Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

Objective: To analyze the serotypes and drug resistance of Salmonella isolated from food-borne disease surveillance samples in Longwan District, Wenzhou City, Zhejiang Province, so as to provide evidence for the prevention and treatment of Salmonella infection. Methods: Salmonella strains isolated from feces or anal swabs of patients with foodborne diarrhea in Longwan District People's Hospital from 2018 to 2024 were collected. After re-identification, slide agglutination test was used to identify serotypes. The drug susceptibility test of live Salmonella strains was performed using the broth microdilution method, and the resistance patterns were analyzed. Results: A total of 2 293 samples were collected, and 186 strains of Salmonella were isolated, with a detection rate of 8.11%. The detection rate was higher from May to October. A total of 28 Salmonella serotypes were identified, with S. typhimurium (72 isolates, 38.71%), S. enteritidis (31 isolates, 16.67%), and S. London (30 isolates, 16.13%) being dominant. Among the 121 Salmonella live strains, 20 strains were susceptible to 14 antibacterial drugs. A total of 101 strains were resistant to antibacterial drugs, and the drug resistance rate was 1.65%-67.77%, with the drug resistance rate of ampicillin being the highest, and the drug resistance rate of imipenem was the lowest. S. typhimurium had the highest resistance rate to tetracycline (78.26%). S. enteritidis had the highest resistance rate to ampicillin (100.00%). S. London had the highest resistance rate to tetracycline (66.67%). Fifty-five types of drug resistance patterns were detected, showing a number of drug resistance of 1-10, of which 76 strains were multi-drug resistant, accounting for 75.25%. The predominant multidrug resistance patterns were ampicillin/sulbactam-cefazolin-ampicillin-nalidixic acid (10.53%), tetracycline-ampicillin-nalidixic acid (9.21%), and ampicillin/sulbactam-ampicillin-nalidixic acid (7.89%). Conclusions Salmonella strains isolated from foodborne diseases in Longwan District were mainly detected in summer and autumn. S. typhimurium, S. enteritidis, and S. London were the predominant serotypes. The drug resistance of Salmonella to different antibacterial drugs was different, and the drug resistance spectrum showed diversity.

OBJECTIVES: To investigate the subcellular localization and biological functions of transmembrane protein 240 (TMEM240). METHODS: NCBI BLAST and TMHMM bioinformatics software were used for protein sequence analysis and prediction of transmembrane domain of TMEM240. Brain tissues from male C57BL/6 mice (18-20 days old) were examined for distribution of TMEM240 using in situ hybridization, and qPCR and Western blotting were used to detect TMEM240 expression in different mouse tissues and in cortical neurons at different time points (n=3). In the in vitro experiment, HepG2 and Neuro-2a cells were transfected with plasmids for overexpression of TMEM240, and subcellular localization of TMEM240 was analyzed using cell imaging. In primary cultures of cortical neurons isolated from C57BL/6 mice, TMEM240 expression and its biological functions were investigated using qPCR, Western blotting, and immunofluorescence staining. RESULTS: Human and mouse TMEM240 proteins share a 97.69% similarity in the protein sequences, and both are transmembrane proteins with two transmembrane domains. TMEM240 mRNA and protein were highly expressed in mouse brain tissues and cortical neurons. In isolated mouse cortical neurons, TMEM240 expression reached the peak level after primary culture for 9 days and distributed in scattered spots within the cells. In HepG2 cells, TMEM240 was characterized as intracellular membrane structures and showed 80% colocalization with peroxisomes. In Neuro-2a cells, TMEM240 overexpression caused significant enhancement of the expressions of Rho GDP dissociation inhibitor β (ARHGDIB) at both the mRNA and protein levels. CONCLUSIONS TMEM240 is a novel intracellular subcellular structure specifically expressed in neurons with significant potential for targeted cellular function regulation.
Animals ; Humans ; Mice ; Peroxisomes/metabolism* ; Membrane Proteins/genetics* ; Mice, Inbred C57BL ; Neurons/metabolism* ; Male ; rho-Specific Guanine Nucleotide Dissociation Inhibitors ; Hep G2 Cells ; Brain/metabolism*

Objective:To investigate the feasibility and safety of implementing a domestic vehicle-mounted remote mobile robotic surgical system in thyroid surgery applications, integrated with 5G communication technology.Methods:Using the main system located on the vehicle-mounted mobile robot operating platform of the 960th Hospital of PLA Joint Logistics Support Force and the slave system of Weifang Traditional Chinese Hospital, the remote radical thyroidectomy 5G communication technology, and analyze the clinical and information transmission data of two female patients who underwent remote mobile robot thyroid cancer surgery on October 21, 2024 at Weifang Traditional Chinese Medicine Hospital.Results:The remote radical thyroidectomy was conducted by the robosurgeons utilizing a vehicle-mounted mobile robotic surgical system, and the procedure was successfully completed without necessitating intermediate open surgery. The operation durations for patient 1 and patient 2 were 135 minutes and 108 minutes, respectively, with 7 and 13 lymph nodes dissected, respectively. The average delay in surgical data transmission was recorded at 61.9 milliseconds, with no instances of signal interruption or frame loss. The procedure proceeded smoothly, without any jamming, and the audio and video transmissions were consistently clear. Follow up for 21 days after surgery showed no complications such as hoarseness, skin damage, or lymphatic fistula.Conclusion:The implementation of a vehicle-mounted remote mobile robotic surgery system for thyroid surgery has demonstrated safety and feasibility. Furthermore, the utilization of the 5G network offers rapid data transmission and minimal latency, closely approximating the therapeutic efficacy of traditional robotic thyroidectomy.

Objective:To investigate the correlation between fibrinogen/albumin ratio (FAR) and overall burden of cerebral small vessel disease (CSVD).Methods:Patients with CSVD who visited the Department of Neurology, Zhengzhou Central Hospital Affiliated to Zhengzhou University from May 2023 to May 2024 were included retrospectively. All patients underwent MRI to evaluate the total CSVD burden score (range: 0-4) by cerebral microbleeds, white matter hyperintensities, lacunar and enlarged perivascular spaces. 0-1 point was the mild burden group, and 2-4 points were the moderate-to-severe burden group. FAR was calculated as serum fibrinogen (g/L)/albumin (g/L)×100%. Spearman correlation analysis and multivariate logistic regression analysis were used to determine the relationship between FAR and total CSVD burden. Results:A total of 261 patients with CSVD were enrolled, including 145 males (55.6%), aged 64.08±8.74 years. There were 110 patients (42.1%) in the CSVD mild burden group and 151 (57.9%) in the moderate-to-severe burden group. Spearman correlation analysis showed that there was a significant positive correlation between FAR and total CSVD burden scores ( r=0.385, P<0.001). Univariate analysis showed that the proportion of patients with diabetes, history of stroke or transient ischemic attack, as well as age, FAR, homocysteine and fibrinogen in the CSVD moderate-to-severe burden group were significantly higher than those in the mild burden group, while serum albumin and high-density lipoprotein cholesterol were significantly lower in the mild burden group (all P<0.05). Multivariate logistic regression analysis showed that higher FAR (odds ratio 1.433, 95% confidence interval 1.201-1.710; P<0.001) and homocysteine (odds ratio 1.093, 95% confidence interval 1.026-1.164; P=0.005) were significantly independently associated with the moderate-to-severe total CSVD burden. Conclusion:The level of FAR is closely associated with the severity of the total CSVD burden in patients with CSVD.

Objective: To explore the clinical and molecular genetic features of a Chinese patient with catecholaminergic polymorphic ventricular tachycardia (CPVT). Methods: Clinical data including resting electrocardiography, echocardiography and treadmill exercise testing of a patient with CPVT admitted to our department in March 2013 were analyzed, and the peripheral venous blood samples of the patient and his family members and 400 ethnicity-matched healthy controls were obtained. All exons and exon-intron boundaries of the six CPVT-related genes including RYR2, CASQ2, TRDN, CALM1, KCNJ2 and ANKB were sequenced to detect the variants related to CPVT. The relationship between the genotypes and phenotypes was analyzed to direct the target therapy. Results: Recurrent syncope induced either by exercise or extreme frightened fear was observed in this patient. There was no positive family history of syncope or sudden death. The resting electrocardiography and echocardiography of the patient were normal, while the exercise testing revealed bidirectional and polymorphic ventricular tachycardia. A cardiac ryanodine receptor gene mutation (R2401H) was identified in this patient, while this mutation was absent in his parents and sister and 400 controls. No variant was detected in the remaining five candidate genes. Treatment with high dose of metoprolol succinate (118.75 mg/d) was effective and patient was free of syncopal attack during the 2 years follow-up. Conclusion This is the first report on RyR2-R2401H mutation in Chinese patient with CPVT, and high dose of metoptolol is the effective therapy option for CPVT related to RyR2 mutation.

Objective To investigate the impact of peritoneal albumin leakage on malnutrition-inflammation-atherosclerosis (MIA) syndrome in continuous ambulatory peritoneal dialysis (CAPD) patients. Methods A cross-sectional study of a cohort of 130 CAPD patients without edema or active infection was performed. In order to identify peritoneal transport characteristics in CAPD patients, a standard peritoneal equilibration test (PET) was carried out. For malnutrition and inflammation, serum albumin and high-sensitivity C-reactive protein (hs-CRP) levels were measured. Mean-carotid artery intima media thickness (IMT) was used to determine atherosclerosis. Residual glomerular filtration rate (rGFR) was defined as the average of 24-hour urinary urea and creatinine clearances. Results Pearson and Spearman correlation analysis showed that peritoneal albumin leakage amount was positively correlated with age, body mass index, night dwell time, blood glucose, 4 h D/P creatinine levels and hs-CRP levels (r=0.204, P<0.05 ;r=0.314, P<0.01; r=0.265, P<0.01; r=0.212, P<0.05; r=0.401, P<0.01; r=0.216, P<0.05); whereas it was negatively correlated with diastolic perssure, serum albumin levels, glucose level of dialyzate and peritoneal Kt/V (r=-0.209, P<0.05; r=-0.123, P<0.05; r=-0.271, P<0.01; r=-0.212, P<0.01). Overall, there was no correlation between peritoneal albumin leakage and IMT. Patients was significantly greater (P<0.01), and there was a positive correlation between peritoneal albumin leakage amount and IMT (r=0.650, P<0.01). Conclusions Peritoneal albumin leakage is significantly associated with peritoneal transport characteristics, malnutrition and inflammatory state in CAPD patients. High peritoneal albumin leakage amount is a risk factor for atherosclerosis in patients with rGFR less than 1 ml·min-1(1.73 m2)-1.