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.Additions and revisions of general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ
XU Xinyi ; WEI Shifeng ; ZHANG Qiming ; HE Langchong ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):045-050
Objective: To provide reference for the correct understanding and accurate implementation of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.
Methods: Introduce the main characteristics and content of the additions and revisions of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.
Results: The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition are more harmonized with the relevant guidelines of the ICH Q series, and the inclusion of advanced and mature instrument analysis technology standards and analysis method standards related to drug safety, efficacy, and quality controllability is further increased.
Conclusion: The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition have provided a more convenient new bridge for China’s drugs to go international, standardized testing technology support for achieving full process quality control, and better meet the needs of drug research and development, production, quality control, and supervision in China.
3.Dihuang Yinzi Improves Cognitive Function of Mouse Model of Learning and Memory Impairments by Regulating Synaptic Plasticity via SIRT2
Wenting WANG ; Yangjing HAO ; Wenna SU ; Qinqing LI ; Shifeng CHU ; Junlong ZHANG ; Wenbin HE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):9-17
ObjectiveTo investigate the effects of Dihuang Yinzi on the cognitive function in the mouse model of learning and memory impairments induced by scopolamine (SCOP) and explore the treatment mechanism. MethodsA mouse model of learning and memory impairment was induced by intraperitoneal injection of SCOP. Sixty male C57BL/6J mice were randomized into six groups: control (0.9% NaCl, n=10), model (SCOP 1 mg·kg-1·d-1, n=10), low-, medium-, and high-dose Dihuang Yinzi (SCOP 1 mg·kg-1·d-1 + Dihuang Yinzi 5.5, 11.0, and 22.0 g·kg-1·d-1, n=10), and donepezil (SCOP 1 mg·kg-1·d-1 + donepezil 0.84 mg·kg-1·d-1, n=10). Mice were administrated with corresponding drugs for 6 weeks. Modeling started in the 4th week, and mice in other groups except the control group were injected with SCOP intraperitoneally 40 min after daily gavage. Behavioral testing began in the 5th week, 30 min after modeling each day. The Morris water maze and novel object recognition tests were carried out to evaluate the spatial learning and memory function of mice. Nissl staining was employed to observe the survival of neurons and Nissl bodies in the hippocampal CA1 region. Western blot was employed to determine the protein levels of silent information regulator 2 (SIRT2), α-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) receptor 1 (GluA1), protein kinase A (PKA), cAMP response element-binding protein (CREB), phosphorylated-CREB (p-CREB), postsynaptic density protein 95 (PSD95), growth-associated protein-43 (GAP-43), and synaptophysin (SYN) in the hippocampus. Immunofluorescence was used to detect the expression of doublecortin (DCX) in the hippocampal dentate gyrus (DG) region. ResultsCompared with the control group, the model group showed impaired learning and memory (P<0.01), obvious neuronal damage in the hippocampal CA1 region, a reduction in neuron survival (P<0.01), a decrease in DCX expression in the hippocampal DG region (P<0.01), down-regulated proteins levels of GluA1, PKA, p-CREB/CREB, PSD95, SYN, and GAP-43 in the hippocampal tissue (P<0.05, P<0.01), and an up-regulated protein level of SIRT2 (P<0.01). Compared with the model group, the medium- and high-dose Dihuang Yinzi groups and the donepezil group showed improvements in learning and memory (P<0.05, P<0.01), while the low-, medium-, and high-dose Dihuang Yinzi groups and the donepezil group had increased neuron survival (P<0.05, P<0.01). The medium-dose Dihuang Yinzi group and the donepezil group showed increased DCX expression (P<0.05, P<0.01). The medium- and high-dose Dihuang Yinzi groups and the donepezil group showed up-regulation in the protein levels of GluA1, PKA, p-CREB/CREB, PSD95, SYN, and GAP-43 (P<0.05, P<0.01) and down-regulation in the protein level of SIRT2 (P<0.01). ConclusionDihuang Yinzi can improve the cognitive function in the mouse model of learning and memory impairments induced by SCOP by inhibiting the upregulation of SIRT2, activating the PKA/CREB signaling pathway, improving synaptic plasticity, and reducing hippocampal neuronal damage.
4.Obesity-driven oleoylcarnitine accumulation in tumor microenvironment promotes breast cancer metastasis-like phenotype.
Chao CHEN ; Hongxia ZHANG ; Lingling QI ; Haoqi LEI ; Xuefei FENG ; Yingjie CHEN ; Yuanyuan CHENG ; Defeng PANG ; Jufeng WAN ; Haiying XU ; Shifeng CAO ; Baofeng YANG ; Yan ZHANG ; Xin ZHAO
Acta Pharmaceutica Sinica B 2025;15(4):1974-1990
Obesity is a significant risk factor for cancer and is associated with breast cancer metastasis. Nevertheless, the mechanism by which alterations in systemic metabolism affect tumor microenvironment (TME) and consequently influence tumor metastasis remains inadequately understood. Herein, we found that perturbations in circulating metabolites induced by obesity promote metastasis-like phenotypes in breast cancer. Oleoylcarnitine (OLCarn) concentrations were elevated in the serum of obese mice and humans. Administration of exogenous OLCarn induces metastasis-like characteristics in breast cancer cells. Mechanistically, OLCarn directly interacts with the Arg176 site of adenylate cyclase 10 (ADCY10), leading to the activation of ADCY10 and enhancement of cAMP production. Mutations at Arg176 prevent OLCarn from binding to ADCY10, disrupting the ADCY10-mediated activation of cyclic adenosine monophosphate (cAMP) signaling pathway. This activation promotes transcription factor 4 (TCF4)-dependent kinesin family member C1 (KIFC1) transcription, thereby driving breast cancer metastasis. Conversely, the neutralization of both ADCY10 and KIFC1 through knockdown or pharmacological inhibition abrogates the oncogenic effects mediated by OLCarn. Hence, obesity-induced systemic environmental changes lead to the aberrant accumulation of OLCarn within the TME, making it a potential therapeutic target and biomarker for breast cancer.
5.The value of electrocardiographic parameters in assessment of severe coronary artery lesions
Sumeng WANG ; Fangfang ZHANG ; Liantao NIE ; Kexin LUO ; Shifeng LI
The Journal of Practical Medicine 2024;40(17):2465-2470
Objective To investigate the value of electrocardiographic parameters in assessing severe coronary artery lesions in patients with coronary artery disease.Methods A total of 364 patients with coronary heart disease admitted to the Second Affiliated Hospital,Zhengzhou University from January 2022 to September 2023 were selected as the subjects.The patients were divided into severe lesion group(n=123)and non-severe lesion group(n=241)based on the Gensini score.The two groups were compared in terms of baseline data and electrocardiographic parameters.Logistic regression was used to analyze the factors affecting severe lesions and the efficacy of ECG parameters assessment.A column-line plot of ECG parameters to assess severe lesions was created.The joint incremental value of ECG parameters and the area under the ROC curve for assessing severe lesions were calculated.Results The patients in the severe lesion group were elder in age and they showed significantly higher rates in creatine kinase isoenzyme,amino-terminal brain natriuretic peptide precursor,QRS time frame,frontal QRS-T pinch angle,smoking,hypertension,diabetes mellitus,pathologic Q waves,left ventricular hyper voltage,fragmented QRS waves,and significantly lower rates in low HDL cholesterol and ejection fraction,as compared to the non-severe lesion group(all P<0.05).Logistic regression analysis showed that pathological Q waves(OR=3.71,95%CI:1.93~7.15,P<0.001),left ventricular hyper voltage(OR=5.05,95%CI:1.66~15.41,P=0.004),fragmented QRS waves(OR=2.17,95%CI:1.14~4.11,P=0.018),and frontal QRS-T pinch angle(OR=1.01,95%CI:1.00~1.02,P=0.023)were the factors for assessing severe lesions.The incremental value of combined ECG parameters for severe lesions:C-statistic 0.09(95%CI:0.02~0.16,P=0.009),NRI 0.37(95%CI:0.20~0.55,P<0.001),and IDI 0.12(95%CI:0.08~0.17,P<0.001).The ROC curves showed an AUC of 0.79(95%CI:0.74~0.84,P<0.001),a sensitivity of 63.41%,and a specificity of 85.89%for the combined assessment of severe lesions by ECG parameters.Conclusion The combined observations of electrocardiographic parameters such as pathologic Q waves,left ventricular hyper voltage,fragmented QRS waves,and frontal QRS-T pinch angle have an affirmativeclinical value in the assessment of severe lesions.
6.Anti-inflammatory role of colchicine in the prevention of ischemic stroke
Pengfei ZHANG ; Shijun XIONG ; Xiuxiu LI ; Shifeng GUO
International Journal of Cerebrovascular Diseases 2024;32(5):364-368
Inflammation is associated with the occurrence and recurrence of ischemic stroke, and patients with coronary artery disease who receive colchicine treatment have a lower incidence of vascular events. However, the efficacy and safety of anti-inflammatory therapy with colchicine in preventing recurrent stroke is unclear. This article reviews the relevant mechanisms of action of colchicine and its role in the prevention of ischemic stroke, aiming to provide reference for the secondary prevention of ischemic stroke.
7.Application of ciprofol-alfentanil in short urological surgery
Yaxin HOU ; Shifeng HE ; Wangyue ZHANG ; Xiling TANG ; Zhentao SUN
Chongqing Medicine 2024;53(5):707-711
Objective To evaluate the application effect of ciprofol-alfentanil in short urological surgery.Methods A total of 80 patients who were to undergo urological general anesthesia surgery in this hospital were divided into two groups by random number method:ciprofol-alfentanil group(group C)and propofol-alfentanil group(group P).Group C was injected with ciprofol 0.4 mg/kg,group P was injected with propofol 1.5-2.0 mg/kg,and when the bispectral index(BIS)was<60,the intravenous injection of alfen-tanil(10 μg/kg)and rocuronium bromide(0.6 mg/kg)was continued.When the modified alertness/sedation score(MOAA/S score)was 0,the laryngeal mask was placed and mechanical ventilation was used.During the maintenance period,ciprofol 0.8-1.2 mg·kg-1·h-1 was infused intravenously in group C,and propofol 4-6 mg·kg-1·h-1 was infused intravenously in group P.The heart rate(HR),blood pressure(BP),oxygen saturation(SpO2),end-tidal carbon dioxide(PetCO2),BIS and MOAA/S score were recorded at the begin-ning of anesthesia induction(T0),laryngeal mask insertion(T1),ureteroscopy entry(T2),10 min after sur-gery(T3)and the end of surgery(T4).The consciousness disappearance time,operation time,anesthesia re-covery time,drug dosage,injection pain during induction,hypotension,bradycardia and other adverse reactions during the operation were recorded.Results There was no significant difference in HR,SpO2,PetCO2,BIS value,MOAA/S score,operation time,consciousness disappearance time,and anesthesia recovery time be-tween the two groups at each time point(P>0.05).The dosage of sedative drugs in group C was less than that in group P(P<0.05).Compared with group P,systolic blood pressure and diastolic blood pressure at T1-T3 and diastolic blood pressure at T4 increased in group C(P<0.05).Compared with T0,systolic blood pressure at T1-T4 in group C and group P decreased,diastolic blood pressure at T2-T4 in group C de-creased,and diastolic blood pressure at T1-T4 in group P decreased(P<0.05).Compared with group P,the injection pain and the incidence of intraoperative hypotension were reduced in group C(P<0.05).Conclusion Cipro-fol-alfentanil is superior to propofol-alfentanil in short urological surgery.
8.Effects of anti-HLA donor-specific antibodies and desensitization on engraftment of haploidentical hematopoietic stem cell transplantation
Yao MA ; Yanfang ZHANG ; Kang ZHOU ; Yun LUO ; Shu CHEN ; Shifeng LOU ; Jianchuan DENG
Journal of Army Medical University 2024;46(4):319-325
Objective To investigate the effects of anti-HLA donor-specific antibodies(DSA)and desensitization for DSA+patients on engraftment of haploidentical hematopoietic stem cell transplantation(haplo-HSCT).Methods The patients who underwent haplo-HSCT and examinations for HLA antibodies and DSA in our department from March 2017 to July 2023 were recruited in this study.The effects of desensitization measure on engraftment in the DSA+patients after haplo-HSCT were analyzed.Results Among the 70 patients who underwent haplo-HSCT and test for HLA antibodies,15(21.4%)patients were DSA positive,including 7(46.7%)cases of strong positive,3(20.0%)cases of moderate positive,and 5(33.3%)cases of weak positive.The median duration for neutrophil implantation was significantly extended in the DSA+patients than the negative patients(P=0.027).For the 6 patients developed graft failure(GF),4 were DSA+which was statistically higher than the DSA-patients(P=0.025).Multivariate regression analysis showed that DSA was an independent factor affecting GF(HR=9.273,95%CI:1.505~57.124,P=0.016).Among the 10 patients(7 strong positive and 3 moderate positive DSA)received desensitization therapy,4 patients received combination desensitization,with a 100%rate of successful transplantation,and 6 received single desensitization,with 4(66.7%)experiencing GF,so the GF rate was obviously lower in the combination than the single desensitization(P=0.008).Conclusion In haplo-HSCT patients,DSA is an important factor leading to implantation delay and GF.While,single desensitization treatment has limited efficacy.In combined DSA desensitization therapy,the decrease of antibody titer should be dynamically monitored to ensure the successful implantation of stem cells and reduce GF rate.
9.Discussion on the medication law of Wang Xugao for the treatment of phlegm-drinking disease based on data mining
Baixiao CHEN ; Ying ZHONG ; Canmei LI ; Yangling HUANG ; Shifeng LIN ; Yaping ZHANG
International Journal of Traditional Chinese Medicine 2024;46(1):97-102
Objective:To explore the prescription ideas of treating phlegm-drinking disease in Wang Xugao Lin Zheng Yi An; To analyze the medication law of Wang Xugao's clinical treatment of phlegm-drinking disease. Methods:The database was established based on the medical records of the chapter of phlegm, fluid retention and liver wind and phlegm fire contained in Wang Xugao Lin Zheng Yi An. Excel 2017 software was used to analyze the frequency, taste and meridian tropism of all Chinese materia medica. For Chinese materia medica with frequency≥10, IBM SPSS Modeler 18 software was used to analyze the association rules based on Apriori algorithm, and SPSS 25.0 software was used for cluster analysis based on Ochiai algorithm. Results:A total of 80 medical cases were included, involving 114 prescriptions, including 191 flavors of Chinese materia medica . High-frequency Chinese materia medica mainly included Poria, Pinelliae Rhizoma, Citri Reticulatae Pericarpium, Atractylodis Macrocephalae Rhizoma and Armeniacae Semen Amarum, etc. The main properties in Wang Xugao's medication for the treatment of phlegm-drink disease were warm, followed by cold and mild. The main tastes were sweet, bitter and pungent. Drugs mainly belong to the lung meridian and spleen, stomach, liver, kidney meridians; several core medicinal pairs were obtained, such as Farfarae Flos - Armeniacae Semen Amarum, Pinelliae Rhizoma - Zingiberis Rhizoma, Uncariae Ramulus cum Uncis - Haliotidis Concha, etc. Eight groups of core drug combinations could be sorted out by clustering analysis.Conclusions:In the treatment of phlegm-drinking disease, Wang Xugao paid attention to the simultaneous treatment of multiple viscera to coordinate the balance between the viscera, emphasized the complex etiology of phlegm-drinking disease combined with cold, fire and dampness, attached importance to the treatment of healthy qi to retreat pathogens, the regulation of three-energizer to regulate qi flow. The treatment of three-energizer, promoting yang and reducing phlegm, clearing liver and dispelling wind are the main methods. Medication mainly chooses properties of sweet and warm, with bitter and pungent.
10.Analysis of clinical characteristics and risk factors for diabetes mellitus complicated with urinary tract infection in children
Alim NIJAT ; Shifeng MA ; Alim XAMSIYA ; Jing ZHANG ; Rongxiu ZHENG
Tianjin Medical Journal 2024;52(10):1051-1055
Objective To investigate clinical features and risk factors of childhood diabetes mellitus(DM)complicated with urinary tract infection(UTI).Methods The data of 160 children with DM in our hospital in the past 2 years were collected as the research object,and they were divided into the UTI group and the non-UTI group UTI,with 80 cases in each group.The clinical data of children with DM and UTI were collected and analyzed,including DM type,sex,age,body mass index(BMI),living environment,duration of disease,length of hospital stay,indwelling catheter,ketoacidosis,antibiotic and insulin use,the types of bacteria isolated from urine samples and various laboratory indicators on admission.Results Pathogen bacteria mainly included Escherichia coli(n=37,46.2%),Enterococci(n=21,26.2%)and Klebsiella pneumoniae(n=9,11.2%)in the UTI group.Univariate analysis showed that there were significant differences in obesity,duration of disease,length of hospital stay,indwelling catheter,ketoacidosis,antibiotic use,glycosylated hemoglobin(HbA1c),albumin(ALB)and serum creatinine(Cr)between the two groups(P<0.05).Multivariate regression analysis showed that risk factors for DM complicating UTI included prolonged hospitalization(OR=2.087,95%CI:1.562-2.789),indwelling urinary catheter(OR=15.886,95%CI:2.336-108.007),ketoacidosis(OR=9.300,95%CI:1.169-73.992),duration of disease≥36 months(OR=20.548,95%CI:2.425-174.119),increased HbA1c(OR=16.686,95%CI:3.666-75.955)and serum Cr(OR=1.010,95%CI:1.002-1.019),while the increased serum ALB(OR=0.799,95%CI:0.702-0.910)was its protective factor.Conclusion Pathogenic bacteria in the UTI group are mainly Escherichia coli.Children with DM and UTI are closely related to the length of hospitalization,indwelling catheter,ketoacidosis,duration of disease,HbA1c,serum Cr and ALB levels.

Result Analysis
Print
Save
E-mail