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应用体积排阻色谱法测定口蹄疫灭活疫苗中的146S抗原含量
引用本文:徐嫄,邹兴启,李翠,朱元源,何天慈,杨延丽,林旋,宋艳民,郑金来,张松平,赵启祖.应用体积排阻色谱法测定口蹄疫灭活疫苗中的146S抗原含量[J].生物工程学报,2018,34(5):676-684.
作者姓名:徐嫄  邹兴启  李翠  朱元源  何天慈  杨延丽  林旋  宋艳民  郑金来  张松平  赵启祖
作者单位:中国兽医药品监察所;中国科学院过程工程研究所生化工程国家重点实验室;北京标驰泽惠生物科技有限公司
基金项目:国家重点研发计划 (No. 2016YFD0501500),公益性行业 (农业) 科研专项经费资助 (No. 201303046) 资助。
摘    要:旨在应用体积排阻色谱法测定口蹄疫灭活疫苗中的146S抗原含量。使用TSKgel G4000SWXL(7.8 mm×30 cm)色谱柱,以pH 7.2的缓冲盐体系作为流动相,流速为0.6 mL/min,进样量为100μL,检测波长为259 nm。以口蹄疫病毒(O型)灭活146S抗原纯化样品建立标准曲线;使用灭活抗原液配制3份口蹄疫灭活疫苗,并进行精密度、重复性、特异性、耐受性验证;应用该方法快速测定16批疫苗的146S含量。结果表明,抗原浓度在0.56–67.42μg/mL范围内,其峰面积与浓度的线性关系良好(R~2=0.996,n=10),3份疫苗146S抗原测定回收率分别为93.6%(RSD=2.7%,n=3)、102.3%(RSD=2.6%,n=3)、95.5%(RSD=5.1%,n=3),方法重复性好、准确性强(RSD=0.5%,n=6),且操作简便、高效,对16批疫苗的测定结果较理想。应用该方法有望快速高效地检测口蹄疫灭活疫苗的146S抗原含量,为疫苗的质量控制提供有力支持。

关 键 词:体积排阻色谱,口蹄疫,灭活疫苗,146S抗原
收稿时间:2017/10/9 0:00:00

Using size-exclusion chromatography to quantify the 146S antigen in inactivated foot-and-mouth disease vaccine
Yuan Xu,Xingqi Zou,Cui Li,Yuanyuan Zhu,Tianci He,Yanli Yang,Xuan Lin,Yanmin Song,Jinlai Zheng,Songping Zhang and Qizu Zhao.Using size-exclusion chromatography to quantify the 146S antigen in inactivated foot-and-mouth disease vaccine[J].Chinese Journal of Biotechnology,2018,34(5):676-684.
Authors:Yuan Xu  Xingqi Zou  Cui Li  Yuanyuan Zhu  Tianci He  Yanli Yang  Xuan Lin  Yanmin Song  Jinlai Zheng  Songping Zhang and Qizu Zhao
Institution:1 China Institute of Veterinary Drug Control, Beijing 100081, China,1 China Institute of Veterinary Drug Control, Beijing 100081, China,1 China Institute of Veterinary Drug Control, Beijing 100081, China,1 China Institute of Veterinary Drug Control, Beijing 100081, China,1 China Institute of Veterinary Drug Control, Beijing 100081, China,2 National Key Laboratory of Biochemical Engineering, Institute of Process Engineering, Chinese Academy of Sciences, Beijing 100190, China,2 National Key Laboratory of Biochemical Engineering, Institute of Process Engineering, Chinese Academy of Sciences, Beijing 100190, China,2 National Key Laboratory of Biochemical Engineering, Institute of Process Engineering, Chinese Academy of Sciences, Beijing 100190, China,3 Beijing Biaochizehui Biological Technology Co. Ltd., Beijing 102600, China,2 National Key Laboratory of Biochemical Engineering, Institute of Process Engineering, Chinese Academy of Sciences, Beijing 100190, China and 1 China Institute of Veterinary Drug Control, Beijing 100081, China
Abstract:
Keywords:size-exclusion chromatography  foot-and-mouth disease  inactivated vaccine  146S antigen
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