Bortezomib pharmaceutical composition and preparation method thereof
A technology for bortezomib and composition, which is applied in the field of bortezomib-containing pharmaceutical compositions and the preparation thereof, can solve the problems of rapid growth of related substances, prolonged configuration time, poor water solubility of bortezomib, etc., and achieves rapid dissolution and improved stability. sexual effect
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Embodiment 1
[0039]
[0040] Preparation:
[0041] At room temperature, 1.0g bortezomib was dissolved in 50mL tert-butanol, 0.5g meglumine was dissolved in 100mL water for injection, slowly added to the bortezomib tert-butanol solution, water for injection was added to 800ml, and mannitol 6.0 g, stir until dissolved, add water for injection to 1000ml to obtain the intermediate medicinal solution; the intermediate medicinal solution is filtered through a 0.2 μm pressure filter membrane through nitrogen pressure, and 1ml is dispensed into injection bottles, freeze-dried, and stoppered. Capping and packaging to obtain freeze-dried powder injection. The freeze-drying process is as follows: pre-freezing stage: -45°C for 2.5 hours, -25°C for 3 hours; primary sublimation: -30°C for 11 hours, -20°C for 25.5 hours, -10°C for 4 hours, 0°C Keep for 4 hours; secondary drying: keep for 5 hours at 30°C.
Embodiment 2
[0043]
[0044] Preparation:
[0045] At room temperature, dissolve 1.0g bortezomib in 50mL tert-butanol, dissolve 0.6g meglumine in 100mL water for injection, slowly add to the bortezomib tert-butanol solution, add water for injection to 800ml, add mannitol 8.0 g, stir until dissolved, add water for injection to 1000ml to obtain the intermediate medicinal solution; the intermediate medicinal solution is filtered through a 0.2 μm pressure filter membrane through nitrogen pressure, and 1ml is dispensed into injection bottles, freeze-dried, and stoppered. Capping and packaging to obtain freeze-dried powder injection. The freeze-drying process adopts the freeze-drying process in Example 1.
Embodiment 3
[0047]
[0048] Preparation:
[0049] At room temperature, 1.5g of bortezomib was dissolved in 100mL of tert-butanol, 0.8g of meglumine was dissolved in 150mL of water for injection, slowly added to the solution of bortezomib in tert-butanol, water for injection was added to 800ml, and mannitol 8.0 g and 0.2g of histidine, stirred until dissolved, added water for injection to 1000ml, to obtain the intermediate medicinal solution; the intermediate medicinal solution was filtered through a 0.2μm pressure filter membrane through nitrogen pressure, and then packed in 1ml into injection bottles, Freeze-drying, plugging, capping and packaging to obtain a freeze-dried powder injection. The freeze-drying process adopts the freeze-drying process in Example 1.
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