Objective:To establish a suitable freeze-drying process for bortezomib injection.Methods:Vacuum freeze-drying process was evaluated,including conditions such as medicinal liquid volume,pre-freezing temperature,sublimation drying temperature,desorption drying temperature,etc.Results:The optimal conditions were 0.8 mL medicinal liquid per bottle,pre-freezing temperature-40 ℃.Under vacuum condition,sublimation drying temperature was-40～-25 ℃ and the desorption drying temperature was 35 ℃.Conclusion:The bortezomib for injection prepared by this process has been verified to be suitable for mass production,and the product quality meets national standards and regulations.
关键词
注射用硼替佐米/真空冷冻干燥法/制备工艺
Key words
bortezomib injection/vacuum freeze-drying/prepare process
维普
万方数据