Rapidly-dissolving and stabile montelukast oral solid preparation and preparation method thereof

A technology of montelukast sodium and solid preparation, which is applied in the field of leukotriene receptor antagonists, can solve the problems of increase in substance, decrease in content, inequivalence, etc., so as to improve the dissolution rate, improve the stability, and avoid unequal effect of risk

Active Publication Date: 2013-08-14
QILU PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The currently disclosed montelukast sodium tablets adopt direct powder-mixing and wet granulation technology, and under the condition of no additives in the prescription, it is easy to lead to a decrease in content and an increase in related substances, etc.
The samples prepared by the above two processes were compared with "Sing

Method used

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  • Rapidly-dissolving and stabile montelukast oral solid preparation and preparation method thereof
  • Rapidly-dissolving and stabile montelukast oral solid preparation and preparation method thereof
  • Rapidly-dissolving and stabile montelukast oral solid preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] Example 1. Prescription composition of montelukast sodium tablets: specification 10 mg (calculated as montelukast), prescription quantity is 1000 tablets.

[0077]

[0078] Preparation:

[0079] Take the prescribed amount of montelukast sodium and pass through a 100-mesh sieve, and microcrystalline cellulose, lactose, croscarmellose sodium, hyprolose, and magnesium stearate pass through a 60-mesh sieve respectively;

[0080] Get the sodium hydroxide of prescription quantity, add appropriate amount of water to be mixed with 0.5% sodium hydroxide aqueous solution, set aside.

[0081] Put the above-mentioned montelukast sodium, microcrystalline cellulose, lactose, croscarmellose sodium, and hyprolose into a wet mixing granulator and mix evenly; Add the prepared amount of 0.5% sodium hydroxide aqueous solution into the machine, high-speed shear granulation, oven-dry at 50-60°C, and granulate; then add magnesium stearate, and mix in a mixer. Tablet.

[0082] Opadry coa...

Embodiment 2

[0083] Example 2. Prescription composition of montelukast sodium tablets: specification 10 mg (calculated as montelukast), prescription quantity is 1000 tablets.

[0084]

[0085] Preparation:

[0086] Take the prescribed amount of montelukast sodium and pass through a 100-mesh sieve, and microcrystalline cellulose, lactose, croscarmellose sodium, hyprolose, sodium carbonate, and magnesium stearate pass through a 60-mesh sieve respectively;

[0087] Put the above-mentioned montelukast sodium, microcrystalline cellulose, lactose, croscarmellose sodium, hydroxypropyl cellulose, and sodium carbonate in a mixer and mix evenly, then add magnesium stearate and mix . Direct mixing powder compression tablet.

[0088] Opadry coating powder 32K12968 (coating material) is used to coat the obtained montelukast sodium tablets, and the consumption of Opadry coating powder 32K12968 is 4% of the total amount of the above-mentioned montelukast sodium tablets, namely 8.00 g, coated to mak...

Embodiment 3

[0089] Embodiment 3. Montelukast Sodium Chewable Tablets Prescription Composition: Specification 5mg (calculated as Montelukast), prescription quantity is 1000 tablets

[0090]

[0091] Preparation:

[0092] Take the prescribed amount of montelukast sodium and pass through a 100-mesh sieve, red iron oxide through a 80-mesh sieve, mannitol, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, cherry flavor, aspartame and magnesium stearate respectively through a 60 mesh sieve;

[0093] Get the sodium hydroxide of prescription quantity, add appropriate amount of water to be mixed with 0.7% sodium hydroxide aqueous solution, set aside.

[0094] Put the above-mentioned montelukast sodium, mannitol, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, red iron oxide, cherry essence and aspartame in a wet mixing Mix evenly in the granulator; add the prepared amount of 0.7% sodium hydroxide aqueous solution into the wet mixing granul...

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Abstract

The invention relates to a rapidly-dissolving and stabile montelukast oral solid preparation and a preparation method thereof, wherein the preparation uses montelukast as a raw material drug, is added with a diluents, a disintegrating agent, an additive, an adhesive and a lubricant as auxiliary materials, and uses a pharmaceutically acceptable preparation technology. The preparation and the preparation technology can raises a dissolving speed of the oral preparation, enables the oral preparation to substantially raise the dissolving speed in a dissolving mediums of pH1.0 and pH 4.5, and can raises the medicament stability.

Description

technical field [0001] The invention relates to a leukotriene receptor antagonist montelukast sodium oral solid preparation and a preparation method thereof. Background technique [0002] Montelukast sodium is a leukotriene regulator developed and marketed by Merck. It is widely used in the prevention and long-term treatment of bronchial asthma, exercise-induced asthma, and allergic rhinitis, especially in pediatric respiratory diseases. It is the only long-acting control drug that can be used alone in addition to inhaled hormones for asthma treatment at home and abroad in recent years. [0003] Montelukast sodium is a potent and selective leukotriene D4 receptor antagonist, which can selectively inhibit various stimuli (sulfur dioxide, exercise and cold air, etc.) and various allergens (pollen, dander, etc.) etc.) caused by the increase of inflammatory factor leukotriene polypeptide, thereby inhibiting the immediate phase and delayed phase inflammatory response, reducing o...

Claims

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Application Information

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IPC IPC(8): A61K31/47A61K47/04A61K9/16A61K9/20A61K9/30A61P11/06A61P11/02A61P37/08
Inventor 王晶翼杨兴国杨清敏于艳玲郑晓清张明会
Owner QILU PHARMA HAINAN
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