Freezing-dried clofarabine powder injection and its preparation method
The technology of freeze-dried powder injection and clofarabine is applied in the field of freeze-dried preparation of clofarabine and its preparation, which can solve the problems of poor solubility of clofarabine, potential safety hazards of clinical medication, deformation of aluminum-plastic composite cover, etc. It dissolves quickly, avoids deformation of aluminum-plastic composite cover, and improves stability.
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Embodiment 1
[0028] Common method prepares clofarabine freeze-dried powder injection (-25 ℃)
[0029] prescription
[0030] Clofarabine 20g
[0031] Mannitol 500g
[0032] Add water for injection to 15000ml
[0033]
[0034] A total of 1000 bottles were made
[0035] Take the prescribed amount of clofarabine and put it in a container, add 80% of the water for injection, stir to dissolve and mix evenly, then add the prescribed amount of mannitol, stir to dissolve and mix evenly, measure the content of intermediates, and add injection after passing the test. Dilute to the full volume with water, filter with a 0.22 μm microporous membrane under aseptic conditions until clear, fill the filtrate into a sterile vial, partially plug it with a butyl rubber stopper, put it into a plate, and send it to a freeze dryer , close the door, turn on the freeze dryer, use heat transfer oil to cool the plate layer, so that the product temperature drops, when the sample rea...
Embodiment 2
[0038] Ordinary method prepares clofarabine freeze-dried powder injection (-40 ℃)
[0039] prescription
[0040] Clofarabine 20g
[0041] Mannitol 800g
[0042] Add water for injection to 15000ml
[0043]
[0044] A total of 1000 bottles were made
[0045] Take the prescribed amount of clofarabine and put it in a container, add 80% of the water for injection, stir to dissolve and mix evenly, then add the prescribed amount of mannitol, stir to dissolve and mix evenly, measure the content of intermediates, and add injection after passing the test. Dilute to the full volume with water, filter with a 0.22 μm microporous membrane under aseptic conditions until clear, fill the filtrate into a sterile vial, partially plug it with a butyl rubber stopper, put it into a plate, and send it to a freeze dryer , close the door, turn on the freeze dryer, use heat transfer oil to cool the plate layer, so that the product temperature drops, when the sample r...
Embodiment 3
[0048] prescription
[0049] Clofarabine 20g
[0050] Mannitol 200g
[0051] Add water for injection to 8000ml
[0052]
[0053] A total of 1000 bottles were made
[0054] Take the prescribed amount of clofarabine and put it in a sterile container, add water for injection, heat slightly to dissolve, then add the prescribed amount of mannitol, stir to dissolve and mix evenly, measure the content of the intermediate, and use it under sterile conditions after passing the test. Filter through a 0.22 μm microporous membrane until clear, fill the filtrate in a sterile 25ml vial, partially plug it with a butyl rubber stopper, put it in a plate, turn on the freeze dryer in advance, and use heat transfer oil to cool the plate until the plate When the temperature reaches -40~-45°C, quickly send the clofarabine solution filled in sterile vials into the freeze dryer, close the door, and keep the plate temperature at -40~-45°C to lower the product temperat...
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