1.Quality evaluation of inactivated poliomyelitis vaccine made from Sabin strains after optimization
Chinese Journal of Biologicals 2023;36(11):1353-1360
Objective To evaluate the product quality of inactivated poliomyelitis vaccine made from Sabin strains(sIPV)after optimization of preparation formula.Methods The quality attributes of sIPV products after preparation optimization(no phenol red and no bacteriostatic agent)were evaluated,and the quality comparability with the listed sIPV products was analyzed;270 Wister rats of half male and half female were immunized with the finished products before and after preparation optimization simultaneously by intramuscular injection,measured for the level of neutralizing antibody in serum,evaluated for the immunogenicity,and analyzed for the compa-rability;The finished products with optimized preparation were placed at 37 ℃,room temperature(20~25 ℃)and 2~8 ℃ for accelerated and long-term stability tests separately,detected for the content of key indicator D antigen to evaluate the stability,and analyzed for the comparability with historical data of the listed products.Results After preparation formula optimization,the detection results of the sIPV vaccine for typeⅠ,Ⅱ,and Ⅲ D antigen content,protein content,pH value,Vero cell protein residue,bovine serum albumin residue,Vero cell DNA residue,and free formaldehyde content all conformed to the requirements of Chinese Pharmacopoeia Ⅲ (2020 edition)and the enterprise standard. Before and after the process optimization,the quality attributes,immunogenicity and accelerated and long-term stability trends were consi-stent.Conclusion The formulation of the optimized sIPV vaccine no longer contains phenol red and bacteriostatic agent ingredients,of which the safety has been improved;The quality attributes,immunogenicity,and stability of the product are highly similar to those before optimization;All indicators met the requirements during the validity period and the product has good stability.
2.Expression of paxillin and vascular endothelial growth factor in lung carcinoma and its clinical implications.
Chinese Journal of Practical Internal Medicine 2001;0(02):-
Objective To investigate the expressions of paxillin and vascular endothelial growth factor (VEGF) in lung carcinoma.Method SP immunohistological staining was used to detect the expression of paxillin and VEGF in 79 patients with lung carcinoma.Result 1.The expression rate of PAX and VEGF was 34.1% and 64.6%respectively.2.Significant positive correlation was found between the expression of PAX and lymphoid metastasis (P
3.Seed cells in neuro-tissue engineering on repairing spinal cord injury
Hanbing ZENG ; Shi LI ; Wanli LI
Orthopedic Journal of China 2006;0(08):-
The inhibitory environment and loss of axonal connections after spinal cord injury pose many obstacles to regenerating the lost tissue.Cellular therapy provides a means of restoring the cells lost to the injury and could potentially promote functional recovery after such injuries.This review presents a summary of the various types of cellular therapy used to treat spinal cord injury.A wide range of cell types have been investigated for such uses and the advantages and disadvantages of each cell type are discussed along with the research studying each cell type.Based on the current research,suggestions are given for future investigation of cellular therapies for spinal cord regeneration.
4.Expression and significances of β-catenin in Barrett esophagus and esophageal adenocarcinoma
Wanli WANG ; Li WEI ; Fan ZHANG
Chinese Journal of Postgraduates of Medicine 2009;32(28):20-22
Objective To study the significance of the expression of β-catenin(β-cat) in Barrett esophagus and esophageal adenocarcinoma (EAC) and the relationship between its expression and clinicopathological factom.Methods By using SP immunohistochemistry technique,β-cat wag detected in the normal esophageal mucosa group (20 cases),Barrett esophagus with dysplasia group (26 cages) and EAC group (50 cases).Results The membranous expression of β-cat appeared in all of nomal esophageal mucosa.The rate of cytoplasmic and/or nuclear expression of β-cat in the Barrett esophagus with dysplasia group and the EAC group was 38.5% (10/26) and 60.0% (30/50) respectively,and compared with the normal esophageal mucosa group,the difference was signfficant (P<0.01).The rate of cytoplasmic and/or nuclear expression of β-cat in the EAC group with lymphatic metastasis and the EAC group exceeding deep smooth muscle was 90.0% (18/20) and 72.2%(26/36) respectively,and compared with that in the nonlymphatic metastasis and the non-exceeding deep smooth muscle patients [43-3%(13/30) and 28.6% (4/14)],the difference was significant (P<0.01).Conclusion Cytoplasmic and/or nuclear expression of β-cat might play a role in the carcinogenesis and progression of EAC and might be a predictor indicating the metastatic potential of EAC.
5.Weight-reducing effect of calcium pyruvate and chitosan combined with Chinese herbs used as food and medicine on rats with nutritional obesity
Jing LEI ; Xuanshe LI ; Wanli XUE
Chinese Journal of Tissue Engineering Research 2006;10(31):190-192
BACKGROUND: Calcium pyruvate has great effect on reducing bodymass, and chitosan can regulate immunity system, promote bone growth, decrease blood sugar and adjust blood lipid. Calcium pyruvate and chi tosan capsule (CCC) was made by calcium pyruvate and chitosan combined with Chinese medicine, which can be used both as food and medicine. However, its effect still needs further observation. OBJECTIVE: To investigate the weight-reducing effect of CCC on obesity rats, and explore its mechanism.DESIGN: A randomized controlled trial.SETTING: Teaching and Research Section of Preventive Medicine, Department of Public Health, Xi'an Medical College, and Department of Public Health, Medical School of Xi' an Jiaotong University.MATERIALS: The experiment was conducted in the Department of Public Health, Medical School of Xi'an Jiaotong University from April to July 2001. Totally 60 healthy male weaning SD rats with body mass of 50-80 g,were provided by the Animal Center of Xi'an Jiaotong University. CCC,mainly composed of calcium pyruvate and chitosan, mixed with Chinese medicine extract after prepared with distilled water, was made by the author.METHODS: ①Grouping and modeling: The 60 rats were randomly divided into 5 groups: blank control group, model control group, high, middle and low dose CCC supplement groups, respectively with 12 rats in each group. The rats in the blank control group were fed w ith basal diet; the other groups were fed with high fat and nutrition diet to establish rat models of nutritional obesity. ②Administration: The rats in the blank and model control groups were given suspension mixed with starch matrix in capsule and distilled water at same dose. The rats in the high, middle and low dose CCC groups were intragastrically infused with 3, 1.5 and 0.75 g/kg CCC, once aily for 30 days. ③Detection: Body mass, body length and wet weight of fat tissue were measured before and after administration to calculate the obese index and ratio of fat weight/body mass. The adipocyte number and adipocyte size were observed by 400-fold microscope and ocular micrometer, respectively. The detection of serum triglyceride (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C) and serum leptin levels were performed according to the leptin radioimmunity analyzer kit.MAIN OUTCOME MEASURES: ①Body mass, body length and obesity index before and after administration. ②Wet weight of fat, fat/body mass,adipocyte number and size. ③TG, TC, HDL-C and serum leptin.RESULTS: All the 60 rats were involved in the result analysis. Before administration, the body mass of the blank control group was obviously lower than other 4 groups (P < 0.01), and there was no significant difference among the 4 groups (P > 0.05). After administration, the mean body mass,obesity index, wet weight of fat tissue, ratio of fat/body mass and leptin level of the high, middle and low CCC groups were lower than the model group (P < 0.05 or 0.01), and the adipocyte size were significantly smaller than those in the model group (P < 0.05 or 0.01), but the adipocyte number was more than the model group (P < 0.05 or 0.01). Meanwhile, level of TG and TC of the high and middle dose CCC groups were lower than the model group (P < 0.05 or 0.01), there was no significant difference in the body length and HDL-C of each group.CONCLUSION: ①CCC shows evident weight-reducing effect on rats with nutritional obesity, which is not related to the ability of CCC to enhance the serum leptin level. ②CCC can also lower the blood lipid level.
6.Diagnosis and treatment of blunt pancreatic injury:a report of 32 cases
Changjiang QIN ; Songluo SUN ; Shijie LI ; Li ZHENG ; Wanli MA
Chinese Journal of General Surgery 2001;0(09):-
Objective To explore the methods for early diagnosis and treatment of blunt pancreatic injury.Methods The clinical data of 32 patients with blunt pancreatic injury treated in our hospital from Janurery 2004 to Janurery 2009 were retrospectively analyzed.Results The conformity diagnosis rate of CT was 79.3%.Four cases received nonoperative treatment including 3 cases of grade I and 1 of grade II injury.A total of 28 cases with blunt pancreatic injury underwent operation: 5 grade I and 7 grade II cases underwent debridement and drainage;among the patients with grade Ⅲ injury,4 underwent distal pancreatectomy in combination with splenectomy,and 2 pancreatectomy with spleen preservation;amongst the 5 patients with grade Ⅳ injury,4 underwent Roux-en-Y pancreaticojejunostomy and 1 underwent distal pancreatectomy in combination with splenectomy;of the 5 patients with grade Ⅴ injury,1 case was operated on using duodenorrhaphy and diverticulization,2 underwent the Whipple′s procedare and 2 had damage control surgery.Three patients died of multiple organ failure,and complications occurred in 19(76.0%).Pancreatic fistula and pancreatic pseudocysts were the main complications.Conclusions In the absence of major pancreatic ductal injury,and the clinical conditions were stable,pancreatic injuries can be treated with nonoperative management.Operative treatment is suitable for severe blunt pancreatic injury.Appropriate operation,based on patient condition and the classification of pancrecatic trauma,is the key to increase the cure rate and decrease mortality rate.
7.Changes of immunocyte subsets and their related factors in children with immune thrombocytopenia
Wenyong KUANG ; Mincui ZHENG ; Wanli LI ; Haixia YANG ; Ruijuan LI
Journal of Chinese Physician 2017;19(4):525-529
Objective To investigate the changes of T cells and dendritic cells (DCs) and their related factors in children with immune thrombocytopenia (ITP) before and after therapy,and to analyze their clinical significance.Methods T-cells and DCs subsets were determined by flow cytometry both in 64 children with ITP (ITP group) before and after therapy and the control group.The serum levels of interleukin (IL)-4,interferon-γ (IFN-γ),transforming growth factor beta 1 (TGF-β1),and IL-27 were detected by enzyme linked immunosorbent assay (ELISA).Results Treatments of glucocorticoid or IVIg were effective in 41 cases of 64 ITP children.Compared to the control group,helper T cells (Th),Th/suppressor T cells (Ts),T regulatory cells (Treg),plasmacytoid DC (pDC),pDC/myeloid DC (mDC),and TGF-β1 in ITP patient group before treatment were significantly lower,while IFN-γ and IFN-γ/IL-4 were significantly higher (P <0.05).In ITP group,Th,Th/Ts,Treg,pDC,pDC/mDC,TGF-β1,and IL-27 were significantly increased,while IFN-γ and IFN-γ/IL-4 were decreased in children with ITP after therapy and achieved response (P < 0.05).However,there was no significant difference between before and after therapy in ITP children without treatment response (P > 0.05).Conclusions T cells and DCs subsets disorder and abnormal cytokine levels are observed in children with ITP,which can be corrected by immunosuppressive therapy,indicating that Th1 overactivity and the decrease of Treg and pDC both in quantity and function may be related to the pathogenesis of ITP in children.
8.Outcome of radical operation on Hirscbsprung disease:laparotomy versus modified Soave procedure
Chongjiang QIN ; Songluo SUN ; Wanli MA ; Li ZHENG ; Dahan LIU
Chinese Journal of Postgraduates of Medicine 2009;32(26):26-28
Objective To make a comparison between the outcome of modified Soave procedure and laparotomy on Hirschsprung disease(HD)in children.Method Chose the 21 eases who underwent transanal modified Soave procedure(modified Soave procedure group)and 25 eases had done by laparotomy (laparotomy group)from January 2001 to January 2007,clinical data of two groups were compared.Results Modified Soave procedure group showed lower level of IL-6 and CRP[(10.7±1.6)ng/L,(27.7±4.1)mg/L]on 48 h postoperation than laparotomy group[(22.0±2.3)ng/L,(73.7±15.0)mg/L](P < 0.01).The mean operative time,hospital stay,the mean time of anal aerofluxus and the cost of hospitalization in modified Soave procedure group were much shorter than those in laparotomy group(P< 0.01).While the complication rate of two groups had no statistical difference.Moreover,there were no significant difference of rectal high pressure zone length and resting anal canal pressure between two groups at 1 year after operation.Conclusion Transanal modified Soave procedure for HD is a minimal invasive surgery,especially in young patients with short-segment type and common type of HD.
9.Effects of glutamine combined with early enteral nutrition on severe acute pancreatitis’ systemic inlfammation
Guoxiang YANG ; Wanli ZHANG ; Hansong DU ; Ronglin ZHAI ; Li QIU
Chinese Journal of Biochemical Pharmaceutics 2014;(2):115-117
Objective To study the glutamine combined with early enteral nutrition’s effects on severe acute pancreatitis’systemic inlfammation. Methods 150 Cases with severe acute pancreatitis were divided into total parenteral nutrtion group(TPN group), early enteral nutrition group(EEN group) and Glutamine and early enteral nutrition group(G+EEN group) according to their therapeutic methods. The curative effects, APACHEⅡscore and liver and kidney function were compared after treatment. Inlfammatory cytokines of hs-CRP, TNF-α, IL-1β, IL-6, IL-8 and IL-10 before and after treatment were detected and compared. Results The efifciency rate in G+EEN group was signiifcantly better than that in TPN and EEN group(P<0.05), with lower APACHEⅡscore and better liver and kidney function. The level of hs-CRP, TNF-α, IL-1β, II-6 and IL-8 after treatment in G+EEN group were signiifcantly lower than that in TPN and EEN group(P<0.05), except IL-10, which was signiifcantly higher than that in TPN and EEN group (P<0.05). Conclusion Glutamine combined with early enteral nutrition could signiifcantly ameliorate severe acute pancreatitis’systemic inlfammation, its curative effects is better than early enteral nutrition and total parenteral nutrition.
10.Dissolution testing combined with computer simulation technology to evaluate the bioequivalence of domestic amoxicillin capsule.
Ruixue PAN ; Yuan GAO ; Wanli CHEN ; Yulan LI ; Changqin HU
Acta Pharmaceutica Sinica 2014;49(8):1155-61
Re-evaluation of bioequivalence of generic drugs is one of the key research focus currently. As a means to ensure consistency of the therapeutic effectiveness of drug products, clinical bioequivalence has been widely accepted as a gold standard test. In vitro dissolution testing based on the theory of the BCS is the best alternative to in vivo bioequivalence study. In this article, the conventional dissolution method and flow-through cell method were used to investigate the dissolution profiles of domestic amoxicillin capsules in different dissolution media, and the absorption behavior of the drugs with different release rates (t85% = 15-180 min) in the gastrointestinal tract was predicted by Gastro Plus. The flow-through cell method was thought better to reflect the release characteristics in vivo, and amoxicillin capsules with regard to the release rates up to 45 min (t85% = 45 min) were having a satisfied bioequivalence with the oral solution according to the C(max) and AUC. Although two different dissolution profiles of domestic amoxicillin capsules were found by flow-through cell methods, prediction results revealed that domestic capsules were probably bioequivalent to each other.