发酵虫草菌类产品的标准比较与评价.docVIP

发酵虫草菌类产品的标准比较与评价 杨平 赵晓霞 张永文 国家食品药品监督管理总局药品审评中心 X 关注成功！ 加关注后您将方便地在 我的关注中得到本文献的被引频次变化的通知！ 新浪微博 腾讯微博 人人网 开心网 豆瓣网 网易微博 摘????要： 目前市场上已获得药品批准文号的发酵虫草菌类产品包括5种发酵虫草菌粉原料药及其相关制剂。由于原料药的起始菌株均为从天然冬虫夏草中分离而来, 它们的名称和化学成分类似, 临床作用也较为相近。但因其菌种和发酵工艺不同, 质量具有明显的差异性, 临床应用也各有侧重, 故在使用中应予以明确区分。该类产品的研究开发多在上世纪80~90年代, 不同产品的质量标准差异较大, 部分产品质量控制水平较低。且目前发酵虫草菌类产品存在同时按化学药批准文号和中药批准文号管理的情况, 其名称使用、监管和临床应用也较为混乱。本文通过对发酵虫草菌类产品的批准文号类别、质量标准及应用情况进行比较和梳理, 总结了该类产品的标准情况和存在问题, 提出规范产品名称、统一文号管理类别、增加专属性质量控制内容等相关建议, 以期对发酵虫草菌粉及相关制剂的标准执行、质量控制以及药品监管提供参考。 关键词： 发酵虫草菌; 质量标准; 评价; 监管; 作者简介：杨平, 博士, 主要研究方向:中药、天然药物药学评价与研究。Tel:010 E-mail:yangp@。 收稿日期：2017-09-15 Discussions on specifications of fermented Cordyceps sinensis products and reviews YANG Ping ZHAO Xiao-xia ZHANG Yong-wen Center for Drug Evaluation; Abstract： There are five kinds of fermented Cordyceps raw materials and their preparations that have been approved as medicine on the market. Since the initial strains were all isolated from natural Cordyceps sinensis, they have similar name, chemical components and even clinical applications. However, because of the different strains and fermentation process, difference exists among the five materials, as a result, they should be clearly distinguished in use. Most of the products were researched and developed during the 1980 s and 1990 s, the quality control standards of some products were not perfect. Some of the products are approved as Chinese medicine, others are approved as chemical drugs. And there has a confusion of products name, management and clinical application. In this paper, the approval numbers, standards and clinical applications of these products were summarized, in order to provide reference for standard implementation, quality control and drug regulation for fermented Cordyceps raw materials and their preparations. Keyword： fermented Cordyceps sinensis; specifications; review; regulation; Received： 2017-09-15 发酵虫草菌类产品是指从天然冬虫夏草中分离得到的菌株经过人工培育发酵形成的菌丝体制成的各种产品。其中最早发现的菌株是1972年中国学者从青海省采集