According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the standards system of Water for Pharmaceutical Purposes has been perfected. This article focuses on the Work Background, Overall Approach,Work Methodology,Standard Framework,Key Content and Significance on the standards system of Water for Pharmaceutical Purposes in the Chinese Pharmacopoeia 2025, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.

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.

According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition,the standards system of Water for Pharmaceutical Purposes has been perfected.This article focuses on the Work Background,Overall Approach,Work Methodology,Standard Framework,Key Content and Significance on the standards system of Water for Pharmaceutical Purposes in the Chinese Pharmacopoeia 2025,which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.

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 man-agement system,and novel tools and methods with Chinese characteristics.Results:The ChP 2025 edition demon-strates three prominent features in microbiological-related standards:enhanced international harmonization,intro-duced emerging molecular biological technologies,and established a risk-based microbiological quality control sys-tem.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:This study aims to construct a machine learning model to predict depression symptoms in the elderly and analyze the key influencing factors of depression in the elderly using the shapley additive interpretation (SHAP) method.Methods:Based on entries from the 2018 China Health and Retirement Longitudinal Study database, a sample of 5 954 elderly individuals was selected. Feature selection using Support Vector Machine Recursive Feature Elimination, Extreme Gradient Boosting (XGBoost) - Recursive Feature Elimination (RFE), and the Lasso algorithm, which was combined with five classifiers-logistic regression, decision trees, random forests, support vector machines, and XGBoost-to explore the classification effectiveness for depressive symptoms in the elderly. Finally, the SHAP method was used to interpret the analysis of the model with the highest receiver operating characteristic curve areas under the curve (AUC).Results:The accuracy of 15 prediction models ranged from 0.702 to 0.743, with AUC between 0.730 and 0.795. Sensitivity was reported at 0.546 to 0.588, while specificity ranges from 0.783 to 0.865. The model XGBoost-RFE-XGBoost presented the highest AUC. Based on SHAP values, the top four factors influencing depressive symptoms in older adults were life satisfaction, duration of nighttime sleep, disability status, and self-rated health.Conclusion:This study developed a highly efficient and interpretable risk prediction model for depressive symptoms in older adults, which could help identify high-risk older adults and give personalized interventions.

The microbial limit standards in the Chinese Pharmacopoeia 2020 edition primarily focus on total aerobic microbial count and specified objectionable microorganisms,which are insufficient for comprehensively assessing the potential risks posed by microbial contamination to drug efficacy and patient safety.With the increasing com-plexity of rising regulatory requirements,there is an urgent need to establish a scientific and systematic microbial risk assessment and control framework.In response,the Chinese Pharmacopoeia 2025 edition,introduces a new general guideline 9212 Risk Assessment and Control of Unacceptable Microorganisms for Non-sterile Products.This chapter systematically constructs a framework for the identification and control of risks associated with unacceptable microorganisms,filling a gap in the relevant field within international pharmacopoeias.This article systematically elaborates on its key elements based on its core framework and content.It covers the development background,core concepts,testing and identification strategies,evaluation of risk characterization factors,formulation of risk control measures,and implementation pathways.The aim is to provide pharmaceutical enterprises and regulatory agencies with systematic and clear practical guidance.

Whole Genome Sequencing(WGS)technology,leveraging its significant advantages in precise microbial identification and traceability analysis,has become a core tool in international pharmaceutical microbial quality control.The release and implementation of the Guideline 9110 for Microbial Whole Genome Sequencing Technology in the Chinese Pharmacopoeia 2025 Edition marks the official entry of China's pharmaceutical microbial quality con-trol into the genomic era.Guideline 9110 establishes universal technical specifications for the application of WGS technology in pharmaceutical microbial quality control,covering laboratory general requirements,key technical parameters,technical workflow,major factors affecting sequencing results,method validation,and application guidance.This article focuses on the background of the standard's development and its technical rationale,provi-ding a systematic interpretation of key technical indicators,the scope of application,and essential points for techni-cal implementation.It aims to offer theoretical guidance and practical references for the industry in applying WGS technology.

The microbial limit standards in the Chinese Pharmacopoeia 2020 edition primarily focus on total aerobic microbial count and specified objectionable microorganisms,which are insufficient for comprehensively assessing the potential risks posed by microbial contamination to drug efficacy and patient safety.With the increasing com-plexity of rising regulatory requirements,there is an urgent need to establish a scientific and systematic microbial risk assessment and control framework.In response,the Chinese Pharmacopoeia 2025 edition,introduces a new general guideline 9212 Risk Assessment and Control of Unacceptable Microorganisms for Non-sterile Products.This chapter systematically constructs a framework for the identification and control of risks associated with unacceptable microorganisms,filling a gap in the relevant field within international pharmacopoeias.This article systematically elaborates on its key elements based on its core framework and content.It covers the development background,core concepts,testing and identification strategies,evaluation of risk characterization factors,formulation of risk control measures,and implementation pathways.The aim is to provide pharmaceutical enterprises and regulatory agencies with systematic and clear practical guidance.

Whole Genome Sequencing(WGS)technology,leveraging its significant advantages in precise microbial identification and traceability analysis,has become a core tool in international pharmaceutical microbial quality control.The release and implementation of the Guideline 9110 for Microbial Whole Genome Sequencing Technology in the Chinese Pharmacopoeia 2025 Edition marks the official entry of China's pharmaceutical microbial quality con-trol into the genomic era.Guideline 9110 establishes universal technical specifications for the application of WGS technology in pharmaceutical microbial quality control,covering laboratory general requirements,key technical parameters,technical workflow,major factors affecting sequencing results,method validation,and application guidance.This article focuses on the background of the standard's development and its technical rationale,provi-ding a systematic interpretation of key technical indicators,the scope of application,and essential points for techni-cal implementation.It aims to offer theoretical guidance and practical references for the industry in applying WGS technology.

Objective To explore the efficacy of bilateral facial muscle training combined with visual electromyography biofeedback on facial nerve function recovery in patients with idiopathic facial nerve palsy. Methods Patients with idiopathic facial nerve palsy admitted to Shanghai Fifth People’s Hospital, Fudan University from July 2022 to July 2024 were selected and randomly divided into a control group and an intervention group. The control group received conventional physical factor therapy, while the intervention group received bilateral facial muscle training combined with visual electromyography biofeedback therapy based on the control group’s regimen. After 20 treatment sessions, the total effective rate, the House-Brackmann (H-B) facial nerve grading system, the Sunnybrook Facial Grading System (SFGS) score, and the average value ratio of maximal amplitudes of bilateral frontalis and zygomaticus muscles were compared between the two groups. Results A total of 90 patients were included, 45 in each group. After 20 treatment sessions, the total effective rate was significantly higher in the intervention group than in the control group (84.4% vs 75.6%, P＝0.003). Compared with the control group, the intervention group demonstrated a significantly lower H-B grade (P＝0.003) and a higher SFGS score (P＝0.001). The average value ratios of maximal amplitudes of the affected versus healthy side frontalis (P＝0.013) and zygomatic (P＝0.022) muscles were higher in the intervention group than in the control group. Conclusions Bilateral facial muscle training combined with visual electromyography biofeedback is an effective approach for treating idiopathic facial nerve palsy, effectively promoting the recovery of facial nerve function, and improving facial symmetry and facial muscle function.