Degarelix acetate lyophilized powder injection and preparation method thereof
A technology of degarelix acetate and freeze-dried powder for injection is applied in the field of degarelix acetate freeze-dried powder for injection and its preparation, which can solve problems such as instability, achieve convenient clinical use, low production cost, and repeatability. good effect
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[0017] Example 1
[0018]
[0019] Accurately weigh mannitol and sodium acetate, add 90% water for injection, dissolve and stir evenly, then add degarelix acetate, dissolve and stir evenly, adjust the pH to 0.5mol / L acetic acid or 0.1mol / L sodium hydroxide solution 5.0. After passing the intermediate inspection, add water for injection to the full amount. The solution is pumped into a sterile room, filtered through a 0.22μm microporous filter membrane until it is clear, and filled into a 10ml vial with a volume of 4ml per bottle, added with a butyl rubber stopper, and placed on a plate. Put the loaded sample to be freeze-dried in a freeze-drying box, close the door, turn on the machine, and cool down. When the product temperature reaches -40℃, keep it for 3 hours, and then open the condenser valve. When the condenser valve temperature reaches -45 When the temperature is ℃, turn on the vacuum pump, when the vacuum reaches 20Pa or less, start heating and sublimation drying, the fi...
Example Embodiment
[0020] Example 2
[0021]
[0022] Accurately weigh mannitol and sodium acetate, add 90% water for injection, dissolve and stir evenly, then add degarelix acetate, dissolve and stir evenly, adjust the pH to 0.5mol / L acetic acid or 0.1mol / L sodium hydroxide solution 7.4. After passing the intermediate inspection, add water for injection to the full amount. The solution is pumped into a sterile room, filtered through a 0.22μm microporous filter membrane until it is clear, and filled into a 10ml vial with a volume of 4ml per bottle, added with a butyl rubber stopper, and placed on a plate. Place the sample to be freeze-dried on the plate in a freeze-drying oven, close the door, turn on, and cool down. When the product temperature reaches -40℃, keep it for 2 hours, and then open the condenser valve. When the condenser valve temperature reaches -45 When the temperature is ℃, turn on the vacuum pump, when the vacuum reaches below 20Pa, start to heat up and sublimate and dry, and final...
Example Embodiment
[0023] Example 3
[0024]
[0025]
[0026] Accurately weigh mannitol and sodium acetate, add 90% water for injection, dissolve and stir evenly, then add degarelix acetate, dissolve and stir evenly, adjust the pH to 0.5mol / L acetic acid or 0.1mol / L sodium hydroxide solution 6.5. After passing the intermediate inspection, add water for injection to the full amount. The solution is pumped into a sterile room, filtered through a 0.22μm microporous filter membrane until it is clear, and filled into a 10ml vial with a volume of 4ml per bottle, added with a butyl rubber stopper, and placed on a plate. Put the loaded sample to be freeze-dried in a freeze-drying box, close the door, turn on the machine, and cool down. When the product temperature reaches -40℃, keep it for 3 hours, and then open the condenser valve. When the condenser valve temperature reaches -45 When the temperature is ℃, turn on the vacuum pump, when the vacuum reaches 20Pa or less, start to heat up and sublimate and ...
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