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.

Neovascular age-related macular degeneration(ARMD)is a condition where various causes induce the formation of choroidal neovascularization(CNV)in the macula, leading to macular hemorrhage, accumulation of fluid, and development of fibrosis, resulting in a large, dark spot in the center of the visual field, causing severe central vision loss in over 90% of patients. Endothelial progenitor cells(EPCs)are a heterogeneous group of cells that play a crucial role in neovascularization. Under pathological stimulation, EPCs are mobilized into the systemic circulation, migrate toward the avascular zone, and promote the restoration of blood vessels and endothelialization in the damaged area. Toll-like receptors(TLRs)are pattern recognition receptors and type Ⅰ transmembrane proteins that are mainly expressed in monocytes, dendritic cells, and other immune cells, recognizing the surface of pathogens and transmitting signals to cells, participating in the innate immune response and adaptive immune response. Studies have shown that most TLRs are involved in the development of neovascularization, and EPCs can express TLRs. Therefore, exploring the role of EPCs/TLRs in the pathogenesis of ARMD can help us understand the disease and may provide new insights for targeted therapy in the future.

Objective To analyze the short-term clinical efficacy and influencing factors of ustekinumab monoclonal antibody(UST)in the treatment of Crohn′s disease(CD).Methods Retrospective cohort study was used to collect the clinical data of CD patients treated with UST in the 10th People′s Hospital affiliated to Tongji University from December 2020 to October 2022.The main analysis is the short-term clinical efficacy and influencing factors of UST treatment for CD at weeks 8 and 16,And analyze the endoscopic response rate of some patients.Results A total of 91 CD patients who first used UST were included.The 8-week clinical response rate of UST treat-ment for CD was 61.5%,and the clinical response rate was 45%;The clinical response rate at 16 weeks was 71.4%,and the clinical response rate was 54.9%.56 cases underwent endoscopic re-examination in our hospital,and the endoscopic response rate at 16 weeks was 41.1%.Univariate analysis showed that fistula(including anal fistula,personal history of anal fistula,and intestinal skin fistula)is associated with clinical remission in Crohn′s disease patients at 8/16 weeks.Further multivariate COX regression analysis showed that the presence of a history of anal fistula surgery was an independent protective factor affecting clinical remission in CD patients treated with UST at 8 weeks(HR = 0.04,95%CI:0.00～0.38;P = 0.005)and 16 weeks(HR = 0.04,95%CI:0.01～0.34;P = 0.003)compared to those without fistula;Narrow lesions are an independent risk factor for 16 week clinical remission in CD patients compared to non-narrow and non-penetrating lesions(HR = 1.75,95%CI:1.08～2.84;P = 0.023).No patients were found to have stopped medication due to serious adverse reactions.Conclusions UST can improve the clinical remission and response of CD patients at 8/16 weeks,and has good short-term clinical efficacy.CD patients with a personal history of anal fistula are recommended to use UST monoclonal antibodies,while patients with stenotic lesions should be cautious in using UST monoclonal antibodies.Whether the patient has undergone surgical treatment in the past,as well as whether UST has been used on the first or non-first line,has no significant impact on clinical remission.

Aging is a necessary process for organisms.The antioxidant capacity in the body decreases, which induces the activation of inflammasomes, autophagy dysregulation, protein misfolding in the lens, resulting in lens opacification. With the increase of age, the secretion of melatonin and glutathione(GSH)gradually decreased, and the pro-oxidant/pro-inflammatory factors increased, which created ideal conditions for the formation of age-related cataract(ARC). A series of changes such as oxidative stress, inflammation and autophagy dysregulation accompany the occurrence of aging, which is also the basis of various diseases. Melatonin has antioxidant, anti-inflammatory, regulation of autophagy and circadian rhythm effects, and has shown benefits in age-related macular degeneration(ARMD), diabetic retinopathy(DR), and glaucoma. Although phacoemulsification and lens implantation have developed maturely, they consume a lot of medical resources. This article reviews the research of melatonin in ARC, which may prevent/delay the formation of ARC, thereby reducing the economic burden of patients and reducing the loss of medical resources.

Objective:To observe the changes of protein expression of apoptosis signal pathway in prefrontal cortex of rats with post-stroke depression(PSD) after lateral ventricle injected of brain-derived neurotrophic factor precursor(proBDNF).Methods:Among 55 healthy adult female SD rats, 25 rats were randomly selected as PSD group, and the other 30 rats were randomly divided into normal group ( n=10), depression group ( n=10) and stroke group ( n=10). The middle cerebral artery occlusion(MCAO) model was established by thread occlusion in the stroke group, the chronic stress depression model in the depression group was established by the combination of chronic unpredictable mild stress(CUMS) and the solitary feeding method.And the rats in the PSD group were established MCAO model first, then they were received CUMS stress and solitary rearing one week later so as to establish PSD model.Two weeks after the establishment of the model, 15 rats in PSD group were randomly divided into proBDNF group, rats in tPA group and NS control group.One week after buried tube of lateral ventricle, rats in tPA and proBDNF were injected into the lateral ventricle for one week.The protein expressions of c-Jun N-terminal kinase(JNK), p-JNK, p53, p-p53 and Bax in prefrontal cortex of rats in each group were detected by Western blot at the 4th and 8th week after modeling.SPSS 17.0 software was used for data analysis, one-way ANOVA was used for comparison between groups, and SNK- q was used for pairwise comparison. Results:The expressions of p-p53, p53, p-JNK, JNK and Bax in prefrontal cortex of normal group, depression group, stroke group and PSD group were significantly different at the end of 4th and 8th week after MCAO modeling ( F=3.426-90.355, all P<0.05). Post-hoc analysis showed that, compared with the normal group, the expressions of p-JNK (0.378±0.042) and Bax (0.478±0.054) in the prefrontal cortex of PSD rats increased significantly at the end of the 4th week(both P<0.05), and the expressions of p-JNK(0.411±0.056), p-p53 (0.286±0.083) and Bax (0.471±0.008) in the prefrontal cortex of PSD group increased significantly at the end of the 8th week(all P<0.05). After lateral ventricle injection of proBDNF, there were significant differences in the expression of p-p53, p53, p-JNK, JNK and Bax among proBDNF group, tPA group and NS group ( F=16.915-287.039, all P<0.01). Post-hoc analysis showed that, compared with NS group, the expressions of p-JNK (0.35±0.01)and p-p53 (0.31±0.01)in prefrontal cortex of proBDNF group increased significantly(both P<0.05). After lateral ventricle injection of proBDNF, there were significant differences in body weight, sucrose preference rate, horizontal movement distance among proBDNF group, tPA group and NS group ( F=18.741-76.305, all P<0.01), and compared with tPA group and NS group, behavioral indexes of proBDNF group (body weight (224.36±3.23) g, sucrose preference rate (69.83±1.72)%, horizontal movement distance (57.93±2.09) blocks, vertical movement distance (19.79±1.81)) decreased significantly(all P<0.05). Conclusion:The proBDNF promotes the activation of apoptosis signal pathway in the rats with PSD.

Objective To investigate the independent association of serum Fetuin-B with metabolic syndrome in obese Chinese adults.Methods Cross-sectional data on socio-demographic,lifestyle,clinical characteristics, and serum Fetuin-B were collected for 1 318 Chinese adults with central obesity.Associations of serum Fetuin-B with metabolic syndrome and insulin resistance were analyzed using multivariable Logistic regression analysis.Results A total of 820(62.2%)individuals were identified as metabolic syndrome.Subjects with metabolic syndrome showed significantly increased levels of serum Fetuin-B than those with non-metabolic syndrome[(4.18 ±1.39 vs 4.02 ± 1.35)μg/ml,P=0.043].Increased serum Fetuin-B were significantly associated with increased fasting plasma glucose and insulin levels, as well as prevalences of non-alcoholic fatty liver disease(NAFLD)and insulin resistance.After adjustment for potential confounders, serum Fetuin-B was significantly associated with increased risks of metabolic syndrome and insulin resistance(OR=1.19,95%CI 1.06-1.34,P=0.004;OR=1.15,95%CI 1.01-1.30,P=0.031 respectively).Conclusion Serum Fetuin-B level was significantly associated with NAFLD;and elevated serum Fetuin-B was significantly associated with increased risk of metabolic syndrome.

Objective To establish a high performance size esclusion chromatography (HPSEC) method for the determination of high molecular weight impurities of cefotiam hydrochloride for injection.Methods A TSK G2000 SWXL column(7.8 mm × 30 cm,5μm) was used,the mobile phase consisting of phosphate budder solution [0.1 mol·L-1 disodium hyrogen phosphate-0.1 mol·L-1 sodium dihydrogen phosphate (61:39)],the flow rate was 0.7 mL· min-1,the detection wavelength was 254 nm,the column temperature was 30 ℃,the injection volume was 20 μL,and the concentration of polymers was quantified by external standard method.Results For HPSEC method,the calibration curves were linear in the range of 5.0-25.0 μg·mL-1 for cefotiam,and the LOD and LOQ was 0.1 μg·mL-1 and 0.246 μg· mL-1,the RSD for replicate for injections of reference solution was 0.50％,the sample solution was not stable in room temperature.Conclusion The method has high separation efficiency and good specificity,which provides reference for the further study of the polymer of cefotiam hydrochloride for injection.

Objective To establish a severe sepsis/septic shock prognosis prediction model based on randomize forest law (RF model), and to evaluate the prognostic value of this model for patients with severe sepsis/septic shock. Methods 497 patients with severe sepsis/septic shock admitted to intensive care unit (ICU) of Zhejiang Hospital from September 2013 to May 2017 were enrolled. The basic data, vital signs and symptoms, biochemical indexes and blood routine indexes on the 1st, 3rd, 5th day and prognosis were collected. According to the 28-day prognosis, the patients were divided into death group and survival group, and the specific indicators about the prognosis of severe sepsis/septic shock were screened. A RF model was constructed by using the specificity indicators. The assessment effectiveness of RF model, sequential organ failure assessment (SOFA), acute physiology and chronic health evaluation Ⅱ(APACHE Ⅱ) were evaluated by receiver operating characteristic (ROC) curve analysis. Results In 497 cases of severe sepsis/septic shock, 201 cases died, 28-day mortality was 40.4%. ① According to the index difference of death group and survival group, 19 specific parameters of the RF model were selected, which included the age; 24-hour urine output, urea nitrogen (BUN), serum creatinine (SCr), platelet count (PLT) on the 1st day; heart rate (HR), mean arterial pressure (MAP), cyanosis and clammy skin on the 3rd day; temperature, HR, MAP, 24-hour urine output, PLT, fever, cyanosis, dyspneic, clammy skin, piebald on the 5th day. ② ROC curve analysis showed that the area under the ROC curve (AUC) of RF model predicting 28-day mortality was higher than that of SOFA and APACHE Ⅱ score on the 1st, 3rd, 5th day (AUC: 0.836 vs. 0.643, 0.554, 0.766 and 0.590, 0.670, 0.758). The sensitivity of RF model to predict the 28-day mortality was 86.1%, the specificity was 77.0%, the accuracy was 80.7%. Conclusion The evaluation model based on random forest can effectively predict the death risk of 28-day in patients with severe sepsis/septic shock, and its predictive efficiency is better than that of the SOFA and APACHE Ⅱ score.

Objective To evaluate the reliability and validity of hepatocellular carcinoma (HCC)using the liver imaging reporting and data system (LI-RADS).Methods By using the LI-RADS v2013.1,two radiologists evaluated 1 62 patients with cirrhosis or with a risk of HCC according to an inclusion criteria.The Kappa value was used to evaluate the consistency between two different diagnoses and was compared with pathological and follow-up results.The accuracy of the LI-RADS was assessed including sensitivi-ty,specificity,positive predictive value,negative predictive value,positive likelihood ratio,negative likelihood ratio and accuracy rating.Results In all 1 62 patients,there were HCCs in 97 patients including 7 patients belonging to the LR3,benign diseases in 50,and other kinds of malignancy in 1 5.The Kappa value was 0.882 (P =0.000)between two observers on LI-RADS grading. The sensitivity,specificity and accuracy rating of LI-RADS grading in diagnosing HCC was 100.00%,91.30%,and 97.06%,re-spectively.Conclusion The LI-RADS has high consistency and stability in evaluation and diagnosis of HCC by enhanced CT.LR3 di-agnosis should be cautious because of a susceptible development to HCC,which can be improved through the combination of clinic and laboratory examination.

The molecular descriptors of impurities with known structure in cefdinir were calculated, selected and associated with the chromatographic retention behavior to establish a model. This quantitative structure retention relationships (QSRR) model for the related substances of cefdinir was established under specific chromatographic condition and verified by other impurities. 12 molecular descriptors were used to establish the QSRR model, F_AFRBWF, Blbn_J, SsCH3, SssCH2, SsNH2, SssNH, SssS, SHdCH2, EEM_AFc, EEM_AFpl, EEM_XFpl and Pi_MaxQ. The relativity between true values and predictions in QSRR of cefdinir is R2 = 0.9836 (n = 18), ΔRRT is no more than 0.154, as 10.17% in RRT. The results indicate that the QSRR model for the related substances of cefdinir can be used to evaluate the analysis methods for related substances and predict the chromatographic behavior of new impurities, which will provide a new way for the evaluation of the effectiveness for drug quality control.