荧光定量RT-PCR滴度检测法在腮腺炎减毒活疫苗制造中的应用  

Application of Fluorescence Quantitative RT-PCR for Live-attenuated Mumps Vaccine Manufacturing

作　　者：张敬武 刘先超 

机构地区：[1]大连市药品检验所,辽宁大连116021 [2]科兴(大连)疫苗技术有限公司,辽宁大连116620

出　　处：《中国药房》2015年第18期2578-2580,共3页China Pharmacy

摘　　要：目的:为促进荧光定量逆转录-聚合酶链反应(RT-PCR)滴度检测法在腮腺炎减毒活疫苗制造中的实际应用提供参考。方法:建立滴度-ct值标准曲线回归方程;分别用微量细胞病变法和荧光定量RT-PCR滴度检测法对10批腮腺炎减毒活疫苗单次收获液及成品进行滴度检测,比较检测结果。结果:两种方法检测结果经配对t检验分析,P分别为0.743、0.868,差值均值分别在(-0.174,0.094)、(-0.113,0.153)之间,差异无统计学意义,可以认为等同。结论:荧光定量RT-PCR滴度检测法可用于腮腺炎减毒活疫苗制造过程中的单次收获液及成品滴度检测,有望进一步升级为《中国药典》方法。OBJECTIVE：To provide reference for improving the practical application of fluorescence quantitative reverse transcription-polymerase chain reaction（RT-PCR） for the live-attenuated mumps vaccine manufacturing. METHODS：A regression equation of standard titer-ctvalue was established;micro cytopathic effect（micro-CPE）and fluorescence quantitative RT-PCR were respectively adopted for the titer of 10 batches of single harvest liquid of live-attenuated mumps vaccine and end products,and the results were compared. RESULTS：According to the t-test analysis,the P were respectively 0.743 and 0.868,and the average values were in the range of（-0.174,0.094）and（-0.113,0.153）,with no significant differences. They were similar. CONCLUSIONS：Fluorescence quantitative RT-PCR can be used for the titer detection of single harvest liquid and end products in the process of live-attenuated mumps vaccine manufacturing. And it is expected to further upgrade to Chinese Pharmacopoeia method.

关 键 词：腮腺炎减毒活疫苗 S79株 荧光定量逆转录-聚合酶链反应滴度检测法 病毒滴度 

分 类 号：R373.1[医药卫生—病原生物学] R392[医药卫生—基础医学]