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Drug composition containing pirfenidone, and preparation method thereof

A technology of pirfenidone and solid composition, which is applied in the field of pirfenidone pharmaceutical composition, and can solve problems such as the absence of pirfenidone on the market

Inactive Publication Date: 2013-01-02
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, there is no pirfenidone on the market in China

Method used

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  • Drug composition containing pirfenidone, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 Preparation of Pirfenidone Tablets (1000 Tablets)

[0024] Composition of raw materials Weight ratio (%) Pirfenidone 50.00 lactose 20 microcrystalline cellulose 21 Croscarmellose Sodium 3.00 Hydroxypropyl Cellulose 4.50 Magnesium stearate 1.50 Total 100.00

[0025] Take by weighing prescription quantity and take pirfenidone and pass through 100 mesh sieves, mix with lactose, microcrystalline cellulose, croscarmellose sodium, and mix for subsequent use; make soft material with 5% hydroxypropyl cellulose solution, Granulate with 18 mesh sieve; oven dry at 50°C; pass through 24 sieves for granulation, add magnesium stearate, mix evenly, compress into tablets, and the weight gain of coating is about 2%-4%.

Embodiment 2

[0026] The preparation of embodiment 2 pirfenidone tablets (1000)

[0027] Composition of raw materials Weight ratio (%) Pirfenidone 66.67 lactose 13.83 microcrystalline cellulose 10.00 Croscarmellose Sodium 5.00 Hydroxypropyl Cellulose 4.00 Magnesium stearate 0.50 Total 100.00

[0028] Take by weighing prescription quantity and take pirfenidone and pass through 100 mesh sieves, mix with lactose, microcrystalline cellulose, croscarmellose sodium, and mix for subsequent use; make soft material with 5% hydroxypropyl cellulose solution, Granulate with 18 mesh sieve; oven dry at 50°C; pass through 24 sieves for granulation, add magnesium stearate, mix evenly, compress into tablets, and the weight gain of coating is about 2%-4%.

Embodiment 3

[0029] Example 3 Preparation of Pirfenidone Tablets (1000 Tablets)

[0030] Composition of raw materials Weight ratio (%) Pirfenidone 50 lactose 14.00 microcrystalline cellulose 20.00 Croscarmellose Sodium 10.00 Hydroxypropyl Cellulose 5.00 Magnesium stearate 1.00 Total 100.00

[0031] Take by weighing prescription quantity and take pirfenidone and pass through 100 mesh sieves, mix with lactose, microcrystalline cellulose, croscarmellose sodium, and mix for subsequent use; make soft material with 5% hydroxypropyl cellulose solution, Granulate with 18 mesh sieve; oven dry at 50°C; pass through 24 sieves for granulation, add magnesium stearate, mix evenly, compress into tablets, and the weight gain of coating is about 2%-4%. Example 4 Preparation of Pirfenidone Tablets (1000 Tablets)

[0032] Composition of raw materials Weight ratio (%) Pirfenidone 66.67 lactose 4.83 microcrystalline cell...

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Abstract

The present invention belongs to the technical field of medicine, and particularly relates to a solid drug composition containing pirfenidone, and a preparation process thereof. The drug composition contains pirfenidone, a binder and a disintegrating agent, and can be prepared into tablets, granules and capsules.

Description

technical field [0001] The invention relates to a pirfenidone medicinal composition and a preparation method of the composition, belonging to the technical field of medicine. Background technique [0002] Pirfenidone is a non-peptide synthetic molecule with a molecular weight of 185.23 Daltons. Its chemical element is expressed as C12H11NO, and its structure is known. [0003] Fibrotic diseases such as pulmonary fibrosis, liver fibrosis, myocardial fibrosis, etc. are important diseases that seriously endanger human life and health. With global industrialization and changes in people's life and diet, the incidence of fibrotic diseases is gradually increasing . It is a common disease all over the world, and its morbidity and mortality have increased in the past 10 years. It is estimated that the number of patients suffering from IPF in the United States, Europe, and Japan is about 220,000, of which there are 90,000 IPF patients in the United States. The prevalence of IPF i...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/28A61K31/4418A61P11/00
Inventor 肖博郭夏宋雪梅
Owner BEIJING VENTUREPHARM BIOTECH
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