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《Chinese Journal of Blood Transfusion》 2014-01
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Composition analysis of intravenous immunoglobulin from seven Chinese blood fractionation industries

SUN Pan;MA Li;DIAO Ge;LIN Fangzhao;YUAN Jing;LI Changqing;Institute of Blood Transfusion,Chinese Academy of Medical Science & Peking Union Medical College;Guizhou Taibang Biological Products Co.Ltd;  
Objective To investigate the composition of intravenous immunoglobulin from seven domestic blood fractionation industries,and try to provide references for improving domestic IVIG product quality.Methods The contents of IgG,IgA,IgD,IgE,IgM and IgG subclasses of all IVIG samples were determined by ELISA.Results We investigate 26 batches of IVIG from seven domestic industries and 6 batches from a foreign manufacturer for comparison.Average results are described bellow(domestic vs foreign) :IgG(g / mL) :0.052 ± 0.003 vs 0.048 ± 0.003;IgA(μg / mL) :154.1 ± 30.8 vs 120.3 ± 52.5;IgM(μg / mL) :7.6 ± 1.5 vs 4.7 ± 5.0;IgD(ng / mL) :145.5 ± 29.1 vs 207.8 ± 23.9;IgE(ng / mL) :13.9 ± 2.7 vs 93.7 ± 17.8;IgG subclass:IgG1(%) :58.4 ± 3.3 vs 60.4 ± 2.1;IgG2(%) :32.0 ±2.9 vs 31.5 ±1.8;IgG3(%) :7.0 ±1.1 vs 6.4 ± 0.5;IgG4(%) :2.6 ±1.1 vs 1.7 0.9.Conclusion All IVIG in our investigation have no significant differences in IgG levels and IgG subclasses contents,and all meet the quality requirements of the Chinese Pharmacopoeia.However,other immunoglobulin except IgM were significantly different between domestic products and foreign ones.
【Fund】: 协和青年科研基金项目(3332013110)
【CateGory Index】: R446.62;R392-33
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【Co-citations】
Chinese Journal Full-text Database 6 Hits
1 NING Ze-shu,ZHANG Jie,LIAO Hong-mei,et al.Department of Neurology,Hunan Provincial Children's Hospital,Changsha 410007,China;Children Viral Cerebellitis:A Clinical Analysis of 38 Cases[J];Chinese General Practice;2007-23
2 LITing-ting,LIGuang-qian;Clinical Analysis of 31 Children with Acute Cerebellitis[J];Journal of Applied Clinical Pediatrics;2007-06
3 CUI Sumei,HAO Qinghua,GAO Hongqin(Shanxi Kangbao Biological Product CO.,Ltd.,Changzhi 046000,China);Effect of sheep red blood cells and complement activity on anticomplementary activity in human intravenous immunoglobulin(PH4)[J];Journal of Shanxi Medical University;2013-03
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5 CHI Yan-yan;WANG Fei;ZHANG Hui;ZANG Heng-chang;School of Pharmaceutical Sciences,Shandong University;Shandong Taibang Biological Products Co. ,Ltd.;Beijing Kaiyuan Shengshi Sciencce and Technology Development Co. ,Ltd.;;Summary of viral inactivation /removal methods in plasma- derived products[J];Journal of Pharmaceutical Research;2014-04
6 ZHONG Li-jun;JIANG Wei;WANG Feng-shan;ZANG Heng-chang;School of Pharmaceutical Sciences,Shandong University;Shandong Taibang Biological Products Co.,Ltd.;;Research Progress on Human Coagulation Factor Ⅷ[J];Food and Drug;2014-03
【Secondary Citations】
Chinese Journal Full-text Database 1 Hits
1 Wang Yu Chengdu Institute of Biological Products,Chengdu;Preparation of a Freeze-dried Low pH Intravenous Immunoglobulin[J];Chinese Journal of Biologicals;1992-02
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