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Avanafil tablet and preparation method thereof

A kind of avanafil, non-tablet technology, applied in the field of pharmaceutical preparations, can solve the problems of low dissolution rate, affecting drug bioavailability and curative effect, and slow dissolution, so as to optimize the uneven content and improve the slow dissolution of drugs Effect

Inactive Publication Date: 2016-06-15
SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] The purpose of the present invention is to provide a kind of avanafil tablet and preparation method thereof, to overcome the problem that existing avanafil is affected by the bioavailability and curative effect of medicine due to slow dissolution and low dissolution rate

Method used

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  • Avanafil tablet and preparation method thereof
  • Avanafil tablet and preparation method thereof
  • Avanafil tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] This embodiment relates to a kind of avanafil tablet and preparation method thereof:

[0051] Composition of prescription components:

[0052]

[0053]

[0054] Preparation:

[0055] 1. get above-mentioned consumption avanafil crude drug and mannitol and mix 80 mesh sieves, then adopt fluidized bed top spray technology, add binding agent 10% (w / w) hydroxypropyl cellulose aqueous solution, granulate, Pass through a 20-mesh sieve for granulation to obtain drug granules;

[0056] II. Take the above-mentioned amount of fumaric acid, then adopt a fluidized bed top spraying process, add a binder 10% (w / w) hydroxypropyl cellulose aqueous solution, granulate, pass through a 20-mesh sieve for granulation, and obtain acid granules;

[0057] III. The drug granules and acid granules obtained in I and II are added with the above-mentioned amount of low-substituted hydroxypropyl cellulose, light calcium carbonate, magnesium stearate, and yellow iron oxide, mixed, and compress...

Embodiment 2

[0059] This embodiment relates to a kind of avanafil tablet and preparation method thereof:

[0060] Composition of prescription components:

[0061]

[0062]

[0063] Preparation:

[0064] 1. get above-mentioned consumption avanafil crude drug and mannitol and mix 80 mesh sieves, then adopt fluidized bed top spray technology, add binding agent 10% (w / w) hydroxypropyl cellulose aqueous solution, granulate, Pass through a 20-mesh sieve for granulation to obtain drug granules;

[0065] II. Take the above-mentioned amount of fumaric acid, then adopt a fluidized bed top spraying process, add a binder 10% (w / w) hydroxypropyl cellulose aqueous solution, granulate, pass through a 20-mesh sieve for granulation, and obtain acid granules;

[0066] III. The drug granules and acid granules obtained in I and II are added with the above-mentioned amount of low-substituted hydroxypropyl cellulose, light calcium carbonate, magnesium stearate, and yellow iron oxide, mixed, and compress...

Embodiment 3

[0068] This embodiment relates to a kind of avanafil tablet and preparation method thereof:

[0069] Composition of prescription components:

[0070]

[0071] Preparation:

[0072] 1. get above-mentioned consumption avanafil crude drug and mannitol and mix 80 mesh sieves, then adopt fluidized bed top spray technology, add binding agent 10% (w / w) hydroxypropyl cellulose aqueous solution, granulate, Pass through a 20-mesh sieve for granulation to obtain drug granules;

[0073]II. Take the above-mentioned amount of fumaric acid, then adopt a fluidized bed top spraying process, add a binder 10% (w / w) hydroxypropyl cellulose aqueous solution, granulate, pass through a 20-mesh sieve for granulation, and obtain acid granules;

[0074] III. The drug granules and acid granules obtained in I and II are added with the above-mentioned amount of low-substituted hydroxypropyl cellulose, light calcium carbonate, magnesium stearate, and yellow iron oxide, mixed, and compressed into table...

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Abstract

The invention relates to an avanafil tablet and a preparation method thereof. The avanafil tablet is composed of the following components in percentage by weight: 55-80% of medicine granules, 10-20% of acid granules, disintegrating 3-15% solution agent, 0.5-5% basic carbonate, 0.5-2% lubricant; respectively prepare avanafil drug granules and acid granules by fluidized bed granulation process, and add conventional excipients for tableting , by controlling the particle size of the prepared drug granules and the hardness of the tablet during tablet compression, the dissolution rate and peak value of the drug can be adjusted to meet the required requirements and obtain qualified products.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an avanafil tablet and a preparation method thereof. Background technique [0002] Avanafil (Avanafil) is an oral rapid-acting highly selective phosphodiesterase-5 (PDE-5) inhibitor obtained by Vivus Company of the United States from Tanabe Seiyaku Company of Japan, and is used for the treatment of erectile dysfunction. The biggest advantage of avanafil is that it works quickly and has no obvious side effects. [0003] Generic Name: Avanafil [0004] English name: Avanafil [0005] Chemical name: (S)-4-[(3-chloro-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1-pyrrolidinyl]-N-(2-pyrimidine Methyl)-5-pyrimidinemethanesulfonamide [0006] The chemical structural formula is: [0007] [0008] Molecular formula: C 23 h 26 ClN 7 o 3 [0009] Molecular weight: 483.95 [0010] Avanafil is a more potent and selective PDE5 inhibitor than sildenafil. Preclinical studie...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/506A61P15/10
CPCA61K9/2077A61K9/2054A61K31/506
Inventor 张菊红刘杰孙慧娟王明森王帆李大伟刘正平张建强祝美华
Owner SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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