abstract |
The invention provides a freeze-drying process for preparing bortezomib for injection, which is characterized in that bortezomib liquid medicine is subpackaged and then freeze-dried, and the primary drying stage is characterized in that: heating the plate layer to-20 ℃, and maintaining the pressure of 50-60Pa for 15-18 h; and then, the temperature of the plate layer is unchanged, the pressure is adjusted to be 80-90 Pa, and the pressure is maintained for 8-12 h. The bortezomib for injection prepared by the process has the advantages of no spray bottle, full and complete appearance, content meeting the requirement, improved stability of product content, improved drying efficiency, shortened freeze-drying time, and suitability for industrial production. |