1.A prediction model for mild cognitive impairment risk among the elderly
MA Zongkang ; LIU Xinglang ; LI Huihui ; HE Guowei ; YAN Ping ; ZHANG Chuanrong ; MA Xuan ; CHE Yajie ; YU Shan ; CHEN Fenghui
Journal of Preventive Medicine 2026;38(2):124-129
Objective:
To develop a prediction model for mild cognitive impairment (MCI) risk among the elderly, so as to provide a tool for MCI early screening.
Methods :
From July 2022 to September 2024, a multi-stage stratified random cluster sampling method was used to recruit permanent residents aged ≥65 years from the Xinjiang Uygur Autonomous Region as study participants. Data on sociodemographic characteristics, nutritional status, body composition indices, bone mineral density, and handgrip strength were collected through questionnaires and physical examinations. Sarcopenia was defined based on appendicular skeletal muscle index and handgrip strength. MCI was assessed using the Mini-Mental State Examination, with adjustments for educational level. Participants were randomly divided into a training set and a validation set in a 7∶3 ratio. LASSO regression and multivariable logistic regression models were employed to screen for predictors and construct an MCI risk prediction model. The predictive performance of the model was evaluated using receiver operating characteristic (ROC) curve and decision curve analysis (DCA).
Results:
A total of 1 641 participants were surveyed, including 755 males (46.01%) and 886 females (53.99%). The majority of participants were aged 65-<75 years, comprising 1 154 individuals (70.32%). MCI was detected in 517 participants, corresponding to a detection rate of 31.51%. Resultsfrom LASSO regression and multivariate logistic regression analysis showed that residence (rural, OR = 2.323, 95% CI: 1.682-3.210), age (75-<85 years, OR = 1.405, 95% CI: 1.019-1.937; ≥85 years, OR = 3.655, 95% CI: 1.696-7.875), educational level (primary school, OR = 0.341, 95% CI: 0.247-0.472; junior high school, OR = 0.255, 95% CI: 0.160-0.408; high school, OR = 0.286, 95% CI: 0.154-0.531; bachelor's degree or above, OR = 0.120, 95% CI: 0.041-0.351), history of alcohol consumption (yes, OR = 3.216, 95% CI: 2.164-4.779), risk of malnutrition (yes, OR = 1.464, 95% CI: 1.064-2.014), sarcopenia (yes, OR = 3.197, 95% CI: 2.332-4.385), and waist-to-hip ratio (abnormal, OR = 1.540, 95% CI: 1.159-2.048) were identified as predictive factors for MCI among the elderly. In the training set, the area under the ROC curve, sensitivity, and specificity were 0.788, 0.719, and 0.712, respectively. In the validation set, the corresponding values were 0.784, 0.913, and 0.542, respectively. DCA demonstrated that the model provided a higher clinical net benefit for predicting MCI risk when the risk threshold probability ranged from 0.124 to 0.764.
Conclusion
The prediction model developed in this study demonstrates good discriminative ability and clinical utility, indicating its substantial value for predicting the MCI risk among the elderly.
2.Mechanism of Shenling baizhu san in ameliorating ulcerative colitis via regulating flora metabolism-related proteins and TLR4/NF-κB/NLRP3 inflammatory axis
Jiajia XU ; Yu YOU ; Jiaoman WANG ; Yuhui LIU ; Shiyao CHANG ; Zhixian HE ; Ping LI ; Ziyan WANG ; Wei XIONG ; Fei HAN
China Pharmacy 2026;37(15):1992-1997
OBJECTIVE To investigate the mechanism of Shenling baizhu san (SLBZS) in ameliorating ulcerative colitis (UC). METHODS Mice were randomly divided into normal group, model group, and low-, medium-, high-dose SLBZS groups (3, 6, 12 g/kg), with 10 mice in each group. Except for the normal group, mice in other groups were given free access to 3% dextran sulfate sodium solution for 7 days to establish UC models. Simultaneously, mice in each group were intragastrically administered corresponding medicinal liquid or double-distilled water once a day for consecutive 7 days. After the last administration, the histopathological morphology of colon tissues was observed; the serum levels of inflammatory factors including tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β) and IL-18 were detected; the total bile acid contents in liver, gallbladder and colon tissues were determined; the expression level of NOD-like receptor family pyrin domain-containing protein 3 (NLRP3) in colon tissues was tested. The expression levels of flora metabolism-related proteins [G protein-coupled receptor 41(GPR41),GPR43,farnesoid X receptor (FXR), G protein-coupled bile acid receptor 1 (TGR5), flavin-containing monooxygenase 3 (FMO3), cytochrome P450 family 27 subfamily A member 1 (CYP27A1), CYP7A1] in liver or colon tissues, as well as the proteins related to Toll-like receptor 4 (TLR4)/nuclear factor-κB (NF-κB)/NLRP3 inflammatory axis [TLR4, NF-κB, phosphorylated NF-κB (p-NF-κB), myeloid differentiation factor 88 (MyD88), NLRP3, apoptosis-associated speck-like protein containing a CARD (ASC), caspase-1] in colon tissues were measured. RESULTS Compared with the model group, the colon tissue injury and inflammatory cell infiltration were alleviated in medium- and high-dose SLBZS groups. The serum levels of TNF-α, IL-1β and IL-18, total bile acid contents in liver and colon tissues, as well as the protein expression levels of FMO3 and CYP7A1 in liver tissues, TLR4, p-NF-κB, NF-κB, MyD88, NLRP3, ASC and caspase-1 in colon tissues were significantly decreased (P<0.05). Meanwhile, the total bile acid content in gallbladder, the protein expression levels of GPR41 and GPR43 in colon tissues, along with CYP27A1, FXR and TGR5 in liver tissues were significantly increased (P<0.05). CONCLUSIONS SLBZS may relieve colonic inflammatory injury and ameliorate UC by regulating the expression of flora metabolism-related proteins and inhibiting the abnormal activation of TLR4/NF-κB/NLRP3 inflammatory axis.
3.Effect of Schisanlactone E on Neuroinflammation and Synaptic Damage in APP/PS1 Mice and Their Relationship with Th17/Treg Immune Balance
Wenjing YU ; Miao YANG ; Chunxiang HE ; Jiawei HE ; Zhenyan SONG ; Ping LI ; Shaowu CHENG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(22):112-123
ObjectiveTo investigate the effect of schisanlactone E in ameliorating neuroinflammation and synaptic injury in APP/PS1 mice and to elucidate whether its mechanism is related to the regulation of helper T cell 17 (Th17)/regulatory T cell (Treg) immune balance. MethodsAPP/PS1 transgenic mice were assigned into model, low- and high-dose (2 mg·kg-1·d-1 and 4 mg·kg-1·d-1, respectively) schisanlactone E, and donepezil (1 mg·kg-1·d-1) groups. C57BL/6J mice were used as the control group. Each group received the corresponding drug by gavage for 30 days. Learning and memory abilities were assessed by the Morris water maze and novel object recognition tests. The percentages of Th17 and Treg cells in the peripheral blood were analyzed by flow cytometry. The mRNA levels of retinoid-related orphan receptor γt (RORγt), interleukin (IL)-17A, forkhead box protein 3 (FoxP3), and IL-4 in the hippocampus were determined by Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR). The synaptic ultrastructure in the hippocampus was observed by transmission electron microscopy. The protein levels of synapsin Ⅰ and postsynaptic density protein 95 (PSD95) in the hippocampus were measured by Western blot. Aβ aggregation and microglial activation in the hippocampus were observed by immunofluorescence staining. The mRNA levels of tumor necrosis factor (TNF)-α, IL-6, and IL-1β in the hippocampus were determined by Real-time PCR. ResultsCompared with the control group, the model group showed prolonged escape latency (P<0.05), decreased time spent in the target quadrant, platform crossings, novel object exploration time, and percentage of novel object contact frequency (P<0.05, P<0.01), increased Aβ aggregation in the hippocampal tissue (P<0.01), an increased proportion of Th17 cells (P<0.05), a decreased proportion of Treg cells (P<0.05), and an increased Th17/Treg ratio (P<0.01) in the peripheral blood. Furthermore, the hippocampal tissue in the model group exhibited upregulated mRNA levels of RORγt and IL-17A (P<0.05, P<0.01), downregulated mRNA levels of FoxP3 and IL-4 (P<0.01), decreased synapses (P<0.05), decreased PSD density, synaptic interface curvature, and active zone length (P<0.05, P<0.01), and increased synaptic cleft width (P<0.05), downregulated protein levels of Synapsin Ⅰ and PSD95 (P<0.01), increased microglial activation (P<0.01), and upregulated mRNA levels of TNF-α, IL-6, and IL-1β (P<0.05). Compared with the model group, the high-dose schisanlactone E group and the donepezil group exhibited shortened escape latency and increased time in the target quadrant and platform crossings (P<0.05, P<0.01). The schisanlactone E groups and the donepezil group showed increased novel object exploration time (P<0.05, P<0.01) and percentage of novel object contact frequency (P<0.05, P<0.01), and reduced hippocampal Aβ aggregation (P<0.05, P<0.01). The schisanlactone E groups showed a decreased proportion of Th17 cells (P<0.05) and an increased proportion of Treg cells (P<0.05) in the peripheral blood, and all treatment groups showed a decreased Th17/Treg ratio (P<0.05, P<0.01). The high-dose schisanlactone E group showed a downregulated mRNA level of RORγt in the hippocampal tissue (P<0.05), and all treatment groups showed a downregulated mRNA level of IL-17A (P<0.05, P<0.01), and upregulated mRNA levels of FoxP3 and IL-4 (P<0.05, P<0.01). The schisanlactone E groups and the donepezil group showed increased synapses, active zone length, synaptic interface curvature, and PSD density, decreased synaptic cleft width (P<0.05, P<0.01), and upregulated protein levels of synapsin Ⅰ and PSD95 (P<0.05, P<0.01). The high-dose schisanlactone E group and the donepezil group showed decreased microglial activation in the hippocampus (P<0.01). The schisanlactone E groups and the donepezil group showed downregulated mRNA levels of TNF-α, IL-6, and IL-1β in the hippocampal tissue (P<0.05, P<0.01). ConclusionSchisanlactone E significantly improves the cognitive function in APP/PS1 mice by regulating the Th17/Treg immune balance, inhibiting neuroinflammation, and ameliorating synaptic injury.
4.Aspirin Curcumin Ester Inhibits High Glucose/Aβ1-42-induced Microglial Inflammatory Response by Regulating Glucose Metabolism Reprogramming
Wenjing YU ; Miao YANG ; Chunxiang HE ; Ze LI ; Jiawei HE ; Ping LI ; Zhenyan SONG ; Shaowu CHENG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(22):124-137
ObjectiveTo observe the effect of aspirin curcumin ester (CA) on the activation and glucose metabolism reprogramming of the mouse microglia (BV2) model of inflammation induced by high glucose/β-amyloid (Aβ)1-42, and to explore the potential mechanism of CA in reducing neuroinflammatory response in the brain. MethodsThe BV2 activation model was constructed by high glucose combined with Aβ1-42 oligomers. BV2 cells were treated with Aβ1-42 oligomers (10 μmol·L-1) in a high glucose (50 mmol·L-1) environment and allocated into normal, high glucose, Aβ, and high glucose + Aβ groups. The cell morphology of each group was observed under a bright field. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) was adopted to assess the mRNA levels of inflammatory factors including tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-1β (IL-1β) as well as glycolysis-related glucose transporter type 1 (GLUT1), hexokinase 2 (HK2), phospofructokinase-2/fructose-2,6-bisphosphatase 3 (PFKFB3), and pyruvate kinase M2 (PKM2). To reveal the effects of CA on inflammatory response and glucose metabolism in BV2 cells exposed to high glucose/Aβ1-42, this study established the BV2 cell model of inflammatory activation by high glucose and Aβ1-42 oligomer intervention. The cells were allocated into normal, model (50 mmol·L-1 glucose + 10 μmol·L-1 Aβ1-42), CA (10 μmol·L-1), 2DG (0.2 mmol·L-1), and DADA (1 mmol·L-1) groups. Cell counting kit-8 (CCK-8) was used to detect cell survival rate. The cell morphology of each group was observed under a bright field. The expression of inflammatory factors TNF-α, IL-6, and IL-1β and glycolysis-related key enzymes GLUT1, HK2, PFKFB3, and PKM2 at the mRNA level in each group was measured by real-time PCR. The protein levels of GLUT1, HK2, PFKFB3, and PKM2 were determined by Western blot. The glycolysis rate in each group was measured by seahorse. LC-MS was employed to identify the glucose metabolism intermediates. The morphology of mitochondria in cells was observed by electron microscopy. ResultsConstruction of the BV2 cell model: Compared with the normal group, the Aβ group and the high glucose + Aβ group showed more amoeboid-shaped cells and cell aggregation. The high glucose + Aβ group exhibited increased the mRNA levels of TNF-α, IL-1β, and IL-6 (P<0.05, P<0.01), as well as those of key glycolytic enzymes GLUT1, HK2, PFKFB3, and PKM2 (P<0.01). The Aβ group also showed significantly increased mRNA levels of PKM2 and PFKFB3 (P<0.01). Effects of CA on the inflammatory response and glucose metabolism in BV2 cells exposed to high glucose/Aβ1-42: Compared with the normal group, the model group exhibited amoeboid-shaped cells and cell aggregation, upregulated mRNA levels of TNF-α, IL-1β, IL-6, iNOS, GLUT1, HK2, PFKFB3, and PKM2 (P<0.01) and protein levels of GLUT1, HK2, and PFKFB3 (P<0.05, P<0.01), an increased basal glycolysis rate (P<0.01), a decreased compensatory glycolysis rate (P<0.01), increased glycolytic intermediates and reduced TCA cycle intermediates. In addition, the mitochondria in the model group exhibited a decreased number (P<0.05), impaired crista integrity (P<0.01), an increased proportion of vacuolization (P<0.01), and abnormal mitochondrial morphology. Compared with those in the model group, the number of amoeboid-shaped BV2 cells reduced in the CA and 2DG groups, while most BV2 cells in the DADA group became elongated spindle-shaped. All the three treatment groups showed downregulated mRNA levels of TNF-α, IL-1β, IL-6, GLUT1, HK2, PFKFB3, and PKM2 (P<0.05, P<0.01), downregulated protein levels of GLUT1, HK2, and PFKFB3 (P<0.05, P<0.01), and slow compensatory glycolysis and basal glycolysis (P<0.05, P<0.01). Glycolytic intermediates were decreased and TCA cycle intermediates were increased in the CA and 2DG groups. Mitochondrial morphology largely returned to the normal level in all the three treatment groups, with an increase in mitochondrial number (P<0.05), improved crista integrity (P<0.05, P<0.01), and a decreased proportion of vacuolization (P<0.05). ConclusionAβ1-42 oligomers can activate BV2 cells and enhance glycolytic activity in the high glucose environment. CA can reduce the expression of inflammatory factors and inhibit the activation of BV2 cells by regulating the glucose metabolism reprogramming in BV2 cells.
5.Paeoniflorin Ameliorates Neuroinflammation and Cognitive Impairment in Rat Model of Alzheimer's Disease via JAK2/STAT3 Signaling Pathway
Mengfen ZHOU ; Shuyao TANG ; Xin SUN ; Gangying FU ; Xinxing ZHOU ; Jiawei HE ; Wenjing YU ; Ping LI ; Shaowu CHENG ; Zhenyan SONG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(22):138-147
ObjectiveTo investigate the effects of paeoniflorin (PF) on neuroinflammation and cognitive impairment in the rat model of Alzheimer's disease (AD) and to clarify whether its mechanism is associated with regulation of the Janus kinase 2 (JAK2)/signal transducer and activator of transcription 3 (STAT3) signaling pathway. MethodsGlycosides related to AD-associated neuroinflammation were screened through bibliometric analysis, and the potential targets of PF were predicted through network pharmacology and molecular docking. A rat model of AD was established by intraperitoneal injection of D-galactose (100 mg·kg-1·d-1). Rats were assigned into a control group, a model group, a PF (200 mg·kg-1) group, and a donepezil (0.5 mg·kg-1·d-1) group, and drugs were administered by gavage for 21 days. The learning and memory abilities were evaluated by the Morris water maze (MWM). Hematoxylin-eosin (HE) staining and Nissl staining were performed to observe hippocampal neuronal morphology. The mRNA levels of inflammatory factors were determined by Real-time quantitative polymerase chain reaction (Real-time PCR), and the protein levels of molecules in the JAK2/STAT3 signaling pathway were determined by Western blot. ResultsCompared with the control group, the model group showed prolonged escape latency and decreased platform crossings and time spent in the target quadrant (P<0.05, P<0.01), accompanied by increased expression of interleukin-1β (IL-1β) and tumor necrosis factor-α (TNF-α), as well as elevated ratios of phosphorylated (p)-JAK2/JAK2 and p-STAT3/STAT3 (P<0.01). Compared with the model group, the PF group and donepezil group exhibited shortened escape latency and increased platform crossings and time spent in the target quadrant (P<0.05, P<0.01), decreased expression levels of IL-1β and TNF-α, upregulated mRNA levels of interleukin-4 (IL-4) and interleukin-10 (IL-10), and reduced ratios of p-JAK2/JAK2 and p-STAT3/STAT3 (P<0.05, P<0.01). ConclusionPaeoniflorin can alleviate cognitive impairment and neuroinflammation in the rat model of AD by inhibiting the JAK2/STAT3 signaling pathway.
6.The epidemiologic characteristics of parasitic and vector-borne diseases in Minhang and Jinshan districts, Shanghai
Dun-jia WANG ; Xiao-lu HE ; Tian-tian ZHANG ; Tang WANG ; Zhao-peng DONG ; Can-lei SONG ; Shi-ji TAO ; Zheng-xing HOU ; Yu-ping CHENG ; Yi-bin ZHOU
Acta Parasitologica et Medica Entomologica Sinica 2026;33(3):173-179
Objective The aim of the study is to analyze the incidence patterns and epidemiological characteristics of parasitic and vector-borne diseases in the Minhang and Jinshan districts of Shanghai, and provide evidence-based information for optimizing prevention and control measures. Methods We collected information from epidemic reports and epidemiological investigation forms for cases of parasitic and vector-borne diseases from 2005 to 2024 in Shanghai's Minhang and Jinshan districts. Descriptive epidemiological method were adopted to conduct a comparative analysis of incidence trends, epidemic characteristics, and infection sources. Results A total of 229 cases in 7 categories were reported between 2005 and 2024, with an average annual incidence rate of 0.36/100 000. The average annual incidence rate in Minhang District was significantly higher than that in Jinshan District. The most prevalent diseases were malaria and dengue fever, followed by Japanese encephalitis. Monthly case reports were available, predominantly from June to October, with a peak in July-August. A statistically significant difference was observed between the two districts in case distribution during June-October (P<0.001), whereas no significant difference was found for July-August (P=0.331). The majority of cases were young men (111/229,48.47%), aged 20-39 years. Migrant workers/farmers constituted the largest occupational group (55/229, 24.02%). Registered residents of other provinces and cities (147/229,64.19%), and the main source of infection was overseas importation (112/229,48.91%). There were no statistically significant differences in gender and household-registration composition between the two districts (P>0.05). Significant differences existed in age, occupation, and source of infection (P<0.05). The imported diseases were malaria and dengue fever, with Africa and Southeast Asia being the primary source locations. Malaria was the predominant disease imported from other provinces and cities, with cases having been imported from abroad since 2012. Local infections were mainly Japanese encephalitis, followed by malaria (with the last local case reported in 2010). Cases between 2005 and 2009 were predominantly imported from other provinces and cities. The proportion of cases imported from abroad increased sharply after 2010, particularly in Minhang District. Local infections sometimes arise in Jinshan District, with Japanese encephalitis serving as the primary type. Conclusions Incidence rates of parasitic and vector-borne diseases in Minhang and Jinshan districts have generally remained low. To further reduce this disease burden, it will be necessary to strengthen joint measures for prevention and control, eliminate the environmental risk factors of vector organisms, enhance monitoring and precise control of the environment and inbound personnel to prevent the occurrence and transmission of parasitic and vector-borne diseases.
7.Research progress in mechanisms of traditional Chinese medicine polysaccharides in prevention and treatment of alcoholic liver disease.
Yu-Fan CHEN ; He JIANG ; Qing MA ; Qi-Han LUO ; Shuo HUANG ; Jiang QIU ; Fu-Zhe CHEN ; Zi-Yi SHAN ; Ping QIU
China Journal of Chinese Materia Medica 2025;50(2):356-362
Alcoholic liver disease(ALD), a major cause of chronic liver disease worldwide, poses a serious threat to human health. Despite the availability of various drugs for treating ALD, their efficacy is often uncertain, necessitating the search for new therapeutic approaches. Traditional Chinese medicine polysaccharides have garnered increasing attention in recent years due to their versatility, high efficiency, and low side effects, and they have demonstrated significant potential in preventing and treating ALD. Emerging studies have suggested that these polysaccharides exert their therapeutic effects through multiple mechanisms, including the inhibition of oxidative stress and the regulation of lipid metabolism, gut microbiota, and programmed cell death. This review summarizes the recent research progress in the pharmacological effects and regulatory mechanisms of traditional Chinese medicine polysaccharides in treating ALD, aiming to provide a scientific basis and theoretical support for their application in the prevention and treatment of ALD.
Humans
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Liver Diseases, Alcoholic/metabolism*
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Polysaccharides/administration & dosage*
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Drugs, Chinese Herbal/administration & dosage*
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Animals
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Oxidative Stress/drug effects*
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Medicine, Chinese Traditional
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Gastrointestinal Microbiome/drug effects*
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Lipid Metabolism/drug effects*
8.Effect of Biyan Jiedu Capsules on proliferation and apoptosis of nasopharyngeal carcinoma cells based on PI3K/Akt pathway.
Ting LIN ; Yang-Yang TAO ; Ying-Gang TANG ; Ju YUAN ; Hui-Ping DU ; Lin-Yu DENG ; Fang-Liang ZHOU ; Ying-Chun HE
China Journal of Chinese Materia Medica 2025;50(7):1920-1927
To investigate the effects of Biyan Jiedu Capsules on the proliferation and apoptosis of nasopharyngeal carcinoma cells and their molecular mechanism, nasopharyngeal carcinoma cells CNE1 and CNE2 were used. They were divided into control group(30% blank serum medium), low-(10% drug-containing serum + 20% blank serum medium), medium-(20% drug-containing serum + 10% blank serum medium), and high-(30% drug-containing serum medium) concentration group of Biyan Jiedu Capsules according to in vitro experiment. After 24 h of intervention, the effects of Biyan Jiedu Capsules on the proliferation of CNE1 and CNE2 were detected by CCK-8 assay, clonal formation experiment, and EdU staining. The effect of Biyan Jiedu Capsules on apoptosis of CNE1 and CNE2 was detected by flow cytometry. Western blot was used to detect the effect of Biyan Jiedu Capsules on the expression of X-linked apoptosis inhibitor protein(XIAP), survivin, proliferating cell nuclear antigen(PCNA), and PI3K/Akt pathway-related proteins in CNE1 and CNE2. The results showed that compared with the control group, the survival rate of CNE1 and CNE2 in the medium and high concentration groups of Biyan Jiedu Capsules could be decreased in a concentration-dependent way(P<0.05, P<0.01). At the same time, EdU staining and clonal formation experiments showed that the proliferation of CNE1 and CNE2 was significantly inhibited in the medium and high concentration groups of Biyan Jiedu Capsules(P<0.05, P<0.01). Flow cytometry showed that the apoptosis rate of CNE1 and CNE2 was significantly increased in all concentration groups of Biyan Jiedu Capsules(P<0.01), and the apoptosis rate was concentration-dependent. Western blot showed that the expressions of XIAP, survivin, PCNA, p-PI3K, and p-Akt in all concentration groups of Biyan Jiedu Capsules were significantly down-regulated(P<0.05, P<0.01). In conclusion, Biyan Jiedu Capsules can inhibit the proliferation and induce apoptosis of nasopharyngeal carcinoma cells possibly by down-regulating the PI3K/Akt signaling pathway.
Humans
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Apoptosis/drug effects*
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Cell Proliferation/drug effects*
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Nasopharyngeal Carcinoma
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Nasopharyngeal Neoplasms/physiopathology*
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Proto-Oncogene Proteins c-akt/genetics*
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Cell Line, Tumor
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Drugs, Chinese Herbal/pharmacology*
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Phosphatidylinositol 3-Kinases/genetics*
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Signal Transduction/drug effects*
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Capsules
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Carcinoma/drug therapy*
9.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
10.Expert consensus on evaluation index system construction for new traditional Chinese medicine(TCM) from TCM clinical practice in medical institutions.
Li LIU ; Lei ZHANG ; Wei-An YUAN ; Zhong-Qi YANG ; Jun-Hua ZHANG ; Bao-He WANG ; Si-Yuan HU ; Zu-Guang YE ; Ling HAN ; Yue-Hua ZHOU ; Zi-Feng YANG ; Rui GAO ; Ming YANG ; Ting WANG ; Jie-Lai XIA ; Shi-Shan YU ; Xiao-Hui FAN ; Hua HUA ; Jia HE ; Yin LU ; Zhong WANG ; Jin-Hui DOU ; Geng LI ; Yu DONG ; Hao YU ; Li-Ping QU ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2025;50(12):3474-3482
Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards*
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Humans
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Consensus
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Drugs, Chinese Herbal/therapeutic use*
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Surveys and Questionnaires


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