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).
作者
张改梅
陈磊
赵丽丽
谢学超
李国顺
肖海峰
郭林
徐颖之
朱芮波
刘建凯
顾美荣
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)
出处
《国际生物制品学杂志》
CAS
2020年第6期267-270,共4页
International Journal of Biologicals
