冻干甲型肝炎减毒活疫苗原液制备中两种抽提方法效果的比较  

Comparison of effectiveness of two methods for extraction during preparation of bulk of freeze-dried live attenuated hepatitis A vaccine

作　　者：侯丽娟 康远航 周延彬 闻向华 张慧影 李海燕 李树生 徐国亮 张俊敏 HOU Li-juan;KANG Yuan-hang;ZHOU Yan-bin;WEN Xiang-hua;ZHANG Hui-ying;LI Hai-yan;LI Shu-sheng;XU Guo-liang;ZHANG Jun-min(Changchun Institute of Biological Products Co., Ltd., Changchun 130062, China)

机构地区：[1]长春生物制品研究所有限责任公司,吉林长春130062

出　　处：《中国生物制品学杂志》2018年第4期405-408,共4页Chinese Journal of Biologicals

摘　　要：目的比较冻干甲型肝炎减毒活疫苗原液制备中两种抽提方法的效果,为生产工艺的优化提供参考。方法取超声后甲型肝炎病毒(hepatitis A virus,HAV)收获物,分别以抽提方法 A和B进行抽提纯化,并对制备的疫苗原液进行无菌检查、支原体检查及蛋白含量、病毒滴度检测。以优化的抽提方法连续制备3批试验疫苗原液及成品,并参考《中国药典》三部(2010版)及企业内控监测指标相关要求进行全面检定。结果与抽提方法 A相比,抽提方法 B制备的原液蛋白含量明显降低,且差异有统计学意义(P<0.001),而病毒滴度差异无统计学意义(P>0.05)。以抽提方法 B连续制备的3批原液、成品的各项检测指标均符合相关要求。结论以抽提方法 B进行疫苗生产,提高了原液的纯度及疫苗质量。Objective To compare the effectiveness of two methods for extraction during preparation of bulk of freezedried live attenuated hepatitis A（HA）vaccine and provide a reference for optimization of the production process.Methods The harvest of hepatitis A virus（HAV）after ultrasonication was extracted by methods A and B respectively,and the prepared bulks of vaccine were tested for sterility,mycoplasma,protein content and virus titer.Three consecutive batches of bulks and final products were prepared by the optimized method,and subjected to overall control tests according to the requirements in Chinese Pharmacopoeia（Volume Ⅲ,2010 editioin）and the relevant internal standards.Results The protein content in bulk prepared by extraction method B was significantly lower than that by method A（P〈0.001）,while the virus titer showed no significant difference（P〈0.05）.All the quality indexes of three batches of bulks and final products prepared by extraction method B met the relevant requirements.Conclusion Both the purity of bulk and quality of vaccine were improved by extraction method B.

关 键 词：冻干甲型肝炎减毒活疫苗 质量 抽提方法 

分 类 号：R373.21[医药卫生—病原生物学] R392-33[医药卫生—基础医学]