静注巨细胞病毒人免疫球蛋白(pH4)体外药效学研究  

In vitro pharmacodynamics study of human cytomegalovirus immunoglobulin for intravenous injection(pH4)

作　　者：刘波 吴强 张航 李小姣 李伟 杨春 吴佳君 秦婷婷 Liu Bo;Wu Qiang;Zhang Hang;Li Xiaojiao;Li Wei;Yang Chun;Wu Jiajun;Qin Tingting(Quality Control Department,Chengdu Rongsheng Pharmaceuticals Co.,Ltd.,Chengdu 610219,China;Production Management Department,Chengdu Rongsheng Pharmaceuticals Co.,Ltd.,Chengdu 610219,China;Research Management Department,Beijing Tiantan Biological Products Co.,Ltd.,Beijing 100024,China;Plasma Products Research Department,Chengdu Rongsheng Pharmaceuticals Co.,Ltd.,Chengdu 610219,China;Research Quality Department,Chengdu Rongsheng Pharmaceuticals Co.,Ltd.,Chengdu 610219,China)

机构地区：[1]成都蓉生药业有限责任公司质量检定部,成都610219 [2]成都蓉生药业有限责任公司生产管理部,成都610219 [3]北京天坛生物制品股份有限公司科研管理部,北京100024 [4]成都蓉生药业有限责任公司血液制品研发部,成都610219 [5]成都蓉生药业有限责任公司科研质量部,成都610219

出　　处：《国际生物制品学杂志》2023年第2期61-64,共4页International Journal of Biologicals

摘　　要：目的实验室确认静注巨细胞病毒人免疫球蛋白(pH4)(human cytomegalovirus immunoglobulin for intravenous injection,CMV-IVIG)抑制巨细胞病毒(cytomegalovirus,CMV)感染的有效性。方法分别通过免疫荧光染色和细胞病变实验测定CMV-IVIG抑制CMV的即早基因1表达和致细胞病变能力,确认CMV-IVIG有效性。结果即早基因1表达量与病变细胞数量随着制品稀释倍数的增加而增加;27倍稀释的CMV-IVIG可抑制90.77%~95.85%的CMV感染力;103倍稀释的CMV-IVIG可抑制>90%的细胞病变。结论 CMV-IVIG中的中和抗体能特异性中和CMV,阻止CMV感染细胞,且具有良好的量效关系。Objective To confirm the efficacy of human cytomegalovirus immunoglobulin for intravenous injection(CMV-IVIG)against cytomegalovirus(CMV)in laboratory.Methods The effectiveness of CMV-IVIG was confirmed by measuring the ability to inhibit the expression of immediate early gene(IE)1 of CMV and cytopathic changes using immunofluorescence and cytopathic effect tests,respectively.Results The expression of IE1 and the number of diseased cells increased with the increase of dilution ratio,with 27 times diluted CMV-IVIG inhibiting 90.77%-95.85%CMV infection and 103 times diluted CMV-IVIG inhibiting>90%cytopathic effect.Conclusion The CMV specific neutrilizing antibody in CMV-IVIG can neutralize CMV and stop the cell infection with good dose-response relationship.

关 键 词：巨细胞病毒人免疫球蛋白 药效学 基因 即早 致细胞病变 

分 类 号：R965.2[医药卫生—药理学]