1.Mechanism of Huangqi Xiayuxue Decoction Against Hepatocellular Carcinoma via PI3K/Akt/FoxO Signaling Pathway
Xingru XING ; Yuanzhou SHI ; Jiawei WANG ; Di WU ; Yuyao ZHANG ; Yalin WU ; Du CHEN ; Zhen ZHANG ; Sha TIAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):131-141
ObjectiveTo explore the therapeutic effect and mechanism of Huangqi Xiayuxue decoction against hepatocellular carcinoma based on network pharmacology, animal experiments, and cell experiments. MethodsThe active ingredients and corresponding targets of Huangqi Xiayuxue decoction were screened via databases including the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP) and Bioinformatics Analysis Tool for Molecular Mechanism of Traditional Chinese Medicine (BATMAN-TCM). Hepatocellular carcinoma-related targets were retrieved from the GeneCards database. The common targets shared by Huangqi Xiayuxue decoction and hepatocellular carcinoma were subjected to Gene Ontology (GO) functional annotation and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analyses. Huangqi Xiayuxue decoction-containing plasma was prepared. The cell counting kit-8 (CCK-8) assay was adopted to observe the effects of different volume fractions (5%, 10%, 15%, and 20%) of Huangqi Xiayuxue decoction-containing plasma on the proliferation of HepG2, MHCC-97H, Hepa1-6, and Huh-7 cells, and the concentration for subsequent experiments was determined. Flow cytometry was adopted to detect the effects of Huangqi Xiayuxue decoction-containing plasma (5%, 10%, 15%, and 20%) on the apoptosis of MHCC-97H cells. A mouse model of subcutaneous xenograft hepatocellular carcinoma was established. The model mice were assigned into low-, medium-, and high-dose (4.63, 9.25, 18.5 g·kg-1) Huangqi Xiayuxue decoction and sorafenib (20 mg·kg-1) groups. Body mass and tumor volume of mice were dynamically monitored during the intervention period. After 3 weeks of intervention, hematoxylin-eosin (HE) staining was performed to observe tumor morphology. Terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (TUNEL) assay was employed to detect cell apoptosis. Immunohistochemistry (IHC) was adopted to examine the expression of cysteinyl aspartate-specific proteinase-3 (Caspase-3), B-cell lymphoma-2 (Bcl-2), and Bcl-2-associated X protein (Bax) in the tumor tissue. Real-time PCR and Western blot were employed to verify the changes in apoptosis-related factors and the phosphatidylinositol 3-kinase/protein kinase B/forkhead box O1 (PI3K/Akt/FoxO1) signaling pathway. ResultsA total of 220 common targets shared by Huangqi Xiayuxue decoction and hepatocellular carcinoma were screened out by network pharmacology, among which tumor protein p53 (TP53), Akt1, and signal transducer and activator of transcription 3 (STAT3) were the core targets. Pathway enrichment analysis indicated that the common targets were involved in cell apoptosis and proliferation, as well as the PI3K/Akt and FoxO signaling pathways. Cell experiments showed that compared with the blank plasma group, all volume fractions of Huangqi Xiayuxue decoction-containing plasma inhibited the proliferation of HepG2, MHCC-97H, Hepa1-6, and Huh-7 cells (P<0.01). The proportion of early apoptotic cells in MHCC-97H cells was increased after treatment with different volume fractions of Huangqi Xiayuxue decoction-containing plasma (P<0.01). Animal experiments revealed that Huangqi Xiayuxue decoction inhibited the growth of tumor volume, promoted tumor cell apoptosis in the high-dose group, up-regulated the protein and mRNA levels of Bax and Caspase-3, down-regulated the protein and mRNA levels of Bcl-2, and reduced the phosphorylation level of the PI3K/Akt/FoxO1 signaling pathway (P<0.05, P<0.01). ConclusionHuangqi Xiayuxue decoction exerts anti-hepatocellular carcinoma effects by inhibiting the activation of the PI3K/Akt/FoxO1 signaling pathway and promoting hepatocellular carcinoma cell apoptosis.
2.Mechanism of Huangqi Xiayuxue Decoction Against Hepatocellular Carcinoma via PI3K/Akt/FoxO Signaling Pathway
Xingru XING ; Yuanzhou SHI ; Jiawei WANG ; Di WU ; Yuyao ZHANG ; Yalin WU ; Du CHEN ; Zhen ZHANG ; Sha TIAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):131-141
ObjectiveTo explore the therapeutic effect and mechanism of Huangqi Xiayuxue decoction against hepatocellular carcinoma based on network pharmacology, animal experiments, and cell experiments. MethodsThe active ingredients and corresponding targets of Huangqi Xiayuxue decoction were screened via databases including the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP) and Bioinformatics Analysis Tool for Molecular Mechanism of Traditional Chinese Medicine (BATMAN-TCM). Hepatocellular carcinoma-related targets were retrieved from the GeneCards database. The common targets shared by Huangqi Xiayuxue decoction and hepatocellular carcinoma were subjected to Gene Ontology (GO) functional annotation and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analyses. Huangqi Xiayuxue decoction-containing plasma was prepared. The cell counting kit-8 (CCK-8) assay was adopted to observe the effects of different volume fractions (5%, 10%, 15%, and 20%) of Huangqi Xiayuxue decoction-containing plasma on the proliferation of HepG2, MHCC-97H, Hepa1-6, and Huh-7 cells, and the concentration for subsequent experiments was determined. Flow cytometry was adopted to detect the effects of Huangqi Xiayuxue decoction-containing plasma (5%, 10%, 15%, and 20%) on the apoptosis of MHCC-97H cells. A mouse model of subcutaneous xenograft hepatocellular carcinoma was established. The model mice were assigned into low-, medium-, and high-dose (4.63, 9.25, 18.5 g·kg-1) Huangqi Xiayuxue decoction and sorafenib (20 mg·kg-1) groups. Body mass and tumor volume of mice were dynamically monitored during the intervention period. After 3 weeks of intervention, hematoxylin-eosin (HE) staining was performed to observe tumor morphology. Terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (TUNEL) assay was employed to detect cell apoptosis. Immunohistochemistry (IHC) was adopted to examine the expression of cysteinyl aspartate-specific proteinase-3 (Caspase-3), B-cell lymphoma-2 (Bcl-2), and Bcl-2-associated X protein (Bax) in the tumor tissue. Real-time PCR and Western blot were employed to verify the changes in apoptosis-related factors and the phosphatidylinositol 3-kinase/protein kinase B/forkhead box O1 (PI3K/Akt/FoxO1) signaling pathway. ResultsA total of 220 common targets shared by Huangqi Xiayuxue decoction and hepatocellular carcinoma were screened out by network pharmacology, among which tumor protein p53 (TP53), Akt1, and signal transducer and activator of transcription 3 (STAT3) were the core targets. Pathway enrichment analysis indicated that the common targets were involved in cell apoptosis and proliferation, as well as the PI3K/Akt and FoxO signaling pathways. Cell experiments showed that compared with the blank plasma group, all volume fractions of Huangqi Xiayuxue decoction-containing plasma inhibited the proliferation of HepG2, MHCC-97H, Hepa1-6, and Huh-7 cells (P<0.01). The proportion of early apoptotic cells in MHCC-97H cells was increased after treatment with different volume fractions of Huangqi Xiayuxue decoction-containing plasma (P<0.01). Animal experiments revealed that Huangqi Xiayuxue decoction inhibited the growth of tumor volume, promoted tumor cell apoptosis in the high-dose group, up-regulated the protein and mRNA levels of Bax and Caspase-3, down-regulated the protein and mRNA levels of Bcl-2, and reduced the phosphorylation level of the PI3K/Akt/FoxO1 signaling pathway (P<0.05, P<0.01). ConclusionHuangqi Xiayuxue decoction exerts anti-hepatocellular carcinoma effects by inhibiting the activation of the PI3K/Akt/FoxO1 signaling pathway and promoting hepatocellular carcinoma cell apoptosis.
3.Chinese expert consensus on the clinical application of recombinant human thyroid-stimulating hormone (2025 edition)
Chentian SHEN ; Yushen GU ; Hui TAN ; Anren KUANG ; Sijin LI ; Yaming LI ; Jing WANG ; Ningyi JIANG ; Jian TAN ; Zhuoying WANG ; Shaoyan LIU ; Xiaoyi LI ; Jugao FANG ; Dingcun LUO ; Youben FAN ; Hui WANG ; Yuetao WANG ; Xuemei WANG ; Feng WANG ; Wei FU ; Feng SHI ; Xuegong LIU ; Zhongwei LÜ ; Yan XING ; Lin LI ; Hui YANG ; Jun XIN ; Yifan ZHANG ; Yue CHEN ; Yansong LIN ; Wei OUYANG ; Shuzhan YAO ; Changjiu ZHAO ; Xinming ZHAO ; Zairong GAO ; Dingde HUANG ; Qiang WEN ; Xingmin HAN ; Cen LOU ; Weibing MIAO ; Wei FAN ; Quanyong LUO ; Hongcheng SHI
Chinese Journal of Clinical Medicine 2026;33(5):932-944
The recombinant human thyroid-stimulating hormone (rhTSH) can be used for differentiated thyroid cancer (DTC) preparation before 131I therapy, and follow-up. Since its approval by the American Food and Drug Administration (FDA) in 1998, rhTSH has been clinically used in European countries, the United States, and other countries for nearly 30 years. In April 2024, China’s first independently developed rhTSH agent was approved. Based on clinical experience and evidence from domestic and international studies, an expert consensus on the application of rhTSH has been developed following thorough consultations among experts. The consensus offers evidence-based recommendations to guide the appropriate use of rhTSH in clinical practice.
4.Mechanisms of Shuangshen Ningxin Capsules in Modulating NF-κB and MAPK Signaling Pathways to Reduce Cardiac Inflammation and Alleviate Myocardial Ischemia-reperfusion Injury in Rats
Shujuan XU ; Gaojie XIN ; Ce CAO ; Zixin LIU ; Yuanyuan CHEN ; Ran ZHAO ; Lu XING ; Yehao ZHANG ; Yue SHI ; Yanlei MA ; Jianhua FU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(23):83-91
ObjectiveTo investigate the effect and mechanism of Shuangshen Ningxin capsules (SSNX) in regulating the nuclear factor-κB (NF-κB) and mitogen-activated protein kinase (MAPK) pathways to inhibit inflammation and alleviate myocardial ischemia-reperfusion injury (MIRI) in rats. MethodsThe 45 healthy male Sprague-Dawley (SD) rats were divided into sham operation group, model group, and SSNX capsules group (90 mg·kg-1). The left anterior descending coronary artery was ligated to establish the MIRI model. Cardiac function was evaluated by echocardiography, and microvascular reperfusion was analyzed using contrast echocardiography. Myocardial inflammation and injury were assessed by hematoxylin and eosin (HE) staining, immunohistochemistry, and TdT-mediated dUTP nick end labeling (TUNEL). The expression levels of cardiac inflammatory cytokines, including interleukin-1α (IL-1α), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) were detected by enzyme-linked immunosorbent assay (ELISA). Core differentially expressed genes (DEGs) and enriched pathways were screened by transcriptome sequencing. Real-time quantitative polymerase chain reaction (Real-time PCR) and Western blot were used to verify the mRNA expression of Toll-like receptor 2 (TLR2), chemokine (C-X-C motif) ligand 1 (CXCL1) and prostaglandin-endoperoxide synthase 2 (PTGS2), as well as the protein expression of Caspase-3, cleaved Caspase-3, p-NF-κB/NF-κB, phosphorylated extracellular signal-regulated kinase 1/2 (p-ERK1/2/ERK1/2) and p-p38 MAPK/p38 MAPK. ResultsCompared with the sham operation group, the ejection fraction (EF), fractional shortening (FS), stroke volume (SV) and cardiac output (CO) of the model group were significantly decreased (P<0.01), the peak time of myocardial perfusion was prolonged (P<0.01), hypoxia-inducible factor (HIF)-1α and α-smooth muscle actin (SMA) expression increased (P<0.01), the concentrations of inflammatory factors IL-1α, IL-6, TNF-α, TLR2, CXCL1 and PTGS2 increased (P<0.01), and the expression of cleaved Caspase-3, p-NF-κB/NF-κB, p-ERK1/2/ERK1/2 and p-p38 MAPK/p38 MAPK proteins was significantly increased (P<0.01). SSNX could improve cardiac function (P<0.05, P<0.01), and significantly shorten the peak time of myocardial perfusion (P<0.01). Moreover, it could also down-regulate HIF-1α and a-SMA expression (P<0.05, P<0.01), and reduce the concentrations of IL-1α, IL-6, TNF-α (P<0.01), and the mRNA expression of TLR2, CXCL1 and PTGS2 (P<0.01). Additionally, SSNX inhibited the apoptosis rate (P<0.01) and significantly reduced the expression of Cleaved Caspase-3, p-NF-κB/NF-κB, p-ERK1/2/ERK1/2 and p-p38 MAPK/p38 MAPK proteins (P<0.01). ConclusionSSNX can alleviate cardiac inflammation by regulating the NF-κB and MAPK signaling pathways, thereby effectively preventing and alleviating myocardial reperfusion injury.
5.Clinical Efficacy of Tangning Tongluo Tablets for Nonproliferative Diabetic Retinopathy
Fuwen ZHANG ; Junguo DUAN ; Wen XIA ; Tiantian SUN ; Yuheng SHI ; Shicui MEI ; Xiangxia LUO ; Xing LI ; Yujie PAN ; Yong DENG ; Chuanlian RAN ; Hao CHEN ; Li PEI ; Shuyu YANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):132-139
ObjectiveTo observe the clinical efficacy and safety of Tangning Tongluo tablets in the treatment of nonproliferative diabetic retinopathy (DR). MethodsFourteen research centers participated in this study, which spanned a time interval from September 2021 to May 2023. A total of 240 patients with nonproliferative DR were included and randomly assigned into an observation group (120 cases) and a control group (120 cases). The observation group was treated with Tangning Tongluo tablets, and the control group with calcium dobesilate capsules. Both groups were treated for 24 consecutive weeks. The vision, DR progression rate, retinal microhemangioma, hemorrhage area, exudation area, glycosylated hemoglobin (HbA1c) level, and TCM syndrome score were assessed before and after treatment, and the safety was observed. ResultsThe vision changed in both groups after treatment (P<0.05), and the observation group showed higher best corrected visual acuity (BCVA) than the control group (P<0.05). The DR progression was slow with similar rates in the two groups. The fundus hemorrhage area and exudation area did not change significantly after treatment in both groups, while the observation group outperformed the control group in reducing the fundus hemorrhage area and exudation area. There was no significant difference in the number of microhemangiomas between the two groups before treatment. After treatment, the number of microhemangiomas decreased in both the observation group (Z=-1.437, P<0.05) and the control group (Z=-2.238, P<0.05), and it showed no significant difference between the two groups. As the treatment time prolonged, the number of microhemangiomas gradually decreased in both groups. There was no significant difference in the HbA1c level between the two groups before treatment. After treatment, the decline in the HbA1c level showed no significant difference between the two groups. The TCM syndrome score did not have a statistically significant difference between the two groups before treatment. After treatment, neither the TCM syndrome score nor the response rate had significant difference between the two groups. With the extension of the treatment time, both groups showed amelioration of TCM syndrome compared with the baseline. ConclusionTangning Tongluo tablets are safe and effective in the treatment of nonproliferative DR, being capable of improving vision and reducing hemorrhage and exudation in the fundus.
6.Development and application on a full process disease diagnosis and treatment assistance system based on generative artificial intelligence.
Wanjie YANG ; Hao FU ; Xiangfei MENG ; Changsong LI ; Ce YU ; Xinting ZHAO ; Weifeng LI ; Wei ZHAO ; Qi WU ; Zheng CHEN ; Chao CUI ; Song GAO ; Zhen WAN ; Jing HAN ; Weikang ZHAO ; Dong HAN ; Zhongzhuo JIANG ; Weirong XING ; Mou YANG ; Xuan MIAO ; Haibai SUN ; Zhiheng XING ; Junquan ZHANG ; Lixia SHI ; Li ZHANG
Chinese Critical Care Medicine 2025;37(5):477-483
The rapid development of artificial intelligence (AI), especially generative AI (GenAI), has already brought, and will continue to bring, revolutionary changes to our daily production and life, as well as create new opportunities and challenges for diagnostic and therapeutic practices in the medical field. Haihe Hospital of Tianjin University collaborates with the National Supercomputer Center in Tianjin, Tianjin University, and other institutions to carry out research in areas such as smart healthcare, smart services, and smart management. We have conducted research and development of a full-process disease diagnosis and treatment assistance system based on GenAI in the field of smart healthcare. The development of this project is of great significance. The first goal is to upgrade and transform the hospital's information center, organically integrate it with existing information systems, and provide the necessary computing power storage support for intelligent services within the hospital. We have implemented the localized deployment of three models: Tianhe "Tianyuan", WiNGPT, and DeepSeek. The second is to create a digital avatar of the chief physician/chief physician's voice and image by integrating multimodal intelligent interaction technology. With generative intelligence as the core, this solution provides patients with a visual medical interaction solution. The third is to achieve deep adaptation between generative intelligence and the entire process of patient medical treatment. In this project, we have developed assistant tools such as intelligent inquiry, intelligent diagnosis and recognition, intelligent treatment plan generation, and intelligent assisted medical record generation to improve the safety, quality, and efficiency of the diagnosis and treatment process. This study introduces the content of a full-process disease diagnosis and treatment assistance system, aiming to provide references and insights for the digital transformation of the healthcare industry.
Artificial Intelligence
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Humans
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Delivery of Health Care
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Generative Artificial Intelligence
7.Serratia marcescens TF-1 for biodegradation of chlorobenzene contaminants in soil and its application in in-situ remediation of chemical industrial sites.
Fang GOU ; Yunchun SHI ; Hao CHEN ; Wenting FU ; Liangjie LI ; Zhilin XING ; Jiangfeng GUO
Chinese Journal of Biotechnology 2025;41(6):2483-2497
Chlorobenzene contaminants (CBs) pose a threat to the eco-environment, and functional strains hold considerable potential for the remediation of CB-contaminated sites. To deeply explore the application potential of functional bacteria in the in-situ bioremediation of CBs, this study focused on the biodegradation characteristics and degradation kinetics of CB and 1, 2-dichlorobenzene (1, 2-DCB) in soil by the isolated strain Serratia marcescens TF-1. Additionally, an in-situ remediation trial was conducted with this strain at a chemical industrial site. Batch serum bottle experiments showed that the degradation rate of CB at the concentrations ranging from 20 to 200 mg/L by TF-1 was 0.22-0.66 mol/(gcell·h), following the Haldane model, with the optimal concentration at 23.12 mg/L. The results from simulated soil degradation experiments indicated that the combined use of TF-1 and sodium succinate (SS) significantly enhanced the degradation of CBs, with the maximum degradation rate of CB reaching 0.104 d-1 and a half-life of 6.66 d. For 1, 2-DCB, the maximum degradation rate constant was 0.068 7 d-1, with a half-life of 10.087 d. The in-situ remediation results at the chemically contaminated site demonstrated that the introduction of bacterial inoculant and SS significantly improved the removal of CBs, achieving the removal rates of 84.2%-100% after 10 d. CB, 1, 4-dichlorobenzene (1, 4-DCB), and benzo[a]pyrene were completely removed. Microbial diversity analysis revealed that the in-situ remediation facilitated the colonization of TF-1 and the enrichment of indigenous nitrogen-fixing Azoarcus, which may have played a key role in the degradation process. This study provides a theoretical basis and practical experience for the in situ bioremediation of CBs-contaminated sites.
Chlorobenzenes/isolation & purification*
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Biodegradation, Environmental
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Soil Pollutants/isolation & purification*
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Serratia marcescens/metabolism*
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Industrial Waste
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Soil Microbiology
8.Value of lymph node ratio combined with AFP,CA199 and CA724 in prognostic evaluation of patients undergoing surgical treatment for cervical cancer
Huijuan CHEN ; Baomei SHI ; Li XING
Chinese Journal of Endocrine Surgery 2025;19(3):439-443
Objective:To evaluate the prognostic value of lymph node ratio (LNR) combined with alpha-fetoprotein (AFP), carbohydrate antigen 199 (CA199) and carbohydrate antigen 724 (CA724) in patients undergoing surgical treatment for cervical cancer.Methods:A total of 118 patients with cervical cancer were treated in Yiwu Central Hospital from Jan.2018 to Aug. 2021. Patients with recurrence, metastasis and death during follow-up were included in the poor prognosis group, and vice versa in the good prognosis group. Clinical data, laboratory indicators and LNR, AFP, CA199 and CA724 levels of the subjects were collected. Lasso-Logistic regression analysis was used to screen independent risk factors affecting postoperative poor prognosis of the study subjects, and receiver operating characteristic (ROC) curve was drawn to analyze the predictive value of LNR combined with AFP, CA199 and CA724 in evaluating postoperative poor prognosis of patients.Results:During the follow-up period, 15 out of 118 patients were lost to follow-up (12.71%, 15/118). Among the remaining 103 patients, 28 patients died, 12 patients had metastasis, and 7 patients had relapse, and the prognosis was 45.63% (47/103). Compared with the good prognosis group, the poor prognosis group had higher clinical stage (stage III), tumor size (> 4.0 cm), differentiation degree (low differentiation), proportion of lymph node metastasis and LNR, AFP, CA199, CA724 levels ( P<0.05). Clinical stage (stage III), differentiation degree (low differentiation), LNR, AFP, CA199, CA724 were independent risk factors for poor prognosis of patients with cervical cancer after surgery ( P<0.05). ROC curve results showed that the area under ROC curve (AUC), 95% CI and specificity of LNR combined with AFP, CA199 and CA724 in evaluating postoperative poor prognosis of cervical cancer patients were 0.904, 0.840-0.969 and 94.60%, respectively, higher than the prediction value of the above indexes alone ( P<0.001) . Conclusion:Abnormal levels of LNR, AFP, CA199 and CA724 are independent risk factors for postoperative poor prognosis in patients with cervical cancer, and the combined detection of these indicators has a higher value in predicting postoperative poor prognosis in patients with cervical cancer.
9.Heart Yin deficiency and cardiac fibrosis: from pathological mechanisms to therapeutic strategies.
Jia-Hui CHEN ; Si-Jing LI ; Xiao-Jiao ZHANG ; Zi-Ru LI ; Xing-Ling HE ; Xing-Ling CHEN ; Tao-Chun YE ; Zhi-Ying LIU ; Hui-Li LIAO ; Lu LU ; Zhong-Qi YANG ; Shi-Hao NI
China Journal of Chinese Materia Medica 2025;50(7):1987-1993
Cardiac fibrosis(CF) is a cardiac pathological process characterized by excessive deposition of extracellular matrix(ECM). When the heart is damaged by adverse stimuli, cardiac fibroblasts are activated and secrete a large amount of ECM, leading to changes in cardiac fibrosis, myocardial stiffness, and cardiac function declines and accelerating the development of heart failure. There is a close relationship between heart yin deficiency and cardiac fibrosis, which have similar pathogenic mechanisms. Heart Yin deficiency, characterized by insufficient Yin fluids, causes the heart to lose its nourishing function, which acts as the initiating factor for myocardial dystrophy. The deficiency of body fluids leads to stagnation of blood flow, resulting in blood stasis and water retention. Blood stasis and water retention accumulate in the heart, which aligns with the pathological manifestation of excessive deposition of ECM, as a tangible pathogenic factor. This is an inevitable stage of the disease process. The lingering of blood stasis combined with water retention eventually leads to the generation of heat and toxins, triggering inflammatory responses similar to heat toxins, which continuously stimulate the heart and cause the ultimate outcome of CF. Considering the syndrome of heart Yin deficiency, traditional Chinese medicine capable of nourishing Yin, activating blood, and promoting urination can reduce myocardial cell apoptosis, inhibit fibroblast activation, and lower the inflammation level, showing significant advantages in combating CF.
Humans
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Fibrosis/drug therapy*
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Animals
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Yin Deficiency/metabolism*
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Myocardium/metabolism*
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Medicine, Chinese Traditional
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Drugs, Chinese Herbal/therapeutic use*
10.Processing technology of calcined Magnetitum based on concept of QbD and its XRD characteristic spectra.
De-Wen ZENG ; Jing-Wei ZHOU ; Tian-Xing HE ; Yu-Mei CHEN ; Huan-Huan XU ; Jian FENG ; Yue YANG ; Xin CHEN ; Jia-Liang ZOU ; Lin CHEN ; Hong-Ping CHEN ; Shi-Lin CHEN ; Yuan HU ; You-Ping LIU
China Journal of Chinese Materia Medica 2025;50(9):2391-2403
Guided by the concept of quality by design(QbD), this study optimizes the calcination and quenching process of calcined Magnetitum and establishes the XRD characteristic spectra of calcined Magnetitum, providing a scientific basis for the formulation of quality standards. Based on the processing methods and quality requirements of Magnetitum in the Chinese Pharmacopoeia, the critical process parameters(CPPs) identified were calcination temperature, calcination time, particle size, laying thickness, and the number of vinegar quenching cycles. The critical quality attributes(CQAs) included Fe mass fraction, Fe~(2+) dissolution, and surface color. The weight coefficients were determined by combining Analytic Hierarchy Process(AHP) and the criteria importance though intercrieria correlation(CRITIC) method, and the calcination process was optimized using orthogonal experimentation. Surface color was selected as a CQA, and based on the principle of color value, the surface color of calcined Magnetitum was objectively quantified. The vinegar quenching process was then optimized to determine the best processing conditions. X-ray diffraction(XRD) was used to establish the characteristic spectra of calcined Magnetitum, and methods such as similarity evaluation, cluster analysis, and orthogonal partial least squares-discriminant analysis(OPLS-DA) were used to evaluate the quality of the spectra. The optimized calcined Magnetitum preparation process was found to be calcination at 750 ℃ for 1 h, with a laying thickness of 4 cm, a particle size of 0.4-0.8 cm, and one vinegar quenching cycle(Magnetitum-vinegar ratio 10∶3), which was stable and feasible. The XRD characteristic spectra analysis method, featuring 9 common peaks as fingerprint information, was established. The average correlation coefficient ranged from 0.839 5-0.988 1, and the average angle cosine ranged from 0.914 4 to 0.995 6, indicating good similarity. Cluster analysis results showed that Magnetitum and calcined Magnetitum could be grouped together, with similar compositions. OPLS-DA discriminant analysis identified three key characteristic peaks, with Fe_2O_3 being the distinguishing component between the two. The final optimized processing method is stable and feasible, and the XRD characteristic spectra of calcined Magnetitum was initially established, providing a reference for subsequent quality control and the formulation of quality standards for calcined Magnetitum.
X-Ray Diffraction/methods*
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Drugs, Chinese Herbal/chemistry*
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Quality Control
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Particle Size

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