1.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
2.Analysis of factors influencing social isolation in elderly people with chronic diseases based on socio-ecological system theory
Liyuan JIA ; Mei YOU ; Lulu ZHANG ; Yuqin JIANG ; Yuan DING ; Yiling LIU ; Xiaohan MAO ; Annuo LIU
Chinese Journal of Modern Nursing 2025;31(14):1903-1907
Objective:To understand the status and influencing factors of social isolation in elderly individuals with chronic diseases.Methods:A multi-stage sampling method was used to select elderly individuals from eight communities or villages in Hefei from July to September 2022. The study employed a general information survey, the Lubben Social Network Scale (LSNS-6) , the Geriatric Depression Scale (GDS-15) , the Social Support Rating Scale (SSRS) , and the Personal Social Capital Scale 16 (PSCS-16) . Binary Logistic regression analysis was used to explore the factors influencing social isolation in elderly individuals with chronic diseases.Results:A total of 1 133 elderly individuals were surveyed, among which 538 had chronic diseases. Among the 538 elderly individuals with chronic diseases, 209 were socially isolated, resulting in a social isolation rate of 38.8%. Binary Logistic regression analysis revealed that living area, fear of falling, depression, social capital, and social support were significant factors influencing social isolation ( P<0.05) . Conclusions:The social isolation rate among elderly individuals with chronic diseases is high. Special attention should be given to elderly individuals living in rural areas, those who fear falling, and those experiencing depression. Additionally, improving social capital and social support can help alleviate social isolation in these elderly individuals.
3.Empirical research of influencing factors of green procurement for medical equipment on the basis of investigation for hospitals of secondary and tertiary grades in Shandong province
Zhen LI ; Tao WANG ; Meina YUAN ; Haixian XU ; Wenxin JIANG ; Baoyang DING
China Medical Equipment 2025;22(10):134-137
Objective:To investigate the influencing factors of green procurement for medical equipment,so as to provide theoretical basis and policy insights for promoting practices of green procurement for medical institutions.Methods:Based on literature review and expert interviews,a questionnaire about influencing factors of green procurement for medical equipment was formulated,which was used to conduct questionnaire survey for medical institutions of secondary and tertiary grades in Shandong province.The questionnaire included the measured indicators and basic information of medical institutions from four dimensions:pressure of external system(7 items),leadership support(4 items),organizational inertia(5 items),and collaboration degree of stakeholder(5 items).The Likert 5-level scale was adopted to conduct scoring of questionnaire,and the differences in various influencing factors between secondary grade hospital and tertiary grade hospital were compared and analyzed.Results:The scores of tertiary grade hospital were respectively 4.00(3.14,4.82),4.25(4.00,5.00),and 3.60(3.00,4.00)at pressure of external system,leadership support(4 items),organizational inertia(5 items)of three dimensions,and they were 3.86(3.11,4.14),4.00(3.75,5.00),and 3.20(2.80,3.80)at secondary grade hospital,and the differences of them between secondary grade hospital and tertiary grade hospital were significant(Z=-2.243,-2.654,-2.538,P<0.05).There was not significant difference at the dimension of collaboration degree of stakeholder between secondary and tertiary hospitals(P>0.05).Conclusion:A series of measures,such as adopting policy support with differentiation,establishing multi-level incentive mechanisms,reducing organizational change resistance,and improving multi-party coordination mechanisms,can further promote green procurement of medical institutions.
4.Danggui Shaoyaosan Regulates Nrf2/SLC7A11/GPX4 Signaling Pathway to Inhibit Ferroptosis in Rat Model of Non-alcoholic Fatty Liver Disease
Xinqiao CHU ; Yaning BIAO ; Ying GU ; Meng LI ; Tiantong JIANG ; Yuan DING ; Xiaping TAO ; Shaoli WANG ; Ziheng WEI ; Zhen LIU ; Yixin ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(16):35-42
ObjectiveTo investigate the effect of Danggui Shaoyaosan on ferroptosis in the rat model of non-alcoholic fatty liver disease (NAFLD) and explore the underlying mechanism based on the nuclear factor E2-related factor 2 (Nrf2)/solute carrier family 7 member 11 (SLC7A11)/glutathione peroxidase 4 (GPX4) signaling pathway. MethodsThe sixty SD rats were randomly grouped as follows: control, model, Yishanfu (0.144 g·kg-1), and low-, medium-, and high-dose (2.44, 4.88, and 9.76 g·kg-1, respectively) Danggui Shaoyaosan. A high-fat diet was used to establish the rat model of NAFLD. After 12 weeks of modeling, rats were treated with corresponding agents for 4 weeks. Then, the body weight and liver weight were measured, and the liver index was calculated. At the same time, serum and liver samples were collected. The levels or activities of total cholesterol (TC), triglycerides (TG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and Fe2+ in the serum and TC, TG, free fatty acids (FFA), malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GPX), and Fe2+ in the liver were measured. Hematoxylin-eosin staining and oil red O staining were employed to observe the pathological changes in the liver. Immunofluorescence was used to assess the reactive oxygen species (ROS) content in the liver. Mitochondrial morphology was observed by transmission electron microscopy. The protein levels of Nrf2, SLC7A11, GPX4, transferrin receptor 1 (TFR1), and divalent metal transporter 1 (DMT1) in the liver were determined by Western blot. ResultsCompared with the control group, the model group showed increases in the body weight, liver weight, liver index, levels or activities of TC, TG, ALT, AST, and Fe2+ in the serum, levels of TC, TG, FFA, MDA, Fe2+, and ROS in the liver, and protein levels of TFR1 and DMT1 in the liver (P<0.01), and decreases in the activities of SOD, GPX and the protein levels of Nrf2, SLC7A11, and GPX4 in the liver (P<0.05, P<0.01). Meanwhile, the liver tissue in the model group presented steatosis, iron deposition, mitochondrial shrinkage, and blurred or swollen mitochondrial cristae. Compared with the model group, all doses of Danggui Shaoyaosan reduced the body weight, liver weight, liver index, levels or activities of TC, TG, ALT, AST, and Fe2+ in the serum, levels of TC, TG, FFA, MDA, Fe2+, and ROS in the liver, and protein levels of TFR1 and DMT1 in the liver (P<0.01), while increasing the activities of SOD and GPX and the protein levels of Nrf2, SLC7A11, and GPX4 in the liver (P<0.01). Furthermore, Danggui Shaoyaosan alleviated steatosis, iron deposition, and mitochondrial damage in the liver. ConclusionDanggui Shaoyaosan may inhibit lipid peroxidation and ferroptosis by activating the Nrf2/SLC7A11/GPX4 signaling pathway to treat NAFLD.
5.Study on the evaluation value the effected ejection fraction in assessment of cardiac function in the elderly patients with heart failure
Shaoxiang DING ; Wei LU ; Xuanzhi JIANG ; Yuejiao XU ; Fangyuan YANG ; Yuqing YUAN
Chongqing Medicine 2025;54(5):1134-1137,1142
Objective To Study the value of effected ejection fraction(eEF)in assessment of cardiac function in elderly patients with heart failure.Methods A total of 1 134 elderly inpatients in this hospital from January 2019 to December 2023 were selected as the research subjects.After admission,relevant examinations and tests were completed,and the cardiac function classification of the New York Heart Association(NYHA)was carried out.Sequential electrocardiogram(ECG)and echocardiogram examinations were completed before treatment.Age,under-lying diseases,left ventricular ejection fraction(LVEF),N-terminal pro-brain natriuretic peptide(NT-proB-NP),and QT interval(QTc)of the ECG were included for classification and statistics,and eEF was obtained,and the evaluation value of eEF on cardiac function was analyzed.Results The numbers of patients with NY-HA cardiac function grades Ⅰ—Ⅳ were 86,434,454 and 160,respectively,and LVEF decreased with the in-crease of the NHYA cardiac function grade.There was statistically significant differences in LVEF among dif-ferent NHYA cardiac function classifications(P<0.05).The QTc of the patients was(434.71±40.96)ms,the eEF was(8.73±2.03)ms,and the ln(NT-proBN)was 7.05±1.70.QTc,eEF,and ln(NT-proBN)all in-creased with the increase of the NHYA cardiac function classification,and there were statistically significant differences in indicators above among different NHYA cardiac function classfications(P<0.05).There was a low correlation between QTc of the ECG,age and cardiac insufficiency(r<0.5,P<0.05);there was a high correlation between eEF,LVEF,and ln(NT-proBNP)and cardiac insufficiency(r≥0.5,P<0.05).Conclusion eEF still has discriminatory value for patients with heart failure with preserved ejection fraction,and it is a good indicator for evaluating the cardiac function of elderly patients with heart failure.
6.Recent Advances in Solid Phase Extraction-Surface-enhanced Raman Spectroscopy Coupling Technologies Based on Novel Adsorbent Materials
Pei-Yuan LU ; Yu-Hao WEN ; Ding-Ding JIANG ; Xian-Wei WANG ; Jia-Mian GUAN ; Gao-Song SHAO
Chinese Journal of Analytical Chemistry 2025;53(10):1597-1606
Solid-phase extraction(SPE)combined with surface-enhanced Raman spectroscopy(SERS)has emerged as a promising analytical technique for detection and analysis of trace components in complex sample matrices.SPE enriches analytes through selective adsorption and solvent elution,effectively increasing the concentration and signal intensity.SERS enables ultra-sensitive and highly selective molecular analysis through the use of SERS-active substrates engineered to amplify Raman signals.The integration of these two techniques overcomes the limitations of conventional Raman spectroscopy in low-concentration detection field,while significantly improving sample preparation efficiency and analytical accuracy.This review provided a comprehensive overview of the characteristics of three SPE-SERS coupling modes,including two-step,one-step,and online integration.Special emphasis was placed on recent advancements in one-step SPE-SERS approaches based on novel functional adsorbent materials such as graphene,metal-organic frameworks,covalent organic frameworks,and molecularly imprinted polymers.Furthermore,future directions and development prospects of SPE-SERS technology were discussed.
7.Fluorescent Probe Development for Rapid Detection of Tiletamine Based on Cop-per Nanozyme and Molecular Imprinting Technology
Jia-Hao LI ; Jiang LING ; Zi-Hao CAI ; Zi-Yuan ZHENG ; Yan-Jun DING
Journal of Forensic Medicine 2025;41(4):355-363
Objective To develop a rapid detection method for tiletamine that is easy to operate and low-cost under the premise of ensuring sensitivity and accuracy,to assist in carrying out rapid screening and drug control work on-site.Methods This study integrates dual-ligand copper nanozymes with mo-lecular imprinting technology.Initially,copper nanozymes were synthesized using readily available raw materials at 120℃.Subsequently,specific cavities were imprinted on their surface at room temperature using a sol-gel method to construct a novel fluorescent sensing probe.This probe was characterized and methodologically validated,and then applied to the detection of actual samples.Results The developed probe exhibited stable fluorescence properties,strong anti-interference capability,and excellent specificity and sensitivity,with a detection limit of 5 ng/mL and a quantitative concentration range from 15 to 500 ng/mL.It enabled the rapid detection of tiletamine in real samples such as blood and e-cigarette oil.Conclusion This fluorescent probe can be used for rapid detection and on-site preliminary screening of tiletamine in various types of samples.It significantly improves the detection efficiency and reduces analysis costs,showing high research value and broad application prospects.
8.Dynamic Sequential Diagnosis and Treatment of Pediatric Nephrotic Syndrome Based on the "Sweat Pore-Qi and Liquid-Kidney Collaterals"
Zhenhua YUAN ; Mingyang CAI ; Yingying JIANG ; Jingjing WU ; Wenqing PAN ; Zichao DING ; Shuzi ZHANG ; Xianqing REN
Journal of Traditional Chinese Medicine 2025;66(10):1007-1010
Based on the viewpoint of "sweat pore-qi and liquid-kidney collaterals", it is believed that children's nephrotic syndrome is caused by the core mechanism of sweat pore constraint and closure, qi and liquid imbalance, and kidney collaterals impairment, and it is proposed that the treatment principle is to nourish the sweat pore, regulate qi and fluid, and supplement the kidney and unblock the collaterals. In clinic, guided by sequential therapy and according to the different disease mechanism characteristics of the four stages, including early stage of the disease, hormone induction stage, hormone reduction stage, hormone maintenance stage, the staged dynamic identification and treatment was applied. For early stage of the disease with edema due to yang deficiency, modified Zhenwu Decoction (真武汤) was applied to warm yang and drain water; for hormone induction stage with yin deficiency resulting in effulgent fire, modified Zhibai Dihuang Pill (知柏地黄丸) plus Erzhi Pill (二至丸) was used to enrich yin and reduce fire; for hormone reduction stage with qi and yin deficiency, modified Shenqi Dihuang Decoction (参芪地黄汤) was used to boost qi and nourish yin; for hormone maintenance stage, modified Shenqi Pill (肾气丸) was used to supplement yin and yang. Meanwhile, the treatment also attaches importance to the combination of vine-based or worm medicinals to dredge collaterals, so as to providing ideas for clinical treatment.
9.Construction and validation of prediction models for delayed encephalopathy after acute carbon monoxide poisoning based on machine learning
Yanwu YU ; Yan ZHANG ; Ding YUAN ; Huihui HAO ; Fang YANG ; Hongyi YAN ; Pin JIANG ; Mengnan GUO ; Zhigao XU ; Changhua SUN ; Gaiqin YAN ; Lu CHE ; Jianjun GUO ; Jihong CHEN ; Yan LI ; Yanxia GAO
Chinese Journal of Emergency Medicine 2025;34(10):1403-1409
Objective:s To investigate the risk factors for delayed encephalopathy after acute carbon monoxide poisoning (DEACMP) in patients with acute carbon monoxide poisoning (ACOP) and to develop predictive models based on machine learning algorithms.Methods:Patients with ACOP hospitalized at the First Affiliated Hospital of Zhengzhou University from August 2019 to October 2024 were included, with the occurrence of DEACMP as the outcome measure. The dataset was randomly divided into training and validation sets at a ratio of 7:3. Lasso regression was used to select features influencing the outcome in training sets. Nine machine learning models—including Random Forest (RF), Extreme Gradient Boosting (XGBoost), and Support Vector Machine (SVM)—were constructed. Receiver operating characteristic (ROC) curves were plotted and the area under the curve (AUC) calculated for each model. Calibration curves were used to assess accuracy, and decision curve analysis (DCA) was applied to evaluate clinical utility. The SHapley Additive exPlanations (SHAP) method was employed to visualize and interpret the best-performing model.Results:A total of 264 ACOP patients were included, of whom 54 (20.5%) developed DEACMP. Lasso regression identified eight key feature variables. Based on these factors, predictive models were constructed, showing good AUC stability across the nine machine learning models in both training (0.92–0.99) and validation sets (0.85–0.91). The RF model performed best, with an AUC of 0.99 in the training set and 0.90 in the validation set; its calibration curve and DCA curve also demonstrated excellent performance. SHAP analysis of the RF model revealed the importance ranking of factors from highest to lowest as follows: Glasgow Coma Scale (GCS) score, duration of coma, age, history of coronary heart disease, CK-MB level, monocyte count, diastolic blood pressure (DBP), and drinking history.Conclusions:The RF model exhibited the highest predictive performance for DEACMP occurrence in ACOP patients. The influencing factors, ranked in order of importance from highest to lowest, are as follows: GCS score, duration of coma, age, history of coronary heart disease, CK-MB level, monocyte count, DBP, and drinking history.
10.Effect and mechanism of composite hydrogel loaded with human umbilical cord mesenchymal stem cell-derived exosomes in promoting knee cartilage regeneration
Yanchi BI ; Ding YUAN ; Liang ZHU ; Haibo ZHAO ; Fan JIANG ; Xiao XIAO ; Tengbo YU
Chinese Journal of Trauma 2025;41(8):778-788
Objective:To investigate the effect and mechanism of injectable photopolymerizable porous gelatin methacrylate anhydride (Porous GelMA)/methacrylated silk fibroin (SilMA) composite hydrogel (PSE) loaded with human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) in promoting knee joint cartilage regeneration.Methods:The porous GelMA solution (60 g/L) was mixed with SilMA solution (200 g/L) at a volume ratio of 6∶1 . The mixture was ultraviolet-irradiated for 30 seconds to form a cured Porous GelMA/SilMA hydrogel (P/S6). The hUCMSC-Exos was isolated via differential centrifugation coupled with ultrafiltration and then was incorporated into the Porous GelMA/SilMA composite solution at 200 μg/ml, followed by ultraviolet irradiation for 30 seconds to generate Exos-loaded PSE. Primary rat chondrocytes (P1) were divided into control group, P/S6 group, and PSE group to characterize the porosity, compressive strength, and sustained exosome release kinetics of PSE hydrogel. Chondrocytes were allocated to control group, interleukin-1β (IL-1β) group, P/S6 group, and PSE group, among which the last three groups were preconditioned with 10 ng/ml IL-1β for 24 hours, and then cultured in complete medium, P/S6 extract and PSE extract for 3 days, respectively, to establish in vitro cartilage defect models, while the control group remained untreated. Western blot and qRT-PCR analysis were conducted to quantify the expression levels of antibody to aggrecan core protein (ACAN), sex-determining region Y-box transcription factor 9 (SOX9), matrix metalloproteinase-13 (MMP13) and collagen type II (COL II). Murine monocyte-macrophage leukemia cells (RAW264.7) were divided into control group, P/S6 group, and PSE group, which were then cultured in complete medium, PSE extract, and PSE extract medium for 3 days, respectively. qRT-PCR was employed to detect the expression levels of recombinant arginase-1 protein (ARG1), mannose receptor (CD206), and inducible nitric oxide synthase (iNOS). Transcriptomic sequencing was used to identify differentially expressed genes during PSE-mediated chondrocyte regeneration, followed by functional enrichment analysis of key signaling pathways. Twenty-four SD rats were selected to establish cartilage defect models and assigned to injury control group, P/S6 group, and PSE group according to the random number table (8 rats per group). The right knee joints of the rats were surgically exposed, and cylindrical osteochondral defects (a diameter of 2.0 mm× a depth of 1.0 mm) were surgically created in the center of the femoral trochlear groove using a drill bit. The injury control group received phosphate-buffered saline, while the P/S6 group and PSE group were injected with corresponding hydrogels followed by photo-crosslinking. Incisions then were closed in layers. At 6 and 10 weeks after injury, specimens were harvested for HE staining and safranin O-fast green staining to evaluate cartilage regeneration and immunohistochemistry staining to quantify the positive area fractions for COL II, MMP13, ARG1, and CD206 in the defect areas. Results:PSE hydrogel exhibited compressive strength matching native cartilage (0.41 MPa), high porosity (85%), and sustained exosome release capacity (cumulative release rate of approximately 85% over 14 days). In chondrocyte repair experiments, compared to the IL-1β group, the PSE group demonstrated significantly upregulated expression of anabolic markers of cartilage (COL II expression increased by 2.1-fold, ACAN by 1.8-fold, and SOX9 by 1.5-fold) ( P<0.01) as well as significantly suppressed expression of catabolic markers (MMP13 expression decreased by 52%) ( P<0.01). In macrophage polarization assays, the PSE group exhibited ARG1 expression increased by 68% when compared to the control group ( P<0.01), thus promoting M2 polarization of macrophages. Transcriptomic analysis revealed that PSE enhanced extracellular matrix (ECM) synthesis by activating the phosphatidylinositol 3-kinase/protein kinase B (PI3K/Akt) pathway and ECM-receptor interaction pathway, as well as by suppressing inflammation-related gene expression. Histological evaluation in animal experiments revealed regeneration of hyaline cartilage with smooth, continuous surfaces in the defect areas in the PSE group. At 10 weeks after surgery, the neocartilage-positive area in the PSE group was (9.94±0.26)%, significantly larger than (1.67±0.11)% in the injury control group ( P<0.01). Besides, the CD206? M2 macrophage-positive area reached (14.44±0.23)% in the PSE group, significantly larger than (3.41±0.36)% in the injury control group ( P<0.01). Conclusions:The PSE hydrogel successfully engineered in the study can significantly promote regenerative repair of knee cartilage defects through a dual mechanism of enhanced ECM anabolism and remodeled inflammatory microenvironment. The core mechanisms involve specific activation of the PI3K/Akt pathway (boosting chondrocyte proliferation and survival) and ECM-receptor interaction pathway (driving ECM synthesis and assembly) by exosome-loaded PSE, while effectively polarizing macrophages toward an anti-inflammatory M2 phenotype so as to coordinately regulate cartilage ECM metabolism and suppress inflammatory responses.

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