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.

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.

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.

Objective:To investigate the value of quantitative parameters of amide proton transfer-weighted (APTw) imaging and dynamic contrast-enhanced (DCE)-MRI for preoperative assessment of human epidermal growth factor receptor 2 (Her-2) gene expression in endometrial cancer (EC).Methods:This research conducted a diagnostic pilot study involving 68 patients with pathologically confirmed EC at the First Hospital of Dalian Medical University from August 2019 to August 2023. Patients were categorized into Her-2-positive group (33 cases) and Her-2-negative group (35 cases) based on postoperative Her-2 gene expression results. Utilizing the APTw and DCE-MRI sequences, quantitative parameters including the asymmetric magnetization transfer ratio (MTR asym) for APTw and the volumetric transfer constant (K trans), plasma volume fraction (V p), extracellular mesenchymal space (V e), and rate constant (K ep) for DCE-MRI were acquired for the lesion site. Statistical differences in the values of each quantitative parameter between the two groups were evaluated using two independent sample t test or Mann-Whitney U test. The study incorporated quantitative parameters and clinicopathological data of patients to identify independent predictors of EC Her-2 gene expression through logistic regression analysis. A diagnostic model was developed using binary logistic regression analysis. The effectiveness of the parameters and diagnostic model was evaluated using receiver operating characteristic curves. DeLong test was used to compare the differences between the areas under the curves (AUC). Results:The study found statistically significant differences in MTR asym, K trans, and V e between the Her-2-positive group and the Her-2-negative group ( Z=2.55, P=0.011; t=-2.03, P=0.047; t=-2.13, P=0.037). However, the differences in V p and K ep were not statistically significant ( Z=0.58, P=0.560; Z=0.19, P=0.849). MTR asym emerged as a significant independent predictor of Her-2 gene expression in EC ( OR=1.016, 95% CI 1.003-1.030, P=0.014). Incorporating MTR asym, K trans, and V e, the diagnostic model yielded an AUC (95% CI) of 0.745 (0.625-0.864). The AUC (95% CI) for MTR asym, K trans, and V e alone were 0.680 (0.551-0.808), 0.623 (0.485-0.760), and 0.656 (0.523-0.789) respectively. The differences in AUC between the diagnostic model and individual predictors MTR asym, K trans, and V e were not found to be statistically significant ( Z=1.40, 1.92, 1.37, P=0.163, 0.055, 0.171). Conclusion:The quantitative parameters of APTw and DCE-MRI sequences can preoperatively assess EC Her-2 gene expression from a different perspective, with MTR asym potentially serving as a valuable independent predictor.

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.

In recent years,increasing attention has been paid to the study on the pathogenesis of cerebral ischemia in terms of the overall structure and function of neurovascular unit(NVU),which has become one of the hot spots in the field of brain sciences and major brain diseases.This paper is intended to outline the roles of the four main NVU cells(neurons,astrocytes,microglia and cerebral microvascular endothelial cells)in brain function and pathogenesis of cerebral ischemia,which are closely related in structure,work together to maintain cerebral homeostasis in function,and play an important role in brain function and cerebral ischemic injuries.NVU injury leads to microvascular and blood brain barrier integrity impairment,neuronal cell death,glial reaction and immune cell infiltration,and even tissue injury and brain edema.This paper also aims to elucidate the roles of NVU structure and function in the pathogenesis of cerebral ischemia,and offer new ideas and strategies for the research related to drugs for prevention and treatment of cerebral ischemia based on NVU structure and function.

21-hydroxylase deficiency(21-OHD) is mainly characterized by cortisol deficiency with or without aldosterone deficiency and hyperandrogenemia.The disease requires lifelong exogenous glucocorticoid/salt supplementation.Excessive doses of exogenous glucocorticoids are often needed to control hyperandrogenemia, but the effect is not satisfactory.Corticotropin releasing factor (CRF) type 1 receptor antagonist can directly block the production of adrenocorticotropin, inhibit the generation of adrenogenic androgen, reduce the dose of glucocorticoid therapy, and thus lower the incidence of adverse reactions.In this article, the current research progress on 21-OHD therapy and CRF1 receptor antagonist was reviewed.

Objective:To evaluate the optimization efficacy of ropivacaine mixed with nalbuphine for epidural labor analgesia through comparison with ropivacaine mixed with sufentanil in primiparas.Methods:Four hundred and forty primiparas with a singleton fetus in vertex presentation without abnormal fetus, aged 19-36 yr, at 37-42 weeks of gestation, who were suitable and volunteered to receive epidural labor analgesia, were selected and randomly divided into observation group (NR group, n=220) and conventional group (C group, n=220).Epidural labor analgesia solution contained nalbuphine 40 mg and ropivacaine 120 mg in 150 ml of normal saline in group NR.Epidural labor analgesia solution contained sufentanil 50 μg and ropivacaine 120 mg in 150 ml of normal saline in group C. The analgesia pump was set up to deliver a 5 ml bolus dose with a 20-min lockout interval, programmed intermittent bolus 10-15 ml/h and background infusion at 2 ml/h after an initial dose of 15 ml to maintain VAS score <3.The length of labor, adverse reactions during labor analgesia, neonatal Apgar score, parameters of umbilical artery blood gas analysis and neonatal behavioral neurological assessment score were recorded. Results:Compared with group C, the incidence of urinary retention, pruritus, nausea and vomiting and fever at birth was significantly decreased in group NR ( P<0.05).The duration of the first and second stages of labor, neonatal Apgar score, pH value of umbilical artery blood, lactate concentrations, and neonatal behavioral neurological assessment score were within the normal range in both groups, and there was no significant difference between the two groups ( P>0.05). Conclusions:Compared with conventional medication, nalbuphine mixed with ropivacaine has the same efficacy when used for epidural labor analgesia in primiparas, but it has a certain optimization efficacy in terms of safety.

Objective To detect the frequency of BRAF/ KRAS and PIK3CA mutations in the small cell lung cancer (SCLC) specimens from a large population of Chinese patients and to analyze the gene mutation and clinical characteristics. Methods A total of 557 samples were collected from SCLC patients from 2009 to 2014.BRAF,KRAS,PIK3CA,NRAS and MEK1 gene mutations were detected by the dideoxy sequencing. Chi-square test was adopted to analyze the correlation between clinical factors and gene mutation. Kaplan-Meier method was utilized for survival analysis. Cox model was used for multivariate prognostic analysis. Results BRAF mutations were detected in 13 out of 557 specimens. The mutation types included V600E (n= 5) ,V600A (n= 2) ,V600M (n= 1) ,D594G (n= 1),G464E (n= 1),K601R (n= 2) and S605N (n= 1).KRAS mutation was detected in 6 cases including G12C (n= 3),G12A (n= 1),G12D (n=1) andG13D (n= 1).PIK3CA mutation was observed in 4 samples including E545G (n= 2) and H1047R (n= 2).Besides,NRAS mutation (Q61R) was detected in 1 case and MEK1 mutation (D61Y) was noted in 1 case. These gene mutations were not significantly correlated with the age, gender, smoking status and clinical staging of the patients. Univariate survival analysis demonstrated the median survival time of patients with gene mutation was (10.30±0. 751) months (95％CI:8. 829-11. 771 months),significantly shorter than (12.80±0. 543) months (95％CI:11. 736-13. 864 months) of their counterparts without gene mutation (P=0. 011). Conclusions BRAF/ KRAS and PIK3CA gene mutation is detected in a small proportion of SCLC patients. These gene mutations are not significantly correlated with the clinical characteristics. Univariate survival analysis demonstrates that negative these gene mutations are negatively correlated with the clinical prognosis of SCLC patients.