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A stable rabeprazole sodium compound

The technology of rabeprazole sodium and compound is applied in the field of rabeprazole sodium compound and preparation thereof, and can solve the problems of rabeprazole sodium having large number of impurities, high total amount of impurities, low optical purity and the like

Active Publication Date: 2011-11-30
TIANJIN HANRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0026] During the research process, repeating the method of the above patent literature, the obtained rabeprazole sodium has more impurities, higher total impurities, and lower optical purity.

Method used

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  • A stable rabeprazole sodium compound
  • A stable rabeprazole sodium compound
  • A stable rabeprazole sodium compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] Add 60 grams of rabeprazole sodium and 300 milliliters of water into a 500ml reaction flask equipped with stirring, thermometer and condenser, add 0.5 grams of dimethylformamide (DMF) to the above aqueous solution, stir for 30 minutes, filter, The filtrate was cooled to 12°C and set aside.

[0068] Cool 1150ml of acetonitrile-methyl ethyl ketone = 5:5 mixture to 13°C, add the above standby solution while stirring, keep warm for 18 hours, crystals precipitate, filter, and dry to obtain 53.3 grams of white crystals. Measured 3 times by Karl Fischer method, get the average value, contain 2.40% (weight percent) moisture. Purity 99.9% (HPLC normalization method), optical purity 99.96% ee (chiral HPLC).

[0069] Elemental Analysis Results:

[0070] Measured value (calculated value), C: 56.68 (56.68), H: 5.29 (5.29), N: 11.02 (11.01),

[0071] O: 12.58 (12.60) , S: 8.41 (8.40).

[0072] The X-ray diffraction pattern of the crystal is shown in figure 1 . Instrument model...

Embodiment 2

[0074] Capsules containing rabeprazole sodium compound

[0075] Prescription: 20 grams of rabeprazole sodium compound, 100 grams of mannitol, 140 grams of lactose, 50 grams of calcium carbonate, 5 grams of magnesium stearate, appropriate amount of 8% ethyl cellulose solution, 1000 enteric-coated capsules, made into 1000 grain.

[0076] Process: Mix rabeprazole sodium compound, mannitol, lactose, and calcium carbonate evenly; add an appropriate amount of binder 8% ethyl cellulose solution to make a soft material, granulate with a 20-mesh screen, and dry at 40°C±2°C , granulated, added externally mixed with magnesium stearate, mixed evenly, packed into capsules, and obtained.

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Abstract

The invention belongs to the technical field of medicines and particularly relates to a rabeprazole sodium compound and a preparation method thereof. Rabeprazole sodium provided by the invention contains less water and has the advantages of chemical purity up to 99.9%, maximum impurity content less than 0.1%, optical purity up to 99.96%ee and good stability. The compound provided by the inventionhas low production cost and stable quality, and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a rabeprazole sodium compound and a preparation method thereof. Background technique [0002] Stomach acid can help digestion, but if there is too much stomach acid, it will damage the stomach and duodenum. When gastric acid is secreted too much, symptoms of acid regurgitation, acid regurgitation, and acid regurgitation will appear. In addition to gastric and duodenal ulcers, it can also cause reflux esophagitis. Gastric and duodenal ulcers are very common diseases. If left untreated, many serious complications can occur, such as bleeding, pyloric obstruction, perforation, and even cancer, which is life-threatening. The incidence of reflux esophagitis in my country is also increasing year by year. Therefore, it is particularly important to inhibit the excessive secretion of gastric acid. Clinically, there are three commonly used antiacids: antacids, proton pump in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D401/12A61K31/4439A61P1/04
Inventor 严洁黄欣
Owner TIANJIN HANRUI PHARMA
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