暴露评估在中药危害物质限量标准中的方法、应用及展望

Methodology,Application and Prospect of Exposure Assessment in the Quality Limit Standard of Chinese Medicine Hazards

中药“安全、有效、质量可控”是我国中医药发展的基石。然而,其内外源性危害物的存在不仅影响了中药的质量和药效,更可能给人们的用药安全带来隐患,阻碍中医药(TCM)的高质量发展。因此探究确保中药质量与安全性的有效方法对中药临床合理用药具有重要意义。暴露评估作为一种定性定量评估危害因子的方法,近年来已逐渐用于制定合理的中药危害物限量标准。为此,该文重点综述了暴露评估用于中药危害物评估的各种方法及其在中药领域中的应用,并针对我国中药危害物暴露评估体系中存在的问题提出合理建议。以期提供适合于我国中药的暴露评估模型,并为我国制定与修改中药危害物限量标准和相关安全检测提供科学的参考和指导。

Chinese medicine is“safe,effective and quality-controlled”,which is the cornerstone of the development of Chinese medicine in China.However,the existence of endogenous and exoge-nous hazards not only affects the quality and efficacy of traditional chinese medic(TCM),but also may bring hidden danger to people’s medication safety and hinder the high-quality development of TCM.Therefore,it is important to explore effective methods to ensure the quality and safety of TCM for the rational clinical use of TCM.Exposure assessment,as a method for qualitative and quantita-tive assessment of hazard factors,has been gradually used to develop reasonable hazard limits for TCM in recent years.To this end,this paper focuses on reviewing various methods of exposure as-sessment for the assessment of TCM hazards and their applications in the field of TCM,and puts for-ward reasonable suggestions for the problems of the TCM hazard exposure assessment system in Chi-na.In order to provide a suitable exposure assessment model for TCM in China,and to provide sci-entific reference and guidance for the development and modification of TCM hazard limits and related safety testing in China.