第二代百日咳疫苗毒性国家标准品的建立  

The establishment of second generation national toxicity standard for pertussis vaccine

作　　者：骆鹏[1] 卫辰[1] 王丽婵[1] 晁哲[1] 杨国友[2] 徐永革[2] 孙琦 叶娟 杨邦玲[4] 祖俊[4] 马霄[1] 

机构地区：[1]中国食品药品检定研究院百白破疫苗与毒素室,北京100050 [2]成都生物制品研究所有限责任公司,四川成都610023 [3]北京天坛生物制品股份有限公司,北京100176 [4]武汉生物制品研究所有限责任公司,湖北武汉430060

出　　处：《微生物学免疫学进展》2017年第4期21-26,共6页Progress In Microbiology and Immunology

摘　　要：目的建立第二代百日咳疫苗毒性国家标准品(简称二代毒性标准品)。方法选用百日咳疫苗生产菌株(编号CS株CMCC58003)进行发酵罐培养,将收获的百日咳菌液灭活后分装冻干后,作为第二代百日咳国家毒性标准品的候选品(简称候选毒性标准品)。以第一代百日咳疫苗毒性国家标准品为标准(简称一代毒性标准品),由4个单位协作标定候选毒性标准品,采用热加速法考察候选毒性标准品的稳定性。结果共获得检定合格的候选毒性标准品1 800支;经4个实验室协作标定,每支二代毒性标准品LPU为21,HSU为41;且稳定性良好。结论候选毒性标准品各项指标均符合要求,可作为第二代百日咳疫苗毒性国家标准品使用。Objective To establish the second generation national toxicity standard for pertussis vaccine. Methods The bacterial culture were fermented and inactivated from the pertussis production strain（CS Strain No. CMCC58003）,sub-assembled and freeze-dried as the candidate for the second generation national toxicity standard for pertussis vaccine（simplified as candidate）. The collaborative calibration of toxicity for candidate were carried out in four laboratories by using the first generation national toxicity standard for pertussis vaccine as control standard. The stability of candidate was investigated by heat accelerating test. Results A total of 1 800 ampoules of qualified candidate were obtained. The toxicity of candidate was calibrated as 21.0 LPU and 41.0 HSU,respectively,in one ampoule,and the heat accelerating test showed the candidate in stable. Conclusion The candidate can serve as the second generation national toxicity standard for pertussis vaccine,which showed in conformity with requirements in all indexes.

关 键 词：百日咳疫苗 百日咳毒性国家标准品 协作标定 

分 类 号：R392-33[医药卫生—免疫学]