决明子类保健食品批准情况及其对食药物质产品研发和监管的启示  

Implications of Approval of Cassiae Semen-based Health Food Products for Development and Supervision of Substances with both Edible and Medicinal Values

作　　者：杜鹏 王丹 田纪祥[3] 王云[3] 孙明霞 陈广耀 DU Peng;WANG Dan;TIAN Jixiang;WANG Yun;SUN Mingxia;CHEN Guangyao(Center for Food Evaluation,State Administration for Market Regulation,Beijing 100070,China;China Nutrition and Health Food Association,Beijing 100028,China;Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]国家市场监督管理总局食品审评中心,北京100070 [2]中国营养保健食品协会,北京100028 [3]中国中医科学院中药研究所,北京100700

出　　处：《中国实验方剂学杂志》2024年第18期228-234,共7页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家市场监督管理总局科技计划项目(2022MK172)。

摘　　要：决明子是国家卫生行政管理部门发布的按照传统既是食品又是中药材的物质(简称食药物质),在我国保健食品领域应用广泛。该研究首先构建决明子类保健食品的信息数据库,分析功能声称、主要原料及剂型分布的共性规律,采用网络图和Apriori算法,对有助于维持血脂(胆固醇/甘油三酯)健康水平、有助于控制体内脂肪和有助于润肠通便3种高功能声称原料进行关联规则分析。其次,基于保健食品的定位和监管要求,结合近年来对决明子的相关研究进展,从安全性、功能声称及质量可控性等方面分析技术审评和产品研发面临的问题。最后,以点带面提出对食药物质类产品进行分类优化准入管理、创新传统养生类保健功能声称、加强质量体系建设及上市后评价管理信息公开等建议,以推动传承和发扬我国传统保健养生文化优势,助力“健康中国”战略。Cassiae Semen is a substance with both edible and medicinal uses approved by the National Health Administration,and it is widely used in health food products in China.In this study,an information database of Cassiae Semen-based health food products was constructed,and the common patterns of functional claims,major raw materials,and dosage forms were analyzed.The Apriori algorithm and network method were used to analyze the association rules of high-frequency ingredients with the three major functional claims:Maintaining blood lipid(cholesterol/triglyceride)level,controlling fat,and relaxing bowel.Secondly,based on the positioning and regulatory requirements of health food and the recent research progress in Cassiae Semen,this paper analyzed the problems in technology review and product development from safety,function claim,and quality controllability.Finally,suggestions were put forward to promote the inheritance and carry forward China's traditional healthcare culture and the achievement of the Healthy China Initiative.These suggestions included classifying and optimizing the access management of health food,innovating the traditional healthcare function claims,and strengthening the quality system construction and information disclosure of post-marketing evaluation.

关 键 词：决明子 保健食品 食药物质 监督管理 上市后评价 

分 类 号：R289[医药卫生—方剂学] R287[医药卫生—中药学] R22[医药卫生—中医学] R2-031R33R24