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A kind of montelukast sodium granule and preparation method thereof

A technology of montelukast sodium and granules, applied in the field of medicine, can solve problems such as hidden safety hazards and human harm, and achieve the effect of slowing down the impact and taking it safely.

Inactive Publication Date: 2016-09-21
珠海天翼医药技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The cis-isomer and montelukast are harmful substances, which are harmful to the human body, especially children, and have great potential safety hazards

Method used

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  • A kind of montelukast sodium granule and preparation method thereof
  • A kind of montelukast sodium granule and preparation method thereof
  • A kind of montelukast sodium granule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024]

[0025]

[0026] According to the above components, proceed as follows:

[0027] (1), stomach-soluble acrylic resin E (PO), titanium dioxide, talcum powder, polyethylene glycol are made into 10% gastric-soluble acrylic resin ethanol solution;

[0028] (2) After the raw materials are evenly mixed with mannitol and microcrystalline cellulose, use 1 / 3 of 10% gastric-soluble acrylic resin ethanol liquid to make a soft material, centrifugally spheronize, and dry at 40 OC to obtain particles below 60 mesh;

[0029] (3), the particles are placed in a fluidized bed, coated with 2 / 3 of 10% gastric-soluble acrylic resin coating liquid, and dried at 40°C for 2 hours;

[0030] (4), take the dried granules, add strawberry essence and aspartame and mix evenly;

[0031] (5) After the content was determined, the finished product 1 was obtained by dispensing according to the specification of 0.5 g containing 4 mg of montelukast.

Embodiment 2

[0033] Raw materials

[0034] According to the above formula, adopt the same preparation method as in Example 1, the difference is only in the replaced components, so as to obtain the finished product 2.

Embodiment 3

[0036]

[0037]

[0038] According to the above formula, adopt the same preparation method as in Example 1, the difference is only in the replaced components, so as to obtain the finished product 3.

[0039] According to above embodiment, carry out test, specifically as follows:

[0040] Stability research between the present invention and commercially available samples

[0041]

[0042] It can be seen from the above results that the stability of the product of the present invention is much stronger than that of the commercially available samples, and it is safer to use.

[0043] The release degree of the present invention and commercially available samples in artificial gastric juice

[0044] sampling time

[0045] As can be seen in this table, its release is stable and easy to absorb.

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Abstract

The invention provides a montelukast granule. The montelukast granule is prepared from the components in percentage by weight: 1-1.5 percent of montelukast, 50-60 percent of filler, 10-30 percent of gastric-soluble acrylic acid resin, 5-10 percent of talc, 1-3 percent of polyethylene glycol, 10-20 percent of titanium dioxide and 0.2-0.5 percent of flavoring agent. With the adoption of the montelukast granule, with the gastric-soluble acrylic acid resin as a coating material and the titanium dioxide as an opacifying agent, as the gastric-soluble acrylic acid resin is difficult to be dissolved in water, and due to the shading action of the titanium dioxide, the influence on the gastric-soluble acrylic acid resin under illumination is retarded, so that the montelukast granule is stable within 1 hour as well as is more safe and convenient to take. The invention also discloses a preparation method of the montelukast granule.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a montelukast sodium granule, and also relates to a preparation method of the montelukast sodium granule. Background technique [0002] Montelukast sodium is an oral selective leukotriene receptor antagonist that specifically inhibits the cysteinyl leukotriene (CysLT1) receptor. [0003] Cysteinyl leukotrienes (LTC4, LTD4, LTE4) are mediators of inflammation released by a variety of cells including mast cells and eosinophils. These important pro-asthmatic mediators bind to cysteinyl leukotriene (CysLT) receptors. Cysteinyl leukotriene type I (CysLT1) receptors are distributed in the human airways (including airway smooth muscle cells and airway macrophages) and other proinflammatory cells (including eosinophils and certain bone marrow stem cells) . CysLTs are associated with the pathophysiological processes of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects inclu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/47A61K47/32A61K47/02A61P11/06A61P11/08
Inventor 张晓明麦耀权
Owner 珠海天翼医药技术开发有限公司
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