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中国精品科技期刊2020
姜雨,李菲菲,付雨,等. 辅酶Q10类保健食品注册审评审批状况分析与建议[J]. 食品工业科技,2022,43(8):264−272. doi: 10.13386/j.issn1002-0306.2020100126.
引用本文: 姜雨,李菲菲,付雨,等. 辅酶Q10类保健食品注册审评审批状况分析与建议[J]. 食品工业科技,2022,43(8):264−272. doi: 10.13386/j.issn1002-0306.2020100126.
JIANG Yu, LI Feifei, FU Yu, et al. Analysis and Suggestions of Evaluation and Approval for Health Foods Containing Coenzyme Q10[J]. Science and Technology of Food Industry, 2022, 43(8): 264−272. (in Chinese with English abstract). doi: 10.13386/j.issn1002-0306.2020100126.
Citation: JIANG Yu, LI Feifei, FU Yu, et al. Analysis and Suggestions of Evaluation and Approval for Health Foods Containing Coenzyme Q10[J]. Science and Technology of Food Industry, 2022, 43(8): 264−272. (in Chinese with English abstract). doi: 10.13386/j.issn1002-0306.2020100126.

辅酶Q10类保健食品注册审评审批状况分析与建议

Analysis and Suggestions of Evaluation and Approval for Health Foods Containing Coenzyme Q10

  • 摘要: 辅酶Q10是一种脂溶性的类维生素苯醌化合物,由酪氨酸在人体内内源性合成,具有参与体内ATP产能、清除自由基和抗氧化、增强免疫力、稳定细胞膜等诸多生理功能。自2003年批准第一个辅酶Q10类保健食品,至2020年辅酶Q10作为备案原料进行管理,我国已批准171个辅酶Q10类保健食品。为更好了解已批准辅酶Q10类保健食品的现状,本文以参与的辅酶Q10保健食品原料目录项目研究工作为切入点,基于原国家食品药品监督管理总局网站及国家市场监督管理总局网站公布的1996~2020年已批准产品的数据,结合注册审评工作实际和相关研究现状,从安全性、功能声称、质量控制方面综合分析了20多年来辅酶Q10类保健食品的审评审批情况,并提出了加强对已公布辅酶Q10原料目录的研究,探索氨基酸、益生菌、蛋白质等膳食营养物质纳入原料目录管理,注重保健食品用原料的专属性质量标准体系建设等意见建议。

     

    Abstract: Coenzyme Q10 is a fat-soluble vitamin-like benzoquinone compound, which is synthesized endogenously from tyrosine in human body. It has many physiological functions, such as participating in ATP production capacity, scavenging free radicals and anti-oxidantion, enhancing immunity, stabilizing cell membranes and so on. Since the first coenzyme Q10 health food was approved in 2003, and by 2020, coenzyme Q10 was used as raw material for record management. China has approved 171 coenzyme Q10 health foods. In order to better understand the current situation of approved coenzyme Q10 health foods, the author took the research work of coenzyme Q10 health food raw materials list project which I participated in tracking as the starting point, based on the original China Food and Drug Administration website and the date of approved products from 1996 to 2020 published on the website of the State Administration of Market Supervision, combined with the actual registration review work and related research status, comprehensively analyzed the review and approval of coenzyme Q10 health foods in the past 20 years from the aspects of safety, function claims, and quality control. The author also proposed some opinions and suggestions on strengthening the study of the published coenzyme Q10 raw material catalogue, and to explore the inclusion of amino acids, probiotics, protein and other dietary nutrients into the raw material catalogue management, pay attention to the construction of the exclusive quality standard system of dietary supplement raw materials.

     

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