流感疫苗中间品—鸡胚尿囊病毒液质量控制的研究  

Quality Control in Intermediate Products of Influenza Vaccine—Chicken Embryo Virus Allantoic Fluid

作　　者：惠琦[1,2] 姜崴[1] 庄茂欣[1] 顾莉莉[1] 柳增善[2] 曹宇[1] 李乐[2] 郑晓丽[1] 

机构地区：[1]长春生物制品研究所,吉林长春130062 [2]吉林大学人兽共患病研究所,吉林长春130062

出　　处：《微生物学杂志》2009年第3期42-45,共4页Journal of Microbiology

摘　　要：为建立流感疫苗中间品—鸡胚尿囊病毒液质量控制点提供依据。用鲎试剂法、微生物限度检查法、沙门菌检查法检测流感疫苗中间品—鸡胚尿囊病毒液的细菌内毒素含量、微生物限度及沙门菌。在300份鸡胚尿囊病毒液中,细菌内毒素含量大于5EU/mL的阳检率为5%;微生物限度检查中小于10个/mL细菌菌落数的占78.67%,小于10个/mL霉菌菌落数的占80.67%,小于10个/mL酵母菌菌落数的占88.67%。沙门菌属的阳检率为4%,其中未检出A～F群的沙门菌。对流感疫苗中间品—鸡胚尿囊病毒液进行细菌内毒素,微生物限度及沙门菌检测可避免不合格尿囊病毒液进入后续生产,污染后续中间品。A quality control point of intermediate products of influenza vaccine--chicken embryo virus allantoic fluid （IPIV） was established in order to provide a foundation. The bacterial endotoxin was tested with TAL, checking limits of microorganisms （CLM） , and Salmonella checking methods. The results showed that in the 300 IPIV samples the positive rate of bacterial endotoxin of more than 5 EU/mL was 5% , bacterial colonies of less than 10 cfu/mL with CLM was 78.67% , mould of less than 10 cfu/mL was 80.67% , and yeast of less than 10 efu/mL was 88.67%. And the positive rate of Salmonella was 4% , and none belonged to A - F groups. Therefore, with the test of bacterial en- dotoxin, CLM, and Salmonella checking could avoid unqualified virus allantoic fluid enter into the follow-up products to pollute the follow-up intermediate products.

关 键 词：流感疫苗 鸡胚尿囊病毒液 细菌内毒素 微生物限度 沙门菌 

分 类 号：Q939.91[生物学—微生物学]