Flavin adenine dinucleotide disodium salt freeze-dried powder needle preparation and preparation thereof
A technology of disodium dinucleotide and flavin adenine, which is applied in freeze-dried delivery, powder delivery, drug combination, etc., and can solve the problems of good solubility and limited clinical application
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Embodiment 1
[0015] Example 1 FAD freeze-dried powder injection
[0016] prescription:
[0017]
[0018]
[0019] Preparation:
[0020] Weigh the prescribed amount of FAD and dissolve it in 80% water for injection to make FAD solution, add the prescribed amount of mannitol, adjust the pH value to 9.0-10.5, heat the medicinal liquid to about 60°C, add 0.1% activated carbon for injection according to the preparation amount , stir for 30min, filter and decarbonize and then use 0.22μm microporous filter membrane for fine filtration. After the intermediate is qualified, it is aseptically filled into a 2.7ml vial (the theoretical amount of each bottle is 1ml), and the liquid is placed in a freezer. Dry box, freeze for 4 hours to make the temperature drop to about -45°C; for the first sublimation for 12 hours, the temperature rises to about -5°C; for the second sublimation for 4 hours, the temperature rises to 30°C, take out after vacuum sealing, Cover and get it.
Embodiment 2
[0021] Example 2 FAD freeze-dried powder for injection
[0022] prescription:
[0023]
[0024] Preparation:
[0025] Weigh the prescribed amount of FAD and add it to heat to about 60°C to dissolve in 80% water for injection, then add the prescribed amount of dextran, adjust the pH value to 9.0-10.5, add 0.1% of activated carbon for injection according to the preparation amount, keep stirring for 30 minutes, filter, remove charcoal, and then use 0.22μm microporous filter membrane for fine filtration. After the intermediate is qualified, it is aseptically filled into a 2.7ml vial (the theoretical amount of each bottle is 1ml), and the medicinal liquid is placed in a freeze-drying box and frozen for 3 hours. , make the temperature drop to about -45°C; for the first sublimation for 8 hours, the temperature rises to about -5°C; for the second sublimation for 4 hours, the temperature rises to 30°C, take it out after vacuum pressing, and tie the cover.
Embodiment 3
[0026] Example 3: FAD freeze-dried powder injection
[0027] prescription:
[0028]
[0029] Preparation:
[0030] Take the FAD of the recipe quantity and add it to be heated to about 60 ℃ and dissolve in 80% water for injection, then add the glycine, sodium metabisulfite, sodium calcium EDTA of the recipe quantity, and adjust the pH value 9.0-10.5 after stirring and dissolving. Add 0.1% activated carbon for needles, keep stirring for 30min, filter, decarbonize, and then use 0.22μm microporous membrane for fine filtration. After passing the test of the intermediate, aseptically fill it into a 2.7ml vial (theoretical amount of each bottle is 1ml). ), put the medicinal liquid in a freeze-drying box, freeze for 3 hours, and make the temperature drop to about -45 °C; the first sublimation 14-16 hours, the temperature rises to about -5 °C; the second sublimation 4-6 hours, The temperature rises to 30 ℃, after vacuuming the lid, take it out, tie the lid, and that’s it.
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