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Composition containing montelukast and desloratadine and preparation method thereof

A technology of desloratadine and montelukast sodium, which is applied in the field of the combination of montelukast sodium and desloratadine and its preparation, and can solve the problems of cumbersome taking, frequent use, poor drug compliance of children, etc. , to achieve the effect of taking convenience and improving solubility

Inactive Publication Date: 2016-03-23
SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The purpose of the present invention is to overcome the technical problems of many existing products, cumbersome taking, and poor drug compliance for children, and provide a kind of montelukast sodium with good stability, convenient taking and suitable for children’s drug compliance / Desloratadine composition formulation and preparation method thereof

Method used

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  • Composition containing montelukast and desloratadine and preparation method thereof
  • Composition containing montelukast and desloratadine and preparation method thereof
  • Composition containing montelukast and desloratadine and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0027] Prescription composition of montelukast sodium / desloratadine granules: specification 4mg / 5mg (calculated as montelukast / desloratadine), prescription volume is 1000 bags.

[0028]

[0029] Preparation Process:

[0030] 1) Preparation of desloratadine-β-cyclodextrin inclusion compound

[0031] Add 5.30g of desloratadine to the reactor at room temperature and dissolve in 50ml of absolute ethanol; obtain the absolute ethanol solution of desloratadine; add 20.00g of β-cyclodextrin to the reactor and add 250ml of distilled water , make a saturated aqueous solution at 60°C, keep warm, and set aside. The above desloratadine absolute ethanol solution was slowly dripped into the stirred saturated aqueous solution, and when turbidity appeared, a white precipitate gradually precipitated out. After continuing to stir for 1 hour, continue stirring to room temperature, and finally cooled with an ice bath, and waited for the precipitate to separate out. After completion, suction f...

Embodiment 2

[0036] Prescription composition of Montelukast Sodium / Desloratadine Tablets: specification 10mg / 5mg (calculated as Montelukast / Desloratadine), prescription quantity is 1000 tablets.

[0037]

[0038] Preparation Process:

[0039] 1) Preparation of desloratadine-β-cyclodextrin inclusion compound

[0040] Add 5.30g of desloratadine to the reactor at room temperature and dissolve in 50ml of absolute ethanol; obtain the absolute ethanol solution of desloratadine; add 20.00g of β-cyclodextrin to the reactor and add 250ml of distilled water , make a saturated aqueous solution at 60°C, keep warm, and set aside. The above desloratadine absolute ethanol solution was slowly dripped into the stirred saturated aqueous solution, and when turbidity appeared, a white precipitate gradually precipitated out. After continuing to stir for 1 hour, continue stirring to room temperature, and finally cooled with an ice bath, and waited for the precipitate to separate out. After completion, suct...

Embodiment 3

[0045] Prescription composition of montelukast sodium / desloratadine chewable tablets: specification 5mg / 5mg (calculated as montelukast / desloratadine), prescription quantity is 1000 tablets.

[0046]

[0047] Preparation Process:

[0048] 1) Preparation of desloratadine-β-cyclodextrin inclusion compound

[0049] Add 5.30g of desloratadine to the reactor at room temperature and dissolve in 50ml of absolute ethanol; obtain the absolute ethanol solution of desloratadine; add 20.00g of β-cyclodextrin to the reactor and add 250ml of distilled water , make a saturated aqueous solution at 60°C, keep warm, and set aside. The above desloratadine absolute ethanol solution was slowly dripped into the stirred saturated aqueous solution, and when turbidity appeared, a white precipitate gradually precipitated out. After continuing to stir for 1 hour, continue stirring to room temperature, and finally cooled with an ice bath, and waited for the precipitate to separate out. After completi...

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Abstract

The invention relates to a composition containing montelukast and desloratadine and a preparation method thereof. The technical problem that existing products are frequently taken and are poor in child medication compliance is solved. The mass part ratio of montelukast to desloratadine is (4-10):5. The invention further provides the preparation method of the composition containing montelukast and desloratadine. The composition and the preparation method can be used in the field of preparation of medicine for treating cough variant asthma.

Description

technical field [0001] The invention relates to a medicine for treating cough variant asthma and a preparation method thereof, in particular to a composition of montelukast sodium and desloratadine and a preparation method thereof. Background technique [0002] Cough variant asthma (CVA), also known as allergic asthma or insidious asthma, is a special type of asthma that is characterized solely by chronic cough, and its prevalence in children is about 0.77%-5.0%. This type of cough is often a long-term intractable dry cough (duration > 1 month), which often occurs at night or is an early morning paroxysmal cough, which is aggravated after exercise. Respiratory irritants (eg, smoke), cold air, laughter, or coughing can all be inducing. Its pathogenesis is not yet clear, mainly persistent airway inflammation and then cause airway hyperresponsiveness. During the occurrence and development of chronic inflammation, mast cells, eosinophils, etc. participate, causing airway hy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/47A61K31/4545A61K47/48A61P11/06
CPCA61K31/47A61K31/4545A61K2300/00
Inventor 蔡琨岳德仁
Owner SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD