Objective:To evaluate the effect of hydrotalcid combined with Tibolone,a compound with the effects of estrogen,progestogen and androgen on the menopause patients with bile-reflux gastritis and 24-hour intragastric bile.Methods:Nineteen menopause women with bile-reflux gastritis proven by gastroscope and 24-hour intragastric bile monitoring were divided into 2 groups at random, which were treated with hydtotalcid 1.0g three times a day and the same dose of hydrotalcid combined with Tibolone 2.5mg one time a day.The severity of the symptoms including heartburn,epigastric distention,nausea and bile vomiting was investigated before and after 2,4 weeks treatment.Twenty-four hour intragastrie bile monitoring was also reexamined.Results:The severity of all the symptoms in the two groups decreased greatly after 2 weeks treatment.After 4 weeks treatment,the severity of all the symptoms decreased further.The total fraction time of bile reflux,the time of the longest bile reflux in two groups decreased greatly after treatment ( P

Objective:To investigate the effect of tibolone on the symptoms of functional dyspepsia in menopausal women.Methods:143 menopausal patients with functional dyspepsia were divided into 3 groups at random.They were treated with tibolone or cisapride or both drugs respectively for 4 weeks.The scores of symptoms including epigastric pain and fullness,abdominal distention after meal,early satiety and belching were recorded before and after 2 or 4 weeks' treatment.From the 3 guoups we drew out 20 patients at random.The gastric emptying was measured before and after 4 weeks' treatment respectively.Results:The symptoms of epigastric pain and fullness,abdominal distention after meal were improved after 2,4 weeks' treatment in three groups.Either tibolone or tibolone combined with cisapride remarkably relieved early satiety and belching,but no response was observed in the treatment of cisapride.The combination of tibolone and cisapride did not show better effect than tibolone treatment alone.The 30-min gastric emptying rates of all groups were significantly improved ( P 0.05).Conclusion:Compared with cisapride,tibolone can increase gastric emptying and show better relief for the symptoms of functional dyspepsia in menopausal patients.

Objective: To establish an experimental animal model of chromic alcoholic fatty liver.Methods: Fifty three Wister rats were divided into four groups: control group and model groups(lower dose ethanol group?medium dose ethanol group and higher dose ethanol group).The rats in model groups were induced by ethanol intragastric infusion of 40%(v/v)ethanol orally [7g/(kg?d) for lower group?8 g/(kg?d) for medium group and 9 g/(kg?d) for higher group],two times a day for the first 4 weeks.Ethanol intragastric infusion of 50%(v/v)ethanol orally [8 g/(kg?d) for lower group,9 g/(kg?d) for medium group and 10 g/(kg?d) for higher group],two times a day for the second 4 weeks.Then,the liver was examined by Ultrasonography.The pathologic changes were observed and the amount of ALT?AST??-GT in serum were detected at the end of the eighth week.Results: At the end of eighth week,serum AST and ?-GT levels were increased significantly in model groups.The typical fatty liver pathologic changes of chronic alcoholism were observed in rats in medium and higher dose model groups.Conclusions: Experimental model of chronic alcoholic fatty liver can be established in rats with ethanol intragastric infusion.

Objective:To study the effect of Lycium Barbarum Pclysaccharide(LBP)on the expression of hepatocyte cytochrome P4502E1(CYP2E1) in rat model of alcoholic fatty liver(AFL).Methods: The AFL rats models were established by ethanol intragastric infusion in ten weeks,then,5% and 10% LBP and 10% GSH intragastric infusions were adopted to treat those AFL model rats.Liver pathologic changes were observed and CYP2E1 gene and protein expressions as well as the contents of malondialdehyde(MDA) and glutathione(GSH) in liver were detected and compared with those in the control group,treatment groups and abstinence treatment group.Results: Fatty degeneration in liver recovered normally in the LBP-treated groups.LBP could inhibit the expressions of CYP2E1 gene and protein,reduce the content of MDA,and increase the content of GSH.The curative effect of LBP was of no significant difference compared with GSH,but had more effect than abstinence treatment.Conclusion: LBP can prevent AFL though inhibiting the hepatocyte CYP2E1 expression markedly.

Objective:To study the effect of Lycium Barbarum Polysaccharide(LBP) on the activity and gene expression of hepatocyte cytochrome P4503A(CYP3A) in rat model with alcoholic fatty liver (AFL). Methods:The AFL rats models were established by ethanol intragastric infusion for ten weeks. Then,those AFL model rats were treated with 5% and 10% LBP and 10% GSH intragastric infusion. Liver pathologic changes were observed and the activity of CYP3A and its gene expression as well as the contents of malondialdehyde(MDA) and glutathione(GSH) in liver were detected and compared among the control group,treatment group and abstinence treatment group. Results:Fatty degeneration in liver recovered normally in the LBP treatment groups. LBP could inhibit the expression of CYP3A gene,reduce the activity of CYP3A and the content of MDA,and increase the content of GSH. The curative effect of LBP was not significantly different from that of GSH,but greater than that of abstinence treatment. Conclusion:LBP can prevent AFL through markedly inhibiting the hepatocyte CYP3A activity and gene expression.

Objective To investigate the expression of long non-coding RNA FRAPT(lncRNA FRAPT) in triple-negative breast cancer(TNBC) cells and analyze its effects on proliferation,cell cycle and drug resistance of TNBC cells.Methods Using scRNASeqDB and TCGA on-line bioinformatics database,the expression of lncRNA FRAPT in TNBC and its correlation with prognosis were detected;TNBC cell line MDA-MB-231 was transfected with si-lncRNA FRAPT and si-Ctrl(negative control) by using Lipofectamine~(TM) 2000 respectively,of which the proliferation and cell cycle changes after transfection were detected by SRB test and flow cytometry,and the drug resistance to chemotherapy drug paclitaxel(PTX)was detected.Results The expression of lncRNA FRAPT was up-regulated in TNBC tissues and cells,and its high expression was positively correlated with the poor prognosis of TNBC patients(Hazard Ratio=1.66,P=0.047).Silencing lncRNA FRAPT significantly inhibited the proliferation of TNBC cells,with the cell cycle arrested in G1 phase,while increased the sensitivity of TNBC cells to PTX.Conclusion LncRNA FRAPT was highly expressed in TNBC and related to tumor prognosis-Silencing lncRNA FRAPT inhibited proliferation and cell cycle of TNBC,and increased the sensitivity to chemotherapy drug PTX.

With the continuous improvement of China's drug regulatory laws and regulations, Life-cycle regulatory management has become a key means and an inevitable development trend to ensure the safety of public drug use. The management of post-approval changes to biological products is gradually shifting towards the risk-based model from the item-based model.In recent years, there has been a significant increase in supplementary applications for manufacturing site changes of marketed therapeutic recombinant protein drugs. However, the risks associated with manufacturing site changes vary under different circumstances. Therefore, the research that needs to be carried out is also different. This paper provides an in-depth discussion on three key aspects: risk assessment and grading, general requirements and special considerations for pharmaceutical research, and common application issues. It outlines general requirements for manufacturing site change, aiming to offer valuable insights for industry needs. Through the collaborative efforts between regulatory authorities and the industry, patient rights and interests can be effectively protected, and high-quality drugs can be made available to the public.

Objective To observe the apoptosis and expression of Toll-like receptor (TLR)-4's mRNA in ischemia-reperfusion injured rat renal tubular epithelia cells (NRK-52E) in vitro, and effect of Cordyceps Sinensis (CS) extractant.Methods Cultured NRK-52E cells were divided into a control group, a model group, and a CS preincubated group. All first removed media and incubated with antimycin A for 1 h, and then recovered the media to simulate the ischemia-reperfusion injury in vitro. We detected the apoptosis ratio of cells by flow cytometer and the mRNA expression of TLR-4, Bax, Bcl-2 gene by reverse transcription-polymerase chain reaction at different time points.Results In ischemia-reperfusion injured NRK-52E, the apoptosis ratio rose as time passed (P＜0.05). We also observed increased mRNA expression of TLR-4, Bax (P＜0.05) and deceased expression of Bcl-2 (P＜0.05). Compared with the model grpup, the CS preincubated NRK-52E cells showed apparent tolerance to ischemia-reperfusion injury, which manifestated lower apoptosis ratio (P＜0.05), decreased expression of mRNA of TLR-4, Bax and increased expression of Bcl-2 (All Ps＜0.05). Conclusion The number of apoptosis cells and the expression of TLR-4 mRNA inceased with ischemia-reperfusion injury of NRK-52E in vitro. CS can prevent the NRK-52E cells from ischemia-reperfusion injury by downregulating TLR-4 gene.

AIM To investigate if scallop (Placopecta magellanicus) skirt glycosaminoglycan (SS-GAG) inhibits the proliferation of vascular smooth muscle cell (VSMC) as heparin does so and to clarify its mechanism. METHODS The inhibitory effects of SS-GAG on the proliferation of rat thoracic aorta and abdominal aorta VSMC induced by fetal bovine serum (FBS) or basic fibroblast growth factor (bFGF) were determined by cell counting, crystal violet staining and MTT colorimetry. The effects of SS-GAG on the expression of proliferating cell nuclear antigen (PCNA) and platelet-derived growth factor (PDGF) in VSMC proliferation induced by bFGF were evaluated by immunohistochemical technique (LSAB method) and computer image analysis system. RESULTSSS-GAG exerted antagonistic effects on VSMC proliferation induced by 20% FBS and 50 μg·L-1 bFGF at concentrations ranging from 50 mg·L-1 to 200 mg·L-1 and repressed the increasing expression of PCNA and PDGF. CONCLUSION SS-GAG significantly inhibits the proliferation of VSMC, which may be carried out through repression of PDGF and PCNA expression.