水痘减毒活疫苗冻干工艺的优化
Optimization of Lyophilization of Live Attenuated Varicella Vaccine
顾开龙 1赵莹 2李欣格 1邹德志 1王学敏 1张明亮1
作者信息
- 1. 辽宁成大生物股份有限公司,辽宁沈阳 110179
- 2. 沈阳市第九人民医院,辽宁沈阳 110021
- 折叠
摘要
目的:对冻干水痘减毒活疫苗的冻干工艺参数进行筛选和优化.方法:通过设计单因素试验和正交试验对水痘减毒活疫苗的关键冻干工艺参数进行优化,采用优化后的冻干曲线制备冻干水痘减毒活疫苗,并测定制品水分含量、外观、病毒滴度等指标.结果:最佳工艺参数为升华干燥温度-20℃,升华干燥真空度 10 Pa,解析干燥温度 30℃,解析干燥时间 8 h;采用优化后冻干曲线制备的疫苗外观为乳白色或白色疏松体,复溶后为澄明液体,可微带乳光,无异物;各种理化性质及水分含量均符合规定,且制品病毒滴度符合标准.结论:优化后的冻干曲线适用于冻干水痘减毒活疫苗的制备.
Abstract
Objective:To screen and optimize the process parameters of lyophilized live attenuated varicella vaccine.Methods:The key parameters of lyophilized live attenuated varicella vaccine are optimized by one-factor experiments and orthogonal design.The lyophilized live attenuated varicella vaccine is prepared by using the optimized lyophilized curve,and the moisture content,appearance,virus titer of the product are measured.Results:The optimal process parameters are sublimation drying temperature-20℃,sublimation drying vacuum degree 10 Pa,analytical drying temperature 30℃,and analytical drying time 8 h;the vaccine prepared by optimized lyophilization curve is opalescent or white loose body,after redissolution,the vaccine is clear liquid with micromilky light and no foreign body;all kinds of physical and chemical properties and moisture content are in accordance with the regulations,and the virus titer of the product are in accordance with the pharmacopoeia standards.Conclusion:The optimized lyophilized curve is suitable for the preparation of lyophilized live attenuated varicella vaccine.
关键词
水痘减毒活疫苗/冻干工艺/正交试验/病毒滴度Key words
live attenuated varicella vaccine/freeze-drying process/orthogonal test/virus titer引用本文复制引用
出版年
2024
NETL
NSTL
万方数据