

1. The scientific and technological field of the project This project belongs to the research field of traditional Chinese medicine. 2. Main technical innovation content This project has been funded by projects such as the General Project of the National Natural Science Foundation of China. For more than ten years, it has focused on the difficult and hot issues of quality control of traditional Chinese medicines& mdash; The separation and analysis of complex systems of traditional Chinese medicine has carried out a series of pioneering work in terms of method innovation and application innovation: In view of the current situation of low extraction and separation efficiency of effective substances, poor representativeness of fingerprint characteristics of complex systems, and difficulty in analyzing multi-component in vivo processes in the quality control of traditional Chinese medicinal materials, 13 common Chinese medicinal materials such as gardenia, fermented soybean, and hawthorn leaves were taken as the research objects. A comprehensive quality control technical system for traditional Chinese medicine has been established from three aspects: rapid and standardized separation and preparation of effective substances, targeted screening of indicator components for fingerprint characteristics of complex systems, and high-efficiency analysis methods for multi-component in vivo processes. It provides novel experimental ideas and analytical methods for modern research on quality control of traditional Chinese medicines and pharmacokinetic research of innovative drugs. The specific contents include: 1) Focusing on the bottleneck problem of the separation and preparation of effective substances in the complex system of traditional Chinese medicine, we creatively proposed and established a standardized and integrated new technology for online separation of effective substances in traditional Chinese medicine, providing candidate compounds for innovative drug research and modernization research of traditional Chinese medicine. Compounds, controls and effective technical platform for the separation and preparation of active monomers in traditional Chinese medicine. It has successfully established a rapid separation and preparation method for 6 major categories of traditional Chinese medicine monomers from 7 Chinese medicinal materials including gardenia, Hypericum perforatum, and hawthorn leaves, including a two-dimensional liquid chromatography column switching system, a high-speed countercurrent online purity monitoring system, etc., overcoming the limitations of traditional separation technology such as time-consuming, cumbersome, and easy pollution when transferred offline. 2) Focusing on the bottleneck problem of poor representativeness of fingerprint characteristics in complex traditional Chinese medicine systems, exploratory research and pioneering application of the indicator component targeted screening technical system were carried out. Based on pattern recognition and chemical informatics combined with pharmacodynamic screening, gardenia, soy bean, and hawthorn leaves were established. Fingerprint characteristic maps of 10 Chinese medicinal materials such as. In view of the blindness in the selection of qualitative and quantitative indicator components in the process of establishing traditional fingerprints, a new strategy for targeted screening of indicator components based on statistical methods has been successfully established, that is, first selecting the ingredients that have a significant impact on the authenticity of medicinal materials through similarity evaluation and cluster analysis. The ingredients that have a significant impact on the quality of medicinal materials are used as qualitative indicators, and then the ingredients that have a significant impact on the quality of medicinal materials are selected as quantitative indicators based on principal component analysis. Thereby providing a technical platform for characterizing the chemical characteristics and pharmacodynamic material basis of traditional Chinese medicines and realizing comprehensive quality control of traditional Chinese medicines. 3) Focusing on the bottleneck problem of the analysis of complex systems of biological samples with large sample sizes and trace concentrations, research on new high-efficiency and energy-efficient in vivo drug analysis methodology based on the concept of high sensitivity, high selectivity, and high throughput analysis was carried out. A dynamic baseline concentration correction method was proposed for the first time, which effectively eliminated the interference of food-derived components in blank plasma and provided reference for the analysis of in vivo processes of traditional Chinese medicines with the same origin of medicine and food. At the same time, based on the disclosure of mass spectrometry fragmentation laws of different types of active monomers in traditional Chinese medicine, rapid identification of active ingredients in in vivo samples is achieved, and a highly sensitive and highly selective in vivo process analysis method for multiple components of traditional Chinese medicine (especially isomers) is established. It provides novel experimental ideas and analytical methods for modernization research on quality control of traditional Chinese medicine and pharmacokinetic research on innovative drugs. 3. This project of intellectual property and application promotion has received funding from 3 national-level topics and 1 provincial-level topic. It has won 32 awards such as the National University Medicine Forum Special Prize, applied for 10 patents, and issued 7 authorizations. It has published 44 papers, including 25 SCI papers, with a total impact factor of 71.831, and a maximum impact factor of 4.946. The total number of citations is 1166, of which 1141 were cited by him, and the maximum of 504 were cited by him for a single article.
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