Comparison and review on specifications of fermented Cordyceps sinensis products.
10.19540/j.cnki.cjcmm.20171012.001
- Author:
Ping YANG
1
;
Xiao-Xia ZHAO
1
;
Yong-Wen ZHANG
1
Author Information
1. Center for Drug Evaluation， China Food and Drug Administration， Beijing 100022， China.
- Publication Type:Journal Article
- Keywords:
fermented Cordyceps sinensis;
regulation;
review;
specifications
- MeSH:
Biological Products;
standards;
Cordyceps;
chemistry;
Fermentation;
Medicine, Chinese Traditional;
standards;
Quality Control
- From:
China Journal of Chinese Materia Medica
2018;43(3):463-468
- CountryChina
- Language:Chinese
-
Abstract:
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.
