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Mirabegron medicine composition and preparation method thereof

A technology of mirabegron and its composition, which is applied in the field of mirabegron pharmaceutical composition and its preparation, can solve problems such as easy moisture absorption, unstable preparation, unstable sustained release, etc., to reduce product production cost, product The effect of stable quality and simple method

Inactive Publication Date: 2016-06-08
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, the oral preparations prepared with reference to the existing methods are not only complicated in process, high in production cost, and difficult to realize industrialized large-scale production, but also have problems such as unstable sustained release, large fluctuations, unstable preparations, and easy moisture absorption.

Method used

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  • Mirabegron medicine composition and preparation method thereof
  • Mirabegron medicine composition and preparation method thereof
  • Mirabegron medicine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Every 1000 described mirabegron pharmaceutical compositions, its formula consists of:

[0045] Mirabegron 25g

[0046] Hydroxypropyl methylcellulose 125g

[0047] Mannitol 62.5g

[0048] Microcrystalline cellulose 20g

[0049] Magnesium stearate 7.5g

[0050] Micropowder silica gel 5g

[0051] Preparation process: 1) Pulverize mirabegron, hydroxypropyl methylcellulose, mannitol and microcrystalline cellulose through a 100-mesh sieve respectively, and set aside;

[0052] 2) Weigh the above-mentioned materials in the prescription amount, make soft materials with 10% povidone K30 absolute ethanol solution, and granulate with 20 mesh;

[0053] 3) Ventilate and dry in a drying oven for 2-3 hours at a temperature of 50±2°C;

[0054] 4) Add magnesium stearate and micropowder silica gel, and mix well with dry granules;

[0055] 5) Calculate the actual tablet weight, adjust the tablet weight, and press the tablet;

[0056] 6) Prepare the prescribed amount of film coating...

Embodiment 2

[0059] Every 1000 described mirabegron pharmaceutical compositions, its formula consists of:

[0060] Mirabegron 50g

[0061] Ethylcellulose 133.3g

[0062] Mannitol 66.7g

[0063] Microcrystalline cellulose 66.7g

[0064] Magnesium stearate 10g

[0065] Micropowder silica gel 6.7g

[0066] Preparation process: 1) Pulverize mirabegron, ethyl cellulose, mannitol and microcrystalline cellulose through a 100-mesh sieve respectively, and set aside;

[0067] 2) Weigh the above-mentioned materials in the prescription amount, make soft materials with 10% povidone K30 absolute ethanol solution, and granulate with 20 mesh;

[0068] 3) Ventilate and dry in a drying oven for 2-3 hours at a temperature of 50±2°C;

[0069] 4) Add magnesium stearate and micropowder silica gel, and mix well with dry granules;

[0070] 5) Calculate the actual tablet weight, adjust the tablet weight, and press the tablet;

[0071] 6) Prepare the prescribed amount of film coating agent with 70% ethanol ...

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PUM

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Abstract

The invention discloses a mirabegron medicine composition. A recipe comprises framework materials; and 20 weight percent to 25 weight percent of mannitol and 10 weight percent to 20 weight percent of microcrystalline cellulose are used as filling agents. The mirabegron medicine composition has the beneficial effects that the stability is high; and the obvious advantages are realized on product yield improvement, cost reduction, industrialization realization and good clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a mirabegron pharmaceutical composition and a preparation method thereof. Background technique [0002] Mirabegron is a selective β3-adrenergic receptor agonist, which is mainly used clinically for the treatment of overactive bladder in adults. Its chemical name is: (R)-2-(2-amino-1,3-thiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl] Phenylacetamide, the structural formula is as follows: [0003] [0004] Mirabegron tablet was developed by Japan Astel-las pharmaceutical company, and was listed in Japan on September 16, 2011, and was approved by the FDA on June 28, 2012 for the treatment of adult overactive bladder ( OAB), trade name Myrbetriq. [0005] Mirabegron sustained-release tablets can reduce the impact of food on its absorption, can be taken before and after meals, can maintain a long-term stable effective blood concentration, and increase the ...

Claims

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Application Information

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IPC IPC(8): A61K47/38A61K47/26A61K31/426A61P13/10
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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