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Solid preparation comprising pirfenidone as active component and application thereof

A technology of pirfenidone and solid preparations, which is applied in the field of medicine and can solve problems such as unclear drug target genes

Active Publication Date: 2013-01-02
ZHUHAI EBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The initial research found that it has a certain anti-inflammatory effect. In recent years, it has been found that it has an inhibitory effect on tissue fibrosis, can inhibit collagen synthesis, reduce the secretion of inflammatory cytokines, and prevent fibroblast proliferation. Specific drug targets gene is unknown

Method used

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  • Solid preparation comprising pirfenidone as active component and application thereof
  • Solid preparation comprising pirfenidone as active component and application thereof
  • Solid preparation comprising pirfenidone as active component and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Make 1000 pirfenidone tablets with the raw materials of following weight ratio.

[0014]

[0015] Preparation Process:

[0016] 1. The pirfenidone raw material is crushed through an 80-mesh sieve, and set aside.

[0017] 2. Pass the lactose through a 60-mesh sieve and set aside.

[0018] 3. Take pirfenidone, pregelatinized starch, lactose, and internally added croscarmellose sodium and mix well.

[0019] 4. Make soft material with 5% PVPK30 solution, granulate with 20 mesh sieve, dry at 60°C, and granulate with 24 mesh sieve.

[0020] 5. Add external croscarmellose sodium and magnesium stearate, mix well, and press into tablets to get ready.

Embodiment 2

[0022] 1. Prepare 6% ethanol solution of Opadry enteric coating agent;

[0023] 2. Take the plain tablet obtained in Example 1, pour it into the coating pan, start the coating pan, and blow hot air, preheat the plain tablet at 30-40°C for 10 minutes, and blow off the drug powder adhering to the tablet core, Spray the coating solution evenly, so that the drug solution is evenly coated on the tablet core, and the pirfenidone enteric-coated tablet is obtained.

Embodiment 3

[0025] Make 1000 pirfenidone tablets with the raw materials of following weight ratio.

[0026]

[0027] Preparation:

[0028] 1. Grind Pirfenib and raw materials through an 80-mesh sieve, and set aside.

[0029] 2. Pass the lactose through a 60-mesh sieve and set aside.

[0030] 3. Take pirfenidone, pregelatinized starch, lactose and microcrystalline cellulose and mix well.

[0031] 4. Make soft material with water, granulate with 20 mesh, dry at 60°C, and granulate with 24 mesh.

[0032] 5. Add croscarmellose sodium and magnesium stearate, mix well, and press into tablets to get ready.

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Abstract

The invention relates to a solid preparation comprising pirfenidone as an active component and application thereof. The solid preparation is an oral solid preparation prepared by carrying out pharmaceutical technology on pirfenidone and pharmaceutically acceptable auxiliary materials. The solid preparation disclosed herein has the advantages of stable and controllable quality, safety and effectiveness, and is mainly clinically used as a medicine for treating idiopathic pulmonary fibrosis to mitigate the symptoms and reduce the mortality.

Description

technical field [0001] The invention relates to an oral solid preparation of pirfenidone. It is oral ordinary tablets, freeze-dried instant tablets, film-coated tablets, enteric-coated tablets, hard capsules and granules made of pirfenidone and pharmaceutically acceptable auxiliary materials through preparation technology. The pirfenidone solid preparation and its application are stable, controllable, safe and effective in quality and belong to the technical field of medicine. Background technique [0002] Idiopathic pulmonary fibrosis (IPF) is a disease of unknown etiology characterized by diffuse alveolitis and alveolar structural disturbances that eventually lead to pulmonary interstitial fibrosis. The disease is mostly sporadic, with an estimated incidence of 3 to 5 / 100,000, accounting for about 65% of all interstitial lung diseases. It is found in all age groups, and the diagnosis is often made between 50 and 70 years old, with a male to female ratio of 1.5 to 2:1. ...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/20A61K9/28A61K9/46A61K9/48A61K31/4418A61P11/00
Inventor 吴浩山李翱梁虹
Owner ZHUHAI EBANG PHARMA
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