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 explore the relationship between the ferroptosis-related molecules heme oxygenase-1(HMOX1)and mitogen-activated protein kinase 14(MAPK14)with the onset and prognosis of acute lung injury(ALI)in children with sepsis.Methods A total of 102 children with sepsis were selected,including 54 in the ALI group and 48 in the non-ALI group.Clinical data,laboratory tests,organ function scores and serum levels of HMOX1 and MAPK14 were compared between the two groups.The mortality rates of children with different levels of HMOX1 and MAPK14 at 28-day and 90-day were analyzed.Results Compared with the non-ALI group,procalcitonin(PCT),lactate(Lac),pediatric organ dysfunction Logistic-2 score(PELOD-2),pediatric risk of mortality score version 3(PRISM III)and sequential organ failure assessment(SOFA)scores were increased in the ALI group(P＜0.05).Serum levels of HMOX1 and MAPK14 were significantly higher in the ALI group than those in the non-ALI group(P＜0.05).HMOX1 and MAPK14 showed good predictive value for the occurrence of ALI in sepsis patients,with AUC values of 0.872(95%CI:0.791-0.930)and 0.825(95%CI:0.737-0.893),and the optimal cutoff values were 3.1 μg/L and 3.8 μg/L,respectively.After grouping by the cutoff values of HMOX1 and MAPK14,there were no significant differences in the 28-day and 90-day mortality rates in children with different levels of HMOX1 and MAPK14(P＞0.05).Conclusion The expression levels of serum HMOX1 and MAPK14 increase in the early stage of sepsis-related ALI,which may serve as biomarkers for the onset of ALI,and they have no significant impact on the prognosis of children.

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.

AIM To investigate the protective effects of Shuangyi Qushi Tongluo Capsules(Shuangyi Capsules)on Dexamethasone(Dex)induced osteoporosis in mice.METHODS The C57BL/6J mice were randomly divided into the control group,the model group,the Xianling Gubao Capsules group(1.5 g/kg),and the low-dose,moderate-dose,and high-dose Shuangyi Capsules groups(0.6,1.2,and 2.4 g/kg).The mouse model of osteoporosis was induced by 8-week intraperitoneal injection of Dex sodium phosphate injection(5 mg/kg).The mice had their femur osteogenesis observed with hematoxylin and eosin(HE)staining and tartrate-resistant acid phosphatase(TRAP)staining;their serum alkaline phosphatase(ALP)and osteocalcin(BGP)activities detected by ELISA;their femoral mRNA expressions of Col-Ⅰ,OCN,and OPN detected by RT-qPCR;and their femoral protein expressions of OPG and RANKL detected by Western blot.Upon the MC3T3-E1 cells exposed to Dex and Shuangyi Capsules,their viability was evaluated by CCK-8 assay;their mineralization determined by alkaline phosphatase staining and alizarin red staining(ARS);and their intracellular ROS level detected using DCFH-DA probe.RESULTS Compared with the model group,Shuangyi Capsules groups demonstrated improved fracture of femoral trabeculae and reduced number of osteoclasts;increased serum ALP and BGP activities(P＜0.05,P＜0.01);increased femoral expressions of Col-Ⅰ mRNA and OPG protein(P＜0.05,P＜0.01);and decreased RANKL protein expression(P＜0.05).Compared with the MC3T3-E1 cells stimulated by Dex,those underwent further treatment of Shuangyi Capsules demonstrated increased cell viability and ALP activity(P＜0.05,P＜0.01);increased mineralization and calcium nodule formation;increased expressions of Col-Ⅰ,OCN,OPN mRNA and OPG protein(P＜0.05,P＜0.01);decreased RANKL protein expression(P＜0.05,P＜0.01);and reduced ROS levels.CONCLUSION Shuangyi Capsules ameliorate Dex-induced osteoporosis in mice by suppressing osteoclast overactivation,enhancing osteoblast activity,and stimulating bone formation through modulation of Col-Ⅰ,OCN,OPN mRNA and OPG/RANKL protein levels.

This study was aimed at investigating infections with Giardia and Cryptosporidium in Ochotona curzoniae in Zoige County,Sichuan Province.O.curzoniae were captured in five townships of Zoige County(Dazhasi,Axi,Hongxing,Tangke,and Maixi)between March and December of 2023.DNA from the gastrointestinal contents was subjected to nested PCR to amplify Giardia bg,gdh,and tpi genes,and the Cryptosporidium SSU rRNA gene.The sequences of PCR-PCR products were analyzed and compared.Phylogenetic trees were constructed to determine the protozoa species and genotypes.A total of 114 O.curzoniae animals were captured,among which 44 samples showed bg gene positivity,and 14 samples showed gdh gene positivity for Giardia.The total detection rate was 43.9％(50/114),and two assemblages were detected(assem-blage E and a new assemblage tentatively termed assemblage OC1);the positivity rate for Cryptosporidium was 7.0％(8/114),and three new genotypes were observed.Mixed infection with Cryptosporidium and Giardia was present in some sam-ples,with a detection rate of 3.5％(4/114).Giardia lamblia and Giardia sp.(REG-1,REG-2)were prevalent in O.curzoni-ae in Zoige County in Sichuan province;assemblage E was the dominant assemblage,and the new assemblage OC1 was pres-ent;and Cryptosporidium sp.(REG-1,REG-2,and REG-3)were identified.In summary,future monitoring of Giardia and Cryptosporidium should be further strengthened in Zoige to provide detailed data for promoting local public health.

In recent years,the prevalence of porcine infectious pleuropneumonia caused by Actinoba-cillus pleuropneumoniae(APP)has significantly increased in large-scale pig farms in China.The i-solation,identification,and biological characteristic testing of newly prevalent strains have impor-tant clinical significance.This study isolated four suspected APP strains(named XB2T-56,JMTLP-443,YD-THB-755,SYZJ-291)from lung samples of pig farms suspected of outbreaks of porcine infectious pleuropneumonia in Hubei Province.They were identified by PCR amplification,and multiplex PCR serological typing,the biological properties were tested by detecting the growth a-bility,hemolytic activity and biofilm forming ability.The drug resistance of the strains was ana-lyzed by drug sensitivity testing,and the virulence of one strain(XB2T-56)in mice and piglets was evaluated.The PCR identification result showed that all four clinical isolates were APP serotype 15 strains.These four strains grew slower than serotype 1 standard strains,had weaker hemolytic activity,but could form stronger biofilms.These strains are all less sensitive to cephalosporin,tylo-sin,sulfamethoxazole,and doxycycline,but sensitive to cefotaxime and enrofloxacin.The mice and piglet infection experiments showed that the isolated strain XB2T-56 has strong virulence.Artifi-cial intranasal infection causes acute death in piglets,with typical symptoms of pleuropneumonia in the lungs,and serotype 15 strains can be isolated from the lesion site.This study indicates that the APP serotype 15 strain has strong virulence,providing new date for the clinical epidemiological characteristics of APP.

Aim To compare the differences in the in vitro anti-precancerous lesions of gastric cancer(PL-GC)activities of different polar extracts from Bombyx batryticatus.Methods Bombyx batryticatus was ex-tracted by ethanol reflux,and the extract was further partitioned using different polarity organic solvents to obtain four fractions:petroleum ether(SYM),ethyl acetate(YSYZ),n-butanol(ZDC),and aqueous phase(SX).The PLGC cell model was established by inducing malignant transformation in GES-1 cells using N-methyl-N-nitro-N-nitrosoguanidine(MNNG).The optimal concentration of four extracts were determined by CCK-8 assay.The proliferation,migration and in-vasion of cells in each group were detected by plate cloning,scratch healing and Transwell assay,respec-tively.The expression levels of E-cadherin,Vimentin and key proteins of the PI3 K/AKT/mTOR signaling pathway in cells of each group were detected by West-ern blot.Meanwhile,chemical components of the four extracts were analyzed by UPLC-Q-TOF-MS/MS.Re-sults Compared with the normal group,the prolifera-tion,migration and invasion abilities of cells in the PL-GC group were significantly enhanced,the expression levels of E-cadherin proteins of PLGC cells were down-regulated,and the expression levels of Vimentin,p-PI3K,p-AKT and p-mTOR proteins of PLGC cells were up-regulated.Compared with the PLGC group,the four extracts attenuated the proliferation,migration and invasion abilities of PLGC cells,down-regulated the protein expression levels of Vimentin,p-PI3K,p-AKT and p-mTOR,and upregulated E-cadherin ex-pression in cells of the SYM,YSYZ,and ZDC groups.There was no statistical significance in the SX group.In addition,there were significant differences in the chemical components of the four different polar extracts of Bombyx batryticatus.The differential compounds were cysteine,histidine,etc.Conclusions The four different polar extracts of Bombyx batryticatus all can exert in vitro anti-PLGC effects by regulating the PI3K/AKT/mTOR signaling pathway to inhibit the EMT process.Among them,the extract of n-butanol had the strongest activity,followed by the extracts of ethyl ace-tate and petroleum ether.The aqueous phase had the weakest activity,and the difference in activity may be related to the different compounds such as Cysteine and Histidine.

Objective To explore the relationship between the ferroptosis-related molecules heme oxygenase-1(HMOX1)and mitogen-activated protein kinase 14(MAPK14)with the onset and prognosis of acute lung injury(ALI)in children with sepsis.Methods A total of 102 children with sepsis were selected,including 54 in the ALI group and 48 in the non-ALI group.Clinical data,laboratory tests,organ function scores and serum levels of HMOX1 and MAPK14 were compared between the two groups.The mortality rates of children with different levels of HMOX1 and MAPK14 at 28-day and 90-day were analyzed.Results Compared with the non-ALI group,procalcitonin(PCT),lactate(Lac),pediatric organ dysfunction Logistic-2 score(PELOD-2),pediatric risk of mortality score version 3(PRISM III)and sequential organ failure assessment(SOFA)scores were increased in the ALI group(P＜0.05).Serum levels of HMOX1 and MAPK14 were significantly higher in the ALI group than those in the non-ALI group(P＜0.05).HMOX1 and MAPK14 showed good predictive value for the occurrence of ALI in sepsis patients,with AUC values of 0.872(95%CI:0.791-0.930)and 0.825(95%CI:0.737-0.893),and the optimal cutoff values were 3.1 μg/L and 3.8 μg/L,respectively.After grouping by the cutoff values of HMOX1 and MAPK14,there were no significant differences in the 28-day and 90-day mortality rates in children with different levels of HMOX1 and MAPK14(P＞0.05).Conclusion The expression levels of serum HMOX1 and MAPK14 increase in the early stage of sepsis-related ALI,which may serve as biomarkers for the onset of ALI,and they have no significant impact on the prognosis of children.

Objective To comprehensively and systematically evaluate the clinical effect of Chuanzhi Tongluo capsule combined with western medical treatment in patients with cerebral infarction using meta-analysis.Methods Domestic databases were searched,including China Knowledge Network,Wanfang,and Wipu databases,and foreign databases were mainly PubMed.The qualified literature was screened according to the inclusion and exclusion criteria,and was evaluated using the software of RevMan5.3 and Stata14.0 after quality assessment.Results Eight randomized controlled trials(RCTs)on the combination of Chuanzhi Tongluo capsule and western medicine were included,with a total of 728 patients with cerebral infarction,among which 365 cases were in the group of Chuanzhi Tongluo capsule combined with western medicine and 363 cases were in the group of western medicine alone.The results were analyzed in terms of the total effective rate,neurological deficit score such as the National Institutes of Health Stroke Scale(NIHSS),daily living scores,such as the Barthel Index and Activities of Daily Living(ADL)scores and inflammation level(Inflammatory mediator IL-6,ultrasensitive C-reactive protein)as the outcome indexes.Meta-analysis results showed that the total effective rate[95%CI,1.18(1.12,1.25),P<0.00001],neurological function impairment score[95%CI,-1.37(-2.08,-0.67),P=0.0001],daily life score[95%,0.88(0.51,1.25),P<0.00001],and inflammation level[95%CI,-0.75(-0.96,-0.54),P<0.00001]were better than those of the control group and showed significant differences.The incidence of adverse events[95%CI,0.89(0.37,2.15),P=0.80],and the difference was not statistically significant with that of western medicine treatment alone.Conclusion Compared with the control group which only used western medicine,the treatment effect of Chuanzhi Tongluo capsule combined with western medicine in the treatment of cerebral infarction is more significant,and the combined treatment can improve the neurological function of the patients,enhance the quality of daily life,and reduce the level of inflammation more effectively.

Objective This study aims to investigate the effects of FGL2 on the immune response of EBV-infected T cells,including their activation,proliferation,exhaustion,and cytokine profile changes.Methods Primary T cells were infected with EBV at different multiplicities of infection(MOI).Expression of FGL2 in T cells,as well as T-cell activation,proliferation,exhaustion,and cytokine levels,were detected using RT-qPCR,Western blot,ELISA,CCK8,and flow cytometry(FCM),respectively.Further experiments involving FGL2 knockdown and overexpression were conducted to elucidate its specific regulatory role in EBV-infected T cells.Results FGL2 expression was significantly upregulated in EBV-infected T cells(P＜0.05).EBV infection also induced enhanced T cell activation(P＜0.001),proliferation(P＜0.001),and exhaustion(P＜0.01).Compared to the T cells+EBV group,the T cells+EBV+FGL2 overexpression group exhibited higher exhaustion levels(P＜0.01),reduced activation(P＜0.05)and proliferation(P＜0.05),decreased pro-inflammatory cytokine levels(P＜0.05),and increased anti-inflammatory cytokine levels(P＜0.05).Conversely,the T cells+EBV+FGL2 knockdown group demonstrated the opposite trends,with elevated activation(P＜0.01),proliferation(P＜0.05),pro-inflammatory cytokine levels(P＜0.05),and reduced exhaustion(P＜0.01)and anti-inflammatory cytokine levels(P＜0.05).Conclusion FGL2 suppresses T cell activation and proliferation,exacerbates T cell exhaustion,inhibits pro-inflammatory cytokine release,and promotes anti-inflammatory cytokine secretion during EBV infection,thereby modulating the immune response of T cells.