两种MEM培养基制备甲型肝炎减毒活疫苗的效果比较

Preparation of Live Attenuated Hepatitis A Vaccine by Hyclone and Nissui MEM

[目的]比较不同厂家MEM培养基制备甲型肝炎减毒活疫苗的效果。[方法]分别用两个厂家的MEM培养基培养人胚肺二倍体2BS细胞,显微镜下观察细胞生长情况。以美国Hyclone MEM培养基为实验组,同时以日本日水株式会社MEM培养基为对照组,其他原材料相同,制备甲型肝炎减毒活疫苗,并按《中华人民共和国药典》三部(2005版)要求进行全面检定。[结果]显微镜下观察,2BS细胞在2种MEM培养基中的生长情况差异无统计学意义,实验组病毒滴度与对照组病毒滴度比较,差异无统计学意义;其余检定指标均符合《中华人民共和国药典》三部(2005版)要求。[结论]美国Hyclone MEM培养基可以替代日本日水MEM培养基,用于甲肝疫苗的规模化生产,显著降低生产成本。

[Objective]To compare the preparation effect of live attenuated hepatitis A vaccine by Hyclone and Nissui MEM.[Methods]Human embryo lung diploid cell 2BS strain was cultured by Hyclone and Nissui MEM respectively and cell growth was observed by microscope.live attenuated hepatitis A vaccine was prepared by Hyclone MEM as test group,Nissui MEM as control,the other materials were same.The quality indexes were tested according to the requirements in Chinese Pharmacopoeia（Volume Ⅲ,2005 edition）.[Results]Growth condition of 2BS cell cultured by Hyclone and Nissui MEM showed no significant change.Titer of test and control group showed no significant difference.The other quality indexes met the requirements in Chinese Pharmacopoeia（Volume Ⅲ,2005 edition）.[Conclusion]Hyclone MEM could substitute Nissui MEM,thus was suitable for large-scale production of HA vaccine and decreased the production cost.