发酵虫草菌类产品的标准比较与评价  

Comparison and review on specifications of fermented Cordyceps sinensis products

作　　者：杨平 赵晓霞 张永文[1] YANG Ping;ZHAO Xiao-xia;ZHANG Yong-wen(Center for Drug Evaluation, China Food and Drug Administration, Beijing 100022, China)

机构地区：[1]国家食品药品监督管理总局药品审评中心

出　　处：《中国中药杂志》2018年第3期463-468,共6页China Journal of Chinese Materia Medica

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20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。该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。There are five kinds of fermented Cordyceps crude drug and their preparations that have been approved as medicine on the market. Since the initial strains of the crude drug were all isolated from natural Cordyceps sinensis,they have similar names,chemical components and even clinical applications. However,because of the different strain species and fermentation processes,there was significant difference in quality. As a result,they should be clearly distinguished in clinical use. Most of the products were researched and developed during the 1980 s and 1990 s,so there was difference in quality standards for different products,and their quality control levels of some products were not perfect. At present,some of the products are approved as Chinese medicine,others are approved as chemical drugs,with a confusion in products name,management and clinical application. In this paper,the approval numbers,quality standards and clinical applications,and current problems of these products were summarized and compared; some suggestions were put forward,such as standardizing the product name,unifying the management of approval number category,and increasing the specific quality control attributes,in order to provide reference for standard implementation,quality control and drug regulation for fermented Cordyceps crude drugs and their preparations.

关 键 词：发酵虫草菌 质量标准 评价 监管 

分 类 号：R284.1[医药卫生—中药学]