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

作　　者：衡燮[1,2] 高娜[1,2] 伍胤杰[1,2] 林小瑞[1,2] 周武刚[1,2] 王微[1,2] 唐聪[1,2] 姜述德[1,2] 杨净思[1,2] 孙明波[1,2] 

机构地区：[1]中国医学科学院 [2]北京协和医学院医学生物学研究所,昆明650118

出　　处：《中国生物制品学杂志》2010年第4期394-395,402,共3页Chinese Journal of Biologicals

基　　金：国家"重大新药创制"科技重大专项(2008ZX09101-031);云南省科技创新强省计划(20007AD015)

摘　　要：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.

关 键 词：脊髓灰质炎灭活疫苗 凝胶过滤层析 离子交换层析 

分 类 号：R373.22[医药卫生—病原生物学] R392.33[医药卫生—基础医学]