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A kind of pharmaceutical composition containing febuxostat and preparation method thereof

A febuxostat and composition technology, applied in the field of febuxostat-containing pharmaceutical composition and its preparation, can solve the problems of affecting drug dissolution and reducing the bioavailability of active ingredients of drugs, so as to improve bioavailability, Effect of prolonging drug release time and improving stability

Active Publication Date: 2020-11-13
GUANGDONG YILI LUODING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Due to the extrusion molding of the tablet, it will affect the dissolution of the drug to a certain extent, thereby reducing the bioavailability of the active ingredient of the drug

Method used

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  • A kind of pharmaceutical composition containing febuxostat and preparation method thereof
  • A kind of pharmaceutical composition containing febuxostat and preparation method thereof
  • A kind of pharmaceutical composition containing febuxostat and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Embodiment 1 A kind of pharmaceutical composition containing febuxostat

[0051] Contains the following components:

[0052]

[0053] Preparation method: comprising the following steps:

[0054] (1) Preparation of adhesive: dissolve the adhesive of the formula dosage in purified water, stir and dissolve, configure into an aqueous solution, and set aside;

[0055] (2) Preparation of drug mixture: Add febuxostat, filler and synergist in the amount of the formula into the high-speed mixing granulator, adjust the stirring speed to 20Hz, the cutting speed to 20Hz, and the mixing time to 7min to prepare the mixed material;

[0056] (3) Preparation of soft materials: Add the binder solution obtained in step (1) to the mixture prepared in step (2) and fully stir and mix in the swing granulator, adjust the stirring speed to 20Hz, and the cutting speed to be 20Hz, the adding time of the binder is 2min, the mixing time is 7min, the soft material is prepared by a wet method, ...

Embodiment 2

[0058] Embodiment 2 A kind of pharmaceutical composition containing febuxostat

[0059] Contains the following components:

[0060]

[0061]

[0062] Preparation method: comprising the following steps:

[0063] (1) Preparation of adhesive: dissolve the adhesive of the formula dosage in purified water, stir and dissolve, configure into an aqueous solution, and set aside;

[0064] (2) Preparation of drug mixture: Add febuxostat, filler and synergist in the amount of the formula into the high-speed mixing granulator, adjust the stirring speed to 40Hz, the cutting speed to 40Hz, and the mixing time to 3min to prepare the mixed material;

[0065] (3) Preparation of soft materials: Add the binder solution obtained in step (1) to the mixture prepared in step (2) and fully stir and mix in the swing granulator, adjust the stirring speed to 40Hz, and the cutting speed to be 40Hz, the adding time of the binder is 1.5min, the mixing time is 4min, the soft material is prepared by ...

Embodiment 3

[0067] Embodiment 3 A kind of pharmaceutical composition containing febuxostat

[0068] Contains the following components:

[0069]

[0070]

[0071] Preparation method: comprising the following steps:

[0072] (1) Preparation of adhesive: dissolve the adhesive of the formula dosage in purified water, stir and dissolve, configure into an aqueous solution, and set aside;

[0073] (2) Preparation of drug mixture: Add febuxostat, filler and synergist in the amount of the formula into the high-speed mixing granulator, adjust the stirring speed to 30Hz, the cutting speed to 30Hz, and the mixing time to 5min to prepare the mixed material;

[0074] (3) Preparation of soft materials: Add the binder solution obtained in step (1) to the mixture prepared in step (2) and fully stir and mix in the swing granulator, adjust the stirring speed to 30Hz, and the cutting speed to be 30Hz, the adding time of the binder is 1.8min, the mixing time is 5min, the soft material is prepared by ...

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Abstract

The invention discloses a pharmaceutical composition containing febuxostat and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The pharmaceutical composition comprises the following components in parts by weight: 20-50 parts of febuxostat, 10-80 parts of a filler, 10-30 parts of an adhesive and 0.1-1 part of a synergist. In the implementation process, the mass ratio of the filler to the drug active ingredient febuxostat is controlled, so that the dissolution rate of the drug components can be effectively improved, and the stability of the pharmaceutical composition is improved; and in the implementation process, the synergist is added into the drug components, and on the basis of improving the dissolution rate and the stability of the pharmaceutical composition, the moisture resistance of the drug is further improved by controlling the specific components and the mass ratio of the synergist, so that the moisture absorption rate of the pharmaceutical composition is low after the drug composition is placed for a long time, and the storage time of the pharmaceutical composition is prolonged.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a febuxostat-containing pharmaceutical composition and a preparation method thereof. Background technique [0002] Febuxostat, whose chemical name is 2-[(3-cyano-4-isobutoxy)phenyl]-4-methyl-5-thiazolecarboxylic acid, is a xanthine oxidase (XO) inhibitor , for the long-term treatment of hyperuricemia with gout symptoms. [0003] Its structural formula is as follows: [0004] [0005] Gout is a crystal-associated arthropathy caused by deposition of monosodium urate (MSU), which is directly related to hyperuricemia caused by purine metabolic disorders and / or decreased uric acid excretion, and belongs to the category of metabolic rheumatic diseases. Gout can be complicated by kidney disease. In severe cases, joint damage and renal function damage can occur. It is often accompanied by hyperlipidemia, hypertension, diabetes, arteriosclerosis and co...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K47/26A61K47/38A61K47/36A61K47/22A61K31/426A61P19/06
CPCA61K9/1617A61K9/1623A61K9/1652A61K31/426A61P19/06
Inventor 曾胜张坤黄信梁烽焱张永谦程燕梁志军
Owner GUANGDONG YILI LUODING PHARMA
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