摘要
中药重金属及有害元素污染问题是阻碍中医药国际化的主要问题之一,其污染来源复杂,影响广泛。目前,主要发达国家已把元素残留纳入药品风险评估,以保证药品质量安全,但我国风险评估技术体系仍处于起步阶段。近年来,我国开始致力于完善中药风险评估技术体系,国内外有关中药中重金属及有害元素风险评估的研究多有报道,旨在评估中药质量安全,推进中医药向国际接轨。基于此,该研究通过整合近年来的研究报道,对比主要发达国家药典标准,梳理不同药品在危害识别、危害特征、评估方法等方面的异同点,探讨中药风险评估技术体系可能存在的问题和发展方向,为完善中药元素限量标准,健全中药风险评估技术体系,最终为提升我国中药产品的国际竞争力提供有力支持。
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.
作者
黎晓欣
路浚齐
李琼霞
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)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2024年第17期4630-4636,共7页
China Journal of Chinese Materia Medica
基金
广州市中医药和中西医结合科技项目(20242A011024)。
关键词
风险评估
重金属及有害元素
中药
risk assessment
heavy metals and harmful elements
traditional Chinese medicine
