Febuxostat capsule drug combination and preparation method thereof
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A technology of febuxostat and its composition, which is applied in the field of febuxostat pharmaceutical composition and its preparation, can solve the problems of small difference in loading amount, poor fluidity, and obvious difference in loading amount, etc., and achieve fast dispersion, The effect of good fluidity and obvious difference in loading capacity
Inactive Publication Date: 2011-04-06
TIANJIN HANKANG PHARMA BIOTECH
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[0021] The present invention aims to overcome the problems of poor fluidity and obvious difference in loading capacity of the existing common capsule preparations, change the shortcomings of febuxostat specifications and large differences in loading capacity, improve the curative effect, and provide febuxostat capsules Good fluidity, small difference in loading capacity
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Embodiment 1
[0058] Febuxostat 80g
[0059] Lactose (Meggle C80) 120g
[0060] Microcrystalline Cellulose (JRS 12) 20g
[0061] Croscarmellose Sodium 10g
[0062] Magnesium Stearate 1g
[0063] The preparation method comprises the following steps:
[0064] 1) Dry febuxostat, lactose, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate at 80°C for 3 hours.
[0065] 2) According to the prescription amount, febuxostat, lactose, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate were weighed and weighed after double-checking.
[0066] 3) Mix febuxostat and other excipients uniformly in equal increments.
[0067] 4) Determination of the main drug content of the granules.
[0068] 5) Adjust the filling amount according to the content, fill the capsules, and get ready.
Embodiment 2
[0070] Febuxostat 120g
[0071] Lactose (Meggle C80) 180g
[0072] Microcrystalline Cellulose (JRS 12) 30g
[0073] Croscarmellose Sodium 15g
[0074] Magnesium Stearate 1.5g
[0075] The preparation method is the same as in Example 1.
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Abstract
The invention discloses a Febuxostat capsule drug combination and a preparation method thereof. The Febuxostat capsule drug combination is characterized in that: ingredients for preparing 1000 capsules are as follows: 80-120g of Febuxostat, 120-180g of lactose (MeggleC80), 20-30g of microcrystalline cellulose (JRS12), 10-15g of croscarmellose sodium, and 1-1.5g of magnesium stearate. The invention also relates to the preparation method of the Febuxostat capsule drug combination, comprising the steps of: respectively drying the raw materials and the auxiliary materials at 80 DEG C for 3 hours, evenly mixing in equal proportion, and filling in capsules. The Febuxostat capsule prepared by the prescription and the preparation method provided by the invention has the advantages of good fluidity, good dissolution, small quality difference, high bioavailability, and good curative effect.
Description
technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a pharmaceutical composition containing febuxostat as an active ingredient and a preparation method thereof. Background technique [0002] Febuxostat, its chemical name is: 2-(3-cyano-4-isobutoxyphenyl)-4-methyl-5-thiazolecarboxylic acid. Molecular formula: C16H16N2O3S, molecular weight: 316.37. Its structural formula is as follows: [0003] . [0004] Pharmacological type: a new generation of xanthine oxidase inhibitors. [0005] Mechanism of action: Febuxostat is a 2-arylthiazole derivative that achieves its therapeutic effect by selectively inhibiting oxidases by lowering serum uric acid levels. [0006] Indications: Febuxostat Tablets is a xanthine oxidase (XO) inhibitor for the long-term treatment of hyperuricemia in gout patients. It is not recommended to use febuxostat tablets for the treatment of asymptomatic hyperuricemia. [0007] Usage and d...
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