摘要
目的探讨Sabin株脊髓灰质炎灭活疫苗(inactivated poliomyelitis vaccine made from Sabin Strains,sIPV)去除2-苯氧乙醇对其质量的影响。方法对3批不含2-苯氧乙醇的sIPV(B1、B2、B3批)按照企业注册标准(简称企标)的要求进行全项检测和效力试验,全项检测结果与含2-苯氧乙醇的25批sIPV(P1~P25批)进行对比。将B1、B2、B3批sIPV置2~8℃储存24个月,评价其稳定性。结果B1、B2、B3批sIPV的2-苯氧乙醇含量检测结果为0,其他项目检测结果均合格,趋势分析均在警戒限范围内波动;Ⅰ、Ⅱ、Ⅲ型病毒D抗原含量与P1~P25批差异均无统计学意义(P均>0.05)。B1、B2、B3于2~8℃储存24个月,各时间点的项目检测结果均合格,其中D抗原含量均在企标上下限范围内波动,Ⅰ、Ⅱ、Ⅲ型效力试验ED_(50)均高于效力参考品的ED_(50)。结论去除2-苯氧乙醇对B1、B2、B3批sIPV产品质量无影响,本实验为sIPV去除2-苯氧乙醇的工艺变更提供了实验依据。
Objective To investigate the effect of removal of 2-phenoxyethanol removal on quality of inactivated poliomyelitis vaccine made from Sabin strain(sIPV).Methods Three batches of 2-phenoxyethanol-free sIPV,with lot numbers of B1,B2 and B3 respectively,were subjected to overall control tests and potency test according to the requirements in the enterprise registration standard,and the results of overall control tests were compared with those of 25 batches of 2-phenoxyethanol-containing sIPV with lot numbers of P1~P25.The sIPV of lots B1,B2 and B3 were stored at 2~8℃for 24 months to evaluate the stability.Results No 2-phenoxyethanol was detected in sIPV of lots B1,B2 and B3,while the results of other control tests met the relevant requirements.The results of trend analysis fluctuated within the warning limit.No significant difference were observed in the D antigen contents of poliomyelitis of typesⅠ,ⅡandⅢor in the lots P1~P25(each P>0.05).After storage at 2~8℃for 24 months,the overall control test results were qualified,while the D antigen contents of sIPV of lots B1,B2 and B3 fluctuated between the upper and lower limits of enterprise registration standard.In potency test,the ED_(50) of poliomyelitis of typesⅠ,ⅡandⅢwere higher than that of potency reference.Conclusion The removal of 2-phenoxyethanol has no significant effect on the qualities of sIPV of lots B1,B2 and B3,which provides an experimental basis for the change of production process for 2-phenoxyethanol removal in sIPV.
作者
周振歆
易力
李亚东
赵勇
段男
胡云光
付晓旭
起李光程
董少忠
ZHOU Zhen-xin;YI Li;LI Ya-dong;ZHAO Yong;DUAN Nan;HU Yun-guang;FU Xiao-xu;QI Li-guang-cheng;DONG Shao-zhong(Institute of Medical Biology,Chinese Academy of Medical Sciences,Kunming 650031,Yunnan Province,China)
出处
《中国生物制品学杂志》
CAS
CSCD
北大核心
2022年第7期780-784,789,共6页
Chinese Journal of Biologicals
基金
国家重大新药创制科技重大专项(2018ZX09737003)。
