基于微芯片电泳技术的疫苗产品残留DNA片段大小分布检测方法的建立、验证及应用  

Establishment,verification and application of detection method for size distribution of residual DNA fragments in vaccine products based on MultiNA microchip electrophoresis technology

作　　者：袁月 马晶 陈婕 陈柯蓉 粟春燕 舒聪妍 李炎 王叔桥 杨蕾 YUAN Yue;MA Jing;CHEN Jie;CHEN Kerong;SU Chunyan;SHU Congyan;LI Yan;WANG Shuqiao;YANG Lei(Sichuan Institute for Drug Control(Sichuan Testing Center of Medical Devices),NMPA Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products,SCMPA Key Laboratory for Quality Monitoring and Risk Assessment of Biological Products,Chengdu 611731,Sichuan Province,China)

机构地区：[1]四川省药品检验研究院(四川省医疗器械检测中心)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,四川省药品监督管理局生物制品质量监测与风险评估重点实验室,四川成都611731

出　　处：《中国生物制品学杂志》2025年第2期204-209,共6页Chinese Journal of Biologicals

基　　金：四川省自然科学基金(2022NSFSC1572)。

摘　　要：目的建立基于MultiNA微芯片电泳系统的残留DNA检测方法,对DNA片段的大小分布进行快速分析。方法基于MultiNA微芯片电泳系统建立对残留DNA片段大小分布检测方法,并验证方法的专属性、检测范围及精密度。利用所建立的方法检测Sabin株脊髓灰质炎灭活疫苗(inactivated poliomyelitis vaccine,IPV)原液及成品中残留DNA片段大小。结果该方法专属性结果良好,检测范围为0~10000 bp,精密度检测CV均小于20%。该方法检测Sabin株脊髓灰质炎灭活疫苗原液,结果显示在400及500 bp左右有DNA片段;成品中未检出。结论建立了基于MultiNA微芯片电泳系统对残留DNA片段大小分布的检测方法,为生物制品中残留DNA片段大小分布检测方法提供了参考。Objective To establish a method for determination of residual DNA fragments based on Multi NA microchip electrophoresis system,thus analyzing the size distribution of DNA fragments in a rapid way.Methods Based on Multi NA microchip electrophoresis system,a method for determination of the size distribution of residual DNA fragments was established,and the specificity,detection range and precision of the method were verified.Furthermore,the method was applied for the detection of the size of residual DNA fragments in the bulks and finished products of Sabin strain inactivated poliomyelitis vaccine(IPV).Results This method showed good specificity,with the detection range of 0-10000 bp and the CVs of precision detection less than 20%.The results showed that the sizes of residual DNA fragments in Sabin strain IPV bulks were about 400 and 500 bp,accompanied with no detection in finished products.Conclusion A method based on Multi NA microchip electrophoresis technology for determination of residual DNA fragments was established,which might provide a reference for determination of the size distribution of residual DNA in biological products.

关 键 词：残留DNA 片段大小 MultiNA微芯片电泳系统 生物制品 

分 类 号：R392-3[医药卫生—免疫学]