Freeze dried powder injection of cytarabine and its preparation process
A technology for freeze-dried powder injection and fluorouracil, which is applied in the field of fluorouracil freeze-dried powder for injection and its preparation, and achieves the effects of good solubility, ensuring safety and extending the validity period
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[0010] Example 1: Add 0.25g of fluorouracil to 4ml of water, adjust the pH to 9.0 with saturated sodium hydroxide under stirring, and stir to form a clear and transparent solution, then filter with a 0.22μm microporous membrane, and then filter The latter solution is freeze-dried; during freeze-drying, the pre-freezing temperature is -30°C, the pre-freezing time is 4 hours, the sublimation drying temperature is -10°C, the sublimation drying time is 25 hours, the re-drying temperature is 20°C, and the re-drying time For 20 hours, then seal the mouth to obtain a fluorouracil powder injection.
Example Embodiment
[0011] Example 2: Add 0.25g of fluorouracil and 0.1g of Tween into 3ml of water, adjust the pH to 9.0 with saturated sodium hydroxide under stirring, and stir to form a clear and transparent solution, and then use a 0.22μm microporous filter membrane Filter, then freeze-dry the filtered solution; during freeze-drying, the pre-freezing temperature is -40°C, the pre-freezing time is 4.5 hours, the sublimation drying temperature is -15°C, the sublimation drying time is 27 hours, and the re-drying temperature is 25°C , And the drying time is 25 hours, and then sealed to obtain fluorouracil powder injection.
Example Embodiment
[0012] Example 3: Add 0.25g of fluorouracil and 0.1g of polyethylene glycol to 3ml of water, adjust the pH to 9.0 with saturated sodium hydroxide under stirring, and stir to form a clear and transparent solution, and then use 0.22μm micropores Filter by membrane, and then freeze-dry the filtered solution; during freeze-drying, the pre-freezing temperature is -25°C, the pre-freezing time is 3 hours, the sublimation drying temperature is -10°C, the sublimation drying time is 20 hours, and the re-drying temperature is At 10°C, the drying time is 30 hours, and then it is sealed to obtain a fluorouracil powder injection.
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