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Recrystallization method of rabeprazole sodium

A technology of rabeprazole sodium and recrystallization, which is applied in the field of medicinal chemistry and achieves the effects of high purity and low impurity content

Active Publication Date: 2015-11-25
NANJING CHANGAO PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] There are many reports on the synthesis method of rabeprazole sodium, such as patent documents CN102952119A, CN102219777A, CN102993179, but there are few reports about its recrystallization method

Method used

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  • Recrystallization method of rabeprazole sodium

Examples

Experimental program
Comparison scheme
Effect test

reference example 1

[0018] Add 10 g of the crude rabeprazole sodium to a 500 mL eggplant-shaped bottle, and add acetone under heating until the crude product is completely dissolved. Stop heating and let stand for crystallization overnight. After filtration, 8.1 g of rabeprazole sodium was obtained. HPLC analysis showed that the impurity content was 0.8%.

reference example 2

[0020] Add 10 g of the crude rabeprazole sodium to a 500 mL eggplant-shaped bottle, and add cyclohexanone under heating until the crude product is completely dissolved. Stop heating and let stand for crystallization overnight. After filtration, 8.3 g of rabeprazole sodium was obtained. HPLC analysis showed that the impurity content was 1.2%. Example 1

Embodiment 1

[0021] Add 10 g of the crude rabeprazole sodium to a 500 mL eggplant-shaped flask, and add acetone-tetrahydrofuran (3:1) mixed solvent under heating until the crude product is completely dissolved. Stop heating and let stand for crystallization overnight. After filtration, 8.5 g of rabeprazole sodium was obtained. HPLC analysis showed that the impurity content was 0.4%.

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PUM

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Abstract

The invention belongs to the field of pharmaceutical chemistry and specifically relates to a recrystallization method of rabeprazole sodium. A mixed solvent of a ketone organic solvent and a cyclic ether organic solvent is used for crystallization, wherein the ketone organic solvent is preferably selected from acetone, methyl ethyl ketone and cyclohexanone; and the cyclic ether organic solvent is preferably selected from tetrahydrofuran and 1,4-dioxane. The rabeprazole sodium prepared according to the method has high purity, contains less impurities and accords with crude drug standards.

Description

Technical field [0001] The invention belongs to the field of medicinal chemistry, and specifically relates to a method for recrystallization of rabeprazole sodium. Background technique [0002] Sodium Reheprazole is a second-generation proton pump inhibitor, which inhibits gastric acid secretion by specifically inhibiting the action of the H+ / K+-ATPase system. It is the latest benzimidazole proton pump inhibitor after omeprazole and lansoprazole. It is clinically suitable for the treatment of peptic ulcers such as gastric ulcer, duodenal ulcer, reflux esophagitis and gastrinoma. Rabeprazole sodium was developed by Japan Eisai, and was launched in Japan in 1997. The dosage form is enteric-coated tablets. Currently on the market in 21 countries around the world, there are also many companies in China that produce rabeprazole sodium enteric-coated tablets and enteric-coated capsules. Rabeprazole sodium for injection was first approved for marketing in India by Cadila Pharmaceutic...

Claims

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Application Information

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IPC IPC(8): C07D401/12
CPCC07B2200/13C07D401/12
Inventor 张竞宋洁梅杜雪梅董莉施月芹王元黄海燕李纬
Owner NANJING CHANGAO PHARMA SCI & TECH CO LTD
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