重组肠道病毒71型疫苗(汉逊酵母)抗原冻干参考品的制备及稳定性研究  

Preparation and stability of freeze-dried recombinant enterovirus 71 vaccine(Hansenula)antigen reference

作　　者：张改梅[1] 陈磊[1] 赵丽丽 谢学超 李国顺[1] 肖海峰 郭林[1] 徐颖之 朱芮波[1] 刘建凯[1] 顾美荣[1] Zhang Gaimei;Chen Lei;Zhao Lili;Xie Xuechao;Li Guoshun;Xiao Haifeng;Guo Lin;Xu Yingzhi;Zhu Ruibo;Liu Jiankai;Gu Meirong(Center of Research and Development,Beijing Minhai Biotechnology Co.,Ltd.,Beijing 102600,China)

机构地区：[1]北京民海生物科技有限公司研发中心,102600

出　　处：《国际生物制品学杂志》2020年第6期267-270,共4页International Journal of Biologicals

摘　　要：目的:制备重组肠道病毒71型(enterovirus 71,EV71)疫苗(汉逊酵母)抗原冻干参考品,用于重组EV71疫苗(汉逊酵母)的抗原含量测定。方法:选取检定合格的重组EV71疫苗(汉逊酵母)原液,加入冻干保护剂,冷冻干燥制备重组EV71疫苗(汉逊酵母)抗原冻干参考品,对其进行保护剂抗原含量标定,并对其进行反复冻融试验,37℃、2~8℃和-20℃稳定性研究。结果:制备的抗原冻干参考品鉴别试验、无菌检查结果均符合规定,水分含量为1.4%。经标定,抗原含量的几何均值为2146 U/ml,几何变异系数为7.2%。10次反复冻融,抗原含量仍无明显变化;37℃放置3个月,抗原含量无明显变化;分别于2~8℃和-20℃放置30个月,抗原含量仍较为稳定。结论:制备了一批稳定的、均一性良好的抗原冻干参考品,可以用于重组EV71型疫苗(汉逊酵母)抗原含量测定。Objective To prepare a lyophilized reference antigen of recombinant enterovirus 71(EV71)vaccine(Hansenula)for the determination of antigen content of recombinant EV71 vaccine(Hansenula).Methods Bulk of qualified recombinant EV71 vaccine(Hansenula)was selected as the raw material of reference,adding freeze-dried protective agent,then lyophilized to prepared freeze-dried recombinant EV71(Hansenula)vaccine antigen reference,after the calibration on the antigen content,the reference was carried on the freeze-thaw test,stored at 37℃,2-8℃and-20℃for the stability study.Results All the quality indexes of prepared reference met the relevant requirements,and the moisture content was 1.4%.After calibration,geometry mean of reference antigen content was 2146 U/ml and geometric variation coefficient was 7.2%.There was no significant change in antigen content after repeated freezing and thawing for 10 times.There was no significant change in antigen content for 3 months at 37℃.The antigen content remained stable at 2-8℃and-20℃for 30 months,respectively.Conclusion A batch of stable and homogeneous reference antigens were prepared,which could be applied for the determination of antigen content in recombinant EV71 vaccine(Hansenula).

关 键 词：肠道病毒71型 疫苗 合成 抗原参考品 稳定性 

分 类 号：R392-33[医药卫生—免疫学]