Quality calculation and analysis technology of Chinese medicine and its application in Shen Mai injection’s industrial production

 

Participants: Yiyu Chen, Yuhang Li, Yongjiang Wu, Zhengyu Xu, Haibin Qu, Yanhua Tian, Xiaohui Fan, Zhufeng Ma, Minjun Chen, Shanfei Zhang, Ping Liu, Min Zhou, Haijiang Zhang, Shiling Tian

 

Major institutions: Zhejiang University, ChiaTai Qingchun Bao Pharmaceutical Co., Ltd.

     This achievement was accomplished during the national "Ninth Five-Year Plan" for scientific and technological research projects, with independent intellectual property rights of the quality control technologies of modern traditional Chinese medicine. The project focused on quality control of Chinese herbal compound injection. By using Shen Mai injection, we evaluated ingredients, intermediates, formulations, pharmaceutical process and other important aspects of the production process. With the help of pharmaceutical informatics technology, we carried out the overall quality evaluation of Chinese herbal medicines and pharmaceutical process stability of traditional Chinese medicine, as well as research on the material basis of Shen Mai injection. The formation of traditional Chinese medicine quality analysis methodology, led to the establishment of corresponding quality control methods, which eventually contributed to the industrial practice of Shenmai injection.

     This achievement were identified to have reached the advanced international level, some were even leading in the field. The technologies were now applied by the ChiaTai Qingchun Bao Pharmaceutical Co., Ltd. Through the application of this technology, the Dengfeng Shen Mai injection strengthened its market competitiveness and made annual sales of more than 300 million yuan a year, outrunning all of its counterparts. The technologies can be further disseminated in the traditional Chinese medicine industry to significantly enhance and develop our nation’s pharmaceutical technology level.