Cobamamide freeze-drying preparation composition for injection and preparing method thereof
A technology for adenosylcobalamin and freeze-dried preparations is applied in the field of pharmaceutical preparations to achieve the effects of less amount of auxiliary materials, low content of related substances and high stability
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Embodiment 1
[0052] Embodiment 1 Adenosylcobalamin freeze-dried preparation composition for injection of the present invention
[0053] prescription:
[0054] Adenosylcobalamin 505mg,
[0055] Mannitol 25g,
[0056] Isoamyl acetate 0.5mg,
[0057] Sodium metabisulfite 0.2 mg,
[0058] Add water for injection to 500ml.
[0059] Preparation:
[0060] 1) Add the prescribed amount of mannitol, isoamyl acetate, and sodium metabisulfite to an appropriate amount of water for injection at 45~50°C, and stir to dissolve;
[0061] 2) Add activated carbon with a volume of 0.5% to absorb for 30 minutes and filter;
[0062] 3) Dilute the water for injection to 500ml, lower the temperature of the liquid medicine to 5-9°C, and adjust the pH to 5.5-7.5;
[0063] 4) Add the prescribed amount of adenosylcobalamin, stir until fully dissolved, and adjust the pH to 5.5-7.0;
[0064] 5) Use a 0.22 μm filter membrane to filter aseptically, divide into 1,000 vials, freeze-dry, crimp the cap, and pack.
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Embodiment 2
[0069] Embodiment 2 Adenosylcobalamin freeze-dried preparation composition for injection of the present invention
[0070] prescription:
[0071] Adenosylcobalamin 505mg,
[0072] Mannitol 25g,
[0073] Isoamyl acetate 0.7mg,
[0074] Sodium metabisulfite 1.0 mg,
[0075] Add water for injection to 500ml.
[0076] Preparation:
[0077] With embodiment 1.
Embodiment 3
[0078] Embodiment 3 Adenosylcobalamin freeze-dried preparation composition for injection of the present invention
[0079] prescription:
[0080] Adenosylcobalamin 505mg,
[0081] Mannitol 25g,
[0082] Isoamyl acetate 1.0 mg,
[0083] Sodium metabisulfite 2.0 mg,
[0084] Add water for injection to 500ml.
[0085] Preparation:
[0086] With embodiment 1.
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