Oral solid tablet containing montelukast sodium and preparation method of oral solid tablet

A montelukast sodium, solid technology, applied in the field of medicine, can solve the problems of poor treatment effect and poor compliance, and achieve the effects of good dissolution effect, fast absorption and good stability

Inactive Publication Date: 2021-03-26
浙江诺得药业有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to overcome the problems of poor compliance and poor therapeutic effect of ambroxol hydrochloride and montelukast sodium in the prior art, the invention provides an oral solid tablet containing montelukast sodium and a preparation method thereof

Method used

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  • Oral solid tablet containing montelukast sodium and preparation method of oral solid tablet
  • Oral solid tablet containing montelukast sodium and preparation method of oral solid tablet
  • Oral solid tablet containing montelukast sodium and preparation method of oral solid tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment l

[0033] (1) The ambroxol hydrochloride solid was ultrasonically pulverized with an ultrasonic power of 35W for 5 minutes to obtain a powder;

[0034] Under the sound field that the frequency is 15KHz and the output power is 60W, add the mixed solvent of methyl alcohol, 2-methyltetrahydrofuran and acetonitrile while stirring in the ambroxol hydrochloride powder, the amount of methyl alcohol, 2-methyltetrahydrofuran and acetonitrile in the mixed solvent Volume ratio is 8:4:2, and the volume of mixed solvent is 5 times of ambroxol hydrochloride weight;

[0035] (2) Control the temperature at 40°C, under a sound field with a frequency of 15KHz and an output power of 40W, add a mixed solvent of ethanol and ethyl acetate to the solution obtained in step (1) while stirring. The volume of the mixed solvent is 10 times of ambroxol hydrochloride weight, the volume ratio of ethanol and ethyl acetate in the mixed solvent is 5:3;

[0036] (3) Cool down to -10°C at a rate of 4.5°C / min, stan...

Embodiment 2

[0039] (1) The ambroxol hydrochloride solid was ultrasonically pulverized with an ultrasonic power of 35W for 5 minutes to obtain a powder;

[0040] Under the sound field that the frequency is 15KHz and the output power is 60W, add the mixed solvent of methyl alcohol, 2-methyltetrahydrofuran and acetonitrile while stirring in the ambroxol hydrochloride powder, the amount of methyl alcohol, 2-methyltetrahydrofuran and acetonitrile in the mixed solvent Volume ratio is 8:5:3, and the volume of mixed solvent is 5 times of ambroxol hydrochloride weight;

[0041] (2) Control the temperature at 40°C, under a sound field with a frequency of 15KHz and an output power of 40W, add a mixed solvent of ethanol and ethyl acetate to the solution obtained in step (1) while stirring. The volume of the mixed solvent is 10 times of ambroxol hydrochloride weight, the volume ratio of ethanol and ethyl acetate in the mixed solvent is 2:1;

[0042] (3) Cool down to 0°C at a rate of 2.5°C / min, stand ...

Embodiment 3

[0045] (1) The ambroxol hydrochloride solid was ultrasonically pulverized with an ultrasonic power of 35W for 5 minutes to obtain a powder;

[0046] Under the sound field that the frequency is 15KHz and the output power is 45W, add the mixed solvent of methyl alcohol, 2-methyltetrahydrofuran and acetonitrile while stirring in the ambroxol hydrochloride powder, the amount of methyl alcohol, 2-methyltetrahydrofuran and acetonitrile in the mixed solvent Volume ratio is 8:5:3, and the volume of mixed solvent is 5 times of ambroxol hydrochloride weight;

[0047] (2) Control the temperature at 40°C, under a sound field with a frequency of 15KHz and an output power of 20W, add a mixed solvent of ethanol and ethyl acetate to the solution obtained in step (1) while stirring. The volume of the mixed solvent is 10 times of ambroxol hydrochloride weight, the volume ratio of ethanol and ethyl acetate in the mixed solvent is 2:1;

[0048](3) Cool down to 0°C at a rate of 2.5°C / min, stand f...

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Abstract

The invention provides an oral solid tablet containing montelukast sodium and a preparation method of the oral solid tablet. The oral solid tablet is prepared from raw materials of ambroxol hydrochloride crystals, the montelukast sodium and auxiliary materials, and the auxiliary materials comprise a filler, a disintegrating agent, a flavoring agent, a wetting agent and a lubricant; the ambroxol hydrochloride crystal accounts for 5%-30% by weight, and the montelukast sodium accounts for 5%-15% by weight. The disintegrating tablet is obtained by spraying a coating solution onto the ambroxol hydrochloride crystals and montelukast sodium powder to obtain coated particles, mixing the coated particles with residual auxiliary materials and performing tabletting. The oral solid tablet prepared bythe method disclosed by the invention is high in disintegration speed, good in mouth feel and small in side effect, has an obvious treatment effect on pulmonary fibrosis, is suitable for old people and children, is wide in audience, and has a very good popularization prospect.

Description

technical field [0001] The invention relates to an oral solid tablet (orally disintegrating tablet) containing montelukast sodium and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] The chemical name of ambroxol hydrochloride is trans-4-[(2-amino-3,5-dibromobenzyl) amino]cyclohexanol hydrochloride: molecular formula: C13H18Br2N2O.HCL, molecular weight: 414.57, is ambroxol It is an active metabolite of bromhexine, and it is a new mucolytic drug. It has the functions of dissolving and secreting mucus and promoting mucus elimination. At the same time, it can promote the secretion of pulmonary surfactant (such as PS) and can promote the emptying of bronchial cilia. Exercise is conducive to the discharge of airway secretions, achieving significant expectoration, anti-inflammation, improving respiratory conditions, and improving pulmonary fibrosis caused by acute respiratory distress syndrome (ARDS). However, mild upper ga...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/26A61K47/10A61K47/38A61K47/32A61K47/46A61K47/18A61K31/47A61K31/137A61P11/00
CPCA61K9/2018A61K9/2054A61K9/2027A61K9/2013A61K9/2068A61K9/2095A61K31/47A61K31/137A61P11/00A61K2300/00
Inventor 殷学治
Owner 浙江诺得药业有限公司
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