1.Quality Consistency Evaluation of Omeprazole Enteric-coated Capsules
Chun GUO ; Minhui CHEN ; Zhonghong LI ; Fei YAN ; Mei CAI ; Zhiyu YAO ; Xiying DUAN
China Pharmacist 2016;19(10):1990-1993
Objective:To establish a method for the determination of omeprazole delayed release capsules and investigate the be-havior of reference preparations to provide experimental basis for generic drugs quality consistency evaluation. Methods:According to the first dissolution method (basket method) stated in 0. 931 of Chinese Pharmacopeia (2015 edition), the type of release media, solu-bility and stability of omeprazole in different media, effect of different treatment methods on the drug adsorption in the solution, differ-ent rotation speed and the methodology of ultraviolet spectrophotometry were investigated. Results:The rotation speed was 75 r·min-1 with the dissolution medium volume of 900 ml. The dissolution profiles of omeprazole delayed release capsules in three different media ( pH 6. 0 phosphate buffer, pH 6. 8 phosphate buffer and water containing 3% Tween-80) were determined with online filteration. The solubility of omeprazole in the different media was 0. 123, 0. 078 and 0. 275 mg·ml-1 , respectively. The results showed that ome-prazole was degraded 44%, 8% and 14% in 2 h in the above three release media, and degraded up to 43% in 6 h in water containing 3% Tween-80. The linear of omeprazole was 0. 209 4-20. 94, 0. 204 8-20. 48 and 0. 2016-20. 16 μg·ml-1 with the average recovery of 99.3% (RSD=0.7%,n=12), 99.7% (RSD=0.9%,n=12) and 99.5% (RSD=0.6%,n=12) respectively in the three media. Conclusion:The method is accurate and reliable, which can be used to study the quality consistency of omeprazole delayed re-lease capsules.
2.Influencing factors of the process of severe middle cerebral artery stenosis
Yan LI ; Lili WANG ; Xinyu ZHAO ; Mingyu XIA ; Chun DUAN ; Mingjie GAO ; Yang HUA
Chinese Journal of Cerebrovascular Diseases 2014;(9):454-460
Objectives Todynamicallyobservethechangesofhemodynamicparametersinpatients with severe stenosis of unilateral middle cerebral artery (MCA)by transcranial Doppler ultrasound (TCD) andtoevaluateandanalyzetherelatedfactorsforinfluencingthestenoticprocess.Methods Atotalof 113 consecutive patients with severe stenosis of unilateral MCA screened by TCD and confirmed by computed tomography angiography (CTA)and digital subtraction angiography (DSA)were enrolled retrospectively. They were divided into either a progressive group (n =43 )or a non-progressive group (n=90)according to the variation of MCA hemodynamic parameters. The effects of age,sex,major risk factors for cerebrovascular disease,clinical symptoms,clinical medication,and drug compliance on the stenotic process were documented and analyzed. Results (1)The comparison of detection rate of the risk factors for cerebrovascular disease:The patients with a history of smoking (72. 1%[n=31])in the progressive group was significantly higher than that (51. 1%[n=46])in the non-progressive group (P=0.022). The period of smoking of the patients in the progressive group were longer than that in the non-progressive group (28 ± 12 years vs. 21 ± 10 years,P=0. 011). (2)Comparison of MCA hemodynamic parameters:The distal pulsatility indexes of MCA stenosis at the first diagnosis in the progressive group were all lower than those in the non-progressive group (0. 66 ± 0. 10 vs. 0. 70 ± 0. 13;t= -2. 096,P=0. 038),and the distal pulsatility indexes of MCA stenosis at the end point in the patients of the progressive group were lower than those in the non-progressive group (0. 61 ± 0. 15 vs. 0. 74 ± 0. 15). There were significant differences (t=-2. 718,P= 0. 008). The peak systolic velocity (PSV)of the progressive MCA stenotic segments at the end point in 10 patients of the progressive group was higher than that in the non-progressive group (299 ± 23 cm/s vs. 244 ± 50 cm/s,t=3. 437;P=0. 001),while PSV of MCA in 33 patients with occlusion in the progressive group were significantly lower than those in the non-progressive group (56 ± 18 cm/s vs. 244 ± 50 cm/s,t= -20. 905;P=0. 000). (3)The regular medication:The patients using statins (atorvastatin calcium)were significantly lower than those of the non-progressive group (2. 3%[n=1] vs. 54. 4%[n=49],χ2 =33. 690;P<0. 01). (4)During the follow up period,the recurrence rates of transient ischemic attack and stroke of the progressive group were significantly higher than those of the non-progressive group (27. 9%[n=12]vs. 6. 7%[n=6],32. 6%[n=14]vs. 2. 2%[n=2];all P<0.01). (5)Multivariate Logistic regression analysis showed that smokers (OR,4. 403,95%CI 1. 094-14.017),cerebrovascular event recurrence (OR,10. 648,95%CI 2. 530 -41. 261),and irregularly taking statins (OR,5. 675,95%CI 1. 631-152. 740)were all closely associated with the progress of severeMCAstenosis.Conclusion EvaluationofthehemodynamicchangesofsevereMCAstenosiswith TCD follow up study can be used as an important basis for clinical assessment of the outcomes. Stop smoking and regularly taking statins may help to delay the progress of MCA stenosis.
4.Prolongation of rat renal allograft survival by recipient-derived immature dendritic cells transfected with IKK2dn gene
Jun OUYANG ; Cai-bin FAN ; Duan-gai WEN ; Chun-yin YAN
Chinese Journal of Organ Transplantation 2010;31(3):148-152
Objective To investigate the effect and mechanisms of recipient-derived immature dendritic cells(imDC) transfected with IKK2dn and loaded with donor antigen on renal allografts survival in the rats.Methods DC were cultured from recipient rats'(Lewis) bone marrow,transfected with IKK2dn and loaded with donor antigen.The expression of CD86 and MHC Ⅱ was detected,and the ability of DC stimulating lymphocyte proliferation in vitro was measured.Male Brown Norwav rats and Lewis rats were used as donors and recipients respectively.Four groups were set up(DC group,empty transfection group,transfection group and control group),receiving 1×10~7 DC,Adv-0-DC,Adv-IKK2dn-DC loaded with BN antigen,and equal volume of normal saline,respectivelv 7 davs before transplantation.In the third party donor-group,Wistar rats as donors were treated the same as DC;group before transplantation.After transplantation,the T lymphocyte proliferation in reciPients was measured and the expression of serum IL-2 and IFN-γ was detected.The survival time of recipients and the acute reiection were observed.Pathological changes were examined tO identify the grade of rejection.Results DC assessment in vivo revealed that the transfected DC could still express CD86 and MHC Ⅱ in a low level as compared with those not transfected with IKK2dn. After DC were loaded with donor's antigen,the expression of CD86 and MHC Ⅱ was up-regulated.After DC were transfected with IKK2dn before loaded with donor's antigen, the expression of CD86 and MHC Ⅱ had no significant change. When DC were loaded with donor's antigen, its allostimulatory activity of T lymphocyte proliferation was enhanced (P<0. 05). When DC were transfected with IKK2dn before loaded with donor's antigen, its allostimulatory activity of T lymphocyte proliferation was not enhanced. Compared with control groups, IKK2dn-transfected DC pulsed with BN splenocyte lysate markedly prolonged the survival of renal allografts (26. 8±1.76d, P<0.01), and elicited markedly lower proliferative responses and reduced IL-2 and IFN-γ production. The pathological grade of rejection was low in the transfection group. Conclusion Recipient-derived imDC transfected with IKK2dn and loaded with donor splenocyte lysate could prolong the renal allograft survival in rats probably by down-regulating the expression of DC costimulatory molecules and inhibiting the T_H 1 cytokine production.
5.Research of autophagy activity between rat bone marrow mesenchymal stem neural differentiation.
Bo LI ; Chun-tian HUANG ; Cai-fang LI ; Ping DUAN ; Xue-fei HAN ; Wen-hai YAN ; Ying XING
Chinese Journal of Applied Physiology 2015;31(1):31-34
OBJECTIVETo study the autophagy activity between rat bone marrow stem cells (BMSCs) neural differentiation in order to explore the mechanism involve in this process.
METHODSBMSCs were passed by 3 generation, then was induced with the revulsant 2% (DMSO) + 200 µmol/L (BHA), NSE expression was detected by immunocytochemical stain, the mRNA expression of autophagy associated genes L3B, Beclinl, Atg5, Atg7, Atg10 were detected by RT-PCR, the autophagy protein LC3B was examined by Western blot and flow cytometry analysis.
RESULTSBMSCs were passed by 3 generation, the purity of BMSCs could reach more than 90%, the morphology of cells were like fibroblasts, after the revulsant 2% DMSO + 200 µmol/L BRA induced, cells were extended long neurites, like nerve cells, positive rate of NSE staining was (83±5) %, RT-PCR results showed that the expression of autophagy associated genes LC3B, Beclinl, Atg5, Atg7 Atg0 were rised after BMSCs neural differentiation, Western blot analysis showed that the LC3B-II protein expression was increased after neural differentiation and the MFI of L3B was highten by flow cytometry.
CONCLUSIONAutophagy is increased after rat BMSC neural differentiation.
Animals ; Autophagy ; Cell Differentiation ; Cells, Cultured ; Flow Cytometry ; Mesenchymal Stromal Cells ; cytology ; Neurons ; cytology ; Rats
6.Myocardial damage and change of mitochondrial Mn-superoxide dismutase activity in craniocerebral injured rats and the intervening effect of ginkgo biloba extract.
Chun-yan HAO ; Feng-zhi WANG ; Hu-bin DUAN
Chinese Journal of Integrated Traditional and Western Medicine 2010;30(3):299-302
OBJECTIVETo investigate the myocardial damage and changes of myocardial mitochondrial Mn-superoxide dismutase (Mn-SOD) activity in craniocerebral injured rats and the effect of Ginkgo biloba extract (GBE) on them.
METHODSCraniocerebral injured rats model was established by fluid-percussion and treated with GBE. The dynamical changes of electrocardiograph (ECG) in 24 h were monitored, the serum level of MB isoenzyme of creatine kinase (CK-MB) and the change of myocardial mitochondrial Mn-SOD activity as well as the pathologic changes of myocardium (HE staining) were observed.
RESULTSThe occurrence of ECG abnormality obviously increased in the injured rats, accompanied with increased serum CK-MB (P<0.05) and decreased myocardial Mn-SOD levels (P<0.05), and the Mn-SOD activity was negatively correlated with the level of CK-MB (r=-0.997, P<0.05). Pretreatment of GBE resulted in the decrease of ECG abnormality occurrence (P<0.01), serum CK-MB level (P<0.05), and degree of myocardial damage, as well as the increase of Mn-SOD activity in post-craniocerebral injured rats.
CONCLUSIONSCraniocerebral injury can result in distinct myocardial damage, which is possibly correlated with the lowering of anti-oxidation stress level of myocardial cellular mitochondria. GBE possesses the protective effect on myocardial damage after craniocerebral injury.
Animals ; Craniocerebral Trauma ; metabolism ; pathology ; Electrocardiography ; Ginkgo biloba ; Male ; Myocardium ; metabolism ; pathology ; Oxidation-Reduction ; Plant Extracts ; pharmacology ; Rats ; Rats, Wistar ; Superoxide Dismutase ; metabolism
7.The expression and biological significance of interleukin-1 receptor I,interleukin-lreceptorⅡand interleukin-1 receptor accessory protein in synovium of osteoarthritis
Hong WANG ; Qingsong ZHANG ; Shu-Hua YANG ; Chao YANG ; De-Yu DUAN ; Chun-Qing MENG ; Li-Jun YAN ;
Chinese Journal of Rheumatology 2003;0(08):-
Objective To investigate the expression of the interleukin-1 receptor(IL-1R)Ⅰ,IL-1RⅡand IL-1R accessory protein(IL-1RAcP)in osteoarthritis and analyse their biological significance.Methods Immunohistochemistry and reverse transcription-polymerase chain raction(RT-PCR)were adopted to detect the expression of IL-1RⅠ,IL-1RⅡand IL-1RAcP on the synovium of 107 OA patients.Results Immunohis- tochemistry showed strong positive expression of IL-1RⅠand IL-1RAcP,and positive expression of IL-1RⅡ. The expression was distributed in lining cells,monocyts and vascular endothelial cells of the sublining area, but all of them were negative or weak positive in normal synoviums.RT-PCR showed the expression of IL-1RⅠ,IL-1RⅡand IL-1RAcP in OA synoviums was significantly enhanced than normal synoviums (P<0.05),and the expression of IL-1RⅠwas significantly enhanced than IL-1RⅡ(P<0.05),but no sig- nificant difference with IL-1RAcP(P>0.05).In stageⅡandⅢOA synoviums,the expression of IL-1RⅠand IL-1 RAcP had no significant difference with normal synoviums(P>0.05).The expression of IL-1RⅡin stageⅢOA synoviums was significantly enhanced than normal(P<0.05).Conclusion IL-1RⅠ,IL-1RⅡand IL-1RAcP play significant roles in the pathogenesis of OA,especially IL-1RⅠand IL-1RAcP.But their increase is only observed in the early stage of OA.These suggest that they may have no association with the development of OA and have no direct association with the severity of OA.OA can be cured by interrupting the signal transduction path in which IL-1 has played biological roles.
8.Relationship of Proteinuria,Immunopathogenesis and Humoral Immunity in Children with Henoch-Schonlein Purpura Nephritis
jin-hua, HE ; zhi-hui, LI ; cui-rong, DUAN ; tian-hui, WU ; yan, YIN ; chun-hua, LUO
Journal of Applied Clinical Pediatrics 1992;0(05):-
Objective To explore the relationship of proteinuria,immunopathogenesis and humoral immunity in children with Henoch-schonlein purpura nephritis(HSPN).Methods Serum IgG,IgA,IgM,C3 and C4 levels were detected with complete-automatic biochemistry analyzer in 47 children with HSPN and 18 heathy children,and the differences in the findings were compared among groups.The levels of IgG,IgA,IgM,C3 and C4 were compared among groups according to the count of proteinuria.The renal tissues were adopteded with immunity in the children with HSPN were taken for biospy examination,and the differences in immunopathalogy were compared among groups with immunof-luorescence assay.Results The IgG,IgA levels in children with HSPN were higher than those of heathy children,on the contrary,the IgM,C3 and C4 levels were lower than those of heathy children(Pa0.05),but the IgM level of the nephritic syndrome group were higher than that of other groups(Pa0.05).Conclusions There is severe disturbance of immunologic function in children with HSPN.There is no connections among serum IgG,IgA,IgM,C3 and C4 levels,proteinuria and renal immunopathlogy.
9.Role of heat shock protein 70 expression in DNA damage induced by 7, 8-dihydrodiol-9, 10-epoxide-benzo(a)pyrene.
Zong-yan LONG ; Pi-ye NIU ; Zhi-yong GONG ; Yan-ying DUAN ; Yong-wen CHEN ; Jing WANG ; Hao TAN ; Jing YUAN ; Tang-chun WU
Chinese Journal of Industrial Hygiene and Occupational Diseases 2005;23(6):454-456
10.Clinical characteristics of 34 children with Hodgkin lymphoma and efficacy of treatment with chemotherapy plus low dose radiotherapy on involved sites.
Yan-long DUAN ; Yong-hong ZHANG ; Ling JIN ; Jing YANG ; Rui ZHANG ; Chun-ju ZHOU
Chinese Journal of Pediatrics 2010;48(9):698-702
OBJECTIVETo summarize the clinical features and to evaluate outcomes and to assess therapeutic effects in 34 children and adolescents with Hodgkin lymphoma treated with risk-adapted combination chemotherapy and low-dose, involved-field radiation therapy (IFRT) in China.
METHODFrom January 2003 to April 2009, 34 hospitalized children with Hodgkin lymphoma were enrolled into the BCH-HL 2003 protocol (revised CCG 5942) in our hospital. Pathological samples were reviewed centrally and classified based on the World Health Organization guidelines. Staging was based on clinical evaluation and was defined by the Ann Arbor staging system. The 34 patients were treated according to the different risk factors in three treatment groups (standard, intermediate, and high risk), and received risk-adapted combination chemotherapy and IFRT. All analyses were calculated by the statistical program SPSS.
RESULTOf the 34 Hodgkin lymphoma patients, 28 were male and 6 were female. The median age was 8.7 years (range from 4 years to 15 years) at the time of diagnosis. In terms of clinical presentation, 53% had bulky lymph nodes, 47.1% had more than 4 node regions involved and 44% had "B" symptoms at presentation. The distribution for stage of disease was 0% for Stage I, 21% for Stage II, 35% for Stage III and 44% for Stage IV disease. All patients had classical histology consisting of three different sub-discipline: 22 cases of mixed cellularity (64.7%). In pathological samples of 25 cases there was EBV encoded RNA (EBER) or latent membrane protein (LMP) staining. The overall survival (OS) was 100% and the 5-year event-free survival was 94.1% with a median follow-up of (26.1 ± 16.3) months. Two patients had early relapse after treatment was finished. Organ toxicity was limited to hematological grades III and IV at rates of 40% and 71% respectively.
CONCLUSIONChildhood Hodgkin lymphoma in our study was more frequently seen in male school aged children. Combined-modality therapy using risk-adapted chemotherapy with radiation is effective and well tolerated. The overall prognosis was good.
Adolescent ; Child ; Child, Preschool ; Combined Modality Therapy ; Female ; Hodgkin Disease ; therapy ; Humans ; Male ; Risk Factors ; Treatment Outcome