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Febuxostat tablets and preparation method and detection method thereof

A technology of Buxostat tablets and Febuxostat, which is applied in the field of western medicine and can solve problems affecting the curative effect of Febuxostat

Active Publication Date: 2013-03-27
GUIZHOU XINBANG PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, since febuxostat is a purine analog, it will inevitably affect the activities of other enzymes involved in the metabolism of purine and pyridine. Therefore, in the treatment of allopurinol, repeated high-dose administration is required to maintain a high drug level, which affects The therapeutic effect of febuxostat
[0006] In addition, there is currently no set of strict and reliable quality testing standards for febuxostat drugs

Method used

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  • Febuxostat tablets and preparation method and detection method thereof
  • Febuxostat tablets and preparation method and detection method thereof
  • Febuxostat tablets and preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0236] Embodiment 1: The febuxostat tablet is made of 80g febuxostat, 110g microcrystalline cellulose, 40g lactose, 18g croscarmellose sodium and 2g magnesium stearate. Take febuxostat and lactose, pass through 80-mesh sieve respectively, and set aside; mix 80g febuxostat with 110g microcrystalline cellulose, 40g lactose, and 8g croscarmellose sodium, and add appropriate amount of purified water to prepare Soft material, granulated with 18-mesh sieve, dried at 70°C, granulated with 18-mesh sieve, added the remaining amount of croscarmellose sodium and 2g magnesium stearate, mixed evenly; tested for intermediates, pressed into tablets after passing the test, and obtained Vegetable tablets: Take 370g ethanol and 100g purified water and place them in a blender, add 30g premixed coating powder under constant stirring, continue to stir for 1 hour, filter the coating solution with a 100-mesh sieve, and set aside; Put the tablet in the coating pot, open the coating pot and start the ...

Embodiment 2

[0237] Embodiment 2: the febuxostat tablet is made of 120g febuxostat, 165g microcrystalline cellulose, 60g lactose, 27g croscarmellose sodium and 3g magnesium stearate. Take febuxostat and lactose, pass through 80-mesh sieve respectively, and set aside; mix 120g febuxostat with 165g microcrystalline cellulose, 60g lactose, and 12g croscarmellose sodium, and add appropriate amount of purified water to prepare Soft material, granulated with 18-mesh sieve, dried at 70°C, granulated with 18-mesh sieve, added the remaining amount of croscarmellose sodium and 3g magnesium stearate, mixed evenly; tested for intermediates, pressed into tablets after passing the test, and obtained Vegetable tablets: Take 550g ethanol and 150g purified water and place them in a blender, add 45g premixed coating powder under constant stirring, continue to stir for 1 hour, filter the coating solution with a 100-mesh sieve, and set aside; Put the tablet in the coating pot, open the coating pot and start t...

Embodiment 3

[0238] Embodiment 3: the febuxostat tablet is made of 40g febuxostat, 95g microcrystalline cellulose, 20g lactose, 10g croscarmellose sodium and 1g magnesium stearate. Take febuxostat and lactose, pass through 80-mesh sieve respectively, and set aside; mix 40g febuxostat with 95g microcrystalline cellulose, 20g lactose, 4g croscarmellose sodium, add appropriate amount of purified water to prepare Soft material, granulated with 18-mesh sieve, dried at 70°C, granulated with 18-mesh sieve, added the remaining amount of croscarmellose sodium and 1g magnesium stearate, mixed evenly; tested for intermediates, pressed into tablets after passing the test, and obtained Vegetable tablet: take 185g ethanol, 50g purified water and place in a blender, add 15g premixed coating powder under the condition of constant stirring, continue to stir for 1 hour, and filter the coating solution with a 100 mesh screen, set aside; Put the tablet in the coating pot, open the coating pot and start the ex...

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Abstract

The invention provides Febuxostat tablets and a preparation method and a detection method thereof. The tablets are prepared from 40 to 120 parts of Febuxostat, 95 to 165 parts of microcrystalline cellulose, 20 to 60 parts of lactose, 10 to 27 parts of croscarmellose sodium and 1 to 3 parts of magnesium stearate according to parts by weight. Aiming at the shortcomings of the prior art, the formula and the preparation process of the Febuxostat tablets are optimized, so that the curative effects of the Febuxostat tablets for treating diseases such as hyperuricemia and gout are more remarkable, and the systematic, complete and effective component identification and content determination methods are established to effectively control the quality of the medicine, thereby ensuring the clinical curative effect.

Description

technical field [0001] The invention relates to a febuxostat tablet, a preparation method and a detection method thereof, and belongs to the technical field of western medicine. Background technique [0002] Gout is a group of heterogeneous diseases with increased blood uric acid caused by purine metabolism disorders and (or) acid excretion disorders. After the Second World War, with the improvement of the economic level of various countries, the change of diet structure, the aging of the population, and the prolongation of life expectancy, hyperuricemia has become a high incidence of the elderly. [0003] Gout has been a common disease in developed countries such as Europe and the United States since ancient times. In the past 20 years, the prevalence of hyperuricemia and gout in Asia has been significantly increasing. [0004] Allopurinol is the only drug used to inhibit the production of uric acid clinically, and it is widely used clinically as a gold drug for gout. Ma...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/426A61K47/38A61P19/06G01N30/88G01N30/90G01N21/33
CPCA61K9/2018A61K9/2054A61K9/28A61K31/426G01N21/33G01N30/88G01N30/90G01N2030/027
Inventor 张观福
Owner GUIZHOU XINBANG PHARMACEUTICAL CO LTD
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