麻疹腮腺炎减毒活疫苗生产用鸡胚的质量控制研究  

Quality control of chick embryo used for manufacture of measles and mumps combined vaccine

作　　者：祁春华[1] 陈晓琦[1] 王珍[1] 

机构地区：[1]武汉生物制品研究所有限责任公司麻疹腮腺炎疫苗室,430060

出　　处：《国际生物制品学杂志》2012年第1期6-8,20,共4页International Journal of Biologicals

摘　　要：目的建立麻疹腮腺炎减毒活疫苗生产用鸡胚的质量控制方法。方法运用酶联免疫吸附测定检测禽白血病病毒；运用双向免疫扩散试验检测马立克氏病病毒．网状内皮组织增生症病毒、禽流感病毒、传染性法氏囊病病毒、多杀性巴氏杆菌；运用血凝试验检测血吸附病毒；运用逆转录一聚合酶链反应检测新城疫病毒；依照《中华人民共和国药典）2010年版三部的要求进行无菌检查及支原体和外源因子检查。结果采用上述方法未在无特定病原体鸡胚（鸡群代码：S、R、D、W、C、F、G、M、H）尿囊液、原代鸡胚成纤维细胞悬液、鸡胚成纤维细胞悬液培养物中检出禽白血病病毒、马立克氏病病毒、网状内皮组织增生症病毒、禽流感病毒、传染性法氏囊病病毒、多杀性巴氏杆菌、血吸附病毒和新城疫病毒，表明采用这些方法对麻疹腮腺炎减毒活疫苗生产用鸡胚进行质量控制是可行的。结论建立了一套用于麻疹腮腺炎减毒活疫苗生产用鸡胚质量控制的快速、特异的检测方法。Objective To establish a quality control method for determining chick embryo used for manufacture of measles and mumps combined vaccine. Methods Avian leukosis virus （ALV） was determined by ELISA. Marek＇ s disease virus （MDV） , retieuloendotheliosis virus （REV） , avian influenza virus （AIV） , infectious bursal disease virus （IBD） and Pasteurella multocida were determined by double immunodiffusion test. Hemadsorption virus （HAV） was determined by hemagglutination test. Newcastle disease virus （NDV） was determined by reverse transcription-polymerase chain reaction. Sterility test and tests for myeoplasma and adventitious agents were carried out according to requirements of Pharmacopoeia of the People＇s Republic of China 2010 Volume m. Results No ALV, MDV, REV, AIV, IBD, Pasteurella multocida, HAV and NDV were detected in allantoic fluids of specific pathogen free chick embryo （the codes of chick group： S, R, D, W, C, F, G, M, H）, primary chick embryo fibroblast （CEF） suspensions and CEF cultures by above methods. The results suggested that it was feasible to use these methods for control quality of chick embryo. Conclusions A set of fast and specific methods for quality control of chick embryo used for manufacture of measles and mumps combined vaccine are established.

关 键 词：鸡胚 麻疹疫苗 腮腺炎疫苗 疫苗 联合 免疫学技术 逆转录聚合酶链反应 

分 类 号：R392.1[医药卫生—免疫学]