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Dexlansoprazole crystal form III and preparation method and application thereof

A technology of lansoprazole crystal and dexlansoprazole, which is applied in the field of dexlansoprazole crystal form III and its preparation and application, can solve problems such as disturbing sleep, great harm, and reduced quality of life, and facilitates production , high biological activity, the effect of relieving burning sensation

Inactive Publication Date: 2015-11-04
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] GERD is very harmful. Patients need to endure the pain of the disease for a long time. GERD attacks at night will seriously interfere with sleep.

Method used

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  • Dexlansoprazole crystal form III and preparation method and application thereof
  • Dexlansoprazole crystal form III and preparation method and application thereof
  • Dexlansoprazole crystal form III and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0080] Preparation of dexlansoprazole crystal form III: Take 10 grams of dexlansoprazole into a 250 ml round bottom flask, add 60 ml analytically pure ethyl acetate, 300 ml n-hexane and activated carbon, heat, reflux, and filter. The filtrate was placed at room temperature for 1 hour, filtered, the filter cake was washed, and dried under reduced pressure at 50-60°C to obtain 9.8 g of dexlansoprazole crystal form with a melting point of 137-140°C.

[0081] The XRD pattern of dexlansoprazole form III has peaks at 6.66, 9.18, 9.94, 10.96, 13.04, 14.74, 14.94, 15.42, 15.66, 17.62, 19.72, 21.00, 24.04, 26.10 and 28.68.

[0082] Infrared absorption spectrum at 3082, 2983, 2890, 2808, 2696, 1584, 1478, 1440, 1305, 1265, 1225, 1044, 1007, 858, 659 and 417cm -1 It has a characteristic band, and its DSC endothermic transition is 137.11-139.78°C.

[0083] See figure 1 , figure 2 , image 3 .

Embodiment 2

[0085] Preparation of dexlansoprazole crystal form III 30mg capsule

[0086] Prepare capsules with the following composition:

[0087]

[0088] Preparation Process:

[0089] Prepare 1000 granules in a kilogram-level wet granulator with high shear force according to the prescription, and place the dexlansoprazole crystal form III in the wet granulator and add sucrose-starch spherical granules and magnesium carbonate in turn. , Pure sucrose, corn starch, low-substituted hydroxypropyl cellulose and hydroxypropyl cellulose, stir for 30 minutes and mix well. The soft material is made of water, granulated in a swing granulator with a 24-mesh sieve, and the wet granules obtained are dried in an oven at 60°C for 4 hours, and then granulated with a 30-mesh shaking sieve. Capsules.

Embodiment 3

[0091] Preparation of dexlansoprazole crystal form III 60mg capsule

[0092] Prepare capsules with the following composition:

[0093]

[0094] Preparation Process

[0095] Prepare 1000 granules in a kilogram-level wet granulator with high shear force according to the prescription, and place the dexlansoprazole crystal form III in the wet granulator and add sucrose-starch spherical granules and magnesium carbonate in turn. , Pure sucrose, corn starch, low-substituted hydroxypropyl cellulose and hydroxypropyl cellulose, stir for 30 minutes and mix well. The soft material is made of water, granulated in a swing granulator with a 24-mesh sieve, and the wet granules obtained are dried in an oven at 60°C for 4 hours, and then granulated with a 30-mesh shaking sieve. Capsules.

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Abstract

The invention belongs to the field of a medical technology and relates to a dexlansoprazole crystal form III, its preparation method and an application of the dexlansoprazole crystal form III in preparation of medicines for treatment of various degrees of erosive esophagitis (EE), maintenance treatment of erosive esophagitis and relief of burning heat sensation, stomach burning heat sensation caused by non-erosive gastroesophageal reflux disease (GERD) and the like. The dexlansoprazole crystal form III is characterized by X-ray powder diffraction spectrum, differential thermal analysis spectrum and infrared spectrum. X-ray powder diffraction characteristic absorption peak (2 theta) values of the crystal form are 6.66, 9.18, 9.94, 10.96, 13.04, 14.74, 14.94, 15.42, 15.66, 17.62, 19.72, 21.00, 24.04, 26.10 and 28.68. The crystal form shows excellent physicochemical property, is economic in solvent recovery, has relatively stable water content and can be directly used in preparations of drugs such as capsules and granules so as to improve properties of preparations.

Description

Technical field [0001] The present invention belongs to the technical field of medicine, and specifically relates to the technical field of drugs for the treatment of gastrointestinal diseases. More specifically, the present invention relates to dexlansoprazole crystal form III and its preparation method and its preparation for treating various degrees of erosions. Esophagitis (EE), maintenance treatment of erosive esophagitis and relief of burning sensation, non-erosive gastroesophageal reflux disease (GERD) caused by the burning sensation of the stomach and other aspects of the application of drugs. Background technique [0002] Gastroesophageal reflux disease (GERD) refers to a disease in which stomach contents flow back into the esophagus, causing uncomfortable symptoms and / or complications. GERD can be divided into three types: non-erosive reflux disease (NERD), erosive esophagitis (EE) and Barrett’s esophagus (BE), and can also be called GERD-related diseases. NERD refers ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D401/12A61K31/4439A61P1/04
CPCC07D401/12C07B2200/13
Inventor 郑志超梅林雨王杏林高晶杨志强罗振福
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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