Nicorandil freeze-dried powder injection and preparation method thereof
A technology for freeze-dried powder injection and nicorandil, which is applied in the field of nicorandil freeze-dried powder injection for injection and its preparation, can solve problems such as instability, and achieves improved stability, delayed degradation speed, and improved product quality. quality effect
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[0020] Example 1
[0021] name
[0022] Preparation:
[0023] 1 Preparation of preparation solution: Dissolve mannitol and nicorandil in order of 80% of the prescribed amount of water for injection, after dissolving, adjust the pH to 7.0-8.0 with sodium citrate solution, and make the volume constant with water for injection.
[0024] 2 The preparation liquid is filtered and sterilized, filled, the filling amount is 1ml, half-stopped, and placed in a freeze dryer for freeze drying.
[0025] 3 Perform freeze-drying in accordance with the following drying procedure: Pre-freezing stage: the plate layer is cooled to -40°C, maintained for 3 hours, then heated to -3°C, maintained for 1 hour, then cooled to -40°C, maintained for 1 hour, and then heated to -3°C , Maintain for 1h, then cool to -40℃, maintain for 1h, enter the sublimation stage; the vacuum degree of sublimation is 200ubar, the sublimation temperature is -20℃, maintain for 10h, then increase to -10℃, maintain for 3h, and then ...
Example Embodiment
[0041] Example 2
[0042] name
[0043] Preparation:
[0044] 1 Preparation of preparation solution: Dissolve mannitol and nicorandil in order of 80% of the prescribed amount of water for injection. After dissolution, adjust the pH of the sodium citrate solution to 7.0-8.0, and adjust the volume of the water for injection.
[0045] 2 The preparation liquid is filtered and sterilized, filled, and filled with 2ml, half-stopped, placed in a freeze dryer for freeze drying.
[0046] 3 Perform freeze-drying in accordance with the following drying procedure: Pre-freezing stage: the plate layer is cooled to -40°C, maintained for 3 hours, then heated to -3°C, maintained for 4 hours, then cooled to -40°C, maintained for 1 hour, and then heated to -3°C , Maintain for 4h, then cool to -40℃, maintain for 1h, enter the sublimation stage; the vacuum degree of sublimation is 200ubar, the sublimation temperature is -20℃, maintain for 10h, then increase to -10℃, maintain 3h, then increase to 0℃ , M...
Example Embodiment
[0048] Example 3
[0049] name
[0050] Preparation:
[0051] 1 Preparation of preparation solution: Dissolve mannitol and nicorandil in order of 80% of the prescribed amount of water for injection, after dissolving, adjust the pH to 7.0-8.0 with sodium citrate solution, and make the volume constant with water for injection.
[0052] 2 The preparation solution is filtered and sterilized, filled, the filling amount is 8ml, half-stopped, and placed in a freeze dryer for freeze drying.
[0053] 3 Perform freeze-drying in accordance with the following drying procedure: Pre-freezing stage: the plate layer is cooled to -40°C, maintained for 3 hours, then heated to -3°C, maintained for 4 hours, then cooled to -40°C, maintained for 1 hour, and then heated to -3°C , Maintain for 4h, then cool to -40℃, maintain for 1h, enter the sublimation stage; the vacuum degree of sublimation is 200ubar, the sublimation temperature is -20℃, maintain for 10h, then increase to -10℃, maintain 3h, then incre...
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