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.

BACKGROUND:At present,modern medical treatment has certain limitations on the treatment of knee osteoarthritis.Traditional Chinese medicine alkaloids can effectively prevent and treat knee osteoarthritis through various mechanisms. OBJECTIVE:To review the mechanism of alkaloids in traditional Chinese medicine in the prevention and treatment of knee osteoarthritis,providing a scientific basis for the clinical development of drugs for the treatment of knee osteoarthritis. METHODS:CNKI,WanFang,PubMed,Web of Science and Google Scholar were retrieved for relevant literature published from database inception to May 2024.The key words were"knee osteoarthritis""osteoarthritis""osteoclast""chondrocyte""alkaloids"in Chinese and English.Duplicates and obsolete non-referenced literature were excluded,and a total of 68 eligible papers were included for further review. RESULTS AND CONCLUSION:Although traditional Chinese medicine has a long history of treating knee osteoarthritis,only a small number of natural compounds are in the preclinical stage of research against knee osteoarthritis.Alkaloids have a greater potential for the prevention and treatment of knee osteoarthritis,among which,sophocarpidine,oxymatrine,sinomenine,and betaine have been shown to be effective in the prevention and treatment of knee osteoarthritis by modulating multiple signaling pathways.Alkaloids can delay the progression of knee osteoarthritis by inhibiting inflammatory response,exerting antioxidant response,inhibiting chondrocyte apoptosis,promoting chondrocyte proliferation,and inhibiting osteoclast formation and differentiation.

The relevant laws and regulations regarding the utilization of the deceased as medical research subjects are not yet fully developed in China nowadays. Taking the deceased as research subjects as a starting point， this paper discussed the definition of the deceased and the scope of their interest protection from multiple perspectives. It posited that the scope of interest protection for the deceased encompassed two components： spiritual personality interests and material personality interests represented by the remains. The spiritual personality interests of the deceased included identification information such as name， portrait， reputation， honor， privacy， and personal information， as well as medical and health information. The personal information of the deceased was not directly affected by the individual’s life and death status and remained relatively independent. In terms of ethical review， the research team approached from two perspectives： the remains and the personal information of the deceased. Based on the standard of whether the research subjects involve a human body， research with the remains of the deceased as the medical research subjects was classified as non-clinical research. According to the standard of whether a human body is clinically operated， research with the personal information of the deceased （including medical and health information） as the medical research subjects was recognized as clinical research without human research operation. This approach provided evidence for the application of existing laws and regulations in ethical review and record management. The ethical review of investigator-initiated clinical research conducted in medical and health institutions， as well as the regulatory conditions for exemption from ethical review， were examined. The forms， content， and acquisition of informed consent were summarized， and the risk-benefit characteristics of the research activity were evaluated， with a view to providing a basis for the smooth and compliant implementation of research activities involving the deceased as medical research subjects.

Objective:To observe the feelings of listening to music and the importance of music in the daily life of post-lingual deaf adults with cochlear implants, and to explore the relevant influencing factors.Methods:This was a cross-sectional survey study. From January 2021 to August 2021,the Music-Related Quality of Life Scale was used to evaluate the music needs and music experiences of 63 post-lingual deaf adults who met the inclusion criteria, including 27 males and 36 females, aged (40.7±12.3) years, at the time of surgery (36.8±13.1) years, and with a preoperative hearing aid ineffective time of (3.9±5.8) years. Indicators analyzed included age, duration of ineffective preoperative hearing aid wear, preoperative music preference, duration of postoperative cochlear implant use, current hearing aid modality, and auditory rehabilitation outcomes. Whether the six factors mentioned above constituted an influence on the subjects′ music listening was investigated using SPSS 25.0 statistical software.Results:All of the observations in the scale were correlated with a single factor. The two sub-dimensions of music experience section were related to the effect of auditory rehabilitation. In the importance section, the effect of auditory rehabilitation was the influential factor of the dimension of "participation importance", and the preoperative enjoyment of music was the relevant influential factor of the dimension of "perceived importance". There was a significant difference between the groups when they were grouped by the above factors ( P value<0.05), while there was no statistically significance between the groups when they were grouped by other factors ( P value>0.05). Conclusions:Post-lingual deaf adults show the need and attempt to listen to music after cochlear implantation. The effectiveness of auditory rehabilitation and the degree of music preference preoperatively are two important factors that influence music listening in implant recipients. Once the level of auditory communication has been restored to a certain degree, it is important to pay more attention to the needs of music for implant recipients and train them in time, especially for those with music preferences preoperatively.

Objective:To analyze the differentially expressed genes of human respiratory syncytial virus (RSV) subtype A genotype ON1, a predominant genotype in Beijing, after infecting A549 cells using transcriptomic sequencing, and provide potential targets for RSV prevention and treatment.Methods:A local strain (61397-ON1) identified by whole-genome sequencing as ON1 genotype of RSV subtype A was selected to infect A549 cells. Total mRNA was extracted, and the differentially expressed genes in infected and uninfected A549 cells were screened by transcriptomic sequencing. GO analysis and KEGG pathway analysis were performed. Besides, six genes with differential expression ratio greater than two times were randomly selected for qRT-PCR verification.Results:There were 1 632 differentially expressed genes between infected and uninfected A549 cells, of which 807 genes were up-regulated and 825 genes were down-regulated. The differentially expressed genes were mainly involved in immune response-related biological processes such as cytokine response and positive regulation of MAPK cascades, and were enriched in MAPK signaling pathway, NOD-like receptor signaling pathway, p53 signaling pathway, TNF signaling pathway, IL-17 signaling pathway and NF-κB signaling pathway. The results of qRT-PCR for six differentially expressed genes were consistent with the trend of transcriptome data.Conclusions:The differentially expressed genes of RSV A subtype ON1 genotype after infecting A549 cells are mainly involved in cytokine response and immune-related signaling pathways. This study provides basic data for further study of the molecular mechanism of RSV infection and the development of prevention and treatment strategies.

To investigate the degrees of EB virus reactivation in patients with inflammatory bowel disease (IBD) treated with different biologics and the levels of important cytokines associated with relapse under the influence of this virus, and to assess its diagnostic efficacy as a risk factor for identifying disease relapse. A case-control retrospective study based on patients′ hospitalization history data was conducted to select a total of 105 patients who were hospitalized in the Department of Gastroenterology, Huashan Hospital, Fudan University, with a confirmed diagnosis of IBD from 2021 to 2023. Based on the quantitative copy level of whole blood EBV DNA to determine the status of EB virus infection in patients, integrated cytokine 8 (IL-2, IL-4, IL-6, IL-10, IL-12p70, IL-17, TNF-α, IFN-γ), C-reactive protein, and fecal calreticulin, to find the risk variable associated with treatment relapse. Logistic regression was used to analyze the relative risk between this variable and treatment relapse, and ROC curves were used to predict the diagnostic efficacy of cytokine multifactorial thresholds for treatment relapse. Results showed that the median age of the study was 37(26, 54)years, with a minimum of 18 years and a maximum of 70 years, with a median age of 34(24, 51) years for Crohn′s Disease (CD) patients and 46(35, 60) years for Ulcerative colitis (UC) patients, with a statistically difference between the ages of the two groups ( t=2.675, P=0.009). The median age at 50 years of patients treated with Vedolizumab (VDZ) in the UC group was higher than in the treatment groups other than VDZ. The highest rate of EB virusreactivation was found in the group treated with immunosuppressants Azathioprine (AZA) combined with anti-tumor necrosis factor-α (anti-TNF-α) and VDZ (62.5% in both groups), and the lowest in the group treated with Ustekinumab (UST) (0%). IL-2 levels were elevated in the AZA+anti-TNF-α and anti-TNF-α groups after EB virus entryreactivation. Three treatment groups, AZA+anti-TNF-α, anti-TNF-α, and VDZ, had elevated levels of IL-6 expression after EB virus entry reactivation.In the anti-TNF-α treatment-related group IL-2was associated with treatment relapse in IBD ( OR=1.127, 95% CI: 1.044-1.256, P=0.007). ROC analysis showed that the AUC for IL-2 combined with EB virus in a replicative state was 0.8282 ( P=0.006), with a negative predictive value and a positive value of 90% and 75%, respectively. As well as IL-6 was associated with treatment relapse of IBD in the anti-TNF-αtreatment-related group as well as in the VDZ-treated group ( OR=1.049, 95% CI: 1.017-1.095, P=0.008). ROC analysis showed that the diagnostic sensitivity and specificity for post-treatment relapse at a critical value of 6.10 pg/ml for IL-6 was 83.33% and 82.93%, respectively. The AUC for IL-6 combined with EB virus in a replicative state was 0.900 ( P<0.000 1), with negative and positive predictive value of 84.09% and 73.33%, respectively. In summary, the imbalance of proinflammatory and anti-inflammatory cytokines varies between drugs, with EBV in a replication-activated state, combined with elevated levels of IL-2 as well as IL-6 expression being a risk factor for relapse in patients treated with anti-TNF-α-related drugs and VDZ.

To investigate the degrees of EB virus reactivation in patients with inflammatory bowel disease (IBD) treated with different biologics and the levels of important cytokines associated with relapse under the influence of this virus, and to assess its diagnostic efficacy as a risk factor for identifying disease relapse. A case-control retrospective study based on patients′ hospitalization history data was conducted to select a total of 105 patients who were hospitalized in the Department of Gastroenterology, Huashan Hospital, Fudan University, with a confirmed diagnosis of IBD from 2021 to 2023. Based on the quantitative copy level of whole blood EBV DNA to determine the status of EB virus infection in patients, integrated cytokine 8 (IL-2, IL-4, IL-6, IL-10, IL-12p70, IL-17, TNF-α, IFN-γ), C-reactive protein, and fecal calreticulin, to find the risk variable associated with treatment relapse. Logistic regression was used to analyze the relative risk between this variable and treatment relapse, and ROC curves were used to predict the diagnostic efficacy of cytokine multifactorial thresholds for treatment relapse. Results showed that the median age of the study was 37(26, 54)years, with a minimum of 18 years and a maximum of 70 years, with a median age of 34(24, 51) years for Crohn′s Disease (CD) patients and 46(35, 60) years for Ulcerative colitis (UC) patients, with a statistically difference between the ages of the two groups ( t=2.675, P=0.009). The median age at 50 years of patients treated with Vedolizumab (VDZ) in the UC group was higher than in the treatment groups other than VDZ. The highest rate of EB virusreactivation was found in the group treated with immunosuppressants Azathioprine (AZA) combined with anti-tumor necrosis factor-α (anti-TNF-α) and VDZ (62.5% in both groups), and the lowest in the group treated with Ustekinumab (UST) (0%). IL-2 levels were elevated in the AZA+anti-TNF-α and anti-TNF-α groups after EB virus entryreactivation. Three treatment groups, AZA+anti-TNF-α, anti-TNF-α, and VDZ, had elevated levels of IL-6 expression after EB virus entry reactivation.In the anti-TNF-α treatment-related group IL-2was associated with treatment relapse in IBD ( OR=1.127, 95% CI: 1.044-1.256, P=0.007). ROC analysis showed that the AUC for IL-2 combined with EB virus in a replicative state was 0.8282 ( P=0.006), with a negative predictive value and a positive value of 90% and 75%, respectively. As well as IL-6 was associated with treatment relapse of IBD in the anti-TNF-αtreatment-related group as well as in the VDZ-treated group ( OR=1.049, 95% CI: 1.017-1.095, P=0.008). ROC analysis showed that the diagnostic sensitivity and specificity for post-treatment relapse at a critical value of 6.10 pg/ml for IL-6 was 83.33% and 82.93%, respectively. The AUC for IL-6 combined with EB virus in a replicative state was 0.900 ( P<0.000 1), with negative and positive predictive value of 84.09% and 73.33%, respectively. In summary, the imbalance of proinflammatory and anti-inflammatory cytokines varies between drugs, with EBV in a replication-activated state, combined with elevated levels of IL-2 as well as IL-6 expression being a risk factor for relapse in patients treated with anti-TNF-α-related drugs and VDZ.

BACKGROUND:Studies have found that chondrocyte ferroptosis can be used as an important pathogenesis to induce the occurrence and development of osteoarthritis.With the continuous development of Chinese medicine,some scholars have found that some traditional Chinese medicine monomers and traditional Chinese medicine compounds can inhibit chondrocyte ferroptosis through various mechanisms of action,and finally play a role in the treatment of osteoarthritis. OBJECTIVE:To explore the relationship between ferroptosis and osteoarthritis and the mechanism by which traditional Chinese medicine deals with ferroptosis in the treatment of osteoarthritis,in order to provide new ideas for the treatment and prevention of osteoarthritis. METHODS:With"osteoarthritis,ferroptosis,chondrocytes,lipid metabolism,traditional Chinese medicine,ROS,GPX 4"as the English and Chinese search terms,CNKI,PubMed,WanFang,and VIP databases were searched for relevant articles regarding the relationship between ferroptosis and osteoarthritis and its traditional Chinese medicine intervention until 2022.Then,a systematic analysis was conducted. RESULTS AND CONCLUSION:Intracellular iron overload will cause lipid peroxidation,resulting in the accumulation of reactive oxygen species and eventually the occurrence of ferroptosis,while excessive iron will accelerate the apoptosis of chondrocytes and affect chondrocyte homeostasis,thereby inducing the development of osteoarthritis.When amino acid metabolism is abnormal,an imbalance in glutamate and cystine exchange causes the accumulation of glutamate outside the cells,and high extracellular concentration of glutamate will cause the depletion of glutathione,indirectly inhibiting the function of ferroptosis-related factors,and contributing to ferroptosis.When cellular lipid metabolism is abnormal,unsaturated fatty acids,an important component of the cell membrane,lose their diallyl hydrogen atoms,leading to the destruction of cells to induce ferroptosis,while lipid metabolism is closely involved in the progression of osteoarthritis.Traditional Chinese medicine can play a role in the prevention and treatment of osteoarthritis by inducing the occurrence of ferroptosis.The research on iron death is still immature,and further research on its action mechanism is expected to open up new ways for the clinical treatment of osteoarthritis.

Wiskott-Aldrich syndrome (WAS) is a rare X-linked recessive genetic disorder characterized by thrombocytopenia, eczema, recurrent infections, and susceptibility to autoimmune diseases. The renal complication of WAS is mainly manifested as IgA nephropathy. Membranous nephropathy (MN) in children mostly has secondary factors, and its occurrence is related to immune disorders. This paper reports a case of WAS in an infant with bleeding tendency and recurrent infections, complicated with nephrotic syndrome during the course, confirmed as MN by pathological examination. After treatment with glucocorticoids, tacrolimus and hematopoietic stem cell transplantation, nephrotic syndrome was manifested as steroid-resistant and partially sensitive to tacrolimus. Proteinuria continued to relieve 3 months after hematopoietic stem cell transplantation and renal function remained stable. WAS complicated with MN is extremely rare, and its renal prognosis is still unclear, which deserves the attention of clinicians.

This case report described the sucussful treatment of a male infant born at 21 weeks and 4 days through assisted reproductive technology. After prenatal consultation and with the strong desire of the parents, active resuscitation and treatment were performed. The infant received 52 days of mechanical ventilation and was extubated to non-invasive ventilation at a corrected gestational age of 28 weeks and 6 days. During hospitalization, no vasoactive drugs were used, and necrotizing enterocolitis did not occur. The gastric tube was removed at a corrected gestational age of 37 weeks and 4 days. At a corrected gestational age of 40 weeks, cranial MRI showed no abnormalities. The infant was discharged at a corrected gestational age of 42 weeks after 143 days of treatment, without the need for any respiratory support. Follow-up until a corrected age of 6 months showed good growth and development.