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Preparation method for revaprzan medicine composition

A technology of loflupridine and composition, which is applied in the field of preparation of loflupridine pharmaceutical composition, can solve problems such as increased tablet hardness, achieve high dissolution rate, avoid electrostatic adhesion, and improve bioavailability

Active Publication Date: 2013-07-03
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0028] (4), the hardness of tablet increases;

Method used

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  • Preparation method for revaprzan medicine composition
  • Preparation method for revaprzan medicine composition
  • Preparation method for revaprzan medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] This example is used to illustrate the preparation method of loflupridine particles in the present invention.

[0092] The PM-L planetary ball mill is used, and then the loflupridine is milled with a water ball, filtered, washed with water, and dried to obtain loflupridine particles.

[0093] The specific process with water ball mill is as follows: use PM-L planetary ball mill, 200ml agate tank, equipped with large, medium and small agate balls, add 18g lorflupridine powder and 100~120ml water to the agate tank, at 42.5Hz (Approximately 570 rpm) for 2 hours.

[0094] Observed through a microscope, the particle diameter of most of the Loflupridine particles is less than 5 microns, and some of them are 12 microns. At the same time, the laser particle size analyzer produced by Omega Company is used for testing, and the D90 is less than 12 microns.

Embodiment 2

[0096] This example is used to illustrate the preparation method of loflupridine particles in the present invention.

[0097] A PM-L planetary ball mill is used to ball mill Lofopridine with water, filter, wash and dry to obtain Lofopridine particles.

[0098] The specific process with water ball mill is as follows: use PM-L planetary ball mill, 200ml agate tank, equipped with large, medium and small agate balls, add 18g lorflupridine powder and 100~120ml water to the agate tank, at 42.5Hz (Approximately 570 rpm) for 1.5 hours.

[0099] Observed through a microscope, the particle diameter of most of the Loflupridine particles is less than 5 microns, and some of them are 12 microns. At the same time, the laser particle size analyzer produced by Omega Company is used for testing, and the D90 is less than 12 microns.

Embodiment 3

[0101] This example is used to illustrate the preparation method of loflupridine particles in the present invention.

[0102] A PM-L planetary ball mill is used to ball mill Lofopridine with water, filter, wash and dry to obtain Lofopridine particles.

[0103] The specific process with water ball mill is as follows: use PM-L planetary ball mill, 200ml agate tank, equipped with large, medium and small agate balls, add 18g lorflupridine powder and 100~120ml water to the agate tank, at 42.5Hz (Approximately 570 rpm) for 1 hour.

[0104] Observed through a microscope, the particle diameter of some loflupridine particles is less than 5 microns, most of which are 20-30 microns. At the same time, the laser particle size analyzer produced by Omega Company is used for testing, and the D90 is less than 25 microns.

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Abstract

The invention relates to a preparation method for a revaprzan medicine composition. The preparation method for a revaprzan medicine composition comprises the following steps of: ball-milling revaprzan in the existence of water to prepare revaprzan particles; and mixing the obtained revaprzan particles with a medicinal excipient to prepare the revaprzan medicine composition. According to the preparation method for the revaprzan medicine composition disclosed by the invention, microparticulation treatment for revaprzan is realized by a ball-milling mode in the existence of water, so that the own static adhesion of the revaprzan particles can be avoided, the revaprzan particles are convenient to convey, and the process is simple and convenient for industrialized production. The medicine composition prepared by the method is high in dissolution rate, and capable of being used for preparing medicines for treating duodenal ulcer, gastric ulcer, gastritis, gastroesophageal reflux disease and functional dyspepsia, and eradicating the indications of Hp.

Description

Technical field [0001] The invention relates to a preparation method of a pharmaceutical composition, in particular to a preparation method of a loflupridine pharmaceutical composition. Background technique [0002] Loflupridine (Revaprazan, trade name Revanex) is a reversible proton pump inhibitor, its structural formula is as follows: [0003] [0004] The mechanism of action of Loflupridine is different from that of proton pump inhibitors (PPIs). + The competitive approach is combined with the K of the proton pump + At or near the binding site, the secretion of acid is directly blocked by a reversible mechanism. [0005] For example, the product code-named YH-1885 Lofopridine developed by YuHan Company of South Korea, its patent number is WO2008078922-A1. [0006] The pharmacological mechanism of Loflupridine is as follows: [0007] (1) Loflupridine does not have the acid activation of the parent compound, but directly inhibits gastric acid secretion. This is different from thiol-r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/506A61P1/04A61P1/14A61J3/00
Inventor 张晓东曹光罗振福黄淑云王平保蔡桂玲
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH