治疗制品

静注巨细胞病毒人免疫球蛋白(pH4)体外药效学研究

  • 刘波 ,
  • 吴强 ,
  • 张航 ,
  • 李小姣 ,
  • 李伟 ,
  • 杨春 ,
  • 吴佳君 ,
  • 秦婷婷
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  • 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

网络出版日期: 2025-08-16

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

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  • 1Quality Control Department, Chengdu Rongsheng Pharmaceuticals Co., Ltd., Chengdu 610219, China; 2Production Management Department, Chengdu Rongsheng Pharmaceuticals Co., Ltd., Chengdu 610219, China; 3Research Management Department, Beijing Tiantan Biological Products Co., Ltd., Beijing 100024, China; 4Plasma Products Research Department, Chengdu Rongsheng Pharmaceuticals Co., Ltd., Chengdu 610219, China; 5Research Quality Department, Chengdu Rongsheng Pharmaceuticals Co., Ltd., Chengdu 610219, China

Online published: 2025-08-16

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。

本文引用格式

刘波 , 吴强 , 张航 , 李小姣 , 李伟 , 杨春 , 吴佳君 , 秦婷婷 . 静注巨细胞病毒人免疫球蛋白(pH4)体外药效学研究[J]. 国际生物制品学杂志, 2023 , 46(2) : 61 -64 . DOI: 10.3760/cma.j.cn311962-20220628-00036

Abstract

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 neutralizing antibody in CMV-IVIG can neutralize CMV and stop the cell infection with good dose-response relationship.
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