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

Inactive Publication Date: 2012-05-09
SHANDONG DANHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Rabeprazole sodium currently used clinically is mostly oral preparations. Since rabeprazole sodium is unstable under acidic conditions and is easily destroyed in gastric acid, it is mostly made into enteric-coated tablets or capsules at present, but oral drugs Hepatic first-pass effect, resulting in poor drug efficacy and low bioavailability

Method used

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  • Rabeprazole sodium for injection as well as preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

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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Abstract

The invention relates to rabeprazole sodium for injection as well as a preparation method and a detection method thereof. The rabeprazole sodium for injection is a medical preparation for injection, which is prepared from rabeprazole sodium as an active ingredient, a stabilizing agent, a pH value regulator and pharmaceutically acceptable auxiliary materials. The rabeprazole sodium for injection, disclosed by the invention, is rapid in effect taking and high in bioavailability, is used for treating gastrohelcosis, duodenal ulcer, erosive gastroesophageal reflux disease, helicobacter pylori injection, Zollinger-Ellision syndrome and the like and is more suitable for being used as a substitutive medicament when oral preparations for treating the diseases have no effect.

Description

technical field [0001] The invention relates to rabeprazole sodium for injection, a preparation method and a detection method thereof, and belongs to the technical field of pharmaceutical preparations. Background technique [0002] The chemical structure of rabeprazole sodium is: [0003] [0004] Chemical name: 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridyl]methyl]sulfinyl]-1H-benzimidazole sodium. [0005] Rabeprazole is a new generation of proton pump inhibitors developed by Japan's Eisai Company. It is the latest benzimidazole substitute after omeprazole and lansoprazole. It was first launched in Japan in 1997. The dosage form is oral solid preparation. On May 12, 2004, Rabeprazole Sodium for Injection was launched in India for the first time. In the treatment of gastric and duodenal ulcers, rabeprazole is similar to or even more effective than omeprazole; it is better than omeprazole in improving symptoms; in the treatment of gastric and esophageal reflux diseases, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/18G01N30/02A61P1/04A61P31/04
Inventor 赵涛
Owner SHANDONG DANHONG PHARMA
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