静注人免疫球蛋白(pH4)对人补体系统的体外影响  

Effect of Human Immunoglobulin(pH4)for Intravenous Injection on complement system in vitro

作　　者：柯兵兵 王德蓉 李世兴 程梦兰 郭江红 KE Bingbing;WANG Derong;LI Shixing;CHENG Menglan;GUO Jianghong(Hubei Engineering Research Center for Drug Quality Control,NMPA Key Laboratory of Quality Control of Blood Products,Hubei Institute for Drug Control,Wuhan 430075,China)

机构地区：[1]湖北省药品监督检验研究院,湖北省药品质量检测与控制工程技术研究中心,国家药品监督管理局血液制品质量控制重点实验室,湖北武汉430075

出　　处：《药学研究》2024年第1期40-43,49,共5页Journal of Pharmaceutical Research

基　　金：湖北省科技厅自然科学基金科研课题(No.2022CFB521)。

摘　　要：目的采用体外补体孵育实验评价静注人免疫球蛋白是否能激活补体系统,探讨本品给药过程中补体系统与类过敏反应之间的关联性。方法分别选取4家企业产品,另加热制备多聚体升高的样品,在体外与人血清共同孵育1 h后,采用ELISA试剂盒测定补体系统激活代表性中间产物及终末复合物Sc5b-9的含量。结果与生理盐水对照组相比,实验组中补体分子C3a、C4a、C5a、Bb、Sc5b-9基本呈下降趋势;制剂经加热处理后,上述补体分子并未出现显著性升高现象。结论静注人免疫球蛋白不能通过激活补体系统进而引发类过敏反应,相反,对补体系统存在一定程度抑制。Objective To evaluate whether Human Immunoglobulin for Intravenous Injection can activate the complement system by complement incubation experiments in vitro and to study the correlation between the complement system and anaphylactoid reactions during the administration of this product.Methods Products from four enterprises were selected,and also were heated to obtain samples with elevated levels of polymers.After incubating the samples with human serum for 1 hour in vitro,the contents of the representative intermediate products of the complement system activation,and the terminal complex Sc5b-9 were determined by ELISA kits.Results Compared with the normal saline control,the complement molecules C3a,C4a,C5a,Bb,and Sc5b-9 in the experimental group basically showed a downward trend;After heating the products,there was no significant increase in the complement molecules described above.Conclusion Human Immunoglobulin for Intravenous Injection cannot cause anaphylactoid reactions by activating the complement system.On the contrary,it inhibited the complement system to a certain extent.

关 键 词：静注人免疫球蛋白 多聚体 补体系统 抑制 类过敏反应 

分 类 号：R979.5[医药卫生—药品]