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Position: Home > Articles > Chromatography of Human Enterovirus 71 Immunoglobulin Journal of Anhui Agricultural Sciences 2013,v.41;No.428 (31) 12262-12265

肌注手足口病(EV71型)人免疫球蛋白层析工艺研究

作  者:
梁小明;周星;何淑琴;黄璠;刘敏亮
单  位:
江西博雅生物制药股份有限公司
关键词:
手足口病;免疫球蛋白;层析;响应面法
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。
译  名:
Chromatography of Human Enterovirus 71 Immunoglobulin
作  者:
LIANG Xiao-ming;Jiangxi Boya Bio Pharmaceutical Co.Ltd.;
关键词:
Hand foot and mouth disease;;Immunoglobulin;;Chromatography;;Response surface method
摘  要:
[Objective] To determine the process parameters of chromatography so as to prepare of human enterovirus 71 immunoglobulin 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 conductivity,followed by the protein concentration,pH.The optimal technological parameters of ion-exchange chromatography is:pH 5.28,protein 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%.

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