使用冻融单一病毒收获液冻干乙脑减毒活疫苗成品质量考察

Investigation of the Live Attenuated Japanese Encephalitis Vaccine Quality Formulated with Freezing-Thawing Single Harvests

目的:使用冻融乙型脑炎减毒活疫苗单一病毒收获液冻干成品,考察可能受影响的成品质量属性。方法:将单一病毒收获液冻存于-70℃冰柜中一段时间,配制前27℃水浴解冻,按照常规生产方法,使用冻融单一病毒收获液配制乙脑减毒活疫苗半成品,并分装、冻干制成成品。采样检测成品可能受冻融工艺影响的质量属性,并对检测结果进行统计学分析。结果:成品质量属性检测结果与公司常规生产均值差异无统计学意义。结论:使用冻融单一病毒收获液冻干成品,已检测的成品质量属性未受影响。

Objective:To investigate the quality of the live attenuated Japanese encephalitis(JE)vaccine formulated with freezing-thawing single harvests.Methods:The single virus harvests should be freezed in a-70℃freezer for a few days,and should be thawed within 27℃water bath before preparation.According to the conventional formulation method,the semi-finished product of JE was prepared with freeze-thaw single virus harvest solution,sub packed and freeze-dried to make the finished product.Sample and test the quality attributes of the finished products that may be affected by freezing-thawing craft,and statistically analyze the test results.Results:The results of the finished product quality attributes had no statistical difference with the average value of the products in our company.Conclusion:The tested quality attributes of the finished products are not affected by using the freezing-thawing single harvests.