当前位置: 首页 > 文章 > 肌注手足口病(EV71型)人免疫球蛋白的研制 安徽农业科学 2013,v.41;No.417 (20) 8805-8807
Position: Home > Articles > Preparation of Human Enterovirus 71 Immunoglobulin for Intramuscular Injection Journal of Anhui Agricultural Sciences 2013,v.41;No.417 (20) 8805-8807

肌注手足口病(EV71型)人免疫球蛋白的研制

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;肠道病毒71型
摘  要:
[目的]研制肌注手足口病(EV71型)人免疫球蛋白,用以治疗重症手足口病。[方法]以特异性血浆为原料,采用低温乙醇法结合离子交换层析制备手足口病(EV71型)人免疫球蛋白,对其层析条件进行优化,制定了手足口病(EV71型)人免疫球蛋白检测的质量标准,并对手足口病(EV71型)人免疫球蛋白相关指标进行检测。[结果]血浆内EV71型中和抗体效价大于1∶60的血浆份数占30%以上,制品各项检测指标符合制定的质量标准。[结论]可直接从自然感染的手足口病的供血浆员中筛选出抗EV71型高效价血浆,制备手足口病(EV71型)人免疫球蛋白。
译  名:
Preparation of Human Enterovirus 71 Immunoglobulin for Intramuscular Injection
作  者:
LIANG Xiao-ming;Jiangxi Boya Biopharmaceutical Co. Ltd.;
关键词:
Hand-foot-mouth disease;;Immunoglobulin;;Enterovirus 71
摘  要:
[Objective]To prepare of Human Enterovirus 71 Immunoglobulin for intramuscular injection so as to treat hand-foot-mouth disease.[Method]Human Enterovirus 71 Immunoglobulin was prepared from the specific plasma,used low-temperature ethanol process and ion-exchange chromatography.[Result]Of the total 939 plasma samples tested,288( 30. 67%) were with the antibody titer greater than 1∶ 60. All testing indicators of the quality standard of human enterovirus 71 immunoglobulin were tested and the results showed the testing indicators were in line with the quality standard.[Conclusion]It's practicable to prepare of Human Enterovirus 71 Immunoglobulin derived from healthy blood donors who were be naturally infected with Enterovirus 71.

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