Pantoprazole sodium freeze-dried powder injection and preparing method thereof
A technology of freeze-dried powder injection and pantoprazole sodium, which is applied in the field of pharmaceutical preparations, can solve problems such as unknown side effects, affect patient safety, etc., and achieve the effects of simple formula, good resolubility, and full appearance
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Embodiment 1
[0058] Pantoprazole sodium 40g (calculated as pantoprazole), mannitol 100g, pantoprazole sodium and mannitol are mixed, add water for injection and stir until fully dissolved, adjust pH to 9.5 with sodium bicarbonate, add water for injection To 1500ml, add a total of 0.05% activated carbon for needles, stir for 15 minutes, filter and decarbonize, filter the medicinal solution with a 0.22μm sterile microporous filter membrane, measure the pH value, content, and half stopper, and then put the medicinal product into The freeze-drying box is pre-frozen, the temperature is -40°C, and the time is 2 hours. After the drug is frozen, start the vacuum machine to evacuate to 10Pa, turn off the freezer, and raise the temperature of the drug to keep the temperature of the frozen product at -40°C ~ -10°C ; The time is 25 hours, the temperature of the drug is gradually raised to 25° C., and the heat preservation and vacuum drying are carried out for 3 hours. Obtain freeze-dried powder.
Embodiment 2
[0060] Pantoprazole sodium 40g (calculated as pantoprazole), mannitol 100g, pantoprazole sodium and mannitol are mixed, add water for injection and stir until fully dissolved, adjust pH to 11.0 with sodium hydroxide, add water for injection To 1500ml, add a total of 0.05% activated carbon for needles, stir for 15 minutes, filter and decarbonize, filter the medicinal solution with a 0.22μm sterile microporous filter membrane, measure the pH value, content, and half stopper, and then put the medicinal product Pre-freeze in a freeze-drying box at -40°C for 2 hours. After the drug is frozen, start the vacuum machine to evacuate to 10 Pa, turn off the freezer, and heat the drug to keep the temperature of the frozen product at -40°C~-10 ℃; the time is 25h, the medicine is gradually heated to 25℃, and vacuum-dried for 3h. Obtain freeze-dried powder.
Embodiment 3
[0062] Pantoprazole sodium 30g (in pantoprazole), mannitol 150g, pantoprazole sodium and mannitol are mixed, add water for injection and stir until fully dissolving, adjust pH to be 10.0 with sodium carbonate, add water for injection to To 1500ml, add a total of 0.05% activated carbon for needles, stir for 15 minutes, filter and decarbonize, filter the medicinal solution with a 0.22μm sterile microporous filter membrane, measure the pH value, content, and half stopper, and then put the medicinal product into The freeze-drying box is pre-frozen, the temperature is -40°C, and the time is 2 hours. After the drug is frozen, start the vacuum machine to evacuate to 10Pa, turn off the freezer, and raise the temperature of the drug to keep the temperature of the frozen product at -40°C ~ -10°C ; The time is 25 hours, the temperature of the drug is gradually raised to 25° C., and the heat preservation and vacuum drying are carried out for 3 hours. Obtain freeze-dried powder.
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