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Stable granular medicine composition containing epinastine or hydrochloride thereof

A technology of epinastine and composition, applied in the field of pharmaceutical technology preparation

Inactive Publication Date: 2013-08-21
BEIJING KEYUAN CHUANGXIN TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the instruction sheet of epinastine hydrochloride granules published by Japan’s independent administrative body Pharmaceuticals and Medical Devices Comprehensive Management Agency, it is mentioned that its prescription consists of erythritol, aspartame, hydroxypropyl cellulose, sodium saccharin, di Silicon oxide, monoammonium glycyrrhizinate, fumaric acid, disodium hydrogen phosphate, essence, etc., but there is no description or hint when epinastine hydrochloride is prepared by a common preparation method, in the prepared preparation, Epinastine hydrochloride, the active ingredient, decomposes significantly over time

Method used

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  • Stable granular medicine composition containing epinastine or hydrochloride thereof
  • Stable granular medicine composition containing epinastine or hydrochloride thereof
  • Stable granular medicine composition containing epinastine or hydrochloride thereof

Examples

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Embodiment 1

[0027]

Embodiment 2

[0029]

Embodiment 3

[0031]

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Abstract

The invention discloses a stable granular medicine composition containing epinastine or hydrochloride thereof. The stable granular medicine composition also comprises a binding agent which has a stabilizing effect on the epinastine or the hydrochloride thereof. Meanwhile, the invention also discloses a preparation method of the stable granular medicine composition. The granular medicine composition disclosed by the invention can also be used as a medicament which urgently needs to be developed in clinic and has an excellent effect on allergic reaction diseases of children.

Description

technical field [0001] The invention belongs to the field of pharmaceutical technology preparation, and in particular relates to a stable granular pharmaceutical composition formed by adopting epinastine or its hydrochloride and a specific binder and a preparation method thereof. Background technique [0002] Epinastine is as shown in the following structural formula (I): [0003] [0004] Structural formula (I) It is chemically known as 3-amino-9,13b-dihydro-1H-dibenzo[c,f]imidazo[1,5-a]azepine hydrochloride. It is reported that a series of substances, including epinastine or its hydrochloride, have highly selective affinity for H1 receptors, and have strong antagonistic effects on histamine, leukotriene C4, PAF, serotonin, etc. And can inhibit the release of chemical mediators such as histamine and SRS-A (slow reacting substance A). [0005] The granular composition involved in the present invention is clinically used for the treatment of children's allergic rhinitis,...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/55A61K47/34A61P11/02A61P17/00A61P17/04A61P37/08
Inventor 李晓红
Owner BEIJING KEYUAN CHUANGXIN TECH
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