Freeze-dried preparation containing decitabine and preparation method of freeze-dried preparation
A decitabine and freeze-dried preparation technology, applied in the field of decitabine-containing pharmaceutical compositions and their preparation, can solve the problems of low solubility, increased process risk, unsuitable for clinical safe use, etc., and achieves good stability , the effect of reducing the difficulty of the process
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Embodiment 1
[0030]
[0031] Preparation:
[0032] At room temperature, dissolve 68.0g of potassium dihydrogen phosphate and 11.6g of sodium hydroxide in 4000mL of water for injection, stir to dissolve, pour into a bag filled with 25g of activated carbon, stir for 15 minutes, and decarbonize to obtain a buffered saline solution. Take 1000mL of water for injection, add 50.0g of meglumine, stir until dissolved, then add 50.0g of decitabine, sonicate to prepare a suspension. Add the buffered saline solution into the decitabine suspension, stir until dissolved to obtain the intermediate drug solution; the intermediate drug solution is filtered through a 0.2 μm pressure filter membrane with nitrogen pressure, and 5ml is dispensed into injection bottles, and frozen Drying, plugging, capping and packaging to obtain the freeze-dried powder injection. The freeze-drying process is as follows: pre-freezing stage: heat preservation at -45°C for 7 hours, heat preservation at -35°C for 24 hours; pri...
Embodiment 2
[0034]
[0035] Preparation:
[0036] At room temperature, dissolve 68.0g of potassium dihydrogen phosphate and 11.6g of sodium hydroxide in 4000mL of water for injection, stir to dissolve, pour into a bag filled with 25g of activated carbon, stir for 15 minutes, and decarbonize to obtain a buffered saline solution. Take 1000mL of water for injection, add 65.0g of meglumine, stir until dissolved, then add 50.0g of decitabine, sonicate to prepare a suspension. Add the buffered saline solution into the decitabine suspension, stir until dissolved to obtain the intermediate drug solution; the intermediate drug solution is filtered through a 0.2 μm pressure filter membrane with nitrogen pressure, and 5ml is dispensed into injection bottles, and frozen Drying, plugging, capping, and packaging to obtain a freeze-dried powder injection. The freeze-drying process is as in Preparation Example 1.
Embodiment 3
[0038]
[0039] Preparation:
[0040] At room temperature, dissolve 68.0g of potassium dihydrogen phosphate and 11.6g of sodium hydroxide in 4000mL of water for injection, stir to dissolve, pour into a bag filled with 25g of activated carbon, stir for 15 minutes, and decarbonize to obtain a buffered saline solution. Take 1000mL of water for injection, add 30.0g of meglumine, stir until dissolved, then add 50.0g of decitabine, sonicate to prepare a suspension. Add the buffered saline solution into the decitabine suspension, stir until dissolved to obtain the intermediate drug solution; the intermediate drug solution is filtered through a 0.2 μm pressure filter membrane with nitrogen pressure, and 5ml is dispensed into injection bottles, and frozen Drying, plugging, capping, and packaging to obtain a freeze-dried powder injection. The freeze-drying process is as in Preparation Example 1.
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