Freeze-dried azacitidine preparation for injection
A technology for azacitidine and freeze-dried preparations, which is applied in the field of pharmaceutical preparations, can solve the problems of reducing the stability of this product, increasing production costs, and being unable to inhibit decomposition, etc., to shorten the preparation time, shorten the freeze-drying cycle, and shorten the freeze-drying time. cycle effect
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[0027] Example 1
[0028] 1) Prescription
[0029] Azacitidine 50g
[0030] Mannitol 50g
[0031] Water for injection to 3L
[0032] 2) Preparation of azacitidine freeze-dried powder for injection:
[0033] Accurately weigh 90% of the prescription amount of water for injection; weigh the prescription amount of azacitidine (100μm in diameter) and mannitol, mix them in a sterile bag for 10 minutes, slowly add to the water for injection, stir to dissolve. Sampling to detect the content of intermediate products; according to the intermediate test results, fill the liquid medicine in a vial with a half stopper; cool the freeze dryer to -40°C in advance, and send the filled sample into the freeze dryer for 2.5 hours; The shelf temperature is raised to -10°C at 10°C / h and kept for 8 hours; the temperature is raised to 40°C at 10°C / h and kept for 14 hours; the ultimate vacuum is then carried out for 2 hours, and the pressure rise experiment should be carried out. The experiment should satisfy ...
Example Embodiment
[0034] Example 2
[0035] 1) Prescription
[0036] Azacitidine 50g
[0037] Mannitol 50g
[0038] Water for injection to 3L
[0039] 2) Preparation of azacitidine freeze-dried powder for injection:
[0040] Accurately weigh 90% of the prescription amount of water for injection; weigh the prescription amount of azacitidine (150 μm in particle size) and mannitol, mix for 10 min in a sterile bag, slowly add to the water for injection, stir to dissolve. Sampling to detect the content of intermediate products; according to the intermediate test results, fill the liquid medicine in a vial with a half stopper; cool the freeze dryer to -40°C in advance, and send the filled sample into the freeze dryer for 2.5 hours; The shelf temperature is raised to -10°C at 10°C / h and kept for 8 hours; the temperature is raised to 40°C at 10°C / h and kept for 14 hours; the ultimate vacuum is then carried out for 2 hours, and the pressure rise experiment should be carried out. The experiment should satisfy <0....
Example Embodiment
[0041] Example 3
[0042] 1) Prescription
[0043] Azacitidine 50g
[0044] Mannitol 50g
[0045] Water for injection to 3L
[0046] 2) Preparation of azacitidine freeze-dried powder for injection:
[0047] Accurately weigh 90% of the prescription amount of water for injection; weigh the prescription amount of azacitidine (particle size of 200μm) and mannitol, mix them in a sterile bag for 10 minutes, slowly add to the water for injection, stir to dissolve. Sampling to detect the content of intermediate products; according to the intermediate test results, fill the liquid medicine in a vial with a half stopper; cool the freeze dryer to -40°C in advance, and send the filled sample into the freeze dryer for 2.5 hours; The shelf temperature is raised to -10°C at 10°C / h and kept for 8h; the temperature is raised to 40°C at 10°C / h and kept for 14h; the ultimate vacuum is then carried out for 2 hours, and the pressure rise experiment should be carried out. The experiment should satisfy <0.1p...
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