食药物质安全性评估方法进展与展望

Progress and prospects of safety assessment methods of medicinal and food homologous substances

食药物质是指既是食品又是中药材的物质,在我国具有悠久的历史,是我国优秀传统文化和医药宝库的重要组成部分。我国食药物质以目录形式法治化管理有近40年的历史,目前已有100余种物质纳入我国食药物质目录。根据《按照传统既是食品又是中药材的物质目录管理规定》,安全性评估是申报食药物质目录的重要基础。食药物质安全性评估总体应遵循食品安全风险评估的原则和要求,但食药物质是一种复杂的混合物,开展安全性评估时,应综合考虑所评估对象的性质、数据充分性等,采取个案分析的原则并应用不同的评估模型和方法。随着大数据、人工智能、高通量高内涵体外测试、计算毒理等新一代技术的发展以及越来越多具有传统食用习惯且作为中药材使用的物质申报食药物质目录,风险评估的技术与方法也不断在食药物质、新食品原料以及地方特色食品的管理中应用,并发挥了重要的科学作用。该文就食药物质安全性评估的方法、面临的问题与挑战以及未来发展趋势等方面进行系统综述。

Food and medicinal substances(FAMS)with both edible and medicinal uses have a long history in China,being an important part of China′s excellent traditional culture and traditional Chinese medicine(TCM).The legal management of FAMS is in the form of catalogue,which has a history of nearly 40 years.More than 100 substances have been included in the China′s FAMS catalogue.According to the Regulation of Food and Medicinal Substances Catalogue,safety assessment is a basis for substances to be included in the catalogue.The safety assessment of FAMS should follow the principles and requirements of food safety risk assessment.However,FAMS is a complex mixture,and the nature and data adequacy of the assessed substance should be comprehensively considered.Different evaluation models and methods should be selected according to the principle of case analysis.With the development of next-generation technologies such as big data,artificial intelligence,high-throughput and high-content in vitro testing,and computational toxicology and the trend of increasing edible substances with medicinal effects applying for the inclusion in the China′s FAMS catalogue,the methods of risk assessment are applied in the management of FAMS,novel food products,and local characteristic food products,playing a scientific role.This paper systematically reviews the methods,challenges,and prospects of safety assessment of FAMS.