静注人免疫球蛋白制剂抗巨细胞病毒中和抗体效价的筛查  

Screening of neutralizing antibody titers against human cytomegalovirus in human immunoglobulin preparations

作　　者：巩艳艳 马杰 陈振 朱孟沼 李曼[2] 

机构地区：[1]山东泰邦生物制品有限公司,山东泰安271000 [2]中国食品药品检定研究院血液制品室,北京100050

出　　处：《中国生物制品学杂志》2016年第2期157-159,共3页Chinese Journal of Biologicals

摘　　要：目的筛查国内、外静注人免疫球蛋白(human intravenous immunoglobulin,IVIG)和静注巨细胞病毒人免疫球蛋白(human intravenous cytomegalovirus immunoglobulin,CMV-IVIG)制品抗CMV中和抗体效价。方法采用微量细胞病变法检测国内、外IVIG制品及CMV-IVIG抗CMV中和抗体效价,并进行比较。结果国外CMV-IVIG制品Cytogam(3 648 U/g IgG)和Cytotect(3 104 U/g IgG)抗CMV中和抗体效价分别是IVIG制品Privigen(1 048 U/g IgG)和Intratect(980 U/g IgG)的3.5和3.2倍;国内CMV-IVIG制品抗CMV中和抗体平均效价(7 195 U/g IgG)是国内13家企业19批IVIG制品(1 836 U/g IgG)的3.9倍;国内IVIG制品抗CMV中和抗体平均效价是国外IVIG制品Privigen和Intratect的1.8和1.9倍,国内CMV-IVIG制品抗CMV中和抗体平均效价是国外CMV-IVIG制品Cytogam和Cytotect的2.0和2.3倍。结论国内、外的CMV-IVIG制品抗CMV中和抗体效价均为相应IVIG制品3倍以上,采用微量细胞病变法筛查血浆用于制备CMV-IVIG具有可行性,为CMV相关疾病的被动免疫制剂的制备提供了实验依据。Objective To screen the neutralizing antibody titers against human cytomegalovirus （HCMV） in domestic and imported human intravenous immunoglobulin （IVIG） and human intravenous cytomegalovirus immunoglobulin （CMV- IVIG）. Methods The neutralizing antibody titers against HCMV in IVIG and CMV-IVIG were determined by microcytopathic effect （micro-CPE）, and the results were compared. Results The neutralizing antibody titers against HCMV in imported CMV-IVIG preparations Cytogam and Cytotect were 3 648 and 3 104 U/g IgG, which were 3.5 and 3.2 times of those in IVIG preparations Privigen （1 048 U/g IgG） and Intratect （980 U/g IgG）, respectively. The mean neutralizing antibody titer in domestic CMV-IVIG preparations （7 195 U/g IgG） was 3. 9 times of those in 19 batches of domestic IVIG manufactured by 13 manufacturers （ 1 836 U / g IgG）. The mean titer of neutralizing antibody against HCMV in domestic IVIG preparations were 1.8 and 1.9 times of those in Privigen and Intratect, while those in domestic CMV-IVIG preparations were 2. 0 and 2. 3 times of those in Cytogam and Cytotect, respectively. Conclusion The neutralizing antibody titers against HCMV in both domestic and imported CMV-IVIG preparations were more than 3 times higher than those in the corresponding IVIG preparations, indicating the feasibility of application of micro-CPE to the screening of material plasma,which provided aIl experimental basis for production of preparations for passive immunization against CMV-associated diseases.

关 键 词：静注人免疫球蛋白 巨细胞病毒 中和抗体 微量细胞病变法 

分 类 号：R457.2[医药卫生—治疗学] R392-33[医药卫生—临床医学]