肌注手足口病(EV71型)人免疫球蛋白层析工艺研究  

Chromatography of Human Enterovirus 71 Immunoglobulin

作　　者：梁小明 周星 何淑琴 黄璠 刘敏亮 

机构地区：[1]江西博雅生物制药股份有限公司,江西抚州344000

出　　处：《安徽农业科学》2013年第31期12262-12265,共4页Journal of Anhui Agricultural Sciences

基　　金：863计划项目"血浆综合利用及特免球蛋白等新产品研发"(编号2012AA021903)

摘　　要：[目的]优化手足口病(EV71型)人免疫球蛋白的层析工艺条件,为制备治疗手足口病(EV71型)的人免疫球蛋白提供依据。[方法]采用单因素试验和响应面分析法,研究样品pH值、蛋白质浓度和电导率对层析后流穿液中免疫球蛋白纯度的影响。[结果]影响层析流穿液中免疫球蛋白纯度的主要因素为电导率,其次是蛋白质浓度,pH值对层析流穿液中免疫球蛋白蛋白纯度影响最小。手足口病(EV71型)人免疫球蛋白的最佳层析工艺参数为:pH 5.28、蛋白质浓度41.62 g/L、电导率为0.24 m/s。[结论]层析优化后的流穿液中手足口病(EV71型)人免疫球蛋白纯度可达到99.60%,可用于制备高纯度的手足口病(EV71型)人免疫球蛋白。[ ObjeCtive] To determine the process parameters of chromatography so as to prepare of human enterovirus 71 immunoglobu｜in for IM injection. [ Method ] The effect of pH, protein concentration and electric conductivity on the contents of immunoglobulin were studied through single factor test and response surface analysis（RSM）. [ Result] The main factors of the contents of immunoglobulin was electric con- ductivity, followed by the protein concentration, pH. The optimal technological parameters of ion-exchange chromatography is ： pH 5.28, pro- tein concentration of 41.62 g/L, the conductivity of 0.24 m/s. [ Conclusion] With the optimized parameters, the contents of immunoglobulin can reach 99.60%.

关 键 词：手足口病 免疫球蛋白 层析 响应面法 

分 类 号：S188[农业科学—农业基础科学]