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-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.

abstractsObjective 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),reticuloendotheliosis 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 mycoplasma and adventitious agents were carried out according to requirements of Pharmacopoeia of the People's Republic of China 2010 Volume Ⅲ.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.