已批准增强免疫力功能的中药类保健食品现状及监管建议
|
摘要
已批准的增强免疫力功能声称保健食品在所有声称功能的保健食品中数量排名第1位,而声称增强免疫力功能的保健食品中配方含有中药的产品约占2/3。保健食品中允许使用的中药有规定的使用范围,一般原料的安全性较高,原料的使用量也不超过文献或法规规定的上限。现行的增强免疫力声称是基于现代药理学、营养学基础上的西医名称提出来的,免疫力的含义范围广泛,机制复杂,对于在中医药理论指导下使用的中药保健食品更有可能是从免疫器官、免疫细胞以及免疫分子的多方面发挥增强免疫力的功效。该文首先分析了目前保健食品原料使用情况,对已批准的保健食品中增强免疫力功能产品情况进行梳理,对中药类保健食品中增强免疫力功能情况、原料的使用情况、原料配伍数量统计分析,再从技术审评和监督管理角度对产品配方、安全性、保健功能、质量控制、生产工艺等多方面深入分析,然后从监管中发现的问题和未来对中药类保健食品需求的角度,提出增强免疫力功能的中药类保健食品注册和监管的建议。
Number of products claiming to enhance immunity function ranks first among all the approved health food products,and number of products whose formula contains Chinese medicine accounts for two thirds of all the products claiming to enhance immunity function. Chinese medicine allowed to be used in health food has a specified range,and the safety of raw materials is generally higher.The usage amount of raw materials shall not exceed the upper limit stipulated in the literature or regulations. The claim of enhancement of immunity function is put forward by western medicine based on modern pharmacology and nutriology. However,immunity is wide in scope and complex in mechanism. The health food that contains Chinese medicine plays an active effect in enhancement of immunity under the guidance of Chinese medicine theory in many ways such as immune organs,immune cells and immune molecules. In this article,the author first analyzed the current use of raw materials for health food,then summarized the approved health food claiming to enhance immunity function,and conducted statistical analysis on the enhancement of immunity for traditional Chinese medicine(TCM)health food,use of raw materials,compatibility of raw materials,conducted in-depth analysis on health food formula,safety,health function,quality control and production process from the perspectives of technical review,supervision and management. Finally,some suggestions on registration and supervision of TCM health food claiming to enhance immunity function were put forward from the perspectives of problems found in the supervision and from the demand of TCM health food in the future.
Number of products claiming to enhance immunity function ranks first among all the approved health food products,and number of products whose formula contains Chinese medicine accounts for two thirds of all the products claiming to enhance immunity function. Chinese medicine allowed to be used in health food has a specified range,and the safety of raw materials is generally higher.The usage amount of raw materials shall not exceed the upper limit stipulated in the literature or regulations. The claim of enhancement of immunity function is put forward by western medicine based on modern pharmacology and nutriology. However,immunity is wide in scope and complex in mechanism. The health food that contains Chinese medicine plays an active effect in enhancement of immunity under the guidance of Chinese medicine theory in many ways such as immune organs,immune cells and immune molecules. In this article,the author first analyzed the current use of raw materials for health food,then summarized the approved health food claiming to enhance immunity function,and conducted statistical analysis on the enhancement of immunity for traditional Chinese medicine(TCM)health food,use of raw materials,compatibility of raw materials,conducted in-depth analysis on health food formula,safety,health function,quality control and production process from the perspectives of technical review,supervision and management. Finally,some suggestions on registration and supervision of TCM health food claiming to enhance immunity function were put forward from the perspectives of problems found in the supervision and from the demand of TCM health food in the future.
引文
[1]中华人民共和国卫生部.卫生部关于进一步规范保健食品原料管理的通知(卫法监发[2002]51号文)[EB/OL].(2002-02-28)[2018-12-06]. http://law. foodmate. net/show-163572.html?_t_t_t=0. 35131812789424877.
[2]雷思敏,肖榕,章莹,等.铁皮石斛中性多糖分离纯化及其体内免疫调节作用研究[J].中药新药与临床药理,2018(6):748.
[3]赵延龙.中药黄芪的临床应用及药理作用分析[J].中医临床研究,2018(11):128.
[4]周悦芳,范培红.中药免疫调节作用研究进展[J].时珍国医国药,2017(1):204.
[5]中华人民共和国国家卫生和计划生育委员会.食品安全国家标准保健食品(GB16470-2014)[S].北京:中国标准出版社,2014.
[6] Chandra R K. Impact of nutritional status and nutrient supplements on immune response and incidence of infection in older individuals[J]. Ageing Res Rev,2004,3(1):91.
[7] Yatim K M,Lakkis F G. A brief journey through the immune system[J]. Clin J Am Soc Nephrol,2015,10(7):1274.
[8]叶放.增强免疫力保健食品人体试食试验人群筛选标准的探讨[J].中国全科医学,2014,17(5):542.
[9]李婉,赵海潞.浅论中医正气理论与现代免疫学的内在联系[C].天津:第十二届全国免疫学学术大会,2017.
[10]孙立伟,李香艳,赵大庆.人参“大补元气”中医及生物学内涵研究[J].世界科学技术———中医药现代化,2016,18(11):1969.
[11] Mark I Avigan,Robert P Mozersky,Leonard B Seeff. Scientific and regulatory perspectives in herbal and dietary supplement associated hepatotoxicity in the United States[J]. Int J Mol Sci,2016,17(3):331.
[12] Seeff L B,Bonkovsky H L,Navarro V J,et al. Herbal products and the liver:a review of adverse effects and mechanisms[J].Gastroenterology,2015,148(3):517.
[13]许娇红,张熠,杨秀静,等.螺旋藻多糖增强免疫力功能试验研究[J].海峡药学,2018,30(1):31.
[14]庄新利.山药多糖的药理作用研究[J].中国保健营养,2018,28(15):258.
[15]裘淼,熊中奎,吕梦宇.大枣多糖的药理作用研究进展[J].中国现代医生,2018,56(22):161.
[16] Chen Juncheng,Tian Shan,Shu Xiaoying. Extraction,characterization and immunological activity of polysaccharides from Rhizoma gastrodiae[J]. Int J Mol Sci,2016,17(7):1011.
[17]张弛,杜庆鹏,白玉萍,等.我国保健食品违规违规广告发布情况分析[J].中国食品卫生杂志,2015,27(3):282.
[18]国家食品药品监督管理总局.总局办公厅公开征求《关于保健食品功能声称管理的意见(征求意见稿)》等的意见[EB/OL].(2016-12-24)[2018-12-06]. http://samr. cfda. gov. cn/WS01/CL0782/167372.html.
[19]国家食品药品监督管理总局.《保健食品注册审评审批工作细则》(2016年版)[EB/OL].(2016-11-18)[2018-12-06].https://wenku. baidu. com/view/91035d1554270722192e453610661ed9ad515559.html.
[20] U.S. Food and Drug Administration. Dietary supplement labeling guide[EB/OL].(2016-12-14)[2018-12-06]. https://www. fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Dietary Supplements/ucm2006823.htm.
[21]郭海燕,谭毅,古琼芳,等.中医体质辨识在亚健康分类以及健康指导中的干预效果分析[J].中国实用医药,2017,12(14):186.
[22]宋晓容,吴海滨,程波敏,等. 1 139例治未病人群的中医体质辨识资料分析[J].中国保健营养,2018,28(5):356.
[23]国家药品监督管理局.国家药品监督管理局《关于发布古代经典名方中药复方制剂简化注册审批管理规定》(2018年第27号)[EB/OL].(2018-06-04)[2018-12-06]. http://www.qhglzfda.gov.cn/html/201864/n191825018.html.
[24]高丕明,罗小兵,虞亚明,等.气虚体质大鼠模型的实验研究[J].中国血液流变学杂志,2017,27(4):367.
[25]张彩云,肖满珊,廖双叶,等.实验性大鼠脾气虚证模型的建立及指标检测[J].广东药学院学报,2015,31(6):808.
[26]徐俞悦,尹超,陈波,等.人参超微粉对正常和免疫力低下小鼠免疫功能的影响[J].中国现代应用药学,2018,35(11):1665.
[27]张旻璐,包海鹰,于晓风,等.灵芝超微粉对小鼠免疫功能的影响[J].人参研究,2014(2):20.
[28]杨明,伍振峰,林环玉,等.中药复方制剂工艺研究问题、模式与策略[J].中草药,2018,49(12):2735.
[29]陈畅,程锦堂,刘安.经典名方研发策略[J].中国中药杂志,2017,42(9):1814.
[30]张世臣,孙裕戴,俊东基,等.基于全程质量控制理念的工业饮片标准化体系建设研究[J].中国中药杂志,2018,43(14):2837.
[31]徐冰,史新元,吴志生,等.论中药质量源于设计[J].中国中药杂志,2017,42(6):1015.
[2]雷思敏,肖榕,章莹,等.铁皮石斛中性多糖分离纯化及其体内免疫调节作用研究[J].中药新药与临床药理,2018(6):748.
[3]赵延龙.中药黄芪的临床应用及药理作用分析[J].中医临床研究,2018(11):128.
[4]周悦芳,范培红.中药免疫调节作用研究进展[J].时珍国医国药,2017(1):204.
[5]中华人民共和国国家卫生和计划生育委员会.食品安全国家标准保健食品(GB16470-2014)[S].北京:中国标准出版社,2014.
[6] Chandra R K. Impact of nutritional status and nutrient supplements on immune response and incidence of infection in older individuals[J]. Ageing Res Rev,2004,3(1):91.
[7] Yatim K M,Lakkis F G. A brief journey through the immune system[J]. Clin J Am Soc Nephrol,2015,10(7):1274.
[8]叶放.增强免疫力保健食品人体试食试验人群筛选标准的探讨[J].中国全科医学,2014,17(5):542.
[9]李婉,赵海潞.浅论中医正气理论与现代免疫学的内在联系[C].天津:第十二届全国免疫学学术大会,2017.
[10]孙立伟,李香艳,赵大庆.人参“大补元气”中医及生物学内涵研究[J].世界科学技术———中医药现代化,2016,18(11):1969.
[11] Mark I Avigan,Robert P Mozersky,Leonard B Seeff. Scientific and regulatory perspectives in herbal and dietary supplement associated hepatotoxicity in the United States[J]. Int J Mol Sci,2016,17(3):331.
[12] Seeff L B,Bonkovsky H L,Navarro V J,et al. Herbal products and the liver:a review of adverse effects and mechanisms[J].Gastroenterology,2015,148(3):517.
[13]许娇红,张熠,杨秀静,等.螺旋藻多糖增强免疫力功能试验研究[J].海峡药学,2018,30(1):31.
[14]庄新利.山药多糖的药理作用研究[J].中国保健营养,2018,28(15):258.
[15]裘淼,熊中奎,吕梦宇.大枣多糖的药理作用研究进展[J].中国现代医生,2018,56(22):161.
[16] Chen Juncheng,Tian Shan,Shu Xiaoying. Extraction,characterization and immunological activity of polysaccharides from Rhizoma gastrodiae[J]. Int J Mol Sci,2016,17(7):1011.
[17]张弛,杜庆鹏,白玉萍,等.我国保健食品违规违规广告发布情况分析[J].中国食品卫生杂志,2015,27(3):282.
[18]国家食品药品监督管理总局.总局办公厅公开征求《关于保健食品功能声称管理的意见(征求意见稿)》等的意见[EB/OL].(2016-12-24)[2018-12-06]. http://samr. cfda. gov. cn/WS01/CL0782/167372.html.
[19]国家食品药品监督管理总局.《保健食品注册审评审批工作细则》(2016年版)[EB/OL].(2016-11-18)[2018-12-06].https://wenku. baidu. com/view/91035d1554270722192e453610661ed9ad515559.html.
[20] U.S. Food and Drug Administration. Dietary supplement labeling guide[EB/OL].(2016-12-14)[2018-12-06]. https://www. fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Dietary Supplements/ucm2006823.htm.
[21]郭海燕,谭毅,古琼芳,等.中医体质辨识在亚健康分类以及健康指导中的干预效果分析[J].中国实用医药,2017,12(14):186.
[22]宋晓容,吴海滨,程波敏,等. 1 139例治未病人群的中医体质辨识资料分析[J].中国保健营养,2018,28(5):356.
[23]国家药品监督管理局.国家药品监督管理局《关于发布古代经典名方中药复方制剂简化注册审批管理规定》(2018年第27号)[EB/OL].(2018-06-04)[2018-12-06]. http://www.qhglzfda.gov.cn/html/201864/n191825018.html.
[24]高丕明,罗小兵,虞亚明,等.气虚体质大鼠模型的实验研究[J].中国血液流变学杂志,2017,27(4):367.
[25]张彩云,肖满珊,廖双叶,等.实验性大鼠脾气虚证模型的建立及指标检测[J].广东药学院学报,2015,31(6):808.
[26]徐俞悦,尹超,陈波,等.人参超微粉对正常和免疫力低下小鼠免疫功能的影响[J].中国现代应用药学,2018,35(11):1665.
[27]张旻璐,包海鹰,于晓风,等.灵芝超微粉对小鼠免疫功能的影响[J].人参研究,2014(2):20.
[28]杨明,伍振峰,林环玉,等.中药复方制剂工艺研究问题、模式与策略[J].中草药,2018,49(12):2735.
[29]陈畅,程锦堂,刘安.经典名方研发策略[J].中国中药杂志,2017,42(9):1814.
[30]张世臣,孙裕戴,俊东基,等.基于全程质量控制理念的工业饮片标准化体系建设研究[J].中国中药杂志,2018,43(14):2837.
[31]徐冰,史新元,吴志生,等.论中药质量源于设计[J].中国中药杂志,2017,42(6):1015.