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Purification method of omeprazole

A technology of omeprazole and omeprazole sodium, applied in the direction of organic chemistry, etc., can solve the problems of poor purity of omeprazole, affecting clinical application, and decreased stability of omeprazole preparations, etc.

Inactive Publication Date: 2014-09-17
LIVZON PHARM GRP INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The prior art discloses the refining and purification method of omeprazole, and the purity of the obtained omeprazole is still very poor, which leads to a sharp decline in the stability of the preparation of omeprazole, which affects its clinical application

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] 20g omeprazole, 10g3, the 5-dichloronitrobenzene crude product is dissolved in 100ml acetonitrile / 20% methylamine trichloromethane mixed solvent, the mixing ratio of acetonitrile, 20% methylamine trichloromethane solution is 1: 1, temperature Raised to 50 degrees Celsius, maintained for 5 hours, during which the stirring continued;

[0015] Adjust the pH to 9.0 with sodium bicarbonate, lower the temperature to 0°C, and keep it for 1 hour to precipitate a solid, wash it with deionized water after centrifugation, and dry it in vacuum at 30°C for 5 hours. Obtained 18g of fine omeprazole with a purity of 99.5%.

Embodiment 2

[0017] 20g omeprazole, 10g3, the 5-dichloronitrobenzene crude product is dissolved in 100ml acetonitrile / 20% methylamine trichloromethane mixed solvent, the mixing ratio of acetonitrile, 20% methylamine trichloromethane solution is 1: 1, temperature Raised to 60 degrees Celsius, maintained for 6 hours, during which the stirring continued;

[0018] Sodium bicarbonate adjusted the pH to 11.0, lowered the temperature to 4 degrees Celsius, and kept it for 2 hours to precipitate a solid, washed with deionized water after centrifugation, and dried in vacuum at 40 degrees Celsius for 7 hours. Obtained 17.8 g of refined omeprazole with a purity of 99.3%.

Embodiment 3

[0020] 20g of omeprazole and 16g of crude 3,5-dichloronitrobenzene were dissolved in 100ml of solvent A, the temperature was raised to 60 degrees Celsius, and maintained for 6 hours, during which the stirring was continued;

[0021] Sodium bicarbonate adjusted the pH to 11.0, lowered the temperature to 4 degrees Celsius, and kept it for 2 hours to precipitate a solid, washed with deionized water after centrifugation, and dried in vacuum at 40 degrees Celsius for 7 hours. Get omeprazole boutique.

[0022] Solvent A is selected from acetonitrile / 20% methylamine chloroform mixed solvent (1:1), chloroform, acetonitrile, acetonitrile / 20% methylamine chloroform mixed solvent (2:1), acetonitrile / 20% methylamine Chloroform mixed solvent (2:1), acetonitrile / 20% methylamine chloroform mixed solvent (3:1), acetonitrile / 20% methylamine chloroform mixed solvent (1:2), acetonitrile / 20% methylamine Amine trichloromethane mixed solvent (1:3), the experimental results are shown in the table b...

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PUM

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Abstract

The invention aims to provide a purification method of omeprazole. A mixed solvent method is employed to refine omeprazole sodium, improve the purity and recovery rate of omeprazole sodium, and improve the quality of product preparation.

Description

technical field [0001] The invention relates to a method for purifying omeprazole. Background technique [0002] Omeprazole, also known as Losec, is a proton pump inhibitor that can effectively inhibit the secretion of gastric acid. It also has an inhibitory effect on pepsin secretion, does not significantly change gastric mucosal blood flow, and does not affect body temperature, gastric cavity temperature, arterial blood pressure, venous hemoglobin, arterial oxygen partial pressure, carbon dioxide partial pressure, and arterial blood pH. It is also effective for gastric and duodenal ulcers, reflux or erosive esophagitis, and Zoe-Ehrlich syndrome, etc. It is also effective for gastric and duodenal ulcers that are ineffective with H2 receptor antagonists. [0003] At present, many patents have reported the preparation method and application of omeprazole and its salts. The methods include single solvent crystallization method, mixed solvent crystallization method, acid-base ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D401/12
CPCC07D401/12
Inventor 汪华侯雪梅李敬焕曹娟
Owner LIVZON PHARM GRP INC