

This project belongs to the basic research on the efficacy of traditional Chinese medicines in the field of traditional Chinese medicine. This project uses modern analytical technology to systematically study the chemical components of traditional Chinese medicine compounds, screen effective components in the body, explain the metabolic changes of the effective components in the body, and obtain indicator components, thereby improving the quality control standards of traditional Chinese medicine compounds. The main technical innovations include: 1. Qualitative analysis of the complex chemical components contained in traditional Chinese medicine compounds and various effective components absorbed in the body through modern analytical technology (liquid-mass spectrometry), elucidates the effective material basis of traditional Chinese medicine compounds, screens effective active ingredients, and guides the development of new traditional Chinese medicine compound preparations. 2. Use liquid chromatography mass spectrometry to establish a method for determining the content of multi-component components in traditional Chinese medicine, conduct multi-component pharmacokinetic studies on the effective substances of traditional Chinese medicine compound, understand the metabolic characteristics of the effective ingredients, and explain the in vivo absorption and metabolism of the effective ingredients of traditional Chinese medicine compound. Process, providing clear controllable indicators for the quality control of traditional Chinese medicine. 3. Using high performance liquid chromatography or liquid mass spectrometry technology, we established an analysis method for simultaneous quantification of multiple characteristic pharmacodynamic components in traditional Chinese medicine compounds, which met the requirement for simultaneous quantification of multiple components in traditional Chinese medicine compounds and improved the quality standards of existing traditional Chinese medicine preparations., used for quality control of traditional Chinese medicine compounds to ensure the uniformity and effectiveness of clinical medication quality. This project has received 1 support from the National Major New Drug Discovery Project, 2 support from the National Natural Science Foundation of China, 2 support from the Shanghai City Science and Technology Commission Fund, 4 support from the Military Fund, and 1 support from the Shanghai City Pharmaceutical Association Fund, with a total amount of more than 5 million yuan; currently, 6 national patents have been applied; 16 relevant SCI papers have been published, with a total impact factor of 31.53 and a maximum impact factor of 2.939. The total number of citations is 124, and the maximum number of citations for a single article is 30; There are 33 core journal papers, with a total of 41 citations, and the highest citations frequency of a single article is 8. Two doctoral students and 18 master's students in pharmaceutical analysis have been trained. The technical methods involved in this project have been successfully applied to improve the quality standards of the in-hospital preparations such as Ganlibao Capsule, Fuzheng Pingxiao Capsule and Wujin Capsule, the traditional Chinese medicine compound preparations of Shanghai Oriental Hepatobiliary Surgery Hospital. At the same time, it guides the preparation development of the traditional Chinese medicine compound Qinggansanjie Granules, ensuring the quality uniformity of the traditional Chinese medicine preparations of Shanghai Oriental Hepatobiliary Surgery Hospital and ensuring the effect of drug treatment for liver cancer patients. This method also plays an important role in the research on the pharmacodynamic material basis and quality control of multiple traditional Chinese medicine compounds such as Xiaochaihu Decoction, Sini Decoction, Qifu Decoction, Gandhi Capsule and Yangxinshi Tablet, and has broad application prospects.
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