人用狂犬病疫苗(地鼠肾细胞)基质残余蛋白标准品的建立  

Establishment of cell matrix residual protein standard for human rabies vaccine(hamster kidney cells)

作　　者：石磊泰[1] 李加[1] 王玲[1] 刘晶晶[1] 张月兰 王辉 雷继军 李玉华[1] SHI Leitai;LI Jia;WANG Ling;LIU Jingjing;ZHANG Yuelan;WANG Hui;LEI Jijun;LI Yuhua(National Institutes for Food and Drug Control,Beijing 102629,China;National Vaccine&Serum Institute,Beijing 101111,China;Wuhan Institute of Biological Products Co.,Ltd.,Wuhan 430070,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]北京生物制品研究所有限责任公司,北京100176 [3]武汉生物制品研究所有限责任公司,武汉430070

出　　处：《中国药品标准》2022年第3期291-297,共7页Drug Standards of China

基　　金：2017年国家标准提高课题“细胞基质残余蛋白测定法”。

摘　　要：目的:研制用于人用狂犬病疫苗(地鼠肾细胞)中地鼠肾细胞蛋白质残留量检测(ELISA法)的国家标准品。方法:分两步进行协作标定和量值溯源,第一步采用Lowry法对原代地鼠肾细胞蛋白质标准品原液进行赋值,第二步采用ELISA法对原代地鼠肾细胞蛋白质标准品进行赋值。结果:数据经统计学处理结果,最终原代地鼠肾细胞蛋白质标准品量值为4.0μg·mL^(-1),95%可信限为:(4.0±0.5)μg·mL^(-1)。结论:建立了国家原代地鼠肾细胞蛋白质标准品,赋值准确可靠、科学严谨,可用于人用狂犬病疫苗(地鼠肾细胞)基质残余蛋白的质量控制。Objective:To establish the national standard for the protein residue detection in rabies vaccine(hamster kidney cells)for human use(ELISA method).Methods:Collaborative calibration and value traceability are carried out in two steps,In the first step,Lowry method was used to assign the bulk of the primary hamster kidney cell protein standard,and in the second step,ELISA method was used to assign the primary hamster kidney cell protein standard.Results:According to the statistical results,the final protein standard value of primary hamster kidney cells was 4.0μg·mL^(-1),and 95%confidence limit was(4.0±0.5)μg·mL^(-1).Conclusions:National primary hamster kidney cell protein standard has been established,which is accurate,reliable,scientific and rigorous,and can be used for the quality control of human rabies vaccine(hamster kidney cells).

关 键 词：原代地鼠肾细胞 标准品 人用狂犬病疫苗 

分 类 号：R921.2[医药卫生—药学]