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.

ObjectiveTo establish a managing mode for illegal and irregular acts of occupational medical examination (OME) institutions to the requirements of the new situation. Methods The OME institutions from the “Guangdong Province Key Occupational Disease Monitoring and Management Platform” were selected as the study subjects using the judgment sampling method. The clues of suspected illegal and irregular acts of OME institutions were found and submitted to the local health commission for investigation and managed according to the case information monitoring and on-site quality assessment. The OME institutions found to have illegal and irregular acts were filed and investigated according to the national law after investigation and verification. A “follow-up inspection” was conducted on five OME institutions for closed loop management. Results A total of 12 OME institutions were found to have suspected illegal and irregular acts, including seven institutions that did not meet the filing requirements for effective personnel, five institutions that conducted projects beyond the scope without filing to the provincial health authorities within 15 work days from the start of the project, and two institutions that failed to fulfill the obligation of informing and reporting to the health authorities, employers, and workers as required. After submitting relevant clues and evidence to the local health commission for investigation and management, seven institutions were not given penalty, and five institutions were given administrative penalties including two institutions were fined and warned, and three institutions were warned. No illegal or irregular acts were found in the five institutions inspected during the “follow-up inspection”. Conclusion It is beneficial to explore the managing mode of “clue discovery, clue submission, investigation and disposal, follow-up inspection” for OME institutions suspected of illegal and irregular acts, which helps urge OME institutions to work in accordance with laws and regulations and effectively protect the legitimate rights and interests of workers' occupational health.

Objective:To study the correlation between zinc finger protein A20 (A20) and basic fibroblast growth factor (BFGF) and liver fibrosis in chronic hepatitis B.Methods:A retrospective study was conducted to select 120 patients with chronic hepatitis B diagnosed and treated in the Fifth Hospital of Shijiazhuang City from January 2019 to December 2020, all of whom underwent liver tissue biopsy, and 25 cases of liver pathological specimens who underwent liver hemangioma resection were selected. The correlation between the expression of A20 and BFGF in liver tissue and the stage of hepatic fibrosis and inflammation were analyzed.Results:The expression of A20 in the S1 - S4 phase was higher than that in the S0 phase: (6.12 ± 1.22)%, (10.18 ± 2.43)%, (16.94 ± 5.06)%, (25.99 ± 7.57)% vs. (0.81 ± 0.29)%; the expression of BFGF in the S1 - S4 phase was higher than that in the S0 phase: (6.12 ± 1.22)%, (10.18 ± 2.43)%, (16.94 ± 5.06)%, (25.99 ± 7.57)% vs. (0.81 ± 0.29)%, there were statistical differences ( P<0.05). The expression of A20 in the G1 - G4 phase was higher than that in the G0 phase: (6.56 ± 1.87)%, (10.01 ± 3.29)%, (15.54 ± 5.01)%, (25.86 ± 8.02)% vs. (0.85 ± 0.71)%; the expression of BFGF in the G1 - G4 phase was higher than that in the G0 phase: (5.91 ± 1.52)%, (9.65 ± 2.48)%, (15.03 ± 4.86)%, (24.62 ± 7.22)% vs. (0.79 ± 0.41)%, there were statistical differences ( P<0.05). The results of Pearson test showed that there was a positive correlation between liver A20 and BFGF ( r = 0.824, P<0.05). Conclusions:The expressions of A20 and BFGF in liver tissue increase with the aggravation of liver pathological fibrosis and inflammation, which can be used as important indicators to evaluate the severity of liver fibrosis.

Objective:To analyze the clinical features of postpartum hepatitis flares in pregnant women with hepatitis B virus (HBV) infection.Methods:A retrospective study was conducted. Patients who met the enrollment criteria were included. Liver function and HBV virology tests were collected from pregnant women with chronic HBV infection at delivery, 6, 24, 36, and 48 weeks after delivery through the hospital information and test system. Additionally, antiviral therapy types and drug withdrawal times were collected. Statistical analysis was performed on all the resulting data.Results:A total of 533 pregnant women who met the inclusion criteria were included, with all patients aged (29.5±3.7) years old. A total of 408 cases received antiviral drugs during pregnancy to interrupt mother-to-child transmission. There was no significant difference in the levels of alanine aminotransferase (ALT, z ?=?-1.981, P ?=?0.048), aspartate aminotransferase (AST, z ?=?-3.956, P ?

The neural circuit is the material carrier for the realization of brain function,consisting of a complex network of different neurons.Neural circuit identification technology tracks the structure and activity of specific neural circuits,to study their adequacy and necessity for brain function,which is crucial for understanding the pathogenesis of brain diseases.As a high-tech tool in the fields of neuroscience and brain science,neural circuit identification technology has been gradually introduced into basic traditional Chinese medicine(TCM)research in recent years.This systematic review considers the principles of neural circuit identification technology and progress in its application in the field of TCM neuroscience.We note that future developments in this field should be based on the overall concept of TCM characteristics and the design of syndrome differentiation and treatment.Further research on the neural circuit mechanisms of diverse method of TCM in diseases will help to promote the deep integration of TCM and modern neuroscience.

Chemogenetic technology is a receptor-ligand system that regulates cell viability and function by changing receptor specificity and affinity, and it achieves precise neuronal regulation by specifically regulating neurons and neural circuits. At present, this technique is widely used in the study of neural circuits. This article briefly describes the application and progress of chemogenetic technology in the study of depression neural circuits, reviews the application of chemogenetic technology in several brain regions closely related to depression, such as ventral tegmental area, nucleus accumbens, prefrontal cortex, hippocampus and lateral habenula, and discusses the potential and challenges of chemogenetic technology as a technology for precise regulation of neural activity in future research, in order to provide reliable ideas and directions for chemogenetic technology in the study of depression neural circuits.

Using high-energy proton to image the region of interest can directly obtain the accurate estimation of the proton stopping power of the lesions,which is of great significance to reduce the range uncertainty in proton therapy.As a fundamental function of proton computed tomography(CT),radiographic imaging plays a crucial role in assisting clinical positioning.The study develops a compact proton CT detector based on an active array pixel CMOS chip in Monte-Carlo simulation toolkit Geant4,and evaluates the radiographic imaging capability of the system using 180 MeV protons.The angles of tracks are successfully reconstructed.CTP404,CTP528,and the CTP515 of specific materials are used for simulation,obtaining the spatial and density resolutions,and measuring the proton relative stopping power(RSP).The image signal-to-noise ratio is improved when using 2° proton scattering angle cut-off value.The spatial resolution is 3-4 lp/cm measured using CTP528 module.The density resolution is better than 0.05 g/cm3,and the RSP resolution is within 5%when CTP404 module is used.Through the imaging of CTP515 phantom of specific material,it is demonstrated that the system has potential for imaging common human tissues.

Objective:To investigate the effects of ovarian cancer domain containing protease-1 (OTUD1) gene on the typeⅠ interferon signaling pathway, and its impact on the antiviral effects of IFN-α.Methods:Dual-luciferase reporter assay was performed to detect the effects of OTUD1 gene on the transcriptional activity of interferon-stimulated response element (ISRE) promoter. Quantitative real-time PCR (qPCR) was used to detect the effects of OTUD1 on IFN-α-induced expression of interferon-stimulated genes (ISGs). The effects of OTUD1 gene on the expression of key proteins in the IFN-α signal transduction pathway were analyzed by Western blot, and its effects on IFN-α-mediated inhibition of hepatitis B virus replication were detected by qPCR and ELISA.Results:In HEK293T and Huh7.0 cells, OTUD1 down-regulated the transcriptional activity of ISRE promoter in the interferon signaling pathway and the expression of antiviral genes such as ISG15 and ISG56. In HEK293T cells, OTUD1 reduced the expression of phospho-Jak1 (p-JAK1) at protein level, but the catalytic inactive mutant of OTUD1 (C320S) could not regulate the expression of ISGs or p-JAK1. In Huh7.0 cells, OTUD1 antagonized the inhibitory effect of IFN-α on hepatitis B virus replication.Conclusions:OTUD1 with the ubiquitination activity can inhibit the interferon JAK-STAT signaling pathway and the expression of ISGs by down-regulating the expression of p-JAK1 protein. OTUD1 antagonizes the effect of IFN-α on viral replication and that may be related to the interferon-induced JAK-STAT signaling pathway.

As the management system of Occupational Medical Examination (OME) institutions is moving to a record-filing model, the traditional management approach might not fulfill the current policy requirements. There is a pressing need for development of high-quality occupational health management system. In this context, the Guangdong Provincial Occupational Health Examination Quality Control Center (hereinafter referred to as the "Provincial Quality Control Center") pioneered the integration of the Performance Excellence Model (PEM) framework into the macro-quality management of OME institutions in Guangdong Province. In light of the current research gaps in the field of macro-quality management for OME institutions, the Provincial Quality Control Center, based on the core principles and standards of PEM, has closely aligned with the professional characteristics of occupational health examinations. The established macro-quality management innovation in OME institutions in Guangdong Province consists of seven dimensions: strategic direction, leadership development, identification of key management subjects, data analysis and management, human resources allocation, process optimization, and the application of quality control outcomes. This system has provided a robust impetus for the ongoing improvement of quality control efforts. The initial implementation of PEM demonstrated notable improvements in macro-quality management for OME institutions. Moving forward, the Provincial Quality Control Center will continue to strengthen the development of key technical personnel, innovate training models, harness the advantages of big data technology, restate and upgrade the system continuously, and refine the macro-quality management mechanisms of OME institutions to ensure that the health rights and interests of workers and employers are effectively safeguarded and enhanced.

{L-End}Objective To analyze the characteristics of hearing loss and the influencing factors of high-frequency hearing loss (HFHL) among noise-exposed workers in an urban rail transit enterprise over five consecutive years. {L-End}Methods A total of 1 268 noise-exposed workers, who exposed to the average noise intensity of <85.0 dB(A), in an urban rail transit enterprise was selected as the research subjects using a judgment sampling method. The pure-tone audiometry results from 2019 to 2023 were collected to analyze the result of hearing loss. The influencing factors of HFHL (average hearing threshold ≥40.0 dB at high frequencies in both ears) were analyzed using the generalized estimating equations (GEE). {L-End}Results The detection rates of threshold elevations at frequencies of 0.5-6.0 kHz increased with increasing frequency from 2019 to 2023 (all P<0.01), with the highest detection rate at 6.0 kHz. The detection rate of speech frequency hearing loss (hearing threshold weighted value≥26.0 dB in the better ear) was 0.1%, 0.0%, 0.4%, 0.2%, and 0.2%, respectively. The detection rate of HFHL from 2019 to 2023 was 2.4%, 2.8%, 2.8%, 2.1%, and 2.8%, respectively. The GEE analysis results showed that the risk of HFHL of the workers in 2022 and 2023 was lower than that in 2019 (all P<0.01), with the odds ratios and 95% confidence intervals ［OR (95%CI)］ of 0.57 (0.41-0.81) and 0.65 (0.48-0.87), respectively. The risk of HFHL was higher among vehicle maintenance worker than train drivers (P<0.05), with OR (95%CI) of 2.37 (1.18-4.77). The risk of HFHL increased with age and length of service among the workers (all P<0.05), with the OR (95%CI) of 2.05 (1.22-3.46) and 1.69 (1.12-2.54), respectively. No interaction was found between type of job and age, type of job and length of service, or age and length of service in the risk of HFHL among the research subjects(all P<0.05). {L-End}Conclusion Noise exposure below the national occupational exposure limits can lead to hearing loss in noise-exposed workers of urban rail transit enterprises, possibly affecting the hearing threshold at 6.0 kHz first. The influencing factors for HFHL in workers of rail transit are age, length of service, and type of job. There is a dose-effect relationship with age and length of service.