National biological standards for antibiotics are critical components of the antibiotic quality control system and serve as reference materials for measuring and calibrating the biological activity of antibiotics. This article systematically reviews the classification, definition of potency units, and current research status of commercially available national antibiotic biological standards in China. At present, these standards can be categorized based on chemical structure, number of components, and development methods. The definition of potency units has evolved from an early “arbitrarily assigned unit” to “being represented by the mass of the antibiotic salt” and, more recently, to the current mainstream approach of “being represented by the mass of the active ingredient”. This evolution reflects a shift in quality control philosophy from primarily biological analysis to a system dominated by chemical analysis supplemented by biological methods. Current research focuses on optimizing potency determination methods, studying the unification of content and potency, and implementing dual quality control of both the potency and the ratio/content of active components in multi-component antibiotics. For complex multi-component antibiotics, the microbiological assay based on biological activity remains irreplaceable in quality control. Future efforts should emphasize further method optimization, ensuring batch-to-batch consistency of standards, and advancing precision quality control as key research priorities for antibiotic biological standards.

ObjectiveTo investigate the current situation of mutual recognition for ethical review outcomes in multicenter clinical research across 10 contracting medical institutions in Guangdong Province， analyze existing issues and propose improvement recommendations， thereby promoting the standardized management of mutual recognition for ethical review outcomes in medical institutions. MethodsData from 381 multicenter clinical studies conducted in these 10 medical institutions from January 24 to October 31， 2024， were collected. Text visualization was performed using Python and the WordCloud library， and statistical analyses were conducted with SPSS 25.0. ResultsOf the 381 studies investigated， industry-sponsored clinical trials （ISTs） accounted for 51.71%， while investigator-initiated clinical trials （IITs） constituted 48.29%. The proportions of ethical committees serving as primary reviewers and collaborative reviewers were 33.33% and 66.67%， respectively. The confirmation methods of mutual recognition outcomes were primarily expedited reviews （50.66%） and meeting reviews （49.34%）， and no cases of “direct confirmation” were found. The Chi-square test revealed statistically significant differences in review confirmation methods based on project type （χ²=14.851， P<0.001） and ethics committee role （χ²= 69.435， P<0.001）. The frequency distribution trend of the contingency table showed that IST projects and primary ethics committees preferred to employ meeting review （58.88% and 79.53% respectively， both higher than the average level of 49.34%）， while IIT projects and the collaborative ethics committees more frequently utilized expedited review （60.87% and 65.75% respectively， both higher than the average level of 50.66%）. ConclusionThe confirmation methods of mutual recognition for ethical review outcomes in multicenter clinical research are significantly associated with the role of the ethics committee and the type of project. It is recommended to improve management systems， enhance information construction and personnel training， as well as clarify mutual recognition responsibilities and strengthen supervision. This aims to ensure review quality while improving mutual recognition efficiency， thereby safeguarding the rights and interests of research participants.

Objective To explore the mechanism of Shengmai Decoction in improving heart failure by regulating mitochondrial apoptosis based on network pharmacology and experimental verification;To provide a basis for its clinical application.Methods The active components and targets of Shengmai Decoction were obtained through TCMSP and TCMID databases.Heart failure and mitochondrial apoptosis related targets were retrieved from GeneCards,OMIM,DrugBank,PharmGKB and TTD databases.A protein-protein interaction(PPI)network at the intersection of drugs and diseases was constructed using the STRING database,and a component-target network was constructed using Cytoscape 3.8.2 software.GO and KEGG pathway enrichment analysis was performed on intersecting targets using the DAVID database.Molecular docking was conducted to assess the binding affinity of key components to core target proteins.A rat model of heart failure was established,and the cardiac function of rats were detected by echocardiogram,ELISA was used to detect serum contents of BNP and NT-proBNP,mitochondrial ultrastructure was observed by transmission electron microscope,and Western blot was used to detect protein expressions of Bcl-2/Bax/Caspase-3 signaling pathway.Results A total of 66 active components and 146 targets of Shengmai Decoction were identified,and 22 intersecting targets with heart failure and mitochondrial apoptosis,including key proteins such as TNF,Bcl-2,Bax and Caspase-3.GO enrichment analysis revealed that the intersecting targets were closely associated with inflammation and cell signaling,while KEGG pathway analysis showed that the targets were primarily involved in the TNF signaling pathway,IL-17 signaling pathway,and mitochondrial function regulation.Molecular docking results indicated that Ginsenoside rh2,Beta-sitosterol and other components of Shengmai Decoction exhibited strong binding affinities with Bcl-2,Bax and Caspase-3.Animal experiments demonstrated that Shengmai Decoction significantly improved cardiac function(P<0.05,P<0.01),reduced serum BNP and NT-proBNP contents(P<0.01),alleviated mitochondrial damage,and inhibited mitochondrial apoptosis by upregulating Bcl-2 and downregulating Bax and Caspase-3 protein expression(P<0.01),thereby protecting cardiomyocytes.Conclusion Shengmai Decoction can target and regulate the Bcl-2/Bax/Caspase-3 signaling pathway,improving pathological processes associated with heart failure,which can provide a foundation for clinical optimization of Shengmai Decoction.

Objective To investigate the effects of ischemia time and storage periods on RNA quality in fresh-frozen breast cancer(BC)and esophageal cancer(EC)tissue samples in order to establish evidence-based protocols for biobank sample management.Methods The tumor(T)and paired normal(N)tissue samples from 6 cases of BC and 6 cases of EC were collected and cryopreserved in Biobank,Shantou Central Hospital.Mirror paraffin-embedded tissues were simultaneously prepared into sections for morphological analysis.The samples were divided into two groups of<15 min and 15-30 min according to ischemia time,and RNA quality was analyzed at 4 storage periods of 8-10 months(T1),14-16 months(T2),26-28 months(T3)and 38-40 months(T4).Results In 96 analyzed samples,93.8%(90/96)exhibited high quality(RIN≥6),with 89.6%(43/48)in BC and 97.9%(47/48)in EC.Significant differences in RIN were observed between BC group and EC group(8.050 vs.8.600,P=0.009).In EC group,RIN value was significantly negatively correlated with RNA yield(P<0.001).Moreover,RIN values of tumor-normal pairs exhibited markedly significant differences(7.550 vs.9.000,P<0.001).In contrast,no significant difference was detected in BC group(8.200 vs.7.700,P=0.348).Statistical analysis showed that RIN value was positively correlated with 28S/18S(P<0.001),but had no correlation with tumor content(P=0.676)and necrotic content(P=0.055).Neither ischemia time(<15 min vs.15-30 min:8.200 vs.8.300,P=0.932)nor storage periods(T1-T4:8.400,7.700,8.450,8.600,P=0.163)compromised RNA quality.Conclusion Organ origin and tissue type could influence RNA quality of fresh-frozen tissue samples.However,limited ischemia time(≤30 min)and long-term storage period(38-40 months)do not adversely affect RNA quality in fresh-frozen breast cancer and esophageal cancer tissue samples.

Objective To investigate the effects of cornuside on intestinal injury in rats with septic shock,and clarify its possible mechanism.Methods SD rats were randomly divided into normal control group,model group,low-,medium-,and high-dose comecarpine glycosides groups,and TREM1 inhibitor(LR12)group.HE staining was used to observe the pathological injury of small intestinal mucosa.The levels of D-lactic acid(D-LA)and diamine oxidase(DAO)in serum and secretory immunoglobulin(sIg A)in small intestine were detected by ELISA.Intestinal mucosal permeability was detected by fluorescein isothiocyanate-dextran(FITC-D)tracer method.ELISA was used to detect the levels of interferon(IFN)-γ,tumor necrosis factor(TNF)-α,interleukin(IL)-1β,IL-10 and arginase(Arg)-1 in serum.The polarization of macrophages in small intestinal tissue was detected by flow cytometry.Western blot was used to detect the protein expression levels of triggering receptor expressed on myeloid cells 1(TREM1),CD86 and CD206 in small intestine.Results Compared with the normal control group,the model group had serious pathological injury of the small intestinal mucosa,and the serum levels of D-LA,DAO,FITC-D,IFN-γ,TNF-α,and IL-1β significantly increased(P<0.05),while the levels of sIg A,IL-10,and Arg-1 significantly decreased(P<0.05).The M1/M2 ratio of macrophages and the expression levels of TREM1 and CD86 proteins in the small intestine tissue significantly increased(P<0.05),while the expression level of CD206 protein significantly decreased(P<0.05).Compared with the model group,the small intestinal mucosal injury of the rats in each dose cornuside group and LR12 group significantly improved,and the serum levels of D-LA,DAO,FITC-D,IFN-γ,TNF-α,and IL-1β significantly decreased(P<0.05),while the levels of sIg A,IL-10,and Arg-1 significantly increased(P<0.05).The M1/M2 ratio of macrophages and the expression levels of TREM1 and CD86 proteins in the small intestine tissue significantly decreased(P<0.05),while the expression level of CD206 protein significantly increased(P<0.05).Conclusion Cornuside can reduce intestinal injury in rats with septic shock,and the mechanism may be related to inhibiting TREM1-mediated M1 polarization of macrophages.

BACKGROUND:Allogeneic hematopoietic stem cell transplantation is currently the most effective method for the radical treatment of thalassemia major,but only half of patients can find compatible bone marrow or peripheral blood stem cells.Sib-derived umbilical cord blood stem cells have different characteristics from bone marrow and peripheral blood stem cells,and are a potential alternative source of hematopoietic stem cells for transplantation in patients with thalassemia major.OBJECTIVE:To investigate the therapeutic effect of human leukocyte antigen matched sibling fresh umbilical cord blood transplantation in the treatment of β-thalassemia major in children.METHODS:Forty-eight children with β-thalassemia major,including 28 males and 20 females,with a median age of 4 years old,were selected from Nanfang Hospital of Southern Medical University from June 2010 to June 2020.All of them received fresh cord blood transplantation from human leukocyte antigen matched sibling.Transplantation conditioning adopted a myeloablative regiment without anti-thymocyte globulin.A combination of cyclosporine A and mycophenolate mofetil with or without short-range methotrexate was administered for graft-versus-host disease.RESULTS AND CONCLUSION:(1)The median infused doses of total nucleated cells and CD34+cells were 8.17×107/kg and 2.40×105/kg,respectively in 48 children.The median follow-up time after cord blood transplantation was 98 months,and 44 cases were successfully engrafted.The median time to neutrophil and platelet engraftment was 28 and 31 days,respectively.Among them,37 cases were found to be donor-type complete chimerism detected as evidence of implantation after transplantation,7 cases were found to be stable mixed chimerism.(2)Among the 44 children with successful implantation,four patients developed acute graft-versus-host disease,and were scored as grade Ⅰ(n=2)and grade Ⅱ(n=2).All the affected organs were skin,and no chronic graft-versus-host disease occurred.(3)After umbilical cord blood transplantation,cytomegalovirus infection and activation occurred in 5 of the 48 cases,sepsis in 12 cases,invasive fungal disease in 3 cases,stomatitis in 21 cases,hemorrhagic cystitis in 8 cases,and hepatic vein occlusion in 1 case.(4)Among 48 children,47 patients survived;1 died of severe pneumonia combined with acute heart failure 28 days after transplantation;43 survived without disease;3 had primary implantation failure,and 1 had pancytopenia after transplantation.The 5-year probabilities of overall survival and disease-free survival were 98％and 89％,respectively.The cumulative incidence of transplant-related deaths at 1 year was 2.1％.(5)The above results indicate that human leukocyte antigen matched sibling fresh umbilical cord blood transplantation is effective in the treatment of β-thalassemia major in children with a low incidence of graft-versus-host disease.

Objective To investigate the mechanism of Achyranthoside Ⅰ inhibits pyroptosis in chondrocytes through the nuclear factor-κB(NF-κB)/NOD receptor protein structure domain related proteins 3(NLRP3)/cystine containing aspartate specific proteins-1(caspase-1)signaling pathway.Methods Primary mouse chondrocytes were divided into blank group(phosphate buffered solution with the same volume),model group[10 ng·mL-1 interleukin-1β(IL-1 β)],control group(10 ng·mL-1 IL-1β+20 μmol·L-1 celecoxib)and experimental group(10 ng·mL-1 IL-1β+3 μg·mL-1 Achyranthoside Ⅰ).After 24 hours of intervention,the cell proliferation was measured by cell counting kit 8,the levels of superoxide dismutase(SOD),malondialdehyde(MDA),IL-1 and IL-6 were detected by enzyme-linked immunosorbent assay,the protein expression levels of NF-κB p65,NLRP3 and caspase-1 were detected by Western Blot.Results The apoptosis rates in experimental,control,model and blank groups were(13.34±0.61)％,(15.64±1.01)％,(21.81±1.10)％and 0;the SOD levels were(147.03±16.49),(130.09±7.33),(122.03±10.71)and(164.40±22.74)nU·mL-1;the MDA levels were(6.43±0.71),(7.63±1.01),(8.89±1.84)and(5.69±0.81)nmol·L-1;the IL-1 levels were(338.69±40.95),(361.78±32.15),(391.44±30.59)and(289.23±25.19)pg·mL-1;the IL-6 levels were(89.96±8.81),(101.10±11.59),(120.39±14.71)and(60.29±6.03)pg·mL-1;the relative expression levels of NF-κB p65 were 0.68±0.05,0.97±0.05,1.26±0.05 and 0.57±0.05;the relative expression levels of NLRP3 were 0.71±0.08,1.02±0.10,1.50±0.06 and 0.31±0.05;the relative expression levels of caspase-1 were 0.70±0.07,1.29±0.08,1.66±0.07 and 0.51±0.07,respectively.Compared with the model group,the differences of above indexes were statistically significant in the experimental group(all P＜0.05).Conclusion Achyranthoside Ⅰ can improve the oxidative stress status induced by IL-1 β in chondrocytes,reduce the expression of proteins related to the NF-κB signaling pathway,and thereby decrease the occurrence of caspase-1 dependent pyroptosis,providing a protective effect on chondrocytes.

Numerous studies have shown that depression is main-ly associated with the abnormal expression of connexin 43(Cx43)in astrocytes(Astro)and its mediated dysfunction of gap junction(GJ).However,the molecular mechanism of post-translational modifications targeting Cx43 to regulate neuroin-flammation-associated depression is still unclear.Post-transla-tional modifications of Cx43 mainly include phosphorylation of specific amino acid sites by PKC,PKA,PKG,MAPK and PTK,and protein degradation of Cx43 through the K48/K63 polyubiq-uitylation and deubiquitination pathways,which ultimately lead to protein degradation through K48/K63 polyubiquitination and deubiquitination.These modifications are ultimately involved in the regulation of neuroinflammatory responses through the associ-ation of GJ function.In this paper,we systematically review the role of Cx43 post-translational modifications in neuroinflamma-tion,with the aim of further exploring the potential application of targeting these modifications to modulate the inflammatory re-sponse mechanism in improving depressive symptoms.

Aim To explore the therapeutic effect and mechanism of Qingjie Huagong decoction in modulating PI3K/AKT/NF-κB signaling pathway in inflammatory response of acute pancreatitis(AP)mice.Methods Twenty-four mice were randomly divided into Blank group,Model group,Ustekin group,and Qingjie Hua-gong decoction group,with six mice in each group.The AP model was prepared by using rain frogin.Serum α-AMS,PNLP,IL-1β,IL-6,IL-8,IL-18,and TNF-α lev-els were detected by ELISA;the pancreatic pathology was detected by HE staining;the expressions of PI3K,AKT,and NF-κB-related proteins and mRNAs were de-tected by immunohistochemistry,Western blot,and RT-qPCR.Results Compared with the blank group,the model group showed obvious pathological damage to the pancreas,with significantly higher serum α-AMS,PN-LP,IL-1β,IL-6,IL-8,IL-18,and TNF-α levels(P＜0.01),and significantly higher levels of PI3K,AKT,and NF-κB-related proteins and mRNA expression(P＜0.01).Compared with the model group,both the Qingjie Huagong decoction group and the ustekin group improved the histopathological changes in the pancreas of AP mice,decreased the serum α-AMS,PNLP,IL-1β,IL-6,IL-8,IL-18,and TNF-α levels,and down-reg-ulated the expression levels of pancreatic PI3K,AKT,NF-κB-related proteins and mRNA(P＜0.05 or P＜0.01).Conclusion Qingjie Huagong decoction may inhibit the inflammatory response and protect pancreat-ic tissues by regulating the expression of PI3K/AKT/NF-κB signaling pathway.

Objective To assess the technical levels of computed tomography (CT) quality control testing capabilities among radiological health technology service institutions in Hubei Province, China. Methods Ten radiological health technology service institutions in Hubei Province were organized to participate in an inter-institutional capability comparison of selected indicators in CT quality control testing with reference to the Specification for testing of quality control in X-ray computed tomography (WS 519—2019). The robust Z-score method was employed to evaluate the results of the capability comparison data from the ten institutions. Results Six institutions achieved a "satisfactory" rating in all assessed indicators, with a satisfaction rate of 60%. Indicators rated as "unsatisfactory" or "questionable" included "positioning light accuracy", "uniformity", "noise", and "high-contrast resolution". Conclusion The CT quality control testing capabilities of some radiological health technology service institutions in Hubei Province require further enhancement. Improved training and education for testing personnel are recommended.