已上市中药复方保健产品评价方法和策略  

Evaluation method and strategy of Chinese medicine compound health care products on the market

作　　者：杨溢 张凤红 周丽华 谭建 倪强[3] 张旭 张琛 唐可 颜静蕊 孙小钧 李靖[3] 李鑫 YANG Yi;ZHANG Feng-hong;ZHOU Li-hua;TAN Jian;NI Qiang;ZHANG Xu;ZHANG Chen;TANG Ke;YAN Jing-rui;SUN Xiao-jun;LI Jing;LI Xin(CONBIO(TianJin)Health Management Center,Tianjin 300011,China;The 983th Hospital of Joint Logistics Support Forces of Chinese PLA,Tianjin 300142,China;Tianjin Third Central Hospital,Tianjin 300170,China)

机构地区：[1]康奥(天津)健康管理中心,天津300011 [2]中国人民解放军联勤保障部队第九八三医院,天津300142 [3]天津市第三中心医院,天津300170

出　　处：《中华中医药杂志》2022年第9期5024-5028,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家重点研发计划(No.2018YFC1706806)。

摘　　要：已上市中药复方保健产品种类很多,仅保健食品就超过10 000种,面对出现的各种问题,却缺乏具体的评价方法和评价体系,因此有必要建立科学可行的方法对其安全性、有效性、经济性和稳定性进行评价。文章总结了中药复方保健产品的优势和特点,论述了已上市中药复方保健产品存在的问题和评价的必要性,建立已上市中药复方保健产品的评价方法、评价内容、评价流程、评价结果判定、风险评估和结果应用等,提出评价策略,为今后已上市产品评价提供研究思路,为政策制定提供有益的借鉴。There are many kinds of Chinese medicine compound health care products on the market, and there are more than 10 000 kinds of health food alone. In the face of various problems, there is a lack of specific evaluation methods and evaluation systems. Therefore, it is necessary to establish scientific and feasible methods to evaluate safety, effectiveness, economy and stability. This paper summarizes the advantages and characteristics of Chinese medicine compound health care products, and discusses the problems existing in the listed Chinese medicine compound health care products and the necessity of evaluation, the evaluation method, content, process, result judgment, risk assessment and result application of the marketed Chinese medicine compound health care products are established. This paper provides evaluation strategy of marketed products in the future, and provides a useful reference for policy formulation.

关 键 词：中药复方保健产品 上市后评价 辨证保健 评价方法 评价策略 

分 类 号：R288[医药卫生—中药学]