Medicinal composition containing febuxostat

A technology of febuxostat and composition, applied in the field of medicine

Inactive Publication Date: 2014-02-12
FUKANGREN BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The addition of lesinurad increased plasma levels of febu...

Method used

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  • Medicinal composition containing febuxostat

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Febuxostat: 20 microns

[0019] Lesinurad: 75 microns

[0020] Types of raw materials

[0021] Preparation process: The two raw materials are micronized separately to make them reach the required particle size. Take febuxostat, pregelatinized starch, lactose, and sodium carboxymethyl cellulose, mix well, add an appropriate amount of water to granulate, dry, granulate, and add magnesium stearate for total blending. Take lesinurad, lactose, and crospovidone, mix well, add appropriate amount of water, granulate, dry, granulate, add magnesium stearate for total mixing, compress double-layer tablets, and perform coating.

Embodiment 2

[0023] The two raw materials were micronized respectively, and the particle size was controlled so that the particle size of febuxostat was 30 microns, and the particle size of lesinurad was 90 microns. They were prepared according to the prescription and process of Example 1 to obtain finished products.

[0024] Measure the dissolution of these two products respectively, and the dissolution method is as follows:

[0025] Dissolution method of febuxostat: paddle dissolution test method, rotation speed 50rpm, dissolution medium is 0.5% SDS solution, dissolution volume 900ml, dissolution medium temperature 37°C, sampling at 15min.

[0026] Lesinurad dissolution method: according to the paddle method dissolution test method, the rotation speed is 50rpm, the dissolution medium is purified water, the dissolution volume is 900ml, the dissolution medium temperature is 37°C, and the sample is taken at 15min.

[0027] The measurement results are as follows:

[0028]

[002...

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Abstract

The invention provides a medicinal composition containing febuxostat. Febuxostat and lesinurad as active components and proper auxiliaries are adopted to prepare the stable preparation through a preparation process. The preparation has excellent in vitro dissolution, and quickly acts in a body.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing febuxostat, which is combined with lesinurad to form a compound preparation. It belongs to the field of medical technology. Background technique [0002] Primary gout was thought to be relatively rare in my country in the past, but in recent years, due to the improvement of nutritional conditions, the extension of average life expectancy, and the attention to this disease, many factors have been discovered. The prevalence rate increases gradually with age, and it is more common in men, with a male-to-female ratio of about 20:1. Women rarely develop the disease, and if it occurs, it occurs mostly after menopause. Many cases reported abroad have a positive family history, most of which are autosomal inheritance, and a few are sex-linked inheritance. Mental workers and economically well-nourished classes are more likely to suffer from the disease. The course of gout is quite long, and tho...

Claims

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Application Information

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IPC IPC(8): A61K31/426A61P19/06A61K31/4196
Inventor 不公告发明人
Owner FUKANGREN BIO PHARMA
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