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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 effect of filtering live attenuated vaccine against chickenpox with filter cartridge and cloth filter, and to provide reference for the optimization of production technology of live attenuated varicella vaccine. Methods The live attenuated vaccine of varicella was filtered through the filter column and the cloth filter respectively. The vaccine solution filtered by two methods was observed under a microscope, and the clarification effect and virus titer of the solution were compared. The two methods were filtered Preparing the vaccine stock solution, preparing the finished product of live attenuated varicella vaccine, performing the 37 ℃ thermal stability test according to the enterprise registration standard of the varicella live vaccine and the relevant test requirements of the Chinese Pharmacopoeia (2010 edition), sterility testing, Virus titer, bovine serum albumin residue, the detection of antibiotic residues. Results The intact cells were not found by microscope, and the virus titer was basically the same. However, the clarified state of live attenuated vaccine prepared by filtration through filter column was better than cloth filter. There was no significant difference in the indexes of vaccine products prepared by the two methods of stock solution, all of which met the registration requirements of live attenuated varicella vaccine. Conclusion In the production of live attenuated varicella vaccine, the effect of using filter column to filter the original liquid is obviously better than that of the cloth filter.