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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: 2014-02-05
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] Embodiment 1 Preparation of pharmaceutical tablet 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] Makes 1000 pieces

[0025] Operation: Take pulverized and sieved 80-mesh pirfenidone, inosine, lactose, and microcrystalline cellulose according to the prescription amount, mix thoroughly with equal volume incremental mixing, and then pulverize and sieve. Take povidone K30, add distilled water to heat it to make a 5% solution of povidone K30, add it to the mixed powder to make a soft material, granulate it with a 20-mesh sieve, dry it at 60°C for 4 hours, collect the granules, add carboxymethyl Sodium starch, mixed evenly, granulated with a 18-mesh sieve to make a suitable preparation.

Embodiment 2

[0026] Embodiment 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] Makes 1000 capsules

[0034] Operation: Weigh 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.

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] 26g pregelatinized starch

[0043] Sucralose 4g

[0044] Lemon essence 1g

[0045] Magnesium stearate 3 g

[0046] Makes 1000 pieces

[0047] The raw materials and auxiliary materials of pirfenidone and inosine were pulverized respectively, and passed through an 80-mesh sieve. Mix pirfenidone and inosine with pregelatinized starch, microcrystalline cellulose, and carboxymethyl starch sodium evenly, use water as a binder to make a soft material, granulate with a 24-mesh sieve, and sieve through a 24-mesh sieve after drying grain. Add croscarmellose sodium, sucralose, lemon essence and magnesium stearate, mix well, and press into tablets to obtain the product.

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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, belonging to the technical field of medicine. Background technique [0002] Hepatic fibrosis refers to the pathological process of chronic liver damage caused by various disease factors. During the repair process, the synthesis and degradation of extracellular matrix such as collagen are out of balance, resulting in the abnormal increase and excessive deposition of ECM in the liver. Liver fibrosis is the only way to develop into cirrhosis, and cirrhosis is an important cause of death in chronic liver diseases. Research suggests that liver fibrosis can be reversed. The etiology of liver fibrosis is complex and difficult to detect early. Drugs targeting liver fibrosis, such as interferon, colchicine, and traditional Chinese medicine, may have side effects or have inaccurate curative effects. Currently, no drug has been approved by the U.S....

Claims

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Application Information

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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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