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投稿时间:2018-02-26
投稿时间:2018-02-26
中文摘要: 分析近年我国保健食品功能声称的分布、原料使用情况和功效/标志性成分检测的现状,探讨原料与功效/标志性成分的对应性和现行检测方法的适用性,为保健食品企业制定产品质量标准和监管部门修订注册管理办法提供研究基础。查询国家食品药品监督管理总局(China Food and Drug Administration,CFDA)网站中2012年~2016年保健食品注册信息,统计产品功能声称及原料使用情况,分析对比保健食品和药品对于相同原料所选用标志性成分指标的异同。2012年~2016年期间增强免疫力、缓解体力疲劳等7类功能声称国产保健食品注册审批数量最多,灵芝、枸杞子等30种原料使用频率最高,7类保健食品功能声称及常用原料、有效成分,企业标准中标志性成分及中国药典测定指标汇总成表。我国保健食品原料和功能声称选择较集中,多数保健食品原料、功效/标志性成分指标吻合度差,亟待明确产品专属功效/标志性成分,建立专属检验方法,有序进行标准更新及产业升级。
Abstract:The distributions of functional claims,use frequency of raw materials,and determination methods of functional/characteristic ingredients of health food in China in recent years were analyzed.The corresponding relationship between raw materials and functional/characteristic ingredients was discussed.The applicability of current functional/characteristic ingredient determination method was discussed at the same time,providing basic research for product quality standard formulation of health food enterprise and registration management regulation amendment of regulatory authorities.Information of health foodregisteredfrom 2012 to 2016 was collected by querying the China Food and Drug Administration(CFDA)website.The numbers of health food functional claims and the use frequency of raw materials were calculated.The difference of characteristic ingredient in same raw material between health food and drug was discussed.During the period of 2012 to 2016,among the domestic health food registered and approved,the number of 7 categories,such as enhancing immune function and alleviating physical fatigue function,were the most.30 kinds of raw materials,such as ganoderma lucidum and Chinese wolfberry were used most frequently.Commonly used materials,active ingredients,determination index in enterprise standards and determination index in Chinese Pharmacopoeia of 7 types of health food were summarized into tables.The raw materials and functions of health food in China were relatively concentrated.And most of the health food's raw materials and functional/characteristic ingredients were poor in conformity.So it was urgent to identify the specific symbolic components and establish exclusive determination methods,so that we can update the standards and upgrade the industry orderly.
keywords: health food raw material functional/characteristic ingredient functional claim determination method
文章编号:201824038 中图分类号: 文献标志码:
基金项目:
Author Name | Affiliation |
GUO Jie,JIA Bo-yang,ZHANG Rong,WU Guo-qing,ZHANG Hua-jun | Beijing Institute for Drug Control,Beijing Center for Health Food and Cosmetics Control,Beijing 102206,China |
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