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.

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:Intro-duce 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 physi-cal and chemical analysis in the Chinese Pharmacopoeia 2025 Edition are more harmonized with the relevant guide-lines 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 review and summarize the experience of robot-assisted laparoscopic trans-plant nephrectomy,share the surgical steps and technical key points,and provide a reference for clinical practice.Methods:A retrospective analysis was conducted on the perioperative data of 5 patients who underwent robot-assisted laparoscopic donor nephrectomy at Peking University Third Hospital from August 2023 to December 2024.The surgical steps and key points were summarized.The continuous variables were described by medians(ranges).Results:A total of 5 patients were included in the analysis,of whom 2 were male and 3 were female.The median age of the patients was 37(31-68)years.The me-dian time from kidney transplantation to donor nephrectomy was 10(3-22)years.The indications for donor nephrectomy included recurrent hematuria,abdominal pain,malignant tumor of the transplanted kidney,and recurrent infection with hydronephrosis of the transplanted kidney.The excised transplanted kidneys from all the 5 patients had a single renal artery and a single renal vein.The median operation time was 212(145-351)min,the median blood loss was 300(20-500)mL,and the median post-operative hospital stay was 7(4-25)days.Only 1 patient experienced intraoperative complications,who experienced an external iliac artery injury during the operation and underwent suture repair.No pa-tient died during the perioperative period.Postoperative pathological results showed that 3 patients had end-stage non-functional kidneys,1 patient had BK virus-associated urothelial carcinoma,and 1 patient had chronic pyelonephritis with renal parenchymal atrophy.Conclusion:Robot-assisted laparoscopic transplant nephrectomy as a new surgical approach is feasible and safe.Compared with traditional open transplant nephrectomy,its advantage lies in the ability to directly observe and prioritize the management of the renal pedicle of the transplanted kidney,while completely freeing and removing the transplanted kidney outside the renal capsule.With the continuous accumulation of experience,this surgical technique is expected to become a powerful alternative to traditional open transplant nephrectomy.

Objective To investigate the safety and efficacy of hepatic arterial infusion chemotherapy(HAIC)using lenvatinib plus immune checkpoint inhibitors(ICI)in the treatment of progressive advanced hepatocellular carcinoma(HCC).Methods The clinical data of 67 patients with HCC of BCLC stage C,who received HAIC treatment at the Guangdong Provincial Hospital of Traditional Chinese Medicine of China from May 2018 to March 2022 and were assessed as in disease progression(PD)status after HAIC treatment,then had to further receive second-line treatment with lenvatinib plus ICI regimen.According to modified Response Evaluation Criteria in Solid Tumors(mRECIST),the tumor responses,including overall survival(OS),progression free survival(PFS),objective response rate(ORR),and disease control rate(DCR),were evaluated.Univariate analysis and multivariate analysis based on the COX proportional hazards regression model were used to determine the prognosis-related risk factors.According to the Common Terminology Criteria for Adverse Events version 5.0(CTCAE 5.0),the treatment-related adverse effects were recorded and evaluated.Results The median OS and median PFS in the 67 patients with HCC of BCLC stage C receiving second-line treatment with lenvatinib plus ICI regimen,who were evaluated as in PD status after first-line HAIC treatment,were 18.4 months and 7.2 months respectively.The ORR and DCR were 22.4％(15/67)and 67.4％(45/67)respectively.Univariate analysis and multivariate analysis showed that Eastern Cooperative oncology Group(ECOG)score and hepatitis B virus(HBV)infection were the independent risk factors affecting OS,while AFP level was an independent risk factor affecting PFS.The main treatment-related adverse reactions included elevation of transaminase level,hypertension,and hyperbilirubinemia.No death occurred during the therapeutic course.Conclusion For patients with HCC of BCLC stage C,who become in PD status after first-line HAIC treatment,second-line treatment with lenvatinib plus ICI regimen carries satisfactory efficacy and its adverse reaction is tolerable.

Objective To discuss the safety and efficacy of hepatic arterial infusion chemotherapy(HAIC)combined with apatinib and carizolizumab in the treatment of hepatocellular carcinoma(HCC)with major portal vein tumor thrombosis(Vp4).Methods The clinical data of patients with HCC complicated by Vp4 from three certain Grade Ⅲ medical centers,who received HAIC combined with apatinib and carizolizumab(triple treatment group)or received HAIC alone(simple HAIC group)from July 2018 to December 2023,were retrospectively collected.Propensity score matching(PSM)was used to balance the general differences between groups,and the pre-PSM and post-PSM overall survival time(OS),progression-free survival time(PFS),and tumor response rate were compared between the two groups.Based on COX proportional hazards regression model the survival-related risk factors were identified.The clinical safety was evaluated by comparing the incidence of adverse reactions between different therapeutic regimens.Results In the overall cohort,the median OS and median PFS in the triple treatment group were 16.4 months and 9.1 months respectively,which in the simple HAIC group were 6.9 months and 4.2 months respectively(both P＜0.001).In the triple treatment group and the simple HAIC group,the objective response rate(ORR)was 41.2％and 15.2％respectively(P＜0.001),and the disease control rate(DCR)was 77.9％and 68.5％respectively(P=0.185).In the PSM cohort,the median OS and median PFS in the triple treatment group were 16.4 months and 9.1 months respectively,which were significantly longer than 7.4 months and 3.7 months respectively in the simple HAIC group.In the triple treatment group and the simple HAIC group,the ORR was 39.5％and 11.6％respectively(P=0.003),and the DCR was 81.4％and 62.8％respectively(P=0.054).Univariate and multivariate analyses showed that HAIC combined with apatinib and carizolizumab treatment was an independent factor influencing both OS and PFS.No statistically significant difference in the incidence of adverse reactions of all levels existed between the two groups,although the incidence of some adverse reactions in triple therapy group was higher than that in the simple HAIC group.Conclusion Compared with pure HAIC therapy,HAIC combined with apatinib and carizolizumab has better survival benefits and tumor response rate,it is clinically safe and effective,besides,the patients can well tolerate this treatment.Therefore,HAIC combined with apatinib and carizolizumab is a promising treatment option for patients with HCC complicated by Vp4.

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 analyze the coordination strategies of residual solvent control in various pharmacopoeias with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines for residual solvents(ICH Q3C),aiming to provide ideas and solutions for coordinating residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Methods Through literature research and review,compare the coordination process between residual solvent control in various pharmacopoeias and ICH Q3C,analyze the implementation strategies of mainstream pharmacopoeia residual solvent control and ICH Q3C coordination in foreign countries,and clarify the differences in residual solvent control between the Chinese Pharmacopoeia and foreign pharmacopoeias.Results It is necessary to coordinate the control of residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Conclusion It is recommended to steadily promote the overall coordination of residual solvent control in Chinese pharmacopoeia and ICH by drawing on the experience of coordination between foreign pharmacopoeias and ICH Q3C,based on the national conditions of China.

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.