狂犬病人免疫球蛋白的药效学研究  

Pharmacodynamics study of human rabies immunoglobulin

作　　者：刘波 杨硕 秦婷婷 张聪明 陆婷婷 李小姣 张航 杨黎明 武志强 孙勇 LIU Bo;YANG Shuo;QIN Ting-ting;ZHANG Cong-ming;LU Ting-ting;LI Xiao-jiao;ZHANG Hang;YANG Li-ming;WU Zhi-qiang;SUN Yong(Chengdu Rongsheng Pharmaceutical Co.,Ltd.,Chengdu 610041,China;Chengdu Institute of Biological Products Co.,Ltd.,Chengdu 610023,China)

机构地区：[1]成都蓉生药业有限责任公司,成都610041 [2]成都生物制品研究所有限责任公司,成都610023 [3]成都蓉生药业有限责任公司质量检定部,成都610041

出　　处：《中国新药杂志》2021年第19期1783-1786,共4页Chinese Journal of New Drugs

摘　　要：目的:实验室内确认狂犬病人免疫球蛋白(human rabies immunoglobulin,HRIG)有效性。方法:通过动物体内实验展示HRIG所含中和抗体具有中和狂犬病病毒保护活体动物的作用;体外细胞学实验展示HRIG所含中和抗体具有中和病毒保护细胞作用。结果:中和抗体浓度0.006和0.003 IU·mL^(-1)组小鼠存活率为0,0.012 IU·mL^(-1)组小鼠存活率为16.7%,0.024 IU·mL^(-1)组小鼠存活率为41.7%,0.048 IU·mL^(-1)组小鼠存活率为75.0%,0.095,0.190和0.380 IU·mL^(-1)组小鼠存活率为100%;中和抗体浓度0.317和0.951 IU·mL^(-1)组病毒感染细胞抑制率为100%,0.106 IU·mL^(-1)组病毒感染抑制率为99%,0.035 IU·mL^(-1)组病毒感染抑制率为58%,0.012 IU·mL^(-1)组病毒感染抑制率趋近于0,HRIG降低病毒感染力的程度随着中和抗体浓度降低而降低。结论:HRIG在体内外均能有效中和病毒,并具有良好的量效关系。Objective:To confirm the efficacy of human rabies immunoglobulin(HRIG).Methods:Animal experiments was used to show the protection effect of the neutralizing antibody contained in HRIG on living animals to neutralize rabies virus in vivo.The function of neutralizing antibody contained in HRIG to neutralize and protect cells was evaluated by cytology experiments in vitro.Results:The survival rate of mice was 0 in 0.006 and 0.003 IU·mL^(-1) groups,16.7% in 0.012 IU·mL^(-1) group,41.7%in 0.024 IU·mL^(-1) group,75.0% in 0.048 IU·mL^(-1) group,and 100% in 0.095,0.190 and 0.380 IU·mL^(-1) groups.The inhibition rate of virus-infected cells was 100% in 0.317 and 0.951 IU·mL^(-1),99% in 0.106 IU·mL^(-1),58% in 0.035 IU·mL^(-1),close to 0 in 0.012 IU·mL^(-1).The degree of HRIG reducing viral infectivity decreases as the concentration of neutralizing antibodies decreasing.Conclusion:HRIG can neutralize the virus effectively in vivo and in vitro,and has a good dose-response relationship.

关 键 词：狂犬病人免疫球蛋白 药效学 有效性 量效关系 

分 类 号：R978.7[医药卫生—药品]