1.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines; further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly; replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
2.Role and mechanism of platelet-derived growth factor BB in repair of growth plate injury
Hongcheng PENG ; Guoxuan PENG ; Anyi LEI ; Yuan LIN ; Hong SUN ; Xu NING ; Xianwen SHANG ; Jin DENG ; Mingzhi HUANG
Chinese Journal of Tissue Engineering Research 2025;29(7):1497-1503
BACKGROUND:In the initial stage of growth plate injury inflammation,platelet-derived growth factor BB promotes the repair of growth plate injury by promoting mesenchymal progenitor cell infiltration,chondrogenesis,osteogenic response,and regulating bone remodeling. OBJECTIVE:To elucidate the action mechanism of platelet-derived growth factor BB after growth plate injury. METHODS:PubMed,VIP,WanFang,and CNKI databases were used as the literature sources.The search terms were"growth plate injury,bone bridge,platelet-derived growth factor BB,repair"in English and Chinese.Finally,66 articles were screened for this review. RESULTS AND CONCLUSION:Growth plate injury experienced early inflammation,vascular reconstruction,fibroossification,structural remodeling and other pathological processes,accompanied by the crosstalk of chondrocytes,vascular endothelial cells,stem cells,osteoblasts,osteoclasts and other cells.Platelet-derived growth factor BB,as an important factor in the early inflammatory response of injury,regulates the injury repair process by mediating a variety of cellular inflammatory responses.Targeting the inflammatory stimulation mediated by platelet-derived growth factor BB may delay the bone bridge formation process by improving the functional activities of osteoclasts,osteoblasts,and chondrocytes,so as to achieve the injury repair of growth plate.Platelet-derived growth factor BB plays an important role in angiogenesis and bone repair tissue formation at the injured site of growth plate and intrachondral bone lengthening function of uninjured growth plate.Inhibition of the coupling effect between angiogenesis initiated by platelet-derived growth factor BB and intrachondral bone formation may achieve the repair of growth plate injury.
3.A survey of HPV and vaccine cognition and vaccination intention among primary health care workers in Shanghai
Lei CHEN ; Yuanying LU ; Yahong SHEN ; Qiaoying ZHANG ; Haiying SHI ; Minglu SHANG ; Xiao ZHANG
Journal of Public Health and Preventive Medicine 2025;36(2):89-90
Objective To understand the awareness and willingness of primary medical staff in Songjiang District, Shanghai towards human papillomavirus (HPV) and its vaccines, and to provide references for improving the vaccination willingness of HPV vaccine and primary prevention of cervical cancer. Methods From July to August 2023, a questionnaire survey was conducted among the in-service medical staff in 17 community health service centers in Songjiang District, Shanghai, using the random sampling method. Descriptive analysis, χ2 test and logistic regression were used for statistical analysis. Results A total of 951 valid questionnaires were collected during the survey. The awareness rate of HPV among medical staff was 92.74%, and the awareness rate of HPV vaccine was 93.38%. The maximum score for HPV knowledge was 6 points, with an average score of (3.99±1.34) points. The maximum score for HPV vaccine knowledge was 10 points, with an average score of (5.63±1.61) points. 881 (92.64%) medical staff were willing to receive or recommend HPV vaccination. Multivariate analysis showed that concerns about being infected with HPV (OR=2.648, 95% CI: 1.459-4.806), qualified score on HPV vaccine knowledge (OR=1.717, 95% CI: 1.012-2.912), high price burden of HPV vaccine (OR=0.343, 95% CI: 0.157-0.746), and concerns about side effects of vaccination (OR=0.443, 95% CI: 0.243-0.805) were the influencing factors for medical staff's willingness to vaccinate. Conclusion There is insufficient knowledge of HPV and its vaccines among primary medical personnel in Songjiang District, Shanghai. It is necessary to strengthen the continuing education of medical personnel through multiple channels, supplement the HPV-related knowledge system, and eliminate their concerns about vaccines.
4.Basiliximab is superior to low dose rabbit anti-thymocyte globulin in pediatric kidney transplant recipients: The younger, the better.
Lan ZHU ; Lei ZHANG ; Wenjun SHANG ; Wenhua LIU ; Rula SA ; Zhiliang GUO ; Longshan LIU ; Jinghong TAN ; Hengxi ZHANG ; Yonghua FENG ; Wenyu ZHAO ; Wenqi CONG ; Jianyong WU ; Changxi WANG ; Gang CHEN
Chinese Medical Journal 2025;138(2):225-227
5.Alzheimer's disease diagnosis among dementia patients via blood biomarker measurement based on the AT(N) system.
Tianyi WANG ; Li SHANG ; Chenhui MAO ; Longze SHA ; Liling DONG ; Caiyan LIU ; Dan LEI ; Jie LI ; Jie WANG ; Xinying HUANG ; Shanshan CHU ; Wei JIN ; Zhaohui ZHU ; Huimin SUI ; Bo HOU ; Feng FENG ; Bin PENG ; Liying CUI ; Jianyong WANG ; Qi XU ; Jing GAO
Chinese Medical Journal 2025;138(12):1505-1507
6.Effect and mechanism of salt-processed Phellodendri Chinensis Cortex in improving insulin resistance based on network pharmacology and experimental verification.
Jin-Jie LEI ; Yang-Miao XIA ; Shang-Ling ZHAO ; Rui TAN ; Ling-Ying YU ; Zhi-Min CHEN
China Journal of Chinese Materia Medica 2025;50(9):2373-2381
This study explores the therapeutic differences and mechanisms of salt-processed Phellodendri Chinensis Cortex in improving insulin resistance(IR) based on network pharmacology, molecular docking, and cellular experiments. The components and intersection targets of Phellodendri Chinensis Cortex in improving IR were collected from databases, and a "drug-component-target-disease" network and protein-protein interaction(PPI) network were constructed to screen core components and targets. A total of 29 active components and 240 intersection targets were identified, of which 13 were core targets. Gene Ontology(GO) and Kyoto Encyclopedia of Genes and Genomes(KEGG) pathway enrichment analyses were used to identify key signaling pathways, and molecular docking was performed to validate the binding activity between core components and targets. An IR model in HepG2 cells was induced using insulin combined with high glucose, and the effects of Phellodendri Chinensis Cortex before and after salt-processing on cell glucose consumption were evaluated. The expression of proteins related to the mitogen-activated protein kinase(MAPK) and phosphatidylinositol 3-kinase(PI3K)-protein kinase B(AKT) signaling pathways was detected by Western blot. The cellular experimental results showed that, compared with the model group, glucose consumption in the drug-treated groups was significantly increased(P<0.01), the phosphorylation level of extracellular regulated protein kinase(ERK) was decreased(P<0.05), the phosphorylation levels of PI3K and AKT were increased, and the expression of glucose transporter 4(GLUT4) was also upregulated(P<0.05). Furthermore, the effect of salt-processed Phellodendri Chinensis Cortex was better than that of raw Phellodendri Chinensis Cortex. The study demonstrates that Phellodendri Chinensis Cortex, both before and after salt-processing, improves IR by regulating the expression of related proteins in the MAPK and PI3K-AKT signaling pathways, with enhanced effects after salt-processing.
Humans
;
Network Pharmacology
;
Phellodendron/chemistry*
;
Insulin Resistance
;
Drugs, Chinese Herbal/chemistry*
;
Hep G2 Cells
;
Signal Transduction/drug effects*
;
Molecular Docking Simulation
;
Protein Interaction Maps/drug effects*
;
Proto-Oncogene Proteins c-akt/genetics*
;
Phosphatidylinositol 3-Kinases/genetics*
;
Glucose/metabolism*
7.The PGAM5-NEK7 interaction is a therapeutic target for NLRP3 inflammasome activation in colitis.
Cheng-Long GAO ; Jinqian SONG ; Haojie WANG ; Qinghong SHANG ; Xin GUAN ; Gang XU ; Jiayang WU ; Dalei WU ; Yueqin ZHENG ; Xudong WU ; Feng ZHAO ; Xindong LIU ; Lei SHI ; Tao PANG
Acta Pharmaceutica Sinica B 2025;15(1):349-370
The innate immune sensor NLRP3 inflammasome overactivation is involved in the pathogenesis of ulcerative colitis. PGAM5 is a mitochondrial phosphatase involved in NLRP3 inflammasome activation in macrophages. However, the role of PGAM5 in ulcerative colitis and the mechanisms underlying PGAM5 regulating NLRP3 activity remain unknown. Here, we show that PGAM5 deficiency ameliorates dextran sodium sulfate (DSS)-induced colitis in mice via suppressing NLRP3 inflammasome activation. By combining APEX2-based proximity labeling focused on PGAM5 with quantitative proteomics, we identify NEK7 as the new binding partner of PGAM5 to promote NLRP3 inflammasome assembly and activation in a PGAM5 phosphatase activity-independent manner upon inflammasome induction. Interfering with PGAM5-NEK7 interaction by punicalagin inhibits the activation of the NLRP3 inflammasome in macrophages and ameliorates DSS-induced colitis in mice. Altogether, our data demonstrate the PGAM5-NEK7 interaction in macrophages for NLRP3 inflammasome activation and further provide a promising therapeutic strategy for ulcerative colitis by blocking the PGAM5-NEK7 interaction.
8.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
Jun ZHANG ; Baoming NING ; Shifeng WEI ; Haoyu SHEN ; Yue SHANG ; Ran ZHU ; Xinyi XU ; Lei CHEN ; Tingting LIU ; Shuangcheng MA
Drug Standards of China 2025;26(1):34-44
To introduce the general thinking,guidelines,work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition,and to summarize and figure out the main characteristics on dosage forms,physico-chemical testing,microbial and biological testing,ref-erence standards and guidelines.The newly revised general chapters of pharmacopoeia give full play to the norma-tive and guiding role of the Chinese Pharmacopoeia standard,track the frontier dynamics of international drug regu-latory science and the elaboration of monographs,expand the application of state-of-the-art technologies,and stead-ily promote the harmonization and unification with the ICH guidelines;further enhance the overall capacity of TCM quality control,actively implement the 3 R principles on animal experiments,and practice the concept of environ-mental-friendly;replace and/orreduce the use of toxic and hazardousreagents,strengthen the requirementsofdrug safety control.This paper aims to provide a full-view perspective for the comprehensive,correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
9.Analysis of Review of Anti-tumor Drug Prescriptions Assisted by Information System
Kai CHENG ; Huan WANG ; Chunxiao DU ; Xue MA ; Lei SHANG ; Zhiqiang HU ; Tingting QI
Herald of Medicine 2024;43(1):47-53
Objective To analyze the problems of review of anti-tumor drug prescriptions and medical orders assisted by an information system to improve the review rules,and to provide a reference for improving review quality of anti-tumor drug prescription.Methods The problem with the pre-review of anti-tumor drug prescriptions and medical orders assisted by the information system in Sichuan Cancer Hospital during 2020-2022 were collected.The data came from the MEDICOM PASS system in Sichuan Cancer hospital.Clinical pharmacists made comments on relevant problems and analyzed the results.Results A total of 9 325 antitumor drug pre-approval problems,including 6 279 outpatient prescriptions(67.3%)and 3 046 inpatient orders(32.7%),among which 6 153(66.0%)were unsuitable indications,1 933(20.7%)were drug contraindications,449(4.8%)were problematic routes of administration,345(3.7%)were unsuitable drug compatibility,177(1.9%)were inappropriate drug frequency,133(1.4%)were problematic drug populations,74(0.8%)were unsuitable single doses,39(0.4%)were unacceptable drug interactions,22(0.2%)were unsuitable drug total.The results of clinical pharmacists'comments were 4 459 reasonable cases,with a false positive rate of 47.8%.The false positive problems included 2 264(50.8%)cases of unsuitable indications,1 933(43.3%)cases of drug contraindications,231(5.2%)cases of problematic routes of administration,and 31(0.7%)cases of unsuitable populations.Conclusion The review of anti-tumor drug prescriptions assisted by an information system can effectively intercept irrational drug use and improve the review quality of prescriptions and medical orders.However,the evidence-based medicine date of antitumor drugs is updated quickly.Pharmacists should constantly improve the prescription review rules based on the latest evidence-based medicine data.
10.Analysis of macular vascular density and retinal thickness of school-age children
Shasha GAO ; Lili SHANG ; Aicun FU ; Minghang CHANG ; Yin HE ; Ming WANG ; Xuemin JIN ; Bo LEI ; Fengyan ZHANG
Chinese Journal of Ocular Fundus Diseases 2024;40(1):44-51
Objective:To observe the correlation between retinal capillary density and retinal thickness in the macula and spherical equivalent (SE) in school-age children.Methods:A cross-sectional study. From May to December 2022, 182 school-age children who visited the ophthalmology department of the First Affiliated Hospital of Zhengzhou University were included. There were 95 males and 87 females. The age ranged from 6 to 12 years, and the spherical equivalent (SE) was +0.50 to -6.00 D. They were divided into three groups based on the SE of the right eyes: 54 eyes in emmetropia group (+0.50≤SE<-0.50 D), 71 eyes in low myopia group (-0.50≤SE<-3.00 D), and 57 eyes in moderate myopia group (-3.00≤SE≤-6.00 D). The macular area of 6 mm×6 mm was scanned using swept-source optical coherence tomography angiography and was divided into three concentric rings centered on the fovea, including the macular central fovea (0-1 mm diameter), inner ring (1-3 mm diameter) and outer ring (3-6 mm diameter). The retinal thickness and blood flow density of superficial vascular plexus (SVP) and deep vascular plexus (DVP) in different zones within 6 mm of the macular area were measured. The relationships between SE and SVP, DVP and retinal thickness in each ring region were investigated by univariate and multivariate linear regression analyses, smooth curve fitting, and threshold effects.Results:There were significant differences in the SVP ( F=6.64, 26.06, 22.69) and DVP ( F=7.97, 25.01, 5.09) of macular central fovea, inner ring and outer ring among the emmetropia, low myopia and moderate myopia groups ( P<0.05). Univariate linear regression analysis showed that the SVP ( β=-0.56,-1.17, -0.79) and DVP ( β=-1.03, -0.93, -0.45) of the three regions were positively correlated with SE ( P<0.05). After smooth curve fitting, threshold effect analysis and multivariate linear regression analysis, the SVP and DVP in the macular central fovea were linearly positively correlated with SE ( β=-0.91, -1.40; P<0.05), and SVP and DVP in the inner ring and outer ring showed an inverted U-shaped curve relationship with SE with the inflection (<3.00 D). When the SE was less than <3.00 D, the SVP and DVP in the inner ring and outer ring were positively correlated with SE ( P<0.05). When the SE was higher than -3.00 D, except for the DVP in the inner ring region, the other parameters were negatively correlated with SE ( P<0.05). There were significant differences in retinal thickness of the inner ring and outer ring ( F=5.47, 16.36; P<0.05), and no significant difference in the macular central fovea among the emmetropia, low and moderate myopia groups ( F=2.16, P>0.05). By using univariate and multivariate linear regression analyses, the retinal thickness in the inner ring and outer ring were negatively correlated with SE ( β =1.99, 3.05; P<0.05). However, no correlation was found between retinal thickness and SE in the macular central fovea ( β=-1.65, P>0.05). Conclusions:In school-age children with SE between +0.50 D and -6.00 D, the retinal capillaries density of the macular central fovea gradually increase, and increase first and then decrease in the inner ring and outer ring with increasing SE. The retinal thickness of inner ring and outer ring gradually decrease and not change significantly in the macular central fovea.


Result Analysis
Print
Save
E-mail