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Crystalline ilaprazole sodium hydrate and preparation method thereof

A technology of ilaprazole sodium and crystalline form, which is applied in the field of crystalline ilaprazole sodium hydrate and its preparation, achieving the effects of simple operation, mild reaction conditions and easy control

Active Publication Date: 2014-10-15
LIVZON PHARM GRP INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, the stability and bioavailability of the drug need to be further improved

Method used

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  • Crystalline ilaprazole sodium hydrate and preparation method thereof
  • Crystalline ilaprazole sodium hydrate and preparation method thereof
  • Crystalline ilaprazole sodium hydrate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] First place the 33% aqueous sodium hydroxide solution in the lower layer of the test tube, dissolve 100 mg of ilaprazole in isopropanol to prepare a saturated solution, and then carefully drop the solution onto the upper layer of the test tube (v / v 1:1) After standing at room temperature for liquid-liquid diffusion for about a week, 80 mg of light yellow needle-like crystals were obtained, and the yield was 80%.

Embodiment 2

[0038] Dissolve 100 mg of ilaprazole sodium in 40°C, pH 11 alkaline isopropanol to make a saturated solution, filter, and slowly lower the temperature to 4°C. After 12 hours, 86 mg of light yellow needle-like crystals are obtained, with a yield of 86%.

Embodiment 3

[0040] At room temperature, 100 mg of ilaprazole sodium was dissolved in isopropanol to make a saturated solution. The solution was placed in an isopropyl ether atmosphere for gas-liquid diffusion at room temperature. After 24 hours, 85 mg of light yellow needle crystals were obtained. The rate is 85%.

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PUM

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Abstract

The invention provides a crystalline Ilaprazole sodium hydrate and a preparation method thereof. An X ray powder diffraction spectrum of the crystalline Ilaprazole sodium hydrate provided by the invention includes diffraction peaks represented by the following 2 theta angles: 5.9 degrees + / - 0.1 degree, 25.4 degrees + / - 0.1 degree and 10.7 degrees + / - 0.1degree. The crystalline Ilaprazole sodium hydrate provided in the invention has high crystal purity. In addition, the method provided in the invention for preparation of the crystalline Ilaprazole sodium hydrate has the advantages of simple operation, mild reaction conditions, easy control, low production cost, definite obtaining of a target product crystal with good repeatability, less introduction of impurities, and significantly improves drug bioavailability.

Description

Technical field [0001] The invention belongs to the field of medicine and relates to a crystalline ilaprazole sodium hydrate and a preparation method thereof. Background technique [0002] Ilaprazole (Ilaprazole) structure belongs to the benzimidazole class and is an irreversible proton pump inhibitor. After oral administration, ilaprazole selectively enters gastric parietal cells and is converted into active metabolites of sulfenamide. It interacts with the sulfhydryl groups on H+ and K+-ATPase to form a covalent bond of disulfide bonds and irreversibly inhibit H+, K+- ATPase produces the effect of inhibiting gastric acid secretion. [0003] The first generation of PPI has limitations in clinical application because it can cause delayed gastric emptying, parietal cell swelling, and obvious gastric acid secretion rebound after drug withdrawal. As one of the new generation of proton pump inhibitors (PPI), ilaprazole has overcome some of the shortcomings of the original similar pro...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D401/14A61K31/4439A61P1/04
Inventor 郑赛利陈嘉媚鲁统部侯雪梅毛文金周月广曾创
Owner LIVZON PHARM GRP INC
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