流感疫苗中间品-鸡胚尿囊病毒液质量控制的研究

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一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lO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。

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

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 cfu/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 endotoxin, CLM, and Salmonella checking could avoid unqualified virus allantoic fluid enter into the follow-up products to pollute the follow-up intermediate products.