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Compound of pantoprazole sodium and a preparation method thereof

A technology for pantoprazole sodium and compound is applied in the refining field of pantoprazole sodium compound, and can solve the problems such as influence on clinical application, poor purity of pantoprazole sodium, decrease of preparation stability of pantoprazole sodium and the like , to achieve the effect of improving clinical drug effect, high yield and suitable for large-scale industrial production

Inactive Publication Date: 2012-06-20
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Existing a lot of patents have reported the preparation method and application of pantoprazole and salt thereof at present, but the pantoprazole salt of its preparation, especially pantoprazole sodium purity is relatively poor, causes the preparation stability of pantoprazole sodium Significantly decreased performance, affecting its clinical application

Method used

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  • Compound of pantoprazole sodium and a preparation method thereof
  • Compound of pantoprazole sodium and a preparation method thereof
  • Compound of pantoprazole sodium and a preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] 200 grams of pantoprazole sodium are dissolved in 1500 ml of water, add 10% sodium dihydrogen phosphate solution, adjust the pH value to 6.6, stir to separate out insoluble matter, filter, wash with 300 ml of purified water, then add 250 ml of ethanol to the gained solid Dissolve it, add the column filled with D101 macroporous resin to pass through, then elute the column with chloroform, collect the eluate, adjust the pH value to 10.3 with 2M potassium bicarbonate solution, precipitate the solid, centrifuge with 200ml ethanol Washing and vacuum drying at 40° C. for 7 hours gave 184.4 g of pantoprazole sodium refined product with a yield of 92.2% and a purity of 99.8%.

Embodiment 2

[0033] 200 grams of pantoprazole sodium are dissolved in 2000ml of water, add 5% potassium hydrogen tartrate solution, adjust the pH value to 7.0, stir to precipitate insoluble matter, filter, wash with 200ml of purified water, then add 300ml of methanol to the resulting solid to make it Dissolve, add to the column filled with AB-8 macroporous resin to pass through, then elute the column with chloroform, collect the eluate, adjust the pH value to 10.0 with 4M sodium bicarbonate solution, precipitate solid, centrifuge, and use 200ml After washing with ethanol and vacuum drying at 37°C for 9 hours, 185.8 g of refined product of pantoprazole sodium was obtained, with a yield of 92.9% and a purity of 99.9%.

Embodiment 3

[0035] 200 grams of pantoprazole sodium are dissolved in 1800ml of water, add 5M sodium bisulfate solution, adjust the pH value to 6.5, stir to separate out the insoluble matter, filter, wash with 300ml of purified water, then add 300ml of dichloromethane in the gained solid to make Dissolve it, add the column filled with D101 macroporous resin to pass through, then elute the column with chloroform, collect the eluate, adjust the pH value to 9.8 with 10% sodium bicarbonate solution, precipitate the solid, centrifuge with 300ml After washing with ethanol and vacuum drying at 40° C. for 8 hours, 181.6 g of refined pantoprazole sodium was obtained, with a yield of 90.8% and a purity of 99.9%.

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Abstract

The invention relates to a compound of pantoprazole sodium and a preparation method thereof, belonging to the technical field of medicines. By the inventive method, the refined product of pantoprazole with high yield above 90% and high purity above 99.8% is obtained, thus improving the stability and clinical application effect of the pantoprazole sodium preparation. The method of the method is simple, easy to operate, and suitable for large industrial production.

Description

technical field [0001] The invention relates to a method for refining pantoprazole sodium compound, which belongs to the technical field of medicine. Background technique [0002] Pantoprazole sodium, its chemical name is: 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)-methyl]-sulfinyl-1H-benzo Imidazole sodium salt monohydrate, molecular formula: C 16 h 35 f 2 N 3 NaO 4 S, molecular weight: 426.52, structural formula: [0003] [0004] As a proton pump inhibitor, H + -K + -Covalent binding of two sites of the ATPase system inhibits the final step of gastric acid production in a dose-dependent manner and inhibits both basal and stimulated gastric acid secretion. It is suitable for acute upper gastrointestinal bleeding such as duodenal ulcer, gastric ulcer, acute gastric mucosal lesions, and compound gastric ulcer. [0005] Existing a lot of patents have reported the preparation method and application of pantoprazole and salt thereof at present, but the pantoprazo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D401/12A61P1/04
Inventor 张锡芬
Owner HAINAN LINGKANG PHARMA CO LTD
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