Montelukast sodium membrane-shape preparation

A technology of montelukast sodium and film preparations, which is applied in the field of drug film preparations containing montelukast sodium, can solve the problems of mutual influence, different physical and chemical properties, influence the solubility of substance B, etc. the effect of interest

Active Publication Date: 2013-11-20
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The acidic agent and alkaline agent in the effervescent agent react during the pulping process and cannot remain in the film at the same time
2) When preparing the compound film, due to the different physical and chemical properties of the active ingredients in the compound, the suitable prescriptio

Method used

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  • Montelukast sodium membrane-shape preparation
  • Montelukast sodium membrane-shape preparation
  • Montelukast sodium membrane-shape preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] 1) Take 50g of montelukast sodium and 700ml of distilled water, stir and disperse evenly, then add PEG40004g, 20g of citric acid, 20g of stevioside and 0.25g of erythrosin in turn while stirring, and finally add 106g of HPMC, stir evenly, 80-mesh sieve to remove insoluble matter and vacuum defoaming. Obtain slurry A.

[0067] 2) Take 50g of montelukast sodium and 700ml of distilled water, stir and disperse evenly, then add PEG40004g, calcium carbonate 20g, stevioside 20g and erythrosin 0.25g in sequence while stirring, and finally add HPMC106g, stir evenly, 80-mesh sieve to remove insoluble matter and vacuum defoaming. Obtain slurry B.

[0068] Add the slurry A and the slurry B into the dosing tank, which is composed of two parallel small tanks with a width of 1.2 cm, and the width of the partition between the small tanks is 0.1 cm. Start the coating dryer, coat with a coating blade, spread the film on a stainless steel belt, and dry at 80°C for 10 minutes. Due to th...

Embodiment 2

[0074] 1) Take 26g of montelukast sodium and add 800ml of distilled water, stir to disperse evenly, then add 10g of PEG400, 4g of tartaric acid, 10g of sodium saccharin and 0.2g of erythrosin in sequence while stirring, and finally add 100g of HPC and 50g of PVP, stir evenly, 80-mesh sieve to remove insoluble matter and vacuum defoaming. Obtain slurry A.

[0075] 2) Take 26g of montelukast sodium and add 800ml of distilled water, stir and disperse evenly, then add 10g of PEG400, 4g of sodium carbonate, 10g of sodium saccharin and 0.2g of allura red pigment in turn while stirring, and finally add 100g of HPC and 50g of PVP, stir at high speed, 80-mesh sieve to remove insoluble matter and vacuum defoaming. Obtain slurry B.

[0076] Add the slurry A and the slurry B into the dosing tank, which is composed of two parallel small tanks with a width of 1.2 cm, and the width of the partition between the small tanks is 0.1 cm. Start the coating dryer, coat with a coating blade, spre...

Embodiment 3

[0082] 1) Take 10g of montelukast sodium and 500ml of distilled water, stir and disperse evenly, then add 10g of acesulfame potassium, 20g of cyclamate, 10g of titanium dioxide, 2g of vitamin E and 15g of fumaric acid while stirring, and finally add 100g of PEO and 33g of maltodextrin , stir evenly, pass through an 80-mesh sieve, remove insoluble matter, and vacuum defoam. Obtain slurry A.

[0083] 2) Take 60g of montelukast sodium and 600ml of distilled water, stir, and disperse evenly, then add 15g of aspartame, 10g of titanium dioxide, and 15g of potassium bicarbonate while stirring, and finally add 100g of PEO, stir evenly, pass through an 80-mesh sieve, and remove Insoluble matter, vacuum defoaming. Obtain slurry B.

[0084] Add the slurry A and the slurry B into the dosing tank, which is composed of two parallel small tanks with a width of 1.2 cm, and the width of the partition between the small tanks is 0.1 cm. Start the coating dryer, coat with a coating blade, spre...

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Abstract

The invention provides a Montelukast sodium film-like preparation, comprising a strip film belt and a treatment effective dose of an active medicine loratadine loaded on the strip film belt, wherein the strip film belt comprises acidic strip film belts and alkaline strip film belts, the acidic strip film belts and the alkaline strip film belts are connected to form one body and alternately arranged, each acidic strip film belt uses a highly water-soluble polymer film forming material as a main body and contains 1 to 20% of an acidic agent on the basis of the weight of the acidic strip film belt, and each alkaline strip film belt uses the highly water-soluble polymer film forming material as a main body and contains 1 to 20% by weight of an alkaline agent on the basis of the weight of the alkaline strip film belt. In the presence of water, the Montelukast sodium film-like preparation provided by the invention becomes an effervescent film, generates considerable bubbles, paralyzes olfactory sensation of people so as to mask odor and is accelerated in dissolving-out.

Description

technical field [0001] The invention relates to a montelukast sodium preparation, in particular to a drug film preparation containing montelukast sodium. Background technique [0002] Montelukast sodium is a potent selective leukotriene D receptor antagonist, which can selectively inhibit the activity of leukotriene polypeptides in airway smooth muscle, block the combination of leukotriene and receptors, and effectively prevent and Inhibit the increase of vascular permeability, airway eosinophil infiltration and bronchospasm caused by leukotrienes, reduce the cellular and non-cellular inflammatory substances in the airway caused by allergen stimulation, reduce airway inflammation, and inhibit Allergen-provoked airway hyperresponsiveness, thereby controlling asthma symptoms. It is prepared into a drug film preparation, which does not need to be taken with water and dissolves on the tongue. It is especially suitable for children, improves patient compliance, and is welcomed b...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K9/46A61K31/47A61P11/06A61P11/00A61P11/02A61P37/08A61K47/34
Inventor 陈芳侯惠民夏怡然
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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