Sabin株脊髓灰质炎灭活疫苗病毒纯化液纯度对照品的建立  

Establishment of reference substance for purified poliovirus of inactivated poliomyelitis vaccine from Sabin strain

作　　者：黄翟 赵王丽 宋天扬 罗正辉 杨东琼 葛绕玲 雷银瓶 范金 易力 HUANG Di;ZHAO Wang-li;SONG Tian-yang;LUO Zheng-hui;YANG Dong-qiong;GE Rao-ling;LEI Yin-ping;FAN Jin;YI Li(Institute of Medical Biology,Chinese Academy of Medical Sciences,Kunming 650000,Yunnan Province,China)

机构地区：[1]中国医学科学院医学生物学研究所,云南昆明650000 [2]昆明市疾病预防控制中心,云南昆明650228 [3]国家药品监督管理局疫苗及生物制品质量控制与评价重点实验室,四川成都611731

出　　处：《中国生物制品学杂志》2022年第2期133-137,共5页Chinese Journal of Biologicals

基　　金：云南省创新团队计划(2019HC006).

摘　　要：目的建立Sabin株脊髓灰质炎灭活疫苗病毒纯化液纯度对照品。方法将Sabin株脊髓灰质炎灭活疫苗病毒纯化液经超滤离心后制备的对照品,在4和-20℃条件下保存,并于保存0、3、6、9、12个月时,采用高效液相色谱法检测纯度。结果Sabin株脊髓灰质炎灭活疫苗病毒纯化液对照品在4和-20℃条件下保存12个月内,目标峰均能被检出,峰型基本保持一致,峰面积百分比均为100%,保留时间RSD为0.69%;4℃时,峰高和峰面积分别降低11.4%和8.8%;-20℃时,峰高和峰面积分别降低44.3%和35.8%。结论由Sabin株脊髓灰质炎灭活疫苗病毒纯化液超滤浓缩后制备的对照品,在4和-20℃条件下放置12个月均保持稳定,可作为Sabin株脊髓灰质炎灭活疫苗病毒纯化液纯度检测对照品使用。Objective To establish the reference substance for purified poliovirus of inactivated poliomyelitis vaccine from Sabin strains(sIPV).Methods The samples prepared by ultrafiltration centrifugation of purified poliovirus were stored at 4 and-20℃,and determined for purity by high performance liquid chromatography(HPLC)after storage for 0,3,6,9 and 12 months.Results The target peaks of the reference substancefor purified poliovirus of sIPV were detected within 12 months after storage at 4 and-20℃,while the peak shapes were basically in agreement,all the percentages of peak areas were 100%,and the RSD of retention time was 0.69%.The peak height and peak area decreased by only 11.4%and 8.8%at 4℃,while by 44.3%and 35.8%at-20℃,respectively.Conclusion The reference substance prepared by ultrafiltration concentration of the purified poliovirus of sIPV was stable after storage at 4 and-20℃for 12 months,which might be used for determination of purity of purified poliovirus of sIPV.

关 键 词：Sabin株脊髓灰质炎灭活疫苗 病毒纯化液 纯度 对照品 

分 类 号：R392-33[医药卫生—免疫学]