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Lansoprazole compound

A technology of lansoprazole and lansoprazole crystals, which is applied in the field of chemical drugs, can solve the problems of not showing anticholinergic or histamine H2 receptor characteristics, and achieve stable properties, short production cycle and high yield Effect

Active Publication Date: 2014-05-07
CHENGDU BAIYU PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It belongs to the compound of substituted benzimidazoles that inhibits gastric acid secretion, and its acid inhibitory effect is mainly by specifically blocking H on the surface of gastric parietal cells. + -K + - ATP transporter has acid secretion function, but this product does not show anticholinergic or histamine H2 receptor properties

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1. Lansoprazole crystal form and its preparation

[0032] Dissolve 10 g of lansoprazole in 26 mL of isobutanol: ammonia (volume ratio v / v of 25:1) solution and stir for 1.5 hours; filter with suction to remove insoluble solid particles that may exist; cool the solution to room temperature; Placed in an open container, crystals gradually precipitate out of the solution; collect the obtained crystal particles and vacuum-dry to constant weight at 60°C to obtain 9.45 g of lansoprazole crystal form of the present invention. The X-ray powder diffraction data is shown in figure 1.

Embodiment 2

[0033] Example 2 Lansoprazole crystal form and its preparation

[0034] Dissolve 16 g of lansoprazole in 54 mL of isobutanol: ammonia (volume ratio v / v: 25: 2) solution and stir for 1.5 hours; filter with suction to remove insoluble solid particles that may exist; cool the solution to room temperature; Placed in an open container, crystals gradually precipitate out of the solution; the obtained crystal particles are collected and dried in vacuum at 60°C to a constant weight to obtain 14.96g of lansoprazole crystal form of the present invention. Its X-ray powder diffraction data is consistent with Figure 1 is similar.

[0035] Example 2. Lansoprazole enteric-coated tablets and preparation method thereof

[0036] We used mannitol as the main dispersion, modified the prescription and preparation process, and formulated the following prescription, which achieved the expected effect. The prescription is as follows:

[0037]

[0038]

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PUM

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Abstract

The invention provides a lansoprazole crystal compound with favorable solubility and stability. The invention also provides a preparation method of the lansoprazole crystal compound and a pharmaceutical composition containing the lansoprazole crystal compound. The crystal compound is suitable for preparing any dosage forms including enteric-coated tablets, enteric capsules, enteric granules, lyophilized agents and the like which are pharmaceutically accepted. The invention also provides the preparation method of the lansoprazole crystal compound and an application of the lansoprazole crystal compound to the treatment of stomach illness.

Description

Technical field [0001] The invention belongs to the technical field of chemical medicine, and specifically relates to lansoprazole crystal form. Background technique [0002] The chemical name of Lansoprazole is: 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]- 1H-benzimidazole, the molecular structure is as follows: [0003] [0004] Molecular formula: C 16 H 14 F 3 N 3 O 2 S, molecular weight: 369.37. Lansoprazole is a new type of proton pump inhibitor. It belongs to substituted benzimidazole compounds that inhibit gastric acid secretion. Its acid suppression effect is mainly by specifically blocking the surface H of gastric parietal cells. + -K + -ATP transport enzyme has acid secretion function, but this product does not show anticholinergic or histamine H2 receptor properties. Because the above-mentioned enzymes play a role in transporting H+ in gastric parietal cells, similar to a proton pump, lansoprazole is also called a proton pump inhibitor, which ca...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D401/12A61K31/4439A61P1/04A61P1/02
CPCC07D401/12
Inventor 马魁洪军
Owner CHENGDU BAIYU PHARMA CO LTD
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