“Chinese Pharmacopoeia” is the legal basis for drug development, production, operation, use and management in China, and the Chinese Pharmacopoeia 2025 Edition is going to be issued and implemented. This article introduces the revision and amendment situations, analyzes the characteristics of the new edition of the Pharmacopoeia and the future development direction of national standards for better understanding and implementation of the latest edition of pharmacopoeia.

BACKGROUND:Spleen has the functions of blood storage,hematopoiesis,and immunity.With the increase of age,the structural degeneration and functional decline of spleen lead to the impairment of immune system function,thus accelerating the aging process of the body.The treatment of spleen aging in tree shrews with highly active umbilical cord mesenchymal stem cells has not been reported. OBJECTIVE:To explore the intervention effect and mechanism of highly active umbilical cord mesenchymal stem cells on spleen aging in tree shrews. METHODS:Highly active umbilical cord mesenchymal stem cells were isolated,cultured,and obtained from the umbilical cord tissue of newborn tree shrews by caesarean section.The differentiation abilities of adipogenesis,osteogenesis,and chondrogenesis were detected by three-line differentiation kit.Cell cycle and surface markers were detected by flow cytometry.The second generation of highly active umbilical cord mesenchymal stem cells were transfected with Genechem Green Fluorescent Protein with infection complex values of 100,120,140,160,180,and 200,respectively,to screen the best transfection conditions.After transfection,the fourth generation of highly active umbilical cord mesenchymal stem cells was injected into the tail vein of tree shrews in the elderly treatment group.The young control group and the aged model group were not given special treatment.After 4 months of treatment,the spleen tissue was taken and the structure of the spleen was observed by hematoxylin-eosin staining.β-Galactosidase staining was used to detect the activity of aging-related galactosidase.Immunohistochemical staining was used to detect the expression levels of p21 and p53 proteins.Ki67 and PCNA immunofluorescence staining was used to detect cell proliferation activity.Immunofluorescence staining was used to detect the expression levels of spleen autophagy protein molecules Beclin 1 and APG5L/ATG5.Reactive oxygen species fluorescence staining was used to detect the content of reactive oxygen species in spleen tissue.CD3 immunofluorescence staining was used to detect the change of the proportion of total T lymphocytes.The secretion levels of interleukin 1β and transforming growth factor β1 in spleen were detected by enzyme linked immunosorbent assay.The distribution of highly active umbilical cord mesenchymal stem cells labeled with green fluorescent protein in spleen tissue was observed by DAPI double staining of nucleus. RESULTS AND CONCLUSION:(1)Highly active umbilical cord mesenchymal stem cells grew in a short spindle shape with fish-like growth,with a large proportion of G0/G1 phase,and had the potential to differentiate into adipogenesis,osteogenesis,and chondrogenesis.(2)Multiplicity of infection=140 and transfection for 72 hours were the best conditions for labeling tree shrews highly active umbilical cord mesenchymal stem cells with Genechem Green Fluorescent Protein.(3)Compared with the aged model group,in the aged treatment group,the spleen tissue cells of tree shrews were arranged closely,and the area of white pulp was increased(P<0.01);the boundary between red pulp and white pulp was clear;the proportion of germinal centers did not show statistically significant difference(P>0.05).The activity level of galactosidase related to spleen tissue aging was decreased(P<0.001),and the expression levels of aging protein molecules p21 and p53 were down-regulated(P<0.001).The expression levels of proliferation-related molecules Ki67 and PCNA were up-regulated(P<0.001,P<0.05);expression levels of autophagy-related molecules Beclin 1 and APG5L/ATG5 were up-regulated(P<0.001),and the content of reactive oxygen species decreased(P<0.001),and the proportion of CD3+T cells increased(P<0.05).The secretion level of interleukin 1β in the aging-related secretion phenotype decreased(P<0.001);no significant difference was found in transforming growth factor β1 level(P>0.05).Compared with the young control group,the above indexes were significantly different in the elderly treatment group(P<0.05).(4)Green fluorescent cells labeled with green fluorescent protein were observed in spleen tissue of tree shrews the elderly treatment group by frozen tissue section observation.The results show that intravenous infusion of highly active umbilical cord mesenchymal stem cells can migrate to spleen tissue,inhibit the production of reactive oxygen species,down-regulate the expression of aging-related proteins,induce autophagy,promote cell proliferation,reduce chronic inflammation,and then improve the structure and function of spleen tissue.

OBJECTIVES: This study aimed to explore the biological functions and clinical value of mothers against decapentaplegic homolog (SMAD) 7 in head and neck squamous cell carcinoma (HNSCC) through bioinformatics analysis and basic experiments. METHODS: The expression of SMAD7 in HNSCC in public databases was studied. Western blot was used to detect the expression of SMAD7 in HNSCC cell lines and normal epithelial cells. The SMAD7 highly expressed HNSCC cell line HSC-4 was silenced, and CCK-8, Transwell assays, and cell scratch experiments were conducted to study the effect of SMAD7 on the biological functions of HSC-4 cells. HNSCC expression profile data were obtained from UCSC xena, and genes related to SMAD7 were selected for gene ontology and Kyoto encyclopedia of genes and genomes gene enrichment analysis, construction of a co-expression gene interaction network, and screening of related cell signaling pathways. Western blot was used to detect the expression changes of proteins in the related cell signaling pathways in HNSCC cells with silenced SMAD7. cBioPortal was utilized to analyze the mutation rate of the SMAD7 gene, and the MethSurv database was used to analyze the methylation level of the SMAD7 gene and its correlation with prognosis. The receiver operating characteristic curve was used to assess the diagnostic value of SMAD7 for HNSCC. TIMER2.0 was used to analyze the correlation between SMAD7 expression and immune cell infiltration. RESULTS: SMAD7 was highly expressed in HNSCC tumor tissues and some cell lines. Silencing the expression of SMAD7 can significantly inhibit the proliferation, migration, and invasion of cancer cells. Silencing SMAD7 can induce the downregulation of vascular cell adhesion molecule 1 (VCAM-1). The bioinformatics analysis showed that the mutation rate of the SMAD7 gene and the methylation level were significantly correlated with the prognosis of patients with HNSCC. The expression of SMAD7 was related to the level of immune cell infiltration in HNSCC. CONCLUSIONS SMAD7 promotes the proliferation, migration, and invasion of HNSCC cells by regulating the expression of VCAM-1. It may be a potential tumor biomarker and therapeutic target for HNSCC.
Humans ; Smad7 Protein/metabolism* ; Prognosis ; Squamous Cell Carcinoma of Head and Neck ; Head and Neck Neoplasms/pathology* ; Cell Line, Tumor ; Cell Movement ; Cell Proliferation ; Signal Transduction ; Gene Expression Regulation, Neoplastic ; Gene Silencing ; Computational Biology

Objective To analyze the correlation and predictive value of serum microRNA(miR)-34b and miR-181c levels with the prognosis of elderly acute ischemic stroke(AIS)patients with mechanical thrombec-tomy.Methods A total of 180 elderly AIS patients in Suining Central Hospital from January 2023 to January 2024 were selected as the study group.According to the 2∶1 control principle,90 healthy elderly patients at the same age and during the same period were selected as the control group.The general data and serum miR-34b and miR-181c levels in the two groups were compared,and the serum miR-34b and miR-181c levels of pa-tients with different degrees of neurological impairment in the study group were compared,and the correlation between the levels of serum miR-34b and miR-181c and the degree of neurological impairment in elderly AIS patients was analyzed.General data and serum miR-34b and miR-181c levels of patients with different progno-sis were compared at admission,and factors affecting adverse prognosis were analyzed,as well as the value of serum miR-34b and miR-181c in predicting adverse prognosis.Results The serum miR-34b level in the study group was lower than that in the control group,and the serum miR-181c level was higher than that in the con-trol group(P＜0.05).In the study group,the serum miR-34b level of patients with severe neurological im-pairment was lower than that of moderate and mild patients,the level of miR-181c was higher than that of moderate and mild patients,and the level of miR-181c was higher than that of mild patients(P＜0.05).The serum miR-34b levels in patients with severe neurological impairment in the study group were lower than those in moderate and mild patients at admission,and those in moderate patients were lower than those in mild patients,miR-181c levels were higher than those in moderate and mild patients,and moderate patients were higher than those in mild patients(P＜0.05).The level of serum miR-34b was negatively correlated with the degree of neurological impairment,and the level of miR-181c was positively correlated with the degree of neu-rological impairment(P＜0.05).The proportion of diabetes mellitus,National Institutes of Health Stroke Scale(NIHSS)score at admission,time from onset to treatment and serum miR-181c level in patients with poor prognosis were higher than those with good prognosis,and the level of miR-34b was lower than those with good prognosis(P＜0.05).Diabetes mellitus,time from onset to treatment,NIHSS score at admission,and serum miR-181c level were all independent risk factors for poor prognosis in elderly AIS patients with me-chanical thrombectomy,while serum miR-34b level was an independent protective factor(P＜0.05).The area under the curve(AUC)of serum miR-34b and miR-181c were 0.751 and 0.758 respectively in predicting the poor prognosis,and the AUC of combined miR-34B and miR-181c was 0.867,which was greater than the AUC predicted by alone(P＜0.05).Conclusion The levels of serum miR-34b and miR-181c are the factors affect-ing the poor prognosis of elderly AIS patients with mechanical thrombectomy,and have the predictive value for the prognosis.

Objective To observe the effect of modified Banxia Xiexin Decoction on inflammatory factors in patients with polycystic ovary syndrome(PCOS)of stomach heat and spleen deficiency type through the regulatory mechanism of intestinal flora.Methods A total of 86 patients with PCOS of stomach heat and spleen deficiency type were randomly divided into control group(45 cases)and observation group(41 cases).The control group was treated with conventional western medicine,and the observation group was treated with modified Banxia Xiexin Decoction on the basis of treatment for the control group.One menstrual cycle constituted a course of treatment,and the treatment lasted for three continuous menstrual cycles.The two groups were observed in the changes of traditional Chinese medicine(TCM)syndrome score,endometrial thickness,serum inflammatory factors of tumor necrosis factor α(TNF-α),C-reactive protein(CRP)and interleukin-6(IL-6),sex hormone levels of luteinizing hormone(LH),estradiol(E2),follicle stimulating hormone(FSH)and LH/FSH,as well as the intestinal flora before and after treatment.The clinical efficacy and pregnancy rate of the two groups were compared after treatment.Results(1)After 3 menstrual cycles of treatment,the total effective rate of the observation group was 87.80%(36/41),and that of the control group was 68.89%(31/45).The intergroup comparison(tested by chi-square test)showed that the clinical efficacy of the observation group was significantly superior to that of the control group(P<0.05).(2)After treatment,the scores of TCM syndromes in the two groups were decreased when compared with those before treatment(P<0.05),and the decrease in the observation group was more significant than that in the control group(P<0.01).(3)After treatment,the endometrial thickness in the two groups was increased when compared with that before treatment(P<0.05),and the increase in the observation group was superior to that in the control group(P<0.01).(4)The pregnancy rate of the observation group was 92.68%(38/41),which was significantly higher than 73.33%(33/45)of the control group,and the difference was statistically significant(P<0.05).(5)After treatment,the levels of serum E2,LH and LH/FSH in the two groups were decreased when compared with those before treatment(P<0.05),but there was no significant change in the level of serum FSH before and after treatment(P>0.05).The comparison between the two groups showed that the decrease of serum E2,LH and LH/FSH levels in the observation group was significantly superior to that in the control group(P<0.01).(6)After tieatment,the levels of serum CRP,IL-6,TNF-α in patients of the two groups were decreased compared with those before treatment(P<0.05),and the decrease in the observation group was superior to that in the control group(P<0.01).(7)After treatment,the levels of Bifidobacteria and Lactobacilli in the intestinal flora of the two groups were higher than those before treatment(P<0.05),and the levels of Enterococcus faecalis and Bacteroides were lower than those before treatment(P<0.05),while the levels of Enterobacter did not change significantly before and after treatment(P>0.05).The comparison between the two groups showed that the increase of the levels of Bifidobacteria and Lactobacilli and the decrease of the levels of Enterococcus faecalis and Bacteroides in the observation group were significantly superior to those in the control group(P<0.05 or P<0.01).Conclusion Modified Banxia Xiexin Decoction has a significant clinical effect in the treatment of PCOS of stomach heat and spleen deficiency type.The decoction is effective on improving the clinical symptoms and inflammatory factor levels of patients by regulating intestinal flora.

Objective:To explore the feasibility of non-invasive prenatal testing (NIPT) for detecting fetal chromosomal copy number variants (CNV).Methods:A retrospective analysis was carried out on NIPT positive samples in Suzhou Municipal Hospital from January 1, 2019 to December 31, 2021. The effect of NIPT on fetal CNV detection was assessed by comparison with the results of karyotype analysis and/or chromosomal microarray analysis (CMA).Results:Among the 525 NIPT positive samples, 146 were CNV cases, of which 84 were further verified by karyotyping and/or CMA, 29(34.5%) were true positive. Among them, 12 cases were pathogenic variants, 2 cases were likely pathogenic variants and 15 cases were variants of uncertain significance.Conclusion:NIPT could detect CNV with high accuracy, and to combine CNV detection and chromosomal aneuploidy detection has great significance to improve the prenatal and postnatal care.

Objective:Induced pluripotent stem cells (iPSCs) cell lines were established using peripheral blood mononuclear cells (PBMCs) from a patient suffering from neonatal respiratory distress syndrome (NRDS) who carried Adenosine triphosphate-binding cassette transporter A3 ( ABCA3) compound heterozygous mutations. Methods:Cell experimental research.Peripheral venous blood was collected and PBMCs were isolated and cultured in vitro. PBMCs were transfected with non-integrated Sendai vector carrying reprogramming factors.The chromosome karyotypes of the established iPSCs were analyzed.Immunofluorescence and flow cytometry were used to detect pluripotency markers of stem cells and verify their differentiation potential.Sanger sequencing was performed to analyze gene mutations.In addition, short tandem repeat (STR) analysis was performed, polymerase chain reaction(PCR) and agarose gel electrophoresis were used to detect virus residual. Results:Karyotype analysis of established iPSCs cell lines showed normal diploid 46, XY karyotype.Immunofluorescence showed positive staining of stem cell pluripotency markers OCT4, SSEA4, Nanog and Sox2.Flow cytometry was used to detected stem cell pluripotency markers and showed expression of TRA-1-60, SSEA-4 and OCT4.After differentiation into all three germ layers, immunofluorescence was performed to detect ectoderm (Pax-6), mesoderm (Brachyury) and endoderm alpha-fetoprotein markers, and the results showed positive staining, which confirmed that the iPSCs had the potential to differentiate.Sanger sequencing showed c. 3997_3998del and c. 3137C>T compound heterozygous mutations.STR analysis showed they originate from PBMCs, and no Sendai virus residual was detected by PCR and agarose gel electrophoresis.Conclusions:In this study, PBMCs from patient carrying ABCA3 compound heterozygous mutations was used to establish iPSCs cell lines.The research lays a foundation for the study of pathogenesis, therapeutic drug screening and cell therapy of NRDS caused by ABCA3 gene mutations.

【Objective】 To establish a blood quality monitoring indicator system, in order to continuously improve blood quality and standardized management. 【Methods】 Based on the research of literature and standards, and guided by the key control points of blood collection and supply process, the blood quality monitoring indicator system was developed. Through two rounds of Delphi expert consultation, the indicator content was further revised and improved according to expert opinions after six months of trial implementation. The indicator weight was calculated by questionnaire and analytic hierarchy process. 【Results】 A blood quality monitoring indicator system covering the whole process of blood collection and supply was constructed, including five primary indicators, namely blood donation service, blood component preparation, blood testing, blood supply and quality control, as well as 72 secondary indicators, including definitions, calculation formulas, etc. Two rounds of expert consultation and two rounds of feasibility study meeting were held to revise 17 items and the weight of each indicator was obtained through the analytic hierarchy process. After partial adjustments, a blood quality monitoring indicator system was formed. 【Conclusion】 A blood quality monitoring indicator system covering the whole process of blood collection and supply has been established for the first time, which can effectively evaluate the quality management level of blood banks and coordinate blood quality control activities of blood banks in Shandong like pieces in a chess game, thus improving the standardized management level