肌注手足口病(EV71型)人免疫球蛋白的研制

Preparation of Human Enterovirus 71 Immunoglobulin for Intramuscular Injection

[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。

[ Objective ] To prepare of Human Enterovirus 71 Immunoglobulin for intramuscular injection so as to treat band-foot-mouth disease. [ Method] Human Enterovirus 71 Immunoglobufin 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 indi- cators 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 Enterovims 71 Immunoglobulin derived from healthy blood donors who were be naturally infected with Enterovirus 71.