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

JIANG Yu; LI Feifei; FU Yu; LI Yuhong; YIN Xiuwen

doi:10.13386/j.issn1002-0306.2020100126

Volume 43 Issue 8

Apr. 2022

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Science and Technology of Food Industry > 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.

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

Center for Food Evaluation, State Administration for Market Regulation, Beijing 100070, China

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Received Date: October 19, 2020
Available Online: February 20, 2022

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Abstract

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.
- coenzyme Q10,
- health foods,
- security,
- efficiency,
- quality controllability

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References

[1]	万艳娟, 吴军林, 吴清平. 辅酶Q10生理功能及应用研究进展[J]. 食品工业科技,2014,35(14):390−395. [WAN Y J, WU J L, WU Q P. Research progress in physiological functions and application of coenzyme Q10[J]. Science and Technology of Food Industry,2014,35(14):390−395.
[2]	国家药典委员会. 中华人民共和国药典二部[M]. 北京: 中国医药科技出版社, 2020: 1457 Chinese Pharmacopeia Commission. Pharmacopeia of the People’s Republic of China volume 2 [M]. Beijing: China Medical Science and Technology Press, 2020: 1457
[3]	邓云菲. 辅酶Q10及其胶囊剂的相关杂质谱研究[D]. 上海: 中国医药工业研究总院, 2019. DENG Y F. Study on correlation impurities profile of coenzyme Q10 and its capsules[D]. Shanghai: China State Institute of Pharmaceutical Industry, 2019.
[4]	廖杰, 赵黎博. 辅酶Q10在化妆品中应用的专利分析[J]. 河南科技,2019,668(6):56−58. [LIAO J, ZHAO L B. Patent analysis of coenzyme Q10 applied in cosmetics[J]. Journal of Henan Science and Technology,2019,668(6):56−58. doi: 10.3969/j.issn.1003-5168.2019.06.023
[5]	杨敬源, 黄卫. 辅酶Q10与癌症治疗相关研究进展[J]. 海南医学,2018,29(2):242−245. [YANG J Y, HUANG W. Progress in application of coenzyme Q10 in cancer therapy[J]. Hainan Medical Journal,2018,29(2):242−245. doi: 10.3969/j.issn.1003-6350.2018.02.029
[6]	林晓明. 高级营养学[M]. 第2版. 北京: 北京大学医学出版社, 2017: 99-105 LIN X M. Advanced nutrition[M]. 2nd Edition. Beijing: Peking University Medical Press, 2017: 99-105
[7]	姜之歆, 王从容. 辅酶Q10治疗线粒体疾病的临床应用进展[J]. 医学综述,2017,23(23):4644−4648. [JIANG Z X, WANG C R. Clinical research and application of coenzyme Q10 in mitochondrial diseases[J]. Medical Recapitulate,2017,23(23):4644−4648. doi: 10.3969/j.issn.1006-2084.2017.23.013
[8]	王虹玲, 武婷茹, 战秀梅. 辅酶Q10抗氧化性及应用研究进展[J]. 食品研究与开发,2015,36(19):188−190. [WANG H L, WU T R, ZHAN X M. Recent advance on antioxidant and application of coenzyme Q10[J]. Food Research and Development,2015,36(19):188−190. doi: 10.3969/j.issn.1005-6521.2015.19.049
[9]	ALMA M, LARA T, ALESSANDRO C, et al. Coenzyme Q10: Clinical applications in cardiovascular diseases[J]. Antioxidants,2020,9(4):341.[2021−06-28 doi: 10.3390/antiox9040341
[10]	HUO J, XU Z, HOSOE K, et al. Coenzyme Q10 prevents senescence and dysfunction caused by oxidative stress in vascular endothelial cells [J]. Oxidative Medicine and Cellular Longevity 2018, 2018: 1−15. [2021-06-28]https://doi.org/10.1155/2018/3181759
[11]	黄聘和, 田嘉军, 蒋勇等. 辅酶Q10胶囊对小鼠免疫功能的调节作用研究[J]. 齐齐哈尔医学院学报,2018,39(4):377−379. [HUANG P H, TIAN J J, JIANG Y, et al. The mediate effect of coenzyme Q10 capsule on the immune function of mice[J]. Journal of Qiqihar Medical University,2018,39(4):377−379. doi: 10.3969/j.issn.1002-1256.2018.04.002
[12]	DAVID M. Coenzyme Q10 supplementation for diabetes and its complications: An overview[J]. The British Journal of Diabetes,2017,17(4):145−148. doi: 10.15277/bjd.2017.149
[13]	HARGREAVES I, MANTLE D, MILFORD D. Chronic kidney disease and coenzyme Q10 supplementation[J]. Kidney Care,2019,4(2):82−90.
[14]	王彬苏, 杨宁, 杨国红等. 辅酶Q10在治疗高血压方面的应用进展[J]. 医学综述,2018,24(22):4616−4420. [WANG B S, YANG N, YANG G H, et al. Advances in application of coenzyme Q10 in treatment of hypertension[J]. Medical Recapitulate,2018,24(22):4616−4420.
[15]	DAVID M, IAIN H. Coenzyme Q10 and degenerative disorders affecting longevity: An overview[J]. Antioxidants,2019,8(2):44. doi: 10.3390/antiox8020044
[16]	ZHAI J Y, BO Y C, LU Y, et al. Effects of coenzyme Q10 on markers of inflammation: A systematic review and meta analysis [J]. PLoS One, 2017, 1(12): e0170172.
[17]	SANAZ M, GHOLAMREZA A, MARYAM M, et al. Effect of coenzyme Q10 supplementation on fatigue: A systematic review of interventional studies[J]. Complementary Therapies in Medicine,2019,4(43):181−187.
[18]	CRANE F L, HATEFI Y, LESTER R L, et al. Isolation of a quinone from beef heart mitochondria[J]. Biochimica et Biophysica Acta,1957,25:220−221. doi: 10.1016/0006-3002(57)90457-2
[19]	李美英, 姜雨, 余超. 我国保健食品功能与原料管理的一点思考[J]. 营养学报,2018,40(3):215−221. [LI M Y, JIANG Y, YU C. Perspectives on regulatory policies for the functions and raw materials of health food[J]. Acta Nutrimenta Sinica,2018,40(3):215−221. doi: 10.3969/j.issn.0512-7955.2018.03.002
[20]	孙桂菊. 我国保健食品产业发展历程及管理政策概述[J]. 食品科学技术学报,2018,36(2):12−20. [SUN G. J. Review of development and management policy of health food industry in China[J]. Journal of Food Science and Technology,2018,36(2):12−20. doi: 10.3969/j.issn.2095-6002.2018.02.002
[21]	国家市场监督管理总局. 市场监管总局关于修订公布食品生产许可分类目录的公告[EB/OL]. (2020-02-26)[2021-06-28]. http://www.gov.cn/zhengce/zhengceku/2020-03/27/content_5496236.htm State Administration for Market Regulation. Announcements of the state administration for market regulation on the amendment and publication of the classified catalogue of food production permits[EB/OL]. (2020-02-26)[2021-06-28]. http://www.gov.cn/zhengce/zhengceku/2020-03/27/content_5496236.htm.
[22]	杜鹏, 张晓娜, 董诗源. 藻类保健食品研发状况及问题探讨[J]. 海峡预防医学杂志,2020,26(6):73−75. [DU P, ZHANG X N, DONG S Y. Research and development status and problems of algae health food[J]. Strait J Prev Med,2020,26(6):73−75.
[23]	中华人民共和国卫生部. 保健食品检验与评价技术规范(2003年版)[M]. 北京: 中华人民共和国卫生部, 2003. Ministry of Health of the People’s Republic of China. Technical standards for testing& assessment of health food (2003 edition) [M]. Beijing: Ministry of Health of the People’s Republic of China, 2003.
[24]	黄娟, 王云娟, 白华, 等. 复配亚麻籽油和辅酶Q10乳液的制备及表征[J]. 农业工程学报,2020,36(6):292−299. [HUANG J, WANG Y J, BAI H, et al. Preparation and characterization of linseed oil and coenzyme Q10 co-loaded emulsions[J]. Transactions of the Chinese Society of Agricultural Engineering,2020,36(6):292−299.
[25]	田明, 冯军, 宛超, 等. 国外保健食品类似产品原料管理的研究及启示[J]. 中国食品学报,2020,20(10):316−321. [TIAN M, FENG J, WAN C, et al. The research and enlightenment of raw material management for health food in foreign[J]. J Chin Inst Food Sci Technol,2020,20(10):316−321.
[26]	HIDAKA T, FUJII K, FUNAHASHI I, et al. Safety assessment of coenzyme Q10 (CoQ10)[J]. Bio Factors,2008,32(1/4):199−208. doi: 10.1002/biof.5520320124
[27]	Health Canada. Coenzyme Q10 (Ubiquinone-10) [S]. Ottawa: Health Canada, 2007.
[28]	刘霁, 白鸿. 我国保健食品注册管理制度的演变与安全监管[J]. 癌变·畸变·突变,2012,24(4):321−324. [LIU J, BAI H. Evolution and safety supervision of health food registration management system in China[J]. Carcinog Teratogs Mutag,2012,24(4):321−324.
[29]	国家市场监督管理总局, 国家卫生健康委员会, 国家中医药管理局公告. 关于发布辅酶Q10 等五种保健食品原料目录的公告(2020年第54号)[EB/OL]. [2020-12-01]. http://gkml.samr.gov.cn/nsjg/tssps/202012/t20201201_324007.html [2021-08-22]. State Administration for Market Regulation. National Health Commission of the People’s Republic of China, National Administration of Traditional Chinese Medicine Administration. Announcement on releasing the catalogue of five raw materials for health food such as coenzyme Q10 (No. 54 of 2020) [EB/OL]. [2020-12-01]. http://gkml.samr.gov.cn/nsjg/tssps/202012/t20201201_324007.html [2021-08-22].
[30]	洪燕, 郑洋滨, 刘波. 辅酶Q10毒理学安全性的小鼠实验评价[J]. 基础医学论坛,2017,21(25):3461. [HONG Y, ZHENG Y B, LIU B. Toxicological safety evaluation of coenzyme Q10 in mice[J]. Public Medical Forum Magazine,2017,21(25):3461.
[31]	隋自洁, 宋昕恬, 崔贞玉, 等. XAP 辅酶Q10 的毒理学安全性试验[J]. 中国实用医药,2010,5(34):60−61. [SUI Z J, SONG X T, CUI Z Y, et al. Toxicology safety trials of XAP coenzyme Q10[J]. China Practical Medicine,2010,5(34):60−61. doi: 10.3969/j.issn.1673-7555.2010.34.036
[32]	梁慧莉, 赵鹏, 李凤文, 等. 辅酶Q10毒理学安全性评价[J]中国热带医学, 2009, 9(2): 237-240 LIANG H L, ZHAO P, LI F W, et al. Toxicology and safety evaluation of coenzyme Q10[J]. China Tropical medicine, 2009, 9(2): 237-240.
[33]	姚文环, 杨非, 颜燕, 等辅酶Q10软胶囊的急性毒性、遗传毒性和亚急性毒性研究[J]. 中国实验方剂学杂志, 2012, 18(23): 293-296. YAO W H, YANG F, YAN Y, et al. Study of acute toxicology, inheritance toxicology and subacute toxicology of coenzyme Q10 [J] Chinese Journal of Experimental Traditional Medical Formulae, 2012, 18(23): 293-296.
[34]	XIN F, JI R, JORGEN D. Acute, subacute toxicity and genotoxic effect of Bio-Quinone Q10 in mice and rats[J]. Regulatory Toxicology and Pharmacology,2009,53(1):1−5. doi: 10.1016/j.yrtph.2008.09.003
[35]	JOHN N, ANDREW S. Risk assessment for coenzyme Q10 (Ubiquinone)[J]. Regulatory Toxicology and Pharmacology,2006,45:282−288. doi: 10.1016/j.yrtph.2006.05.006
[36]	中华人民共和国中央人民政府. 含辅酶Q10和含大豆异黄酮保健食品注册规定印发[EB/OL]. (2009-09-05) [2021-11-02]. http://www.gov.cn/gzdt/2009-09/05/content_1409772.htm The Central People’s Government of the People’s Republic of China. Rovisions on registration of health foods containing coenzyme Q10 and soybean isoflavone[EB/OL]. (2009-09-05) [2021-11-02]. http://www.gov.cn/gzdt/2009-09/05/content_1409772.htm.
[37]	AASETH J, ALEXANDER J, ALEHAGEN U. Coenzyme Q10 supplementation – In ageing and disease[J]. Mechanisms of Ageing and Development,2021,197(4):111521.
[38]	IAIN H, ROBERT A H, DAVID M. Disorders of human coenzyme Q10 metabolism: An overview[J]. International Journal of Molecular Sciences,2020,21(18):6695. doi: 10.3390/ijms21186695
[39]	ANDERS K, EEVA-LIISA A, GUSTAV D. Age-related changes in the lipid compositions of rat and human tissues[J]. Lipids,1989:24.
[40]	GUTIERREZ-M F M, YUBERO-S E, VILLALBA J M, et al. Coenzyme Q 10: From bench to clinic in aging diseases, a translational review[J]. Critical Reviews in Food Science and Nutrition,2018,59(14):1−63.
[41]	MANTLE D , HEATON R A , HARGREAVES I P. Coenzyme Q10 and immune function: An overview [J]. Antioxidants 2021, 10(5): 759. https://doi.org/10.3390/antiox10050759.
[42]	徐彩菊, 孟佳, 傅剑云. 辅酶Q10 在免疫调节中的作用[J]. 中国卫生检验杂志,2007,17(2):222−224. [XU C J, MENG J, FU J Y. Effect of coenzyme Q10 in immunoloregulation[J]. Chinese Journal of Health Laboratory Technology,2007,17(2):222−224. doi: 10.3969/j.issn.1004-8685.2007.02.012
[43]	袁根良, 蒋丽, 殷光玲, 等. 辅酶 Q10 软胶囊增强免疫力功能的试验研究[J]. 食品研究与开发,2014,4(8):111−114. [YUAN G L, JIANG L, YIN G L, et al. Experimental study on effect of coenzyme Q10 soft capsule on the strengthen immune function[J]. Food Research and Development,2014,4(8):111−114. doi: 10.3969/j.issn.1005-6521.2014.08.029
[44]	彭亮, 韩彦彬, 王彦武, 等. 辅酶Q10对小鼠免疫功能影响的实验研究[J]中国卫生检验杂志, 2010, 20(12): 3125-3127 PENG L, HAN Y B, WANG Y W, et al. Experimental study on effect of coenzyme Q10 on the immune function in mice[J]. Chinese Journal of Health Laboratory Technology, 2010, 20(12): 3125-3127.
[45]	TRUSHINA E N, VYBORNOV V D, RIGER N A, et al. Immunomodulating effects of using L-carnitine and coenzyme Q10 in the nutrition of junior athletes[J]. Voprosy Pitaniia,2019,88(2):40−49.
[46]	刘湘宁, 冯智强, 李小玲, 等. 辅酶Q10联合21金维他治疗复发性阿弗他溃疡59例[J]暨南大学学报(自然科学与医学版), 2005, 4(26): 267-268 LIU X N, FENG Z Q , LI X L , et al. Treatment of 59 cases of recurrent aphthous ulcer with coenzyme Q10 combined with 21 jinvita[J]. Journal of Jinan University(Medicine Edition), 2005, 4(26): 267-268.
[47]	鲍福全, 鲍朝霞, 夏仕意, 等. 辅酶Q10治疗复发性口腔溃疡[J]临床医学, 2012, 4(32): 99−100 BAO F Q, BAO C X, XIA S Y , et al. Coenzyme Q10 provides treatment for recurrent oral ulcers[J]. Clinical Medicine, 2012, 4(32): 99−100.
[48]	彭亮, 姚思宇, 何励, 等. 辅酶Q10对自然衰老大鼠的抗氧化作用研究[J]应用预防医学, 2012, 1(6): 378-380 PENG L, YAO S Y, HE L, et al. Study on the antioxidant effect of coenzyme Q10 on natural aging rats[J]. Journal of Applied Preventive Medicine, 2012, 1(6): 378-380.
[49]	彭亮, 赵鹏, 李彬, 张洁宏, 等. 辅酶Q_(10)的人体抗氧化作用研究[J]. 实用预防医学,2011(18):1546−1548. [PENG L ZHAO P LI B, et al. Study on antioxidant function of coenzyme Q10 on human body[J]. Practical Preventive Medicine,2011(18):1546−1548.
[50]	陈田, 杨运泉, 刘文英, 等. 辅酶 Q10 化学合成方法与工艺研究进展评述[J]精细化工中间体, 2007, 13(1): 13−18. CHEN T, YANG Y Q, LIU W Y, et al. Review on chemosynthesis methods and techniques of coenzyme Q10 [J] Fine Chemical Intermediates, 2007, 13(1): 13−18.
[51]	施亚群, 杜维力, 姚鹃, 等. 酵母发酵生产辅酶Q10提取方法研究进展[J]. 生物资源,2017,39(3):168−174. [SHI Y Q, DU W L, YAO J, et al. Progress in extracting coenzyme Q10 produced by yeast fermentation[J]. Biotic Resource,2017,39(3):168−174.
[52]	徐敏强, 扶教龙, 钱大伟, 等. 酸热辅助超声法提取类球红细菌发酵产物CoQ10[J]. 食品工业,2017,38(8):47−51. [XU M Q, FU J L, QIAN D W, et al. Extraction of coenzyme Q10 from rhodobacter sphaeroides with acid heating-assisted ultrasonication[J]. The Food Industry,2017,38(8):47−51.
[53]	张君奇. 类球红细菌高效合成辅酶Q10代谢机制研究[D]. 天津: 天津科技大学, 2019. ZHANG J Q. Studying on the efficient of synthesis coenzyme Q10 metabolic mechanism in rhodobacter sphaeroides[D]. Tianjin: Tianjin University of Science and Technology, 2019.
[54]	白悦彤, 郭秀云, 郑梦凡, 我国保健食品市场现状分析及对策研究[J]. 现代商业, 2019(21): 7−8 BAI Y T, GUO X Y, ZHEN M F. Current situation analysis and countermeasures of health food market in China[J]. Modern Business, 2019(21): 7−8.
[55]	兰韬, 吴琦, 赵琳, 等. 保健食品功效成分、功能声称及其检测标准现状研究[J]. 食品工业科技,2021,42(1):387−396. [LAN T, WU Q, ZHAO L, et al. Study on functional ingredients, functional claims and detection standards of health food[J]. Science and Technology of Food Industry,2021,42(1):387−396.
[56]	国家市场监督管理总局. 保健食品原料目录与保健功能目录管理办法[EB/OL]. 2019-08-20. http: //gkml.samr.gov.cn/nsjg/fgs/201908/t20190820_306117. html. State Administration for Market Regulation. Management method of health food raw material catalogue and health function catalogue [EB/OL]. 2019-08-20. http://gkml.samr.gov.cn/nsjg/fgs/201908/t20190820_306117. html.
[57]	ROVIRA R F, BERMUDO F M. Report of the Scientific Committee of the Spanish Agency for Food Safety and Nutrition (AESAN) on the use conditions for certain substances other than vitamins, minerals and plants in food supplements [J]. Aesa. msc. es.
[58]	中华人民共和国国家卫生和计划生育委员会. GB 16740-2014食品安全国家标准保健食品[S]北京: 中国标准出版社, 2014. State Health and Family Planning Commission of the People' s Republic of China. GB 16740-2014 National food safety standards health food[S]. Beijing: China Standards Press, 2014.
[59]	中华人民共和国中央人民政府. 中共中央国务院关于深化改革加强食品安全工作的意见[EB/OL] 2019-05-20]. http: //www. gov. cn/zhengce/2019-05/20/content_5393212. htm [2021-08-23]. The Central People's Government of the People's Republic of China. Opinions of the CPC Central Committee and the State Council on deepening reform and strengthening food safety work[EB/OL]. [2019-05-20]. http://www.gov.cn/zhengce/2019-05/20/content_5393212.htm [2021-08-23].
[60]	鲁曦, 邓希妍, 丁凡, 等. 食品安全标准化现状及对策研究[J]. 中国标准化,2021(3):106−111. [LU X, DENG X Y, DING F, et al. Status and countermeasures of food safety standardization[J]. China Stand,2021(3):106−111. doi: 10.3969/j.issn.1002-5944.2021.03.013

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