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 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.

Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.

Nonunion of osteoporotic vertebral fractures (OVF), predominantly affecting the elderly, can lead to intractable pain, vertebral collapse, progressive kyphotic deformity, and neurological impairment, significantly compromising patients′ quality of life. There exists considerable debate on diagnosis and management of OVF, encompassing key issues such as clinical diagnosis and staging criteria for nonunion, surgical indications and procedure selection, and postoperative rehabilitation planning. Currently, there lacks standardized clinical guideline and expert consensus on the diagnosis and management of OVF nonunion in China. To address this gap, Minimally Invasive Surgery Group of Chinese Orthopedic Association, Osteoporosis Committee of Chinese Association of Orthopedic Surgeons, Prevention and Rehabilitation Committee for Osteoporosis of Chinese Association of Rehabilitation Medicine and Minimally Invasive Orthopedic Surgery Branch of China Association for Geriatric Care jointly organized domestic experts in spinal surgery, endocrinology, and rehabilitation to formulate the Clinical guideline for the diagnosis and treatment for nonunion of osteoporotic vertebral fractures ( version 2025), based on existing literature and clinical experience and adhering to principles of scientific rigor and practicality. The guideline provided 13 evidence-based recommendations encompassing diagnosis and treatment of OVF nonunion, aiming to standardize its clinical management.

Nonunion of osteoporotic vertebral fractures (OVF), predominantly affecting the elderly, can lead to intractable pain, vertebral collapse, progressive kyphotic deformity, and neurological impairment, significantly compromising patients′ quality of life. There exists considerable debate on diagnosis and management of OVF, encompassing key issues such as clinical diagnosis and staging criteria for nonunion, surgical indications and procedure selection, and postoperative rehabilitation planning. Currently, there lacks standardized clinical guideline and expert consensus on the diagnosis and management of OVF nonunion in China. To address this gap, Minimally Invasive Surgery Group of Chinese Orthopedic Association, Osteoporosis Committee of Chinese Association of Orthopedic Surgeons, Prevention and Rehabilitation Committee for Osteoporosis of Chinese Association of Rehabilitation Medicine and Minimally Invasive Orthopedic Surgery Branch of China Association for Geriatric Care jointly organized domestic experts in spinal surgery, endocrinology, and rehabilitation to formulate the Clinical guideline for the diagnosis and treatment for nonunion of osteoporotic vertebral fractures ( version 2025), based on existing literature and clinical experience and adhering to principles of scientific rigor and practicality. The guideline provided 13 evidence-based recommendations encompassing diagnosis and treatment of OVF nonunion, aiming to standardize its clinical management.

Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.

Objective:To predict the incidence, prevalence, and mortality of dementia in China from 2020 to 2040.Methods:The age-standardized incidence rate (ASIR), incidence number, age-standardized prevalence rate (ASPR), prevalence number, age-standardized mortality rate (ASMR), and death number of dementia in China from 1990 to 2019 were collected from the 2019 Global Burden of Disease Study (GBD) database. We used the overall change rate and estimated annual percentage change (EAPC) to describe the epidemic situation of dementia and compared the trend of dementia between genders. A T-test was used to determine whether EAPC was statistically significant. Every five years, we divided the age into 17 groups to analyze the incidence, prevalence, and mortality of dementia. The prophet model predicted ASIR, ASPR, ASMR, incidence, prevalence, and death from dementia in China from 2020 to 2040.Results:The ASIR, ASPR, and ASMR of dementia showed an increasing trend from 1990 to 2019, with an average annual increase of 0.33%, 0.66%, and 0.15% ( t=10.13, 14.49 and 3.62, all P<0.05). The ASIR, ASPR, and ASMR in males increased faster annually than in females. In 2019, the number of incidence, prevalence, and death from dementia in groups aged≥80 years was the highest among all age groups (685 057 cases, 5 772 861 cases, and 217 827 cases). Prediction results of the prophet model showed that the ASIR, ASPR, and ASMR of dementia were further increased in China from 2020 to 2040, with an average annual increase of 0.55%, 0.78%, and 0.06% ( t=177.63, 161.21, and 7.91, all P<0.05). In 2040, the ASIR, ASPR, and ASMR will reach 117.72/10 5, 940.98/10 5, and 23.64/10 5, respectively. In addition, the number of incidence, prevalence, and death from dementia will show an upward trend from 2020 to 2040. In 2040, the incidence, prevalence, and death will reach 3 334 770 cases, 25 303 146 cases, and 590 138 cases, respectively. Conclusion:From 2020 to 2040, the ASIR, ASPR, ASMR, number of incident cases, number of prevalent cases, and number of deaths due to dementia in China will continue to grow.

Objective:To predict the incidence, prevalence, and mortality of dementia in China from 2020 to 2040.Methods:The age-standardized incidence rate (ASIR), incidence number, age-standardized prevalence rate (ASPR), prevalence number, age-standardized mortality rate (ASMR), and death number of dementia in China from 1990 to 2019 were collected from the 2019 Global Burden of Disease Study (GBD) database. We used the overall change rate and estimated annual percentage change (EAPC) to describe the epidemic situation of dementia and compared the trend of dementia between genders. A T-test was used to determine whether EAPC was statistically significant. Every five years, we divided the age into 17 groups to analyze the incidence, prevalence, and mortality of dementia. The prophet model predicted ASIR, ASPR, ASMR, incidence, prevalence, and death from dementia in China from 2020 to 2040.Results:The ASIR, ASPR, and ASMR of dementia showed an increasing trend from 1990 to 2019, with an average annual increase of 0.33%, 0.66%, and 0.15% ( t=10.13, 14.49 and 3.62, all P<0.05). The ASIR, ASPR, and ASMR in males increased faster annually than in females. In 2019, the number of incidence, prevalence, and death from dementia in groups aged≥80 years was the highest among all age groups (685 057 cases, 5 772 861 cases, and 217 827 cases). Prediction results of the prophet model showed that the ASIR, ASPR, and ASMR of dementia were further increased in China from 2020 to 2040, with an average annual increase of 0.55%, 0.78%, and 0.06% ( t=177.63, 161.21, and 7.91, all P<0.05). In 2040, the ASIR, ASPR, and ASMR will reach 117.72/10 5, 940.98/10 5, and 23.64/10 5, respectively. In addition, the number of incidence, prevalence, and death from dementia will show an upward trend from 2020 to 2040. In 2040, the incidence, prevalence, and death will reach 3 334 770 cases, 25 303 146 cases, and 590 138 cases, respectively. Conclusion:From 2020 to 2040, the ASIR, ASPR, ASMR, number of incident cases, number of prevalent cases, and number of deaths due to dementia in China will continue to grow.

Abstract： Objective　To elucidate the antigenic antibody reaction of recombinant expression of non-structural protein 1 (NS1) of Japanese encephalitis (JE) virus with various mosquito-borne flaviviruses, including JE virus, and the antigenic antibody reaction of serum samples of patients infected with JE virus in acute stage. Methods　In this study, Escherichia coli prokaryotic expression vector (pET) system was used to recombinant express Japanese encephalitis virus NS1 gene. Western Blot assay was performed to detect the antibody responses of the recombinantly expressed protein against a variety of mosquito-transmitted flaviviruses, including JE virus, as well as antigen-antibody reactions of serum from patients with acute JE virus infection. Results　The NS1 gene expression product of JE virus (P3 strain) was in the form of an inclusion body, and the denatured and renatured expression product was displayed as a single band in the denatured gel (polyacrylamide gel electrophoresis, PAGE), with a molecular weight of about 45 000. The results of further antigen-antibody analysis showed that the antigen/antibody hybridization reaction of the expression product with polyclonal or monoclonal antibody of JE virus (mosquito isolates, encephalitis isolates) and serum samples of patients with acute JE virus infection could be completely consistent. The recombinant product showed negative antigen/antibody hybridization reactions with mosquito-transmitted flaviviruses, such as dengue virus and yellow fever virus polyclonal antibodies, but positive reactions with polyclonal antibodies to West Nile virus and Murray Valley encephalitis virus. Conclusions　In this study, the recombinant expression of the NS1 protein of JE virus was successfully obtained, and the antigen/antibody reaction between the recombinant protein and samples of patients infected with mosquito-borne flavivirus and JE virus was analyzed. The study results provide important basic data for elucidating the antigen-antibody reaction between the NS1 protein of JE virus and mosquito-borne flavivirus. The recombinant expression protein obtained in this study provides an important material basis for further research on the function of JE virus NS1 protein.

Objective To investigate whether the characteristics of pathogens mediated by Wolbachia can interfere with Japanese encephalitis virus (JEV) replication and explore the regulatory role of Wolbachia on JEV replication transmitted by Culex mosquitoes. Methods Real-time fluorescence quantitative PCR (qPCR) and RNA fluorescence in situ hybridization (RNA-FISH) were used to detect Wolbachia density in Aa23 (naturally infected with Wolbachia) Aedes albopictus cell and negative control Aa23T Aedes albopictus cells (Wolbachia infection was removed by tetracycline treatment). The plaque assay was conducted to measure the viral titers and cytopathic effect (CPE) in Aa23T and Aa23 cells on days 1 to 8 after JEV (P3 strain) infection. Results qPCR and RNA-FISH results consistently showed that the symbiosis of Wolbachia was negative in Aa23T cell. In Aa23 cells, the copy number of the WSP gene of Wolbachia and the fluorescence signal intensity targeting Wolbachia 16S rDNA increased with cell growth time. In response to JEV infection, Wolbachia prolonged the CPE in viral infected Aa23 cells, which compared to infected Aa23T cells. The plaque assay result has obviously showed that JEV titer in Aa23 cells (106 PFU/mL) was significantly lower than that in Aa23T control cells (108 PFU/mL). Conclusions Wolbachia significantly delays CPE of JEV on cells and inhibits JEV replication in A. albopictus cells. To the best of our knowledge, this is the first report that Wolbachia strongly inhibits JEV infection in mosquito cells. It revealed the role of Wolbachia on inhibition of the viruses that transmitted by Culex mosquitoes. In particular, it provides important experimental data and theoretical basis for application of Wolbachia-based mosquito control technology in prevention and control of JEV.