摘要
目的对目前市售静注人免疫球蛋白(p H 4)(human intravenous immunoglobulin,IVIG)中的人肠道病毒71型(enterovirus 71,EV71)中和抗体效价进行筛查,为EV71相关疾病的被动免疫治疗提供参考。方法采用微量细胞病变法检测24批IVIG制品中的EV71中和抗体效价,并分组进行比较。结果 24批IVIG制品中的EV71中和抗体效价为841.6~1 024.3 U/m L,比活为16 832~20 486 U/g Ig G。4个季度生产的IVIG中EV71中和抗体效价差异无统计学意义(P>0.05),病毒高发季与非高发季采浆生产的IVIG中EV71中和抗体效价差异也无统计学意义(P>0.05)。结论 IVIG制品中EV71中和抗体效价可达50 000 U/瓶(蛋白浓度5%,50 m L/瓶),本研究为EV71相关疾病的被动治疗提供了临床参考依据。
Objective To screen the neutralizing antibody titer against human enterovirus 71（EV71） in commercial human intravenous immunoglobulin（IVIG）（p H 4）, and provide a reference for passive immunotherapy of EV71 related diseases. Methods The neutralizing antibody titers against human EV71 in 24 batches of IVIG were determined by microcytopathic effect（micro-CPE）, and the results in various groups were compared. Results The neutralizing antibody titers against EV71 in 24 batches of IVIG were 841. 6 - 1 024. 3 U/m L, while the specific activities were 16 832 -20 486 U/g Ig G. The neutralizing antibody titers against EV71 showed no significant difference in IVIG manufactured in four quarters（P〉 0. 05）, and in those manufactured with the plasmas collected in high epidemic and in non-epidemic seasons（P 〉0. 05）. Conclusion The neutralizing antibody titer against EV71 in reached 50 000 U per container（protein concentration 5%, 50 m L per container）. The study provided a reference for passive immunotherapy of EV71-related diseases.
出处
《中国生物制品学杂志》
CAS
CSCD
2018年第1期48-51,共4页
Chinese Journal of Biologicals
关键词
手足口病
静注人免疫球蛋白(pH
4)
人肠道病毒71型
中和抗体
Hand-foot-and-mouth disease （HFMD）
Human intravenous immunoglobulin （pH 4）
Human enterovirus 71
Neutralizing antibody
