摘要
目的:建立适用于冻干血液制品胶塞总水分监控预测体系,验证该体系在血液制品水分控制的有效性。方法:探究冻干血液制品生产工艺环节对胶塞总水分的影响,建立胶塞结合水测定法,基于此,建立胶塞总水分监控预测体系,展开该体系指导制备的冻干血液制品展开(5±3)℃和(25±2)℃条件下存储24个月的长期和加速稳定性试验以验证体系有效性。结果:胶塞总水分在冻干血液制品生产工艺过程呈波动状态,胶塞最终总水分主要取决于脉动真空干燥环节,通过高温试验检测胶塞结合水,成功建立基于结合水的胶塞总水分监控预测体系,体系可输出确保冻干血液制品水分长期合格的胶塞水分推荐值,依据该推荐值可确定脉动真空干燥环节的详细参数,体系指导制备的冻干血液制品长期和加速稳定性试验中制品水分均符合预期要求。结论:成功建立胶塞水分监控预测体系,该体系可指导胶塞干燥程度,进而有效保证冻干血液制品水分长期稳定。
Objective:To establish a total moisture monitoring and prediction system of rubber stoppers in freeze-dried blood products,and to verify the effectiveness of the system in blood product moisture control.Methods:To explore the influence of total water content of rubber stoppers in freeze-dried blood product production process,a rubber stopper bound water determination method was established.Based on this,a total water monitoring and prediction system of rubber stoppers was established,and the system to guide the preparation of freeze-dried blood products was launched.Long-term and accelerated stability tests stored for 24 months at(5±3)℃ and(25±2)℃ were used to verify the effectiveness of the system.Results:The total water content of rubber stoppers fluctuated during the production process of freeze-dried blood products.The final total water content of rubber stoppers mainly depended on the pulse vacuum drying process.The high temperature test was used to detect the rubber stopper-bound water and the total moisture content of rubber stoppers based on the bound water was successfully established.Monitoring and prediction system can give the recommended value of the water content of rubber stoppers to ensure that the moisture of the freeze-dried blood product was qualified for a long time.According to the recommended value,the detailed parameters of the pulse vacuum drying process were determined,and the long-term and accelerated stability tests of the freeze-dried blood product prepared via the system met the expected requirements.Conclusion:The moisture monitoring and prediction system of rubber stoppers is successfully established,which can be used for the drying degree of rubber stopper and effectively ensure the long-term stability of the moisture of freeze-dried blood products.
作者
陈晨
董方玉
董雪
李杰
周安
陈勇
杨西建
苏登城
杨砚池
周久越
菅长永
CHEN Chen;DONG Fangyu;DONG Xue;LI Jie;ZHOU An;CHEN Yong;YANG Xijian;SU Dengcheng;YANG Yanchi;ZHOU Jiuyue;JIAN Changyong(Shandong Taibang Biological Products Co.,Ltd.Taian 271000,China)
出处
《中国药品标准》
CAS
2022年第4期351-356,共6页
Drug Standards of China
基金
山东省重大科技创新工程项目“首仿人抗凝血酶Ⅲ产品临床研究及产业化”(项目编号:2018CXGC1418)。
关键词
胶塞
溴化丁基橡胶塞
内包材
胶塞总水分
胶塞结合水
冻干血液制品
水分
rubber stopper
bromobutyl rubber stopper
inner packaging material
total water content of rubber stopper
rubber stopper bound water
freeze-dried blood products
moisture
