中药保健食品的质量控制现状和研究策略
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摘要
中药保健食品在养生和降低疾病发生风险方面具有诸多优势,满足了人们对"大健康"和"治未病"的诉求。但是由于其成分复杂多样、原料质量不一的特征,加之已有质量标准模糊且缺乏整体性,导致保健食品市场混乱,制约了其应有保健功能的发挥,给保健食品的质量控制提出新的挑战。目前,已申报的品种功能性/标志性成分检查大多测定总成分含量,或者单个成分含量,安全性检测和微生物检测方法未能覆盖中药原料污染范围,因此,无法达到鉴别真伪、保证安全和功效的目的。由于中药保健食品近年出现了诸多以中药提取物为原料的产品,但很多提取物却缺乏标准。笔者认为,中药保健食品的质量控制要加强中药提取物的质量控制,从源头控制产品质量,保证产品的一致性;其次,加强整体质量控制,保证产品的真实性;扩大安全性检查的范围,全面保证产品的安全性。同时,着眼于整个生产链,加强全程质量控制,加强原料的全面质量控制,从源头保障产品质量,生产出高质量的中药保健食品。
Health food containing Chinese materia medica has many advantages in health preservation and reducing the risk of disease occurrence,which meets people's demands for " great health" and " preventive treatment of disease". However,due to its complex ingredients,diverse quality of raw materials,as well as the vagueness and lack of integrity for existing quality standards,chaos is caused in the health food market,which restricts its healthy development and also poses new challenges to the quality control of healthy food. At present,the total component content or single component content is determined in most functional/marker component examinations. Safety and microbial detection methods fail to cover the contamination range of the raw materials of Chinese materia medica.Therefore,it is impossible to meet the purpose of ensuring authenticity,safety and efficacy. In recent years,a lot of Chinese materia medica extracts have been used as raw materials for food products,but many extracts lack standards. The author believes that the quality control of health food containing Chinese materia medicas should start with the quality control of Chinese materia medica extracts. In this way,product quality is controlled from source to ensure product consistency; secondly,the overall quality control should be strengthened to ensure the authenticity of the products; the scope of safety inspection shall be expanded to fundamentally ensure the safety of products. At the same time,we should strengthen the quality control of whole process and strengthen the overall quality control of raw materials to produce health food of high quality.
Health food containing Chinese materia medica has many advantages in health preservation and reducing the risk of disease occurrence,which meets people's demands for " great health" and " preventive treatment of disease". However,due to its complex ingredients,diverse quality of raw materials,as well as the vagueness and lack of integrity for existing quality standards,chaos is caused in the health food market,which restricts its healthy development and also poses new challenges to the quality control of healthy food. At present,the total component content or single component content is determined in most functional/marker component examinations. Safety and microbial detection methods fail to cover the contamination range of the raw materials of Chinese materia medica.Therefore,it is impossible to meet the purpose of ensuring authenticity,safety and efficacy. In recent years,a lot of Chinese materia medica extracts have been used as raw materials for food products,but many extracts lack standards. The author believes that the quality control of health food containing Chinese materia medicas should start with the quality control of Chinese materia medica extracts. In this way,product quality is controlled from source to ensure product consistency; secondly,the overall quality control should be strengthened to ensure the authenticity of the products; the scope of safety inspection shall be expanded to fundamentally ensure the safety of products. At the same time,we should strengthen the quality control of whole process and strengthen the overall quality control of raw materials to produce health food of high quality.
引文
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[15]钟文,陈莎,章军,等.重点是原料,还是工艺?———以葛根芩连汤为例探讨中成药质量一致性控制方法[J].中国中药杂志,2016,41(6):1027.
[16]刘芸,丁涛,廖雪晴,等.高效液相色谱-四极杆/静电场轨道阱高分辨率质谱法快速筛查中成药和保健食品中非法添加的42种化学药物[J].分析化学,2016,44(3):423.
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[18]李云成,孟凡冰,陈卫军,等.加工过程对食品中农药残留的影响[J].食品科学,2012,33(5):315.
[19]马妍,陈頔,陈曦,等.分散固相萃取-分散液液微萃取-气相色谱-质谱联用法测定中草药类保健食品中29种有机磷农药残留[J].中国食品卫生杂志,2017,29(5):556.
[20]胡磊,李樱红,周明昊. GC测定以植物或真菌为原料的保健食品中有机磷农药残留[J].中国现代应用药学,2017,34(4):563.
[21]赵祥升.“药食同源”南药-益智中外源污染物检测及防霉变储藏规范研究[D].北京:北京协和医学院,2016.
[22]陶明宝,张乐,刘飞,等.含蒽醌类成分中药的安全性研究进展[J].中药药理与临床,2016,32(6):238.
[2]张怡光,唐仕欢,贾蔷,等.含栀子保健食品配方原料应用分析[J].中国中药杂志,2014,39(22):4470.
[3]方文娟,陈晓云,童国勇,等.保健食品行业提取物原料的现状与加强监管的建议[J].首都公共卫生,2015,9(5):237.
[4]杨扬,周斌,赵文杰.“银杏叶事件”的分析与思考[J].中草药,2016,47(14):2397.
[5]王晓光,黄海舟,沈秀,等.两种市售中药保健食品功效安全的对比评价及相关问题探讨[J].重庆医学,2014,43(12):1463.
[6]戴莹,于春媛,周立新,等.中药类保健食品质量安全主要风险因子分析[J].首都食品与医药,2018(12):142.
[7]王林元,张建军,王淳,等.对中药类保健食品的认识及研究开发策略[J].中国中药杂志,2016,41(21):3927.
[8]肖培根,李连达,刘勇.中药保健食品安全性评估系统的初步研究[J].中国中药杂志,2005,30(1):10.
[9]於洪建,吴春福.我国中药类保健食品的发展趋势[J].中草药,2016,47(18):3342.
[10]杨扬,周斌,赵文杰.“银杏叶事件”的分析与思考[J].中草药,2016,47(14):2397.
[11] Qiu S,Yang W Z,Yao C L,et al. Nontargeted metabolomic analysis and"commercial-homophyletic"comparison-induced biomarkers verification for the systematic chemical differentiation of five different parts of Panax ginseng[J]. J Chromatogr A,2016(1453):78.
[12]萨翼.浅谈含中药提取物的保健食品工艺及质量控制[J].中国中医药信息杂志,2013,20(6):3.
[13]丛骆骆,吴彬,张建武,等.中药提取物标准管理的思路与对策研究[J].中国新药杂志,2015,24(21):2405.
[14]陈士林,刘安,李琦,等.中药饮片标准汤剂研究策略[J].中国中药杂志,2016,41(8):1367.
[15]钟文,陈莎,章军,等.重点是原料,还是工艺?———以葛根芩连汤为例探讨中成药质量一致性控制方法[J].中国中药杂志,2016,41(6):1027.
[16]刘芸,丁涛,廖雪晴,等.高效液相色谱-四极杆/静电场轨道阱高分辨率质谱法快速筛查中成药和保健食品中非法添加的42种化学药物[J].分析化学,2016,44(3):423.
[17]黄芳,吴惠勤,朱志鑫,等.液相色谱-串联质谱法快速筛查减肥类中药及保健食品中非法添加30种化学药[J].分析测试学报,2017,36(1):2.
[18]李云成,孟凡冰,陈卫军,等.加工过程对食品中农药残留的影响[J].食品科学,2012,33(5):315.
[19]马妍,陈頔,陈曦,等.分散固相萃取-分散液液微萃取-气相色谱-质谱联用法测定中草药类保健食品中29种有机磷农药残留[J].中国食品卫生杂志,2017,29(5):556.
[20]胡磊,李樱红,周明昊. GC测定以植物或真菌为原料的保健食品中有机磷农药残留[J].中国现代应用药学,2017,34(4):563.
[21]赵祥升.“药食同源”南药-益智中外源污染物检测及防霉变储藏规范研究[D].北京:北京协和医学院,2016.
[22]陶明宝,张乐,刘飞,等.含蒽醌类成分中药的安全性研究进展[J].中药药理与临床,2016,32(6):238.