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Montelukast sodium pulse capsule and preparation method thereof

A technology of Montelukast sodium and capsules, which is applied in the field of Montelukast sodium pulse-release capsules and its preparation, and can solve the problems of no patent reports on the dosage form of Montelukast sodium pulse capsules.

Active Publication Date: 2014-01-22
TIANYAO PHARMA TECH DEV SHANGHAI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The search found that although some common dosage forms of montelukast sodium have been developed, the dosage form of montelukast sodium pulse capsules designed according to the rhythm of asthma attacks has not yet been patented.

Method used

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  • Montelukast sodium pulse capsule and preparation method thereof
  • Montelukast sodium pulse capsule and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0024] Take 20 g of montelukast sodium, 880 g of lactose (200 mesh), 50 g of hypromellose (EF), and 50 g of croscarmellose sodium; dissolve the hypromellose with an appropriate amount of water, and then add montelukast Sodium, stir evenly; put lactose and croscarmellose sodium in a 4L wet process, first stir at 500rpm, cut and mix at 1000rpm for 180 seconds, then add the aforementioned binder solution containing the main ingredient under the same parameters; add After completion, granulate for an appropriate time, discharge the material, granulate with a 26-mesh oscillating granulator, and then dry to LOD<3.0%, that is, immediate-release granules.

[0025] Then take 30g of montelukast sodium, 690g of lactose (200 mesh), 40g of hypromellose (EF), and 40g of croscarmellose sodium; Sodium wurst, stir evenly; put lactose and croscarmellose sodium in a 4L wet method, first stir at 500rpm, cut and mix at 1000rpm for 180 seconds, and then add the aforementioned binder solution contai...

Embodiment 2

[0028] Take montelukast sodium 20g, microcrystalline cellulose 101 type 150g, lactose (200 mesh) 730g, hypromellose (EF) 50g, low-substituted hydroxypropyl cellulose 50g; Dissolve in water, then add montelukast sodium, and stir evenly; put the above-mentioned microcrystalline cellulose, lactose and low-substituted hydroxypropyl cellulose in a 4L wet process, first stir at 500rpm, cut and mix at 1000rpm for 180 seconds, and then mix the above-mentioned Add the binder solution of the main ingredient under the same parameters; after the addition, granulate for an appropriate time, discharge the material, extrude with a 1.0mm sieve, spheronize, and then dry to LOD<3.0%, that is, the speed Shi Xiaowan. Then get 30g of montelukast sodium, 120g of microcrystalline cellulose 101 type, 570g of lactose (200 mesh), 40g of hypromellose (EF), 40g of croscarmellose sodium; Dissolve in an appropriate amount of water, then add montelukast sodium, and stir evenly; put microcrystalline cellulo...

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Abstract

The invention discloses a montelukast sodium pulse capsule capable of releasing drugs in specific time. The montelukast sodium pulse capsule disclosed by the invention consists of a quick-release part and a release regulation part, wherein the quick-release part consists of quick-release powder or quick-release particles, and the powder or particles of the quick-release part is / are made from hydrophilic accessories; the release regulation part consists of release regulation particles, and the release regulation particles are covered with an exterior coating consisting of one or more pH dependent polymers. Compared with a common preparation, by adopting the pulse release capsule disclosed by the invention, the blood concentration reaches the peak when asthma easily attacks before dawn, the aim of hour treatment can be achieved, and the effectiveness and safety of drugs for asthma patients are improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to montelukast sodium time-selective pulse release capsules and a preparation method thereof. Background technique [0002] Montelukast sodium is a potent cysteinyl leukotriene 1 receptor antagonist drug, which can block the binding of leukotrienes to receptors and block the inflammatory effect of leukotrienes. By selectively inhibiting the activity of leukotriene polypeptides in airway smooth muscle, reducing the expression of vascular endothelial growth factor and adjusting vascular permeability, improving airway edema, effectively preventing and inhibiting airway eosinophil infiltration and bronchospasm. Studies have found that montelukast sodium can reduce the expression of IL-4mRNA in rats and significantly inhibit their delayed airway response. Therefore, montelukast sodium also has obvious immune regulation function, and it can be used clinically as a preventive dr...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/47A61P11/06
Inventor 王红喜
Owner TIANYAO PHARMA TECH DEV SHANGHAI
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