Sabin株脊髓灰质炎灭活疫苗纯化工艺的建立

Development of Purification Procedure of Inactivated Poliomyelitis Vaccine Prepared with Sabin Strain

目的建立Sabin株脊髓灰质炎灭活疫苗(IPV)纯化工艺。方法采用Sepharose CL-6B凝胶过滤和DEAE-Sepharose Fast Flow离子交换层析两步纯化法纯化脊髓灰质炎病毒,进行各项检定后再经除菌过滤和灭活。结果Ⅰ、Ⅱ、Ⅲ型病毒纯化后的蛋白去除率均不低于98.81%,病毒滴度分别为8.75、8.50和8.63lgCCID50/ml,DNA残留量均<100pg/ml。除菌过滤和灭活后,D抗原含量略有下降。结论已建立了Sabin株IPV的纯化工艺,纯化后制备出了高纯度的Sabin株IPV。

Objective To develop a purification procedure of inactivated poliomyelitis vaccine（IPV）prepared with Sabin strain. Methods Poliomyelitis virus was purified by Sepharose CL-6B gel filtration and DEAE-Sepharose Fast Flow ion exchange chromatography, subjected to control tests then sterilized by filtration and inactivated. Results All the removal rates of protein in poliomyelitis virus typesⅠ, Ⅱ and Ⅲ were not less than 98.81%, and the residual DNA contents were less than 100 pg / ml, while the virus titers were 8. 75, 8. 50 and 8. 63 lg CCID50 / ml respectively. The D antigen content in the virus after sterilization by filtration and inactivation decreased slightly. Conclusion A purification procedure of IPV prepared with Sabin strain was developed, and IPV with high purity was prepared.