Rabeprazole sodium for injection as well as preparation method and detection method thereof
A technology for rabeprazole sodium and injection, which is applied to the field of rabeprazole sodium for injection and its preparation, can solve the problems of poor drug efficacy, low bioavailability and the like, and achieves low production cost, strong acid-suppressing effect, The effect of high safety factor
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Embodiment 1
[0041] Weigh 2g of edetate disodium in the prescribed amount, add 900ml of water for injection to dissolve, add 20g of rabeprazole sodium in the prescribed amount, add an appropriate amount of 1mol / L sodium hydroxide solution, stir to dissolve, and oxidize with 1mol / L hydroxide Adjust the pH value of the sodium solution to 11.2, add water for injection to 1000ml, add 0.1% activated carbon for needles, stir for 15 minutes, filter to remove the activated carbon, and use a 0.22??m microporous membrane to sterilize and fine filter. Quantitatively fill in sterile vials, press the stopper, put the subpackaged product solution on the inner partition of the freeze-drying box and pre-freeze at -45°C for 4 hours, so that the vacuum in the drying box is below 13.33Pa. Then slowly heat up to make the temperature of the product gradually rise from -45°C to -15°C for sublimation drying. After the sublimation drying is completed, continue to heat up and continue drying the product at 40°C for...
Embodiment 2
[0043] Weigh 4g of edetate disodium in the prescribed amount, add 900ml of water for injection to dissolve, add 20g of rabeprazole sodium in the prescribed amount, add an appropriate amount of 1mol / L sodium hydroxide solution, stir to dissolve, and hydrate with 1mol / L hydroxide Adjust the pH value of the sodium solution to 12.5, add water for injection to 1000ml, add 0.1% activated carbon for needles, stir for 15 minutes, filter to remove the activated carbon, and use a 0.22? Quantitatively fill in sterile vials, press the stopper, put the subpackaged product solution on the inner partition of the freeze-drying box and pre-freeze at -45°C for 4 hours, so that the vacuum in the drying box is below 13.33Pa. Then slowly heat up to make the temperature of the product gradually rise from -45°C to -15°C for sublimation drying. After the sublimation drying is completed, continue to heat up and continue drying the product at 40°C for 5 hours to obtain a freeze-dried powder. Press the p...
Embodiment 3
[0045] Weigh 8g of edetate disodium in the prescribed amount, add 900ml of water for injection to dissolve, add 20g of rabeprazole sodium in the prescribed amount, add an appropriate amount of 1mol / L sodium hydroxide solution, stir to dissolve, and hydrate with 1mol / L hydroxide Adjust the pH value of the sodium solution to 12.0, add water for injection to 1000ml, add 0.1% activated carbon for needles, stir for 15 minutes, filter to remove the activated carbon, and use a 0.22??m microporous membrane to sterilize and fine filter. Quantitatively fill in sterile vials, press the stopper, put the subpackaged product solution on the inner partition of the freeze-drying box and pre-freeze at -45°C for 4 hours, so that the vacuum in the drying box is below 13.33Pa. Then slowly heat up to make the temperature of the product gradually rise from -45°C to -15°C for sublimation drying. After the sublimation drying is completed, continue to heat up and continue drying the product at 40°C for...
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