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Mirabegron sustained release tablet and preparation method thereof

A technology of mirabegron and sustained-release tablets, applied in the field of mirabegron sustained-release tablets and its preparation, can solve the problems of cumbersome granulation operations and the release of sustained-release components of mirabegron sustained-release tablets, etc. Achieve the effect of easy operation

Inactive Publication Date: 2015-02-18
安徽联创生物医药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Although the above-mentioned prior art discloses a Mirabegron sustained-release tablet and a preparation method thereof, certain defects still exist in the above-mentioned Mirabegron sustained-release tablet: due to the use of an adhesive, the adhesive will inevitably It affects the release of the sustained-release components of Mirabegron sustained-release tablets in the body, and its preparation method adopts wet granulation and dry granulation, and the granulation operation is cumbersome

Method used

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  • Mirabegron sustained release tablet and preparation method thereof
  • Mirabegron sustained release tablet and preparation method thereof
  • Mirabegron sustained release tablet and preparation method thereof

Examples

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Comparison scheme
Effect test

Embodiment 1

[0023] This embodiment relates to a Mirabegron sustained-release tablet and its preparation method:

[0024] The composition ratio of Mirabegron sustained-release tablets is:

[0025]

[0026] (The composition of the film coating premix is ​​hydroxypropyl methylcellulose, iron oxide red, and titanium dioxide; since water is removed during drying, it does not appear in the final product of the formulation)

[0027] The preparation method includes the following steps:

[0028] Step one, raw material pretreatment: take Mirabegron in a mortar and grind and smash it through a 100-mesh sieve. Dibutyl hydroxytoluene, hydroxypropyl cellulose and magnesium stearate are respectively passed through a 100-mesh sieve. The ethylene glycol is passed through a 60 mesh sieve;

[0029] Step 2: Add the pre-treated polyoxyethylene, polyethylene glycol and hydroxypropyl cellulose to the pre-treated Mirabegron according to the above-mentioned dosage ratio, and pass through a 60-mesh sieve 6 times and mix it...

Embodiment 2

[0033] The composition ratio of Mirabegron sustained-release tablets is:

[0034]

[0035] (The composition of the film coating premix is ​​hydroxypropyl methylcellulose, iron oxide red, and titanium dioxide; since water is removed during drying, it does not appear in the final product of the formulation)

[0036] The preparation method includes the following steps:

[0037] Step one, raw material pretreatment: take Mirabegron in a mortar and grind and smash it through a 100-mesh sieve. Dibutyl hydroxytoluene, hydroxypropyl cellulose and magnesium stearate are respectively passed through a 100-mesh sieve. The ethylene glycol is passed through a 60 mesh sieve;

[0038] Step 2: Add the pre-treated polyoxyethylene, polyethylene glycol and hydroxypropyl cellulose to the pre-treated Mirabegron according to the above-mentioned dosage ratio, and pass through a 60-mesh sieve 6 times and mix it evenly as a premix;

[0039] Step 3: Add the pre-treated dibutyl hydroxytoluene to the premix accordi...

Embodiment 3

[0042] The composition ratio of Mirabegron sustained-release tablets is:

[0043]

[0044] (The composition of the film coating premix is ​​hydroxypropyl methylcellulose, iron oxide red, and titanium dioxide; since water is removed during drying, it does not appear in the final product of the formulation)

[0045] The preparation method includes the following steps:

[0046] Step one, raw material pretreatment: take Mirabegron in a mortar and grind and smash it through a 100-mesh sieve. Dibutyl hydroxytoluene, hydroxypropyl cellulose and magnesium stearate are respectively passed through a 100-mesh sieve. The ethylene glycol is passed through a 60 mesh sieve;

[0047] Step 2: Add the pre-treated polyoxyethylene, polyethylene glycol and hydroxypropyl cellulose to the pre-treated Mirabegron according to the above-mentioned dosage ratio, and pass through a 60-mesh sieve 6 times and mix it evenly as a premix;

[0048] Step 3: Add the pre-treated dibutyl hydroxytoluene to the premix accordi...

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Abstract

The invention relates to a mirabegron sustained release tablet and a preparation method thereof. The mirabegron sustained release tablet comprises the following components in percentage by mass: 8%-12% of mirabegron, 55%-65% of polyoxyethylene, 0.6%-1.0% of hydroxypropylcellulose, 0.08%-0.12% of butylated hydroxytoluene, 0.7%-1.1% of magnesium stearate and the balance of polyethylene glycol. The preparation method comprises the following steps: 1, carrying out sieving pretreatment on raw materials; 2, adding polyoxyethylene, polyethylene glycol and hydroxypropylcellulose to the mirabegron, sieving and mixing evenly to obtain a premix; and 3, adding butylated hydroxytoluene to the premix, sieving, adding magnesium stearate, sieving, mixing evenly, carrying out powder vertical compression to obtain the tablet, so as to obtain the mirabegron sustained release tablet. The mirabegron sustained release tablet provided by the invention does not contain an adhesive; the tablet is directly obtained from the powder in a vertical compression manner; and the operation is simple and convenient.

Description

Technical field [0001] The present invention relates to a beta 3 The adrenergic receptor agonist specifically relates to a Mirabegron sustained-release tablet and a preparation method thereof. Background technique [0002] Mirabegron belongs to arylethanolamine β 3 Adrenergic receptor agonist, acting on bladder detrusor smooth muscle β 3 Adrenergic receptors relax the bladder, promote bladder filling and increase urine storage, which can effectively reduce the frequency of urination and improve the frequency of urination caused by overactive bladder; the advantage of Mirabegron sustained-release tablets is that it can reduce the influence of food on its absorption It can be taken before and after meals, can maintain a long-term stable effective blood concentration, increase the efficacy of the drug, make only one tablet a day, convenient to take, and improve patient compliance. Therefore, a new type of Mirabegron sustained-release The tablet and its preparation method are of grea...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K9/22A61K31/426A61K47/38A61P13/10
Inventor 葛德培吴其华
Owner 安徽联创生物医药股份有限公司
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