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含中药保健食品质量控制的现状与研究策略

[Current situation and research strategy of quality control of health food containing Chinese materia medica].

作者信息

Dai Yun-Tao, Jin Ru-Na, Sun Rong, Wang Jin-Bo, Zhang Gui-Min, Chen Shi-Lin

机构信息

Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences Beijing 100700,China.

School of Advanced Medical Science,Shandong University Jinan 250012,China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2019 Mar;44(5):880-884. doi: 10.19540/j.cnki.cjcmm.20190115.003.

Abstract

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.

摘要

含中药的保健食品在养生保健及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”的需求。然而,由于其成分复杂、原料质量参差不齐,加之现有质量标准的模糊性和不完整性,导致保健食品市场乱象丛生,制约了其健康发展,也给保健食品质量管控带来了新挑战。目前,多数功能/标志性成分检测是测定总成分含量或单一成分含量。安全性及微生物检测方法未能涵盖中药原料的污染范围,因此无法达到确保真实性、安全性和有效性的目的。近年来,大量中药提取物被用作食品原料,但许多提取物缺乏标准。笔者认为,含中药保健食品的质量管控应从中药提取物的质量管控入手,如此从源头控制产品质量以确保产品一致性;其次,应加强全面质量管控以确保产品真实性;扩大安全检查范围从根本上确保产品安全性。同时,要强化全过程质量管控,加强原料整体质量把控,以生产出高质量的保健食品。

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