摘要
采用质量源于设计(QbD)理念获得了注射用米氮平冻干工艺一次干燥操作参数的设计空间。采用析因设计考察隔板温度和真空度对冻干过程中制品温度和一次干燥所需时间的影响。经Design Expert 8.0.6软件拟合得到了上述两个参数的设计空间。结果表明,在设计空间内任意选择冻干工艺参数能得到冻干效果相似的注射用米氮平。
The design space （DS） of the operation parameters of primary drying for mirtazapine injection was obtained based on the concept of quality by design （QbD）. The effects of shelf temperature and chamber pressure on the product temperature and primary drying time were investigated with factorial design. The DS of the above two parameters was obtained by Design Expert 8.0.6 software. The results showed that the parameters randomly selected in DS would not affect the lyophilized effect ofmirtazapine for injection.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2013年第8期778-780,共3页
Chinese Journal of Pharmaceuticals
关键词
QBD
冷冻干燥
一次干燥
设计空间
注射用米氮平
quality by design （QbD）
freeze-drying
primary drying
design space
mirtazapine for injection
