阻碍中药国际化的主要问题之一。目前,主要发达国家已将元素残留纳入药品风险评估以确保药品质量和安全,而中国的药品风险评估体系仍处于起步阶段。近年来,中国已努力完善中药风险评估体系。研究人员报告了中药中重金属和有害元素的风险评估,旨在评估中药的质量和安全性,并推动中药与国际标准接轨。本研究回顾了近年来的研究报告,比较了主要发达国家的药典标准,明确了不同药物在危害识别、危害特征和评估方法方面的异同,并探讨了中药风险评估体系可能存在的问题和发展方向。本综述有望提高中药元素限量标准和中药风险评估体系,从而为提升中药产品的国际竞争力提供支持。