中国保健食品动植物原料用量分析  

Dosage Analysis of Traditional Chinese Medicine Materials on China's Health Foods

作　　者：周素娟[1] 黄璐琦[2] 王献仁[1] 白鸿[1] 

机构地区：[1]国家食品药品监督管理局保健食品审评中心,北京100070 [2]中国中医科学院中药研究所,北京100700

出　　处：《中国食品卫生杂志》2009年第3期220-224,共5页Chinese Journal of Food Hygiene

摘　　要：目的考察我国保健食品动植物原料的用量特点、安全性及与药典用量的关系,为技术审评提供数据支持,为保健食品的健康发展提供参考。方法分析2003-2005年SFDA注册保健食品中常用动植物原料的用量情况,并与药典治疗用量进行比较,分析常用动植物用量区间范围分布。结果保健食品动植物原料用量总体偏低,常用原料每日用量远低于药典用量,并多集中于(0～3]和(3～6]两个区间范围,与药典用量符合率多低于5%。其中"药食两用物品"和"可用于保健食品物品"原料用量的中位数分别集中于药典用量下限的20%和30%。结论急需加强动植物原料量效关系研究及安全性研究,尤其是有潜在安全问题动植物原料的研究与管理,及时制订/修订相关技术审评规定和动植物原料名单。Objective To inspect the status quo and characteristics of the traditional Chinese medicine （TCM＇s） application and their safety dosage issues in health foods, in order to provide references and guidance for regulating the technological evaluation of health foods and exploring new evaluation models in health foods. Method The dosage of Chinese medicine of health foods registered with SFDA between 2003 and 2005 were studied. Dosage ranges of the 40 kinds of TCM＇s were compared with the corresponding therapeutic dosages in China Pharmacopoeia （2005）. Results The abovementioned TCM＇s dosages were mostly below the lower limit of the corresponding therapeutic dosages in China Pharmacopoeia. The raw material dosages usually were between the （0-3） and the （3-6） scope. The accordant rates of dosage were 5 percent China Pharmacopoeia. The raw material dosages （median） provided in the Exhibits 1 and 2 of the Public Health Order [2002] 51 Order are mostly congregated within the 20% - 30% range of the minimum dosage specified in China Pharmacopoeia. Conclusion There is an urgent need to strengthen the utility and safety research of TCM＇s, in which raw materials may have potential safety issues. It was suggested that rules on health foods technical evaluation should be established.

关 键 词：营养保健品 植物 食用 动物 食用 参考值 安全 中草药 

分 类 号：R151[医药卫生—营养与食品卫生学]