兽用狂犬病灭活疫苗效力检验参考疫苗的研制  

Study on Animal Reference Vaccine of Inactivated Rabies Vaccines for Potentcy Test

作　　者：李宁[1,2] 支海兵[2] 张伟 薛青红[2] 李润[2] 印春生[2] 赵德明[1] 

机构地区：[1]中国农业大学动物医学院国家动物海绵状脑病实验室,北京海淀100193 [2]中国兽医药品监察所,北京海淀100081 [3]北京出入境检验检验局,北京朝阳100026

出　　处：《中国兽医杂志》2013年第8期73-76,80,共5页Chinese Journal of Veterinary Medicine

基　　金：国家科技基础性工作专项项目(2008FY130100);国家质检总局科技计划项目(2009IK028)

摘　　要：将试制的狂犬病灭活疫苗效力检验参考疫苗分别采用NIH和ELISA方法进行了标定,并组织人员进行了协作标定,确定参考疫苗的效价为5.44IU。对标定后的参考疫苗进行了均一性和稳定性试验,结果参考疫苗的均一性好,在-20℃放置15个月和4℃放置2个月效价稳定,在37℃放置2个月效价大于2.00IU,符合我国和WHO对动物用狂犬灭活疫苗效力的要求。本课题为进一步自主研发检验用标准品提供了试验依据,同时也响应了WHO狂犬病委员会敦促各国研制和标定参考品的要求,填补了我国兽用狂犬病灭活疫苗效力检验标准品的空白。The reference vaccine was calibrated with the methods of NIH and ELISA. After assisted calibration, the potency of the reference vaccine was 5.44IU. The homogeneity of the reference vaccine was.good. It could be stored with stable potency at 20℃ for 15 months and 4℃ fot 2 months, even at 37℃ for 2 months the potency was still more than 2.00 IU. The results of homogeneity and stability test for the calibrated reference vaccine were good enough to meet the related requirements of WHO and China. The survey provided test data for further development of standard substance independently. Responding to the appeal for development and calibration of reference standard by Rabies Committee of WHO, this re- search also filled the bl＇ank of animal rabies vaccine on potentcy test in China.

关 键 词：狂犬病灭活疫苗 效力检验 标准品 

分 类 号：S858.292[农业科学—临床兽医学]