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Shengqing Capsules: Key Constituents and Mechanism of Action in the Treatment of Cholesterol Gallstones from a Liver Perspective

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登记号:G20251414

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关键词: Shengqing capsules Mechanism of action cholesterol gallstones

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成果名称: Shengqing Capsules: Key Constituents and Mechanism of Action in the Treatment of Cholesterol Gallstones from a Liver Perspective
成果登记号: G20251414 学科分类:
绿色分类: 项目关键词: Shengqing capsules  Mechanism of action   cholesterol gallstones    
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Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital

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国家/地区: Shanghai 知识产权: Invention patent, others
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This project falls within the scope of basic clinical application of traditional Chinese medicine (TCM). Building upon the satisfactory therapeutic effects and new drug certification obtained from TCM in the prevention and treatment of gallstone disease, this project aims to screen the key components of Shengqing Capsules, elucidate their mechanisms of action, and represents a successful attempt at modernizing TCM. Gallbladder stones are often treated surgically, but the risks associated with surgery continue to pose a challenge for patients and doctors alike. Currently, there is a lack of safe, effective drugs that significantly reduce the need for surgery in clinical practice. The research team has inherited the clinical experience and academic thoughts of renowned TCM experts, forming the theory of 'treating gallbladder diseases from the perspective of the liver,' and has developed a series of new drugs for cholesterol stone prevention and treatment represented by Shengqing Capsules. A series of studies have been conducted around their efficacy and mechanisms of action, with some phased results obtained, but it has always been unable to systematically elucidate the mechanism of action from the 'liver,' which is a consensus-based source in both modern and traditional Chinese medicine that contributes to the formation of stones. Although Shengqing Capsules are considered a 'small compound formula,' their active ingredients are complex, the key components are unclear, and the mechanism of action is not well defined. This poses a bottleneck for clinical application and promotion. Therefore, this study employs modern systems biology techniques to expand the focus from 'gallbladder' to 'liver,' and to broaden the research subject from 'small compound formula' to 'key components.' With 'liver' as the hub, this study systematically sorts out and explains the mechanism of action of Shengqing Capsules in preventing and treating cholesterol gallstones, both internally and externally. This is of great significance for further improving clinical efficacy, promoting its wider application, and enhancing the theoretical connotations of 'treating bile diseases from the liver.' Key Technological Innovations: 1. First proposed the theory of 'treating gallbladder diseases from the liver' and created a new Chinese medicine for clearing heat and promoting bile flow, Shengqing Capsules. 2. For the first time, established a fingerprint chromatogram of Shengqing Capsules using HPLC method, providing scientific basis for quality control of the drug, and laying the foundation for subsequent elucidation of the key components of Shengqing Capsules in preventing and treating cholesterol stones. 3. Focused on the perspective of systems biology to systematically explain the mechanism of action of Shengqing Capsules in preventing and treating cholesterol stones from shallow to deep within the body. Established a cholesterol stone model in C57 mice. Observed the lithiasis rate and biochemical indicators such as TC; used Oligo GEArray chip to detect liver gene expression profile; molecular biology detection of liver PPAR-γ, NF-κB genes and protein expression. The results showed that Shengqing Capsules can reduce the lithiasis rate, lower TC, LDL-C, MDA and LDH content, enhance GSH and SOD activity; Compared with the model group, 38 genes showed significantly different expression in the Qingsheng Capsule group, including 36 downregulated and 2 upregulated; compared with the model group, 27 genes were downregulated by twice in both the normal group and Qingsheng Capsule group. Qingsheng Capsule can upregulate the expression of PPARγ and CYP7A1 genes and proteins, and inhibit NF-κB nuclear translocation.④ For the first time, using a human L-O2 liver cell oxidative damage model in vitro, the mechanism of action of key components of Qingsheng Capsule in preventing cholesterol gallstones was elucidated, laying the foundation for developing Qingsheng Capsule from a traditional Chinese medicine (TCM) formula into a new type of TCM with clear components and specific targets. An in vitro model of human L-O2 liver cell oxidative damage was established, and the main effective components of Qingsheng Capsule were screened as hesperidin, resveratrol, and rhein; using orthogonal design, the best effective combination for repairing oxidative damaged liver cells was identified as (hesperidin 4: resveratrol 2: rhein 1); Shengqing Capsules have a good repair effect on oxidative damage and can restore liver cell cholesterol metabolism by upregulating the expression of CYP7A1 gene and protein, and downregulating the expression of SCP2 gene and protein. There are 26 published papers, including 1 SCI paper cited 73 times; 2 books have been published. One national invention patent has been obtained, with 2 international and national academic exchanges. Six graduate students have been trained. Clinical application has been over thirty years, enriching the treatment system for gallstone disease, improving the efficacy of non-surgical treatment for gallstone disease, and has received a new drug certificate (No: National Medicine Certificate Z20030053). The research results provide scientific basis for the promotion and application of Shengqing Capsules in the field of gallstone disease; it also lays the foundation for developing a new type of traditional Chinese medicine compound prescription for treating gallstone disease with clear components and targets. It directly benefits the vast number of patients with gallstone disease. It has produced significant economic benefits and certain social benefits.
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