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Montelukast sodium tablet and preparation method thereof

A technology of montelukast sodium tablet and montelukast sodium, which is applied in the field of pharmaceutical preparations, can solve the problems of long drying time, content drop, decomposition, etc., so as to avoid the increase of related substances, improve product stability, Avoid the effect of decreasing content

Active Publication Date: 2010-06-16
LUNAN PHARMA GROUP CORPORATION
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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 tablets produced by this method have good hardness and appearance, but there are still the following problems: 1) The drying time is long, the drying temperature is not easy to control, and the soluble components in the drying process can Migrate between particles, resulting in content differences between particles, easy to cause content decline and increase of related substances during storage
2) Montelukast sodium is easy to change color and decompose when exposed to light, which leads to the need to shade it all the time during production, which causes inconvenience to mass production in the workshop
However, this kind of process is rarely used in China, mainly due to the limitation of auxiliary materials and equipment. Only some conventional auxiliary materials are used, and the hardness of plain tablets is not large. During industrial production, there are phenomena of cap dropping, cracking and unqualified brittleness. directly affect the quality of coating

Method used

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  • Montelukast sodium tablet and preparation method thereof
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  • Montelukast sodium tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 Tablet of Montelukast Sodium

[0024] Montelukast Sodium 100g

[0025] Microcrystalline Cellulose 1299g

[0026] Sodium carboxymethyl starch 120g

[0027] VA64 70g

[0028] Iron Oxide Red 3g

[0029] Micronized silica gel 4g

[0030] Zinc stearate 4g

[0031] Preparation process: Montelukast sodium is passed through a 100-mesh sieve, iron oxide red is passed through a 80-mesh sieve, the prescribed amount of iron oxide red, microcrystalline cellulose, sodium carboxymethyl starch, and VA64 are weighed and mixed evenly, and then the prescribed amount is Montelukast sodium and the above mixture are added in equal amounts for 3 times and mixed evenly, passed through an 80-mesh sieve for dry granulation, plus the prescribed amount of micropowder silica gel and zinc stearate, mixed evenly, compressed into tablets, coated, and made 10,000 tablets in total .

Embodiment 2-9

[0032] Embodiment 2-9 montelukast sodium tablet

[0033] For the convenience of description, see Table 1 for the prescriptions of Montelukast Sodium Tablets in Examples 2-9. In the table, "Example 2" represents the prescription of Example 2, and "Example 3"-"Example 9" represent the prescriptions of "Example 3"-"Example 9" respectively.

[0034] Table 1 Example 2-9 Montelukast Sodium Tablet Prescription

[0035]

[0036] The preparation process was the same as in Example 1, and 10,000 tablets were produced in total.

Embodiment 10

[0037] Example 10 Tablet compression process of montelukast sodium tablet

[0038] 1. Equipment and materials

[0039] 1.1 Equipment

[0040] ZKG-5 type dry granulator (Zhejiang Jiangnan Pharmaceutical Machinery Co., Ltd.); ZDS three-way rotary vibrating screen (Jiangsu Zhangjiagang Yongda Chemical Machinery Factory); ZPS008 rotary tablet press (Shanghai Tianxiang-Jiantai Pharmaceutical Machinery Factory) ; LB-2B disintegration time limit tester (Shanghai Huanghai Drug Inspection Instrument Factory); 78X-2 tablet four-purpose tester (Shanghai Huanghai Pharmaceutical Factory); intelligent drug dissolution tester RCZ-5A (Tianjin University Precision Instrument Factory); 10A type high performance liquid chromatography.

[0041] 1.2 Materials

[0042] Granules prepared according to Example 1.

[0043] 2. Experimental methods and steps

[0044] According to the pre-test results and equipment capabilities, three parameters of the ZPS008 rotary tablet press, hydraulic pressure, ...

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Abstract

The invention belongs to the field of medicine preparations, in particular to a montelukast sodium tablet and a preparation method thereof. Because the montelukast sodium tablet adopts a wet method granulation process and has the problems of long drying time, difficult temperature control and easy causing of content difference, content descent and relevant substance increase between particles, the invention provides the montelukast sodium tablet and the preparation method thereof in order to enhance the stability and the operability of the montelukast sodium tablet. The montelukast sodium tablet provided by the invention comprises montelukast sodium, a filling agent, a disintegrating agent, an adhesive, a colorant, a lubricant and a flow aid. The preparation method of the montelukast sodium tablet provided by the invention adopts direct tabletting after dry method granulation and uses the colorant, the colorant can act as a very good light shielding function in the operational process, the operation is convenient, the influence of a drying process and moist heat to the product quality is avoided, and the product stability is enhanced.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a montelukast sodium tablet 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] At present, the incidence rate of asthma in our country is 1%, and the incidence rate of children is as high as 3-5%, which is a significant increase compared with 10 years ago. Drugs us...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/47A61K47/38A61K47/32A61P11/06
Inventor 赵志全
Owner LUNAN PHARMA GROUP CORPORATION
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