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.

BACKGROUND:Deep muscle stimulation has the effects of releasing muscle adhesion,relieving muscle spasm,improving and restoring muscle compliance and elasticity.Electromyographic biofeedback therapy can promote nerve recovery and improve lower limb motor function and gait. OBJECTIVE:To observe the effect of the effect of deep muscle stimulation combined with electromyographic biofeedback therapy on the spasm of the triceps surae and gait changes after stroke by using a digital muscle detector and three-dimensional gait analysis system. METHODS:A total of 72 patients who met the inclusion criteria were selected from the Rehabilitation Department of the First Affiliated Hospital of Guangdong Pharmaceutical University from October 2020 to October 2023.And they were enrolled and randomly divided into two groups(n=36 per group):a control group and a combined group.The control group received routine rehabilitation therapies,electromyographic biofeedback and pseudo deep muscle stimulation,while the combined group received true deep muscle stimulation treatment on the basis of the control group,five times per week,for 4 consecutive weeks.The oscillation frequency and dynamic stiffness of the affected gastrocnemius muscle,active range of motion of the ankle dorsiflexion muscle,electromyographic signal of the tibialis anterior muscle,Fugl-Meyer assessment of the lower limbs,and three-dimensional gait analysis parameters were statistically analyzed before and after treatment in two groups. RESULTS AND CONCLUSION:After treatment,oscillation frequency and dynamic stiffness values of the inner and outer sides of the affected gastrocnemius muscle in both groups of patients were significantly reduced compared with before treatment(P<0.05),and the combined group showed a more significant decrease compared with the control group(P<0.05).The active range of motion of the ankle dorsiflexion muscle,electromyographic signal of the tibialis anterior muscle,and Fugl-Meyer scores after treatment were significantly increased or improved compared with before treatment(P<0.05),while the combined group showed a more significant increase or improvement compared with the control group(P<0.05).In terms of gait parameters,the walking speed,frequency,and stride in both groups of patients were significantly increased compared with before treatment(P<0.05),while the combined group showed a more significant increase compared with the control group(P<0.05).The percentage time of support phase on the healthy side was shortened compared with before treatment(P<0.05),while the combined group showed a more significant decrease compared with the control group(P<0.05).In addition,there was no significant difference between the two groups except for the percentage of healthy side support(P>0.05).To conclude,the combination of deep muscle stimulation and electromyographic biofeedback can effectively alleviate triceps spasm in the short term after stroke,improve ankle dorsiflexion function,enhance lower limb motor function,and improve gait.The treatment effect is significant and worthy of clinical promotion and application.

The traditional theory of "the spleen governs the dispersion of essence" refers to the spleen's pivotal role in distributing refined nutrients throughout the body. In traditional Chinese medicine （TCM）， lipids are categorized under "gaozhi （膏脂）"， and their transportation and metabolism via apolipoproteins are believed to be closely related to the spleen's dispersing function. The liver， which synthesizes apolipoproteins， is functionally linked to the spleen system in TCM. Impaired dispersion of essence by the spleen and disrupted transportation of gaozhi constitute the pathological mechanism of dyslipidemia due to spleen deficiency. Strengthening the spleen and resolving dampness is the core therapeutic principle. From the perspective of modern medicine， this may involve promoting hepatic functional recovery related to lipid metabolism， thereby enhancing lipid processing and reducing the levels of abnormally accumulated lipids in the bloodstream.

Vascular structure pattern，namely the maturity，morphology and distribution of blood vessels，as one of the pathological features of renal cell carcinoma (RCC)，cannot be ignored when the prognosis is concerned.The current mainstream classification of vascular structure patterns includes pseudoacini，Golgi，lacunar and dispersion patterns.Many studies have shown that the vascular structure patterns in RCC are closely related to the diagnosis and prognosis.Early features such as dendritic penetration of the endothelium contribute to the differential diagnosis of RCC，while different vascular structure patterns are not only related to tumor grade，but also affect the responsiveness of targeted therapy and prognosis.Evaluating these vascular structural patterns can help to understand the biological behaviors of tumors and guide the treatment options，but a unified assessment of vascular structural patterns is still lacking.This paper reviews the research progress on the relationship between vascular structure patterns and RCC prognosis，aiming to provide clinical reference.

Objective To investigate the value of 18F labeled prostate-specific membrane antigen(18F-PSMA)-1007 developing agent PET/CT(18F-PSMA-1007PET/CT)examination in the diagnostic evaluation and therapeutic decision of the newly diagnosed prostate cancer(PCa)and follow up after radical prostatecto-my(RP).Methods This study adopted the retrospective observational study method.A total of 68 patients receiving 18 F-PSMA-1007 PET/CT examination in this hospital from September 2022 to October 2023 were analyzed,including 36 cases of newly diagnosed PCa and 32 cases of biochemistry follow up failure after RP.A total of 30 items of clinical data were collected,including 8 items of basic clinical characteristics,7 items of pa-thology-related characteristics and 15 items of imaging characteristics.The patients clinical characteristics in the newly diagnosed PCa and biochemical failure after RP conducted the descriptive analysis.The Fisher exact probability method was used to analyze the differentiation of the SUVmax of primary lesions in different clini-cal subgroups[different tPSA levels at diagnosis,different mi-T stages,different Gleason scores at postopera-tive pathological puncture and different pathological types]in the newly diagnosed PCa group and the differ-entiation of recurrent lesion detection rates in different clinical subgroups(different tPSA in 18F-PSMA-1007 PET/CT examination,different pathological T stages,different lymph node invasion and different pathological Gleason scores in the biochemical failure after RP group.The Spearman correlation was adopted to test and analyze the correlation between the imaging features of positive lesions and tPSA.Results In the newly diag-nosed PCa group,there were 1 case of prostatic hyperplasia and 35 cases of PCa.SUVmax had no statistical differences among the primary lesions with different tPSA levels(P=0.81),different mi-T stages(P=0.70),different puncture Glleasonscores(P=0.20)and different pathological types(P=0.71).Moreover the tPSA value at diagnosis was positively correlated with the number of metastatic lesions(r=0.410,P=0.01).The clinical treatment decisions in 11 cases(31.43％)were changed according to the examination re-sults.In 9 cases of RP combined with lymph node dissection,the accuracy rate and concordance rate of 18F-PS-MA-1007 PET/CT and MRI in the lymph node detection rate all were 100％.I n the biochemical failure after RP group,the overall recurrent lesion detection rate was 71.88％(23/32),the operative area in situ recurrence(11 cases,34.38％)and bone metastasis(11 cases,34.38％)were most common.The differences of 18F-PS-MA-1007 PET/CT recurrent lesions detection rates had no statistical differences among the patients with dif-ferent tPSA levels(P=0.08),different pathological T stages(P=0.10),different postoperative pathological lymph node invasions(P=0.68)and different pathologic Gleason score in the 18F-PSMA-1007 PET/CT ex-amination.In the 18 F-PSMA-1007 PET/CT examination in the biochemical failure after RP,the tPSA value in the recurrent lesion was positively correlated with the number of recurrent lesions(r=0.48,P=0.01),SUVmax value in the recurrent lesion(r=0.46,P=0.01)and the SUVmean value(r=0.38,P=0.03).The clinical treatment decision in 18 cases(56.25％)was changed according to the examination results.Conclusion 18 F-PSMA-1007 PET/CT has good diagnostic value and efficiency for primary lesion and metastasis lesion of new-ly diagnosed PCa and recurrent foci of biochemical failure after RP.

Objective To investigate the role of PSMA4 in the prognosis,diagnosis and immune infiltration of lung adenocarcinoma(LUAD),and explore its underlying mechanism.Methods The expression profiles and clinical data of LUAD patients were sourced from the Cancer Genome Atlas(TCGA)database.The expression level of PSMA4 in LUAD tissues(n=539)and normal tissues(n=59)were compared using the Wilcoxon rank-sum test.The expression levels of PSMA4 in LUAD tissues and normal tissues were validated by analyzing the GSE40791 and GSE10072 LUAD datasets obtained from the Gene Expression Omnibus(GEO)database.In addition,tumor and adjacent non-cancerous tissues were collected from 10 LU AD undergoing lung biopsy by fiberoptic bronchoscopy in Second Affiliated Hospital of Army Medical University from January to December 2023.The PSMA4 expression in above samples was further verified using RT-qPCR.RT-qPCR was performed to detect the expression of PSMA4 in lung cancer cells and normal lung epithelial cells.Functional enrichment analysis and immune cell infiltration analysis were conducted on the cells with high and low expression of PSMA4.Cox regression analysis and Kaplan-Meier(KM)survival analysis were used to determine the diagnostic and prognostic value of PSMA4 for LUAD,and a nomogram was constructed to predict the overall survival rate at different time points.Results The analysis of TCGA datasets,GSE40791,and GSE10072 LUAD data revealed that PSMA4 expression was significantly higher in LUAD tissues than in normal tissues(P＜0.01).RT-qPCR further confirmed that the expression of PSMA4 was obviously elevated in LUAD tissues and lung cancer cells than adjacent non-cancerous tissues and normal lung epithelial cells(P＜0.01).High PSMA4 expression could be regarded as a marker for LUAD diagnosis and poor prognosis,and was associated with reduced proportions of Tem cells,TFH cells,B cells,NK cells,Tcm cells,and mast cells in the tumor microenvironment.Conclusion PSMA4 presents significant diagnostic performance for LUAD,and is closely associated with the prognosis and immune infiltration of this malignancy.

Objective To compare the therapeutic efficacy of robot-assisted laparoscopic radical prostatectomy versus conventional laparoscopic radical prostatectomy,and analyze the factors influencing treatment outcomes.Methods A retrospective cohort study was conducted on 719 patients(total cohort)who underwent radical prostatectomy in our department from June 2002 to October 2023.According to different surgical methods,they were divided into robot-assisted laparoscopic radical prostatectomy group(robotic group,n=409)and conventional laparoscopic radical prostatectomy group(conventional group,n=310).Clinical characteristics,biochemical recurrence rates,and recovery of urinary continence at 1,3,6,and 12 months post operatively,as well as sexual function recovery at 6 and 12 months after surgery,were compared between the 2 groups.Additionally,the factors influencing biochemical recurrence and urinary continence recovery were analyzed across the entire cohort.Results In the cohort,the robot group demonstrated significantly larger proportions of pathological high T stages(≥pT3,P＜0.01),increased positive lymph node rate(P＜0.01),and greater number of dissected lymph nodes(P＜0.01)than the conventional group.There were no statistical differences between the 2 groups in terms of Gleason score,biochemical recurrence rate,or incidence and type of complications.The robot group exhibited significantly higher rates of urinary continence recovery at 1(P=0.004),3(P＜0.01),6(P=0.002)and 12 months(P=0.004)postoperatively.But no obvious difference was seen in the score of International Index of Erectile Function-5(IIEF-5)between the 2 groups at 6 and 12 months.Across the entire cohort,pathological high T stage(≥pT3,P＜0.01),high Gleason score(＞7,P=0.036),fewer lymph nodes dissected(≤ 10,P＜0.01),and positive lymph nodes(P=0.046)were independent risk factors for biochemical recurrence.Additionally,the surgical method,specifically robot-assisted laparoscopic radical prostatectomy,was identified as a significant factor influencing urinary continence recovery at 12 months postoperatively(P=0.005).Conclusion Compared to conventional laparoscopic radical prostatectomy,robot-assisted laparoscopic radical prostatectomy shows certain effect on reducing biochemical recurrence rate and enhancing recovery of urinary continence in prostate cancer patients at 1,3,6 and 12 months postoperatively.

Objective:To explore the leading role and influence path of the coordinated development of the tight medical community service capacity and the high level of county economy,so as to provide a basis for its deepening reform and long-term development.Methods:Taking 39 pilot compact medical communities in Guangxi in 2022 as research samples,from the perspective of set and whole,the coupling coordination degree model and fuzzy set qualitative comparative analysis were used to analyze the coordinated development status and influence mechanism of their service capacity and county economic level.Results:High-level county economic structure is a necessary condition to promote coupling and coordinated development.Among the six configuration paths that affect the improvement of coupling and coordination degree,the core conditions are stable county economic foundation and sufficient health human resources or(and)health financial resources.The overall solution consistency is 0.996(≥0.8),and the coverage is 0.780(≥0.5).The model has strong explanatory power.Conclusion:Multi-factor internal and external cooperation to promote the coordinated development of the service capacity of the compact medical community and the county economy should focus on the county economic foundation and structure,further improve the income of the compact medical community and pay attention to the optimization and expansion of the talent team.

Objective:To explore the leading role and influence path of the coordinated development of the tight medical community service capacity and the high level of county economy,so as to provide a basis for its deepening reform and long-term development.Methods:Taking 39 pilot compact medical communities in Guangxi in 2022 as research samples,from the perspective of set and whole,the coupling coordination degree model and fuzzy set qualitative comparative analysis were used to analyze the coordinated development status and influence mechanism of their service capacity and county economic level.Results:High-level county economic structure is a necessary condition to promote coupling and coordinated development.Among the six configuration paths that affect the improvement of coupling and coordination degree,the core conditions are stable county economic foundation and sufficient health human resources or(and)health financial resources.The overall solution consistency is 0.996(≥0.8),and the coverage is 0.780(≥0.5).The model has strong explanatory power.Conclusion:Multi-factor internal and external cooperation to promote the coordinated development of the service capacity of the compact medical community and the county economy should focus on the county economic foundation and structure,further improve the income of the compact medical community and pay attention to the optimization and expansion of the talent team.