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Avanafil preparation and preparation method thereof

A technology of avanafil and preparation, which is applied in the field of phosphodiesterase-5 inhibitor and its preparation, can solve the problems of low dissolution rate, affecting drug bioavailability and curative effect, etc., so as to increase affinity and improve bioavailability , quick effect

Inactive Publication Date: 2014-12-10
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

[0006] In order to overcome the technical problem that the dissolution rate of existing avanafil preparations is low, thus affecting the bioavailability and curative effect of the drug, the inventors provided a kind of avanafil preparations and its Preparation

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] This embodiment relates to an avanafil preparation and a preparation method thereof.

[0041] Step (1) Ingredients:

[0042]

[0043] Step (2) Take avanafil, grind it, pass through a 100-mesh sieve, and pass the above-mentioned amounts of fumaric acid, calcium carbonate, mannitol, and low-substituted hydroxypropyl cellulose through a 60-mesh sieve;

[0044] Step (3) Mix the above-mentioned raw and auxiliary materials evenly, granulate the above-mentioned amount of 5% (w / w) soft material made of hydroxypropyl cellulose, sieve 25 mesh, dry at 41°C, granulate with 24 mesh, and then add the above-mentioned Quantities of magnesium stearate and iron oxide yellow are mixed and pressed into tablets;

[0045] Step (4) Use water as a solvent, prepare a film coating premix solution with a solid content of 25% for coating, and the coating weight accounts for 2% of the weight of the entire tablet.

Embodiment 2

[0047] This embodiment relates to an avanafil preparation and a preparation method thereof.

[0048] Step (1) Ingredients:

[0049]

[0050] Step (2) Take avanafil, pulverize it, pass through a 120-mesh sieve, and pass the above-mentioned quantities of citric acid, dextrin, lactose, and sodium carboxymethyl starch through a 60-mesh sieve for later use;

[0051] Step (3) Mix the above-mentioned raw and auxiliary materials evenly, granulate the above-mentioned 5% (w / w) binder soft material made of povidone, sieve 20 mesh, dry at 50°C, granulate at 25 mesh, and then add the above-mentioned Amount of glycerol palmitostearate, red iron oxide mixed, pressed into tablets;

[0052] Step (4) Use water as a solvent to prepare a film coating premix solution with a solid content of 15% for coating test. The coating weight accounts for 3% of the weight of the entire tablet, and the tablet is obtained.

Embodiment 3

[0054] This embodiment relates to an avanafil preparation and a preparation method thereof.

[0055] Step (1) Ingredients:

[0056]

[0057] Step (2) Take avanafil, pulverize it, pass through a 100-mesh sieve, and pass the above-mentioned amounts of adipic acid, microcrystalline cellulose, calcium hydrogen phosphate, and disintegrating agent crospovidone through a 40-mesh sieve;

[0058] Step (3) Mix the above-mentioned raw and auxiliary materials evenly, granulate the above-mentioned amount of 5% (w / w) adhesive starch soft material, sieve 24 mesh, dry at 55°C, granulate at 20 mesh, and then add the above-mentioned amount of Mix polyethylene glycol and edible yellow pigment evenly, and press into tablets;

[0059] Step (4) Use water as a solvent, prepare a film coating premix solution with a solid content of 20%, and conduct a coating test. The coating weight accounts for 5% of the weight of the entire tablet, and the product is obtained.

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Abstract

The invention relates to an Avanafil preparation and a preparation method thereof. The Avanafil preparation consists of the following components in percentage by weight: 10-55% of Avanafil, 2-20% of a disintegrating agent, 18-25% of an acidifying agent, 0.2-10% of an adhesive, 0.2-1.0% of a lubricating agent, 0.1-0.5% of coloring agent and the balance of a filling agent; after raw auxiliary material mixing, wet process palletizing and drying, tablets are finally obtained. The preparation can be used for curing male erectile dysfunction and is taken approximately 30 minutes before sexual behavior, and the maximum frequency of dosage is one time a day. The preparation has good stability and dissolution rate, and also has the advantages of better curative effect, quicker action and lower dosage.

Description

technical field [0001] The invention relates to a phosphodiesterase-5 (PDE-5) inhibitor and a preparation method thereof, in particular to an avanafil preparation and a preparation method thereof. Background technique [0002] Erectile dysfunction (ED) is the inability to obtain or maintain a sustained, satisfying erection. At present, ED is a public health problem worthy of attention, which causes serious negative psychological impact on patients and may affect the quality of life of patients and the relationship between husband and wife. According to the GOSS survey, the incidence of ED in the United States is 33.7%. A global survey from 29 countries found that the incidence of ED ranged from 13% to 28%. In Asia, the incidence of ED is 2%-88%, and it increases with age. Risk factors for ED include physical inactivity, obesity, smoking, hypercholesterolemia, depression, and metabolic syndrome. [0003] Currently, type 5 phosphodiesterase inhibitors (PDES-Is) are recomme...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K31/506A61P15/10
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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