Yang Ping, Zhao Xiao-Xia, Zhang Yong-Wen
Center for Drug Evaluation， China Food and Drug Administration， Beijing 100022， China.
Zhongguo Zhong Yao Za Zhi. 2018 Feb;43(3):463-468. doi: 10.19540/j.cnki.cjcmm.20171012.001.
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 1980s and 1990s， 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.
目前已有五种发酵虫草菌粉及其制剂被批准为药品上市。由于这些菌粉的原始菌株均分离自天然冬虫夏草，它们名称相似、化学成分相近，甚至临床应用也类似。然而，由于菌株种类和发酵工艺不同，其质量存在显著差异。因此，在临床使用中应加以明确区分。这些产品大多是在20世纪80年代和90年代研发的，不同产品的质量标准存在差异，部分产品的质量控制水平不完善。目前，部分产品被批准为中药，部分被批准为化学药，在产品名称、管理和临床应用方面存在混乱。本文对这些产品的批准文号、质量标准、临床应用及存在的问题进行了总结和比较，并提出了一些建议，如规范产品名称、统一批准文号类别管理、增加具体质量控制属性等，以期为发酵虫草菌粉及其制剂的标准执行、质量控制和药品监管提供参考。
