The CMM Analysis and Quality Standards Research Team addresses key issues in the high-quality development of the CMM industry. It conducts systematic research on component analysis and methodological evaluation of complex CMM systems, pharmacodynamic material bases and mechanisms of action, and quality control standards. Supported by national and provincial funds, including the National Major Program and National Natural Science Foundation, the team has achieved significant research outcomes.
The team proposed an integrated CMM quality solution encompassing in-depth research, concise standards, and precise testing, developed a chemical-metabolic-biological analysis method tailored to complex CMM systems, and established a comprehensive CMM quality standard system centered on the Chinese Pharmacopeia. This system has been adopted by international pharmacopeias such as the Chinese Pharmacopeia, United States Pharmacopeia, and European Pharmacopeia. The team also developed precise CMM detection technologies, earning one National Natural Science Award (Second Prize) and two National Science and Technology Progress Awards (Second Prize).
Leveraging these quality control technologies and standards, the team promotes CMM internationalization. It pioneered the development of the United States Pharmacopeia standard for Radix Salviae Miltiorrhizae and the European Pharmacopeia standard for Ramulus Uncariae Cum Uncis, setting a precedent for Chinese scholars in developing international CMM standards. The team has since conducted demonstration research for over 100 commonly used CMM, including Panax notoginseng root and rhizome, Ganoderma lucidum fruiting body, Panax ginseng root and rhizome, and Coix lacrymajobi var. mayuen seed. Its innovative CMM drug, Dan Qi Tong Mai Pian, received clinical trial approval in 2009 and has completed Phase II clinical trials. In November 2024, the team obtained a drug registration certificate for the classic formula Yi Guan Jian Granules.
The structural analysis of CMM macromolecules such as polysaccharides, proteins, and peptides remains a scientific challenge, hindering quality standard development for these components. The team will focus on characterizing CMM macromolecule structures, developing analytical techniques, elucidating the pharmacodynamic materials and mechanisms of animal-based CMM using modern science, and studying the role of CMM polysaccharides via gut microbiota. These efforts aim to drive innovation in CMM quality technologies, facilitate the industrial application of high-quality standards, and promote standardized, high-quality development of the CMM industry.
Panel Members:
Guo De’an (Researcher); Zhang Jianqing (Associate Researcher); Bi Qirui (Associate Researcher); Wei Wenlong (Associate Researcher); Yao Shuai (Associate Researcher); Qu Hua (Associate Researcher)