A kind of rabeprazole sodium preparation for injection and preparation method thereof
A technology for rabeprazole sodium and injection, which is applied in the field of preparation of rabeprazole sodium for injection and its preparation, can solve the problems of complex preparation process, poor stability, and many types of excipients, and achieve improved heat transfer rate and improved Stable, full-looking effect
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Embodiment 1
[0037] 1. The formula of the rabeprazole sodium preparation for injection of the present embodiment (1000 bottles):
[0038] Rabeprazole sodium 20g;
[0039] Mannitol 50g;
[0040] Arginine 1g;
[0041] Sodium hydroxide 1g.
[0042] 2. Preparation process
[0043] (1) Take 1600mL of water for injection at room temperature, add the prescribed amount of mannitol, arginine and sodium hydroxide, the pH is 11.5, stir to dissolve, add rabeprazole sodium, stir to dissolve, then add water for injection to For the full amount, add 0.05% activated carbon, stir for 30 minutes, and decarbonize. Filter with a 0.22μm microporous membrane, dispense into vials, and half-fill with rubber stoppers.
[0044] (2) Cool down to -40°C, pre-freeze for 2 hours; start vacuuming, raise the temperature of the product to 5°C, keep it warm for 18 hours, slowly raise the temperature to 25°C, keep it warm for 3 hours, press the plug, and cover it.
Embodiment 2
[0046] 1. The formula of the rabeprazole sodium preparation for injection of the present embodiment (1000 bottles):
[0047] Rabeprazole sodium 20g;
[0048] Mannitol 50g;
[0049] Arginine 5g;
[0050] Sodium hydroxide 1g.
[0051] 2. Preparation process
[0052] (1) Take 1600mL of water for injection at room temperature, add the prescribed amount of mannitol, arginine and sodium hydroxide, the pH is 11.5, stir to dissolve, add rabeprazole sodium, stir to dissolve, then add water for injection to For the full amount, add 0.05% activated carbon, stir for 30 minutes, and decarbonize. Filter with a 0.22μm microporous membrane, dispense into vials, and half-fill with rubber stoppers.
[0053] (2) Cool down to -40°C, pre-freeze for 2 hours; start vacuuming, raise the temperature of the product to 5°C, keep it warm for 18 hours, slowly raise the temperature to 25°C, keep it warm for 3 hours, press the plug, and cover it.
Embodiment 3
[0055] 1. The formula of the rabeprazole sodium preparation for injection of the present embodiment (1000 bottles):
[0056] Rabeprazole sodium 20g;
[0057] Mannitol 50g;
[0058] Arginine 10g;
[0059] Sodium hydroxide 1g.
[0060] 2. Preparation process
[0061] (1) Take 1600mL of water for injection at room temperature, add the prescribed amount of mannitol, arginine and sodium hydroxide, stir to dissolve, add rabeprazole sodium, stir to dissolve, add water for injection to the full amount, add 0.05 % activated carbon, stirred for 30 minutes, decarbonized. Filter with a 0.22μm microporous membrane, divide into vials, and half-fill with rubber stoppers.
[0062] (2) Cool down to -40°C, pre-freeze for 2 hours; start vacuuming, raise the temperature of the product to 5°C, keep it warm for 18 hours, slowly raise the temperature to 25°C, keep it warm for 3 hours, press the plug, and cover it.
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