生物技术进展 ›› 2019, Vol. 9 ›› Issue (4): 416-421.DOI: 10.19586/j.2095-2341.2019.0011

• 技术与方法 • 上一篇    下一篇

1型肺炎兔抗血清的制备及其在多糖含量检测中的质控研究

赵云霞1,江魁2*,郭爱英1,李景艳1   

  1. 1.华兰生物工程股份有限公司, 河南 新乡 453000;
    2.华兰生物基因有限公司, 河南 新乡 453000
  • 收稿日期:2019-01-28 出版日期:2019-07-25 发布日期:2019-04-16
  • 通讯作者: 江魁,研究员,研究方向为单抗制备。E-mail:382053231@qq.com
  • 作者简介:赵云霞,硕士研究生,研究方向为肺炎多糖结合疫苗。E-mail:lansedaiwei06@163.com。

Preparation of Rabbit Antiserum from Type 1 Pneumonia and its Quality Control in Detection of Polysaccharide Content

ZHAO Yunxia, JIANG Kui, GUO Aiying, LI Jingyan   

  1. 1.Hualan Biological Engineering Inc., Henan Xinxiang 453000, China;
    2.Hualan Gene Engineering Co. Ltd., Henan Xinxiang 453000, China
  • Received:2019-01-28 Online:2019-07-25 Published:2019-04-16

摘要: 建立一种新的1型肺炎兔抗血清制备方法,并进行型别特异性和方法专属性分析后,用于1型肺炎球菌多糖结合及结合疫苗制备过程中多糖含量的测定。以确定的免疫程序,用自制肺炎1型多糖结合物免疫新西兰白兔,采血后分离血清,免疫血清以免疫双扩散法和 ELISA 法与商品诊断血清比较;以速率比浊法分析型特异性和方法专属性。建立了自制家兔兔抗血清的制备方法,且该血清优于商品诊断血清,可达到速率比浊法型特异性和相应方法专属性要求,该方法可用于对1型肺炎球菌结合物及结合疫苗多糖含量测定。研究结果为肺炎球菌结合疫苗中多糖含量的检测提供了有力的保障。

关键词: 肺炎多糖结合疫苗, 家兔兔抗血清, 速率比浊法

Abstract: The new method of rabbit antiserum from type 1 pneumonia was established, and the type specificity and method specificity were analyzed for the determination of polysaccharide content in the preparation process of type 1 pneumococcal polysaccharide binding and conjugate vaccine. The New Zealand rabbits were immunized with designed immunization schedule.Antisera from rabbits were compared with commercial antiserum according to double immunodiffusion and ELISA results.The specificity of the antisera was assessed with rate nephelometry. The preparation method of rabbit antiserum was established, and the serum was superior to the commercial diagnostic serum, which could meet the requirements of turbidimetric type specificity and corresponding method specificity, and could be used to determine the content of polysaccharides in type 1 pneumococcal conjugates and conjugate vaccines. The results of this study provide a strong guarantee for the determination of polysaccharide content in pneumonia.

Key words: pneumonic polysaccharide conjugate vaccine, rabbit antiserum, rate nephelometry