摘要
目的调查国内7个厂家静注人免疫球蛋白(IVIG)制品中各种免疫球蛋白成分含量,为改进国产IVIG质量提供参考依据。方法采用ELISA法测定市售的国内7家血液制品厂生产的26批次IVIG制品中IgG、IgA、IgD、IgE、IgM等免疫球蛋白的含量以及IgG亚型含量;同时测定进口某品牌6批次IVIG制品做对照。结果免疫球蛋白含量国内与进口制品比较,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±2.7vs 93.7±17.8;IgG亚型含量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。结论国内外不同厂家的IVIG制品中IgG含量、IgG亚型差异不明显,均接近正常血浆比例,达到药典相关规定。除IgM含量外IgA、IgD、IgE等含量差异较明显(P<0.05)。
Objective To investigate the composition of intravenous immunoglobulin from seven domestic blood fraction- ation industries,and try to provide references for improving domestic WIG product quality. Methods The contents of IgG, IgA,IgD,IgE,IgM and IgG subclasses of all 1VIG 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 ） ： IsG（g/mL）：0.052±0.003 vs 0.048±0.003;IgA（pg/mL）：154.1±30.8 vs 120.3±52.5;IsM（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/mE）：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±1.1vs6.4±0.5;IgG4（%）：2.6±1.1 vs 1.7±0.9. Conclusion All I~]G 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 immtmoglobulin except IgM were significantly different between domestic products and foreign ones.
出处
《中国输血杂志》
CAS
CSCD
北大核心
2014年第1期40-42,共3页
Chinese Journal of Blood Transfusion
基金
协和青年科研基金项目(3332013110)
