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Chewable tablet containing montelukast sodium

A technology of montelukast sodium and chewable tablets, which is applied in the field of chewable tablets containing montelukast sodium, can solve the problem of not mentioning other effects of colorants, montelukast sodium is easy to change color when exposed to light, and inconvenient for mass production in workshops and other problems, to avoid the decomposition of visible light, improve the operability, and facilitate the production operation.

Active Publication Date: 2013-01-16
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But still there are following problems at present: 1) montelukast sodium is easy to change color and decompose when seeing light, so it must be shaded all the time during production, which causes inconvenience to the batch production in the workshop; 2) the lubricant magnesium stearate commonly used during production is harmful to The stability of this product has obvious influence
Among them, paragraph 4 on page 6 of the description discloses that the coloring agent iron oxide (red, yellow or black) focuses on improving the appearance of the pharmaceutical preparation, and / or makes it easier for patients to identify the preparation, but does not mention other aspects of the coloring agent. effect

Method used

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  • Chewable tablet containing montelukast sodium
  • Chewable tablet containing montelukast sodium
  • Chewable tablet containing montelukast sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1 Montelukast Sodium Chewable Tablets

[0031] Montelukast Sodium 5.2g

[0032] Microcrystalline Cellulose 30g

[0033] Mannitol 60.7g

[0034] Iron Oxide Red 1.5

[0035] 4% PVPK30 ethanol solution 40g

[0036] Zinc stearate 1.0g

[0037] Preparation process: pass montelukast sodium and iron oxide red through a 120-mesh sieve, microcrystalline cellulose and mannitol through a 100-mesh sieve, and then mix iron oxide red and montelukast sodium evenly in equal amounts, After mixing, pass through a 100-mesh sieve for 2 times, then mix the above-mentioned mixed powder with mannitol in equal increments, pass through a 80-mesh sieve after mixing each time, and then add all the internally added raw and auxiliary materials to 4% PVPK 30 The ethanol solution is granulated, after drying, the prescribed amount of zinc stearate is added, mixed evenly, and compressed into tablets.

Embodiment 2-6

[0038] Example 2-6 Montelukast Sodium Chewable Tablets

[0039] For convenience of description, Table 1 describes Examples 2-6 below. The preparation process of embodiment 2-6 is the same as embodiment 1.

[0040] Table 1 Example 2-6 Montelukast Sodium Chewable Tablet Technology Prescription

[0041]

[0042] Note: "Example 2" in the table indicates the content of each prescription corresponding to Example 2, and the unit is g; Example 3-Example 6 can be deduced by analogy.

Embodiment 7-12

[0043] Example 7-12 Montelukast Sodium Chewable Tablets

[0044] For convenience of description, Table 2 describes Examples 7-12 below. The preparation technology of embodiment 7-12 is the same as embodiment 1.

[0045] Table 2 Example 7-12 Montelukast Sodium Chewable Tablet Technology Prescription

[0046]

[0047] Note: "Example 7" in the table represents the content of each prescription corresponding to Example 7, and the unit is g; Example 8-Example 12 and so on.

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Abstract

The invention belongs to the field of medicine preparations, which particularly relates to a chewable tablet of montelukast sodium. Because the production process of the chewable tablet of the montelukast sodium needs the light shielding operation at present, the mass production is inconvenient, and the chewable tablet of the montelukast sodium has the defect of poorer stability. In the invention, zinc stearate and an opacifier of iron oxide red, iron oxide yellow and titanium dioxide are added into the auxiliary materials of a chewable tablet of montelukast, so that the content of relevant substances can be lowered, and the stability of the chewable tablet is enhanced.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a chewable tablet containing montelukast sodium. Background technique [0002] Asthma is a chronic inflammatory disease characterized by tracheal hyperresponsiveness and reversible airway obstruction. As a common chronic disease, it afflicts nearly 10% of the population in developed countries, causing social and economic losses of tens of billions of dollars. In recent decades, the incidence of asthma at home and abroad, especially the incidence of childhood asthma is on the rise. According to the "epidemiological survey" in Shanghai in 2000, the incidence rate of asthma in children was 4.52%, which was 153.51% higher than that of 10 years ago, and children aged 2 to 5 accounted for 50.91%. [0003] Montelukast is a highly selective cysteinyl leukotriene receptor antagonist developed by Merck, which can competitively antagonize the binding of leukotriene D4 to Cys-LT1...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/47A61K47/38A61K47/14A61K47/02A61P11/06
Inventor 赵志全
Owner LUNAN PHARMA GROUP CORPORATION
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