Sa Yi, Chen Guang-Yao, Wang Jin-Bo, Sun Rong
Center for Food Evaluation,State Administration for Market Regulation Beijing 100070,China.
School of Advanced Medical Science,Shandong University Jinan 250012,China The Second Hospital of Shandong University Jinan 250033,China.
Zhongguo Zhong Yao Za Zhi. 2019 Mar;44(5):885-890. doi: 10.19540/j.cnki.cjcmm.20190116.005.
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.
宣称具有增强免疫力功能的产品数量在所有获批的保健食品中位居首位,且配方中含有中药的产品数量占所有宣称具有增强免疫力功能产品的三分之二。允许用于保健食品的中药有特定范围,原料安全性总体较高。原料用量不得超过文献或法规规定的上限。增强免疫力功能的宣称是西医基于现代药理学和营养学提出的。然而,免疫范围广泛,机制复杂。含中药的保健食品在中医理论指导下,在免疫器官、免疫细胞和免疫分子等多方面对增强免疫力发挥着积极作用。本文作者首先分析了保健食品原料的使用现状,然后总结了获批的宣称具有增强免疫力功能的保健食品,并对中药保健食品增强免疫力、原料使用、原料配伍等进行了统计分析,从技术审评、监督管理等角度对保健食品配方、安全性、保健功能、质量控制及生产工艺进行了深入分析。最后,从监管中发现的问题以及未来中药保健食品的需求等角度,对宣称具有增强免疫力功能的中药保健食品注册及监管提出了一些建议。