Pharmaceutical composition for treating hepatic fibrosis and preparation method thereof

A technology of liver fibrosis and composition, applied in the field of medicine, can solve the problems of light sensitivity, many adverse reactions, rashes and dizziness, and achieve the effect of stable drug quality and convenient clinical application

Active Publication Date: 2015-07-15
SICHUAN GUOKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, pirfenidone has more adverse reactions, including nausea, dyspepsia, vomiting, anorexia, photosensitivity, rash, and dizziness

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Example 1 Preparation of pharmaceutical tablets of the present invention

[0017] prescription:

[0018] Pirfenidone 200 g

[0019] Inosine 100 g

[0020] Lactose 250 g

[0021] Microcrystalline cellulose 50 g

[0022] Sodium Carboxymethyl Starch 30 g

[0023] Povidone K30 20 g

[0024] 1000 pieces

[0025] Operation: Weigh the crushed and sieved 80 mesh pirfenidone, inosine, lactose, microcrystalline cellulose according to the prescribed amount, mix them thoroughly with the equal-volume incremental mixing method, and then crush and siev. Take povidone K30, add distilled water and heat to make a 5% povidone K30 solution, add it to the mixed powder to make a soft material, granulate with a 20-mesh sieve, dry at 60°C for 4 hours, harvest the granules, add carboxymethyl Sodium starch, mix well, use an 18-mesh sieve to granulate to make a suitable preparation.

Embodiment 2

[0026] Example 2 Preparation of pharmaceutical capsules of the present invention

[0027] prescription:

[0028] Pirfenidone 250 g

[0029] Inosine 80 g

[0030] Sodium Carboxymethyl Starch 25g

[0031] 5% starch slurry appropriate amount

[0032] Magnesium stearate 3 g

[0033] Made into 1000 tablets

[0034] Operation: Weigh the crushed and sieved 80-mesh pirfenidone and inosine according to the prescription; add 5% starch slurry to make a suitable soft material, granulate with a 24-mesh sieve, dry at 60°C for 4 hours, and granulate ; Add sodium carboxymethyl starch and magnesium stearate, mix well, and fill into hollow capsules to get.

Embodiment 3

[0035] Example 3 Preparation of orally disintegrating tablet of the present invention

[0036] prescription:

[0037] Pirfenidone 180 g

[0038] Inosine 120 g

[0039] Sodium Carboxymethyl Starch 15g

[0040] Croscarmellose Sodium 15g

[0041] Microcrystalline cellulose 30g

[0042] Pregelatinized starch 26g

[0043] Sucralose 4g

[0044] Lemon flavor 1g

[0045] Magnesium stearate 3 g

[0046] 1000 pieces

[0047] The raw materials and auxiliary materials of pirfenidone and inosine are crushed separately and passed through an 80 mesh sieve. Take pirfenidone and inosine, mix well with pregelatinized starch, microcrystalline cellulose and sodium carboxymethyl starch, make soft material with water as binder, granulate with 24 mesh sieve, after drying, sieve 24 mesh grain. Add croscarmellose sodium, sucralose, lemon flavor and magnesium stearate, mix well, press tablets, and get ready.

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PUM

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Abstract

The invention relates to a pharmaceutical composition for treating hepatic fibrosis and a preparation method thereof. The pharmaceutical composition is a formulation prepared from a main ingredient and pharmaceutically acceptable auxiliary materials, wherein the main ingredient comprises 100-300 parts of pirfenidone and 50-150 parts of inosine. The formulation of pirfenidone and inosine is stable in quality, controllable, safe and effective. In clinic, the formulation is mainly used for the treatment of diseases of hepatic fibrosis, cirrhosis, liver cancer, and the like.

Description

Technical field [0001] The invention relates to a pharmaceutical composition for treating liver fibrosis and a preparation method thereof, and belongs to the technical field of medicine. Background technique [0002] Liver fiber refers to the pathological process of chronic liver damage caused by various disease factors. During the repair process, the synthesis and degradation of collagen and other extracellular matrix are out of balance, resulting in abnormal increase in ECM and excessive deposition of ECM in the liver. Liver fibrosis is the necessary way to further develop into cirrhosis, and cirrhosis is an important cause of death in chronic liver disease. Studies believe that liver fibrosis can be reversed. The cause of liver fibrosis is complex and it is difficult to detect early. Drugs for liver fibrosis, such as interferon, colchicine, and traditional Chinese medicine, may have side effects or have inaccurate effects. Currently, no drugs have been approved by the U.S. Fo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/708A61P1/16A61P35/00A61K31/4418
Inventor 石万棋郎天琼邓聪
Owner SICHUAN GUOKANG PHARMA
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