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Medicinal composition containing sildenafil citrate and preparation method thereof

A technology of sildenafil citrate and sildenafil is applied in the field of pharmaceutical preparations and can solve problems such as poor taste

Active Publication Date: 2013-04-17
JIANGSU YABANG AIPUSEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, it is very difficult to give oral medication to patients who cannot swallow, coma or newborns, and the poor taste of ordinary tablets has also become a disadvantage of water dispersion.

Method used

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  • Medicinal composition containing sildenafil citrate and preparation method thereof
  • Medicinal composition containing sildenafil citrate and preparation method thereof
  • Medicinal composition containing sildenafil citrate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Preparation prescription of the present invention is made up of following components by tablet core weight:

[0023]

[0024] Preparation Process:

[0025] (a) Sildenafil citrate, microcrystalline cellulose, croscarmellose sodium added, orange essence and aspartame added inside are mixed through a 100-mesh sieve and added to the fluidized bed In the granulator, turn on the fan and heat to make the auxiliary materials in a fluidized state, spray the atomized 2% hydroxypropyl cellulose binder containing the added orange essence and aspartame into the granulation, and then Dry at 50-60°C, granulate with 20 meshes;

[0026] (b) Add PD-1 type pregelatinized starch, croscarmellose sodium and lubricant to the granules prepared in step (a), mix evenly, and press into tablets.

[0027] The orally rapidly disintegrating tablet containing sildenafil citrate and PD-1 type pregelatinized starch prepared in this example can completely disintegrate in 20 seconds in 37°C water, an...

Embodiment 2

[0029] Preparation prescription of the present invention is made up of following components by tablet core weight:

[0030]

[0031] Preparation Process:

[0032] (a) Sildenafil citrate, calcium hydrogen phosphate, cross-linked polyvinylpyrrolidone added, lemon essence and mannitol added inside are mixed through a 100-mesh sieve, added to a fluidized bed granulator, and Air blower, heating, so that the auxiliary materials are in a fluidized state, spray into the inside with an atomized 5% PVPK30 binder containing lemon essence and mannitol to granulate, then dry at 50-60°C, and granulate with 40 mesh .

[0033] (b) Add PD-1 pregelatinized starch, cross-linked polyvinylpyrrolidone and lubricant to the granules prepared in step (a), mix evenly, and press into tablets.

[0034] The orally rapidly disintegrating tablet containing sildenafil citrate and PD-1 type pregelatinized starch prepared in this example can completely disintegrate in 20 seconds in 37°C water, and can pas...

Embodiment 3

[0036] Preparation prescription of the present invention is made up of following components by tablet core weight:

[0037]

[0038] Preparation Process:

[0039] (a) Sildenafil citrate, lactose, croscarmellose calcium added, stevioside and aspartame added are mixed through a 120-mesh sieve and added to a fluidized bed granulator In the process, turn on the fan and heat to make the auxiliary materials in a fluidized state, spray 2% hydroxypropyl methylcellulose binder containing extra stevioside and aspartame into the inside to granulate, and then Dry at 50-60°C, granulate with 30 mesh.

[0040] (b) Add PD-1 pregelatinized starch, croscarmellose calcium and lubricant to the granules prepared in step (a), mix evenly, and press into tablets.

[0041] The orally rapidly disintegrating tablet containing sildenafil citrate and PD-1 type pregelatinized starch prepared in this example can completely disintegrate in 18 seconds in 37°C water, and can pass through a 600-710 μm sie...

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Abstract

The invention discloses a medicinal composition containing sildenafil citrate and PD-1 type pregelatinized starch and a preparation method thereof. The medicinal preparation prepared from the medicinal composition containing the sildenafil citrate and the PD-1 type pregelatinized starch and the preparation method provided by the invention can be completely disintegrated in water at a degree of 37 DEG C within 15 to 30 seconds, and can pass through a screen in a size of 600 to 710 mu m.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing sildenafil citrate and PD-1 type pregelatinized starch and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Sildenafil citrate, the chemical name is 1-methyl-3-n-propyl-5-[2-ethoxy-5-(4-methylpiperazine-1-sulfonyl)phenyl]- 1,6-dihydro-7H-pyrazolo[4,2-d]pyrimidin-7-one citrate, the structural formula is as follows: [0003] [0004] Sildenafil citrate was developed by Pfizer Pharmaceuticals of the United States and entered clinical research as a 5-phosphodiesterase inhibitor for the treatment of cardiovascular diseases, but in March 1998 it was used to treat male penile erectile function Indications for disorders are approved by the U.S. Federal Food and Drug Administration. In recent years, studies have shown that sildenafil citrate can also be used to treat pulmonary hypertension. [0005] A large number of clinical ...

Claims

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Application Information

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IPC IPC(8): A61K31/519A61K47/36A61P9/12A61P11/00
Inventor 陈再新王淑娟赵晓红毛白杨庄鹏飞徐丽洁孙海棠
Owner JIANGSU YABANG AIPUSEN PHARMA
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