Freeze-drying technology of bortezomib for injection
A technology for bortezomib and injection, applied in the field of freeze-drying technology, can solve the problems of poor quality of freeze-dried finished products, low freeze-drying efficiency, low resolubility, etc., and avoid uneven crystallization, long reconstitution time, ester The effect of low conversion rate
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Embodiment 1
[0066] The lyophilization process of the bortezomib for injection of embodiment 1 comprises the following steps:
[0067] (1) Pre-freezing:
[0068] (1a) Lower the liquid medicine from room temperature to -15°C at a cooling rate of 4.6-5.6°C / min, and keep at -15°C for 2 hours;
[0069] (1b) Cool the sample obtained in step (1a) to -35°C at a cooling rate of 2.3-2.7°C / min, and keep it at -35°C for 2.5h;
[0070] (1c) heating the sample obtained in step (1b) to -21°C at a heating rate of 0.5-0.7°C / min, and keeping it at -21°C for 2 hours;
[0071] (1d) Cool the sample obtained in step (1c) to -38°C at a cooling rate of 2.3-2.7°C / min, and keep it at -38°C for 3 hours;
[0072] (2) Once dry:
[0073] (2a) Under the condition of vacuum degree of 0.2mbar, the temperature of the sample obtained in step (1d) is raised to -31°C at a heating rate of 1-2.5°C / h, and kept at -31°C for 19h;
[0074] (2b) Under the condition of a vacuum degree of 0.2mbar, the temperature of the sampl...
Embodiment 2
[0080] The freeze-drying process of the bortezomib for injection of embodiment 2 comprises the following steps:
[0081] (1) Pre-freezing:
[0082] (1a) Lower the liquid medicine from room temperature to -14°C at a cooling rate of 4.6-5.6°C / min, and keep at -14°C for 3 hours;
[0083] (1b) Cool the sample obtained in step (1a) to -45°C at a cooling rate of 1.8-3.1°C / min, and keep at -45°C for 3h.
[0084] (1c) Heat the sample obtained in step (1b) to -22°C at a heating rate of 0.4-0.8°C / min, and keep at -22°C for 3h.
[0085] (1d) Cool the sample obtained in step (1c) to -35°C at a cooling rate of 2.3-2.7°C / min, and keep at -35°C for 4h.
[0086] (2) Once dry:
[0087] (2a) Under the condition of vacuum degree of 0.15mbar, the temperature of the sample obtained in step (1b) is raised to -33°C at a heating rate of 1-7.5°C / h, and kept at -33°C for 20h;
[0088] (2b) Under the condition of vacuum degree of 0.15mbar, the temperature of the sample obtained in step (2a) is r...
Embodiment 3
[0094] The lyophilization process of the bortezomib for injection of embodiment 3 comprises the following steps:
[0095] (1) Pre-freezing:
[0096] (1a) Lower the liquid medicine from room temperature to -18°C at a cooling rate of 4.6-5.6°C / min, and keep at -18°C for 1 hour;
[0097] (1b) Cool the sample obtained in step (1a) to -40°C at a cooling rate of 1.8-3.1°C / min, and keep at -40°C for 2h.
[0098] (1c) Heat the sample obtained in step (1b) to -20°C at a heating rate of 0.4-0.8°C / min, and keep it at -20°C for 1 hour.
[0099] (1d) Cool the sample obtained in step (1c) to -45°C at a cooling rate of 1.8-3.1°C / min, and keep at -45°C for 2h.
[0100] (2) Once dry:
[0101] (2a) Under the condition of a vacuum degree of 0.25mbar, the temperature of the sample obtained in step (1b) is raised to -30°C at a heating rate of 1-7.5°C / h, and kept at -30°C for 18h;
[0102] (2b) Under the condition of a vacuum degree of 0.25mbar, the temperature of the sample obtained in ste...
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