摘要
目的比较滤柱和布式滤囊两种方法过滤水痘减毒活疫苗原液的效果,为水痘减毒活疫苗生产工艺的优化提供参考。方法分别通过滤柱和布式滤囊对水痘减毒活疫苗原液进行过滤,将经两种方法过滤的疫苗原液置于显微镜下观察,并比较溶液的澄清效果及病毒滴度;将两种方法过滤制备的疫苗原液分装,制备水痘减毒活疫苗成品,按照水痘减毒活疫苗企业注册标准及《中国药典》三部(2010版)相关检定要求进行37℃热稳定性试验、无菌检查、病毒滴度、牛血清白蛋白残留量、抗生素残留量的检测。结果两种方法过滤的原液经显微镜观察均未发现完整细胞存在,且病毒滴度基本相同,但通过滤柱过滤后制备的水痘减毒活疫苗原液的澄清状态明显优于布式滤囊过滤;两种方法过滤的原液制备的疫苗成品的各项指标无明显差异,均符合水痘减毒活疫苗注册标准要求。结论在水痘减毒活疫苗生产中,采用滤柱过滤原液的效果明显优于布式滤囊过滤。
Objective To compare the efficiencies of filtration of bulk of live attenuated varieella vaccine by cloth filter bag and filter column. Methods The bulk of live attenuated varicella vaccine was filtrated by cloth filter bag and filter column respectively, and observed by microscopy, of which the clarities and virus titers were compared. The bulks filtered by two methods were filled, and the prepared final product of vaccine was tested for heat stability at 37 ℃, sterility, virus titer, residual bovine serum albumin and residual antibiotics according to the standard for license of live attenuated varicella vaccine and the requirements in Chinese Pharmacopoeia （Volume m, 2010 edition）. Results No intact cells were observed in the bulks filtered by two methods, while the virus titers were basically identical. However, the clarity of bulk fihered with filter column was significantly superior to that by cloth filter bag. All the indexes of final products prepared with bulks filtered by two methods showed no significant difference, which met the standard for license of live attenuated varicella vaccine. Conclusion The efficiency of filtration by filter column during production of live attenuated varieella vaccine was significantly superior to that by cloth filter bag.
出处
《中国生物制品学杂志》
CAS
CSCD
2015年第9期976-978,共3页
Chinese Journal of Biologicals
关键词
水痘减毒活疫苗
滤柱
布式滤囊
过滤
Live attenuated varicella vaccine
Filter column
Cloth filter bag
Filtration
