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Montelukast sodium granules and preparation method thereof

A technology of montelukast sodium and granules, applied in the field of montelukast sodium granules and its preparation, can solve problems such as poor control of drying temperature, migration of soluble components, poor tablet stability, etc., and achieve convenient and comfortable taking. , Improve stability, and show rapid effect

Active Publication Date: 2018-05-22
南京康舟医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Wet granulation is often used in the process, the drying time is long, the drying temperature is not easy to control, and the soluble components are easy to migrate during the drying process, resulting in a decrease in content and an increase in related substances. The resulting tablet has poor stability and is prone to discoloration and decomposition when exposed to light.

Method used

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  • Montelukast sodium granules and preparation method thereof
  • Montelukast sodium granules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] The Montelukast sodium granules provided in this embodiment are prepared by dry granulation of raw materials. In terms of weight percentage, the raw materials include the following ingredients:

[0044] Montelus Turner 0.5%,

[0045] Mannitol 35%,

[0046] Anhydrous Lactose 43.5%,

[0047] Microcrystalline Cellulose 20%,

[0048] Flavoring agent 0.5%,

[0049] Lubricant 0.5%.

[0050] Wherein, the flavoring agent is cyclamate, and the lubricant is magnesium stearate.

[0051] Preparation method: take montelukastina and anhydrous lactose according to the formula and pass through a 100-mesh sieve respectively, and mix evenly; take mannitol, microcrystalline cellulose and flavoring agent and pass through a 80-mesh sieve respectively, and then mix with montelukast The mixture of sodium and anhydrous lactose is mixed evenly; put the total mixture in a dry granulator, set the parameters, the pressure is 20Mpa, the motor speed is 30rpm, adjust the mesh size of the whole m...

Embodiment 2

[0054] The Montelukast sodium granules provided in this example are prepared from raw materials by dry granulation, and the ingredients of the raw materials are the same as those in Example 1.

[0055]Preparation method: take montelukastina and anhydrous lactose according to the formula and pass through a 100-mesh sieve respectively, and mix evenly; take mannitol, microcrystalline cellulose and flavoring agent and pass through a 80-mesh sieve respectively, and then mix with montelukast The mixture of sodium and anhydrous lactose is mixed evenly; put the total mixture in a dry granulator, set the parameters, the pressure is 2Mpa, the motor speed is 30rpm, adjust the mesh size of the whole material screen, so that the particle size reaches 10 mesh, and add lubricant , Determining the content of intermediates; adding the prepared granules into the hopper of the granule filling machine, adjusting the sub-metering device, setting the volume of each package to 0.5g, and sub-packing t...

Embodiment 3

[0058] The Montelukast sodium granules provided in this embodiment are prepared by fluidized bed granulation of the raw materials, and the raw materials include the following components by weight percentage:

[0059] Montelus Turner 0.5%,

[0060] Mannitol 35%,

[0061] Anhydrous Lactose 43.5%,

[0062] Microcrystalline Cellulose 20%,

[0063] Binder 2%

[0064] Flavoring agent 0.5%,

[0065] Lubricant 0.5%.

[0066] Wherein, the flavoring agent is cyclamate, and the lubricant is magnesium stearate.

[0067] Preparation:

[0068] Pass raw materials such as montelukast sodium, anhydrous lactose, mannitol, microcrystalline cellulose, flavoring agent and other auxiliary materials through a 100-mesh sieve, and mix evenly; suck the total mixed material into the fluidized bed, and spray it with top spray, Use absolute ethanol as the binder, set the spray speed to 1.5ml / min, the blast speed to 3L / min, and the heating temperature to 20°C, so that the moisture content of the par...

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Abstract

The invention disclose montelukast sodium granules and a preparation method thereof, and relates to the field of a montelukast sodium preparation. The montelukast sodium granules provided by the invention are prepared from a raw material by dry granulation or fluidized bed granulation; the raw material comprises the following components in percentage by weight: 0.5% to 1.5% of montelukast sodium,35% to 65% of mannitol, 15% to 45% of lactose anhydrous, 10 to 30% of microcrystalline cellulose, 0% to 20% of adhesive used when a fluidized bed is adopted to carry out granulation, 0.5% to 3.5% of corrigent and 0.5% to 5% of lubricant. The montelukast sodium granules not only have the characteristics of rapid absorption, good dissoluvability, rapid response, convenience and comfort for taking, good taste and the like, but also have excellent stability.

Description

technical field [0001] The invention relates to the field of montelukast sodium preparations, in particular to a montelukast sodium granule and a preparation method thereof. Background technique [0002] Asthma is a chronic inflammatory disease characterized by tracheal hyperresponsiveness and reversible airway obstruction. Leukotrienes are one of the important mediators of bronchial asthma, and they play a key role in the occurrence and development of asthma. Studies have shown that the response it causes is similar to the pathological changes of asthma, whether in vivo or in vitro, and it does not matter in patients with asthma. Period or stable period its level is higher than normal. Leukotriene receptor antagonists have become a new approach in the treatment of asthma. [0003] Montelukast is a highly specific cysteine ​​leukotriene receptor antagonist that blocks the interaction between cysteine ​​leukotrienes and receptors, thereby blocking the tracheal response to l...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/47A61K47/26A61K47/38A61P11/06
CPCA61K9/1623A61K9/1652A61K9/1694A61K31/47
Inventor 孙浩张瑾
Owner 南京康舟医药科技有限公司
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