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Microporous membrane controlled-release coated febuxostat pellets and preparation method thereof

A technology of Buxostat pellets and Febuxostat, which is applied to medical preparations, pharmaceutical formulas, microcapsules, etc. of non-active ingredients

Inactive Publication Date: 2017-05-17
FOSHAN TENGRUI MEDICINE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] 1. Listing situation abroad

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Preparation of drug-containing pill core: get 10% febuxostat, 30% microcrystalline cellulose, 5% carboxymethyl starch sodium, and 55% lactose in a mixer and mix evenly, add an appropriate amount of 5% hypromellose sodium solution as The adhesive is used to make a soft material, which is extruded through a 0.6-0.8mm sieve, rolled into a ball, and then boiled and dried to obtain a pill core.

[0032] Preparation of pellets with different coating weight gains:

[0033] Coating weight gain A prescription: Eudragit NE 30D aqueous dispersion 20kg, PVP 1kg, talcum powder 3kg, triethyl citrate 0.1kg.

[0034] Coating weight gain B prescription: Eudragit NE 30D aqueous dispersion 60kg, PVP 3kg, talcum powder 9kg.

[0035] Weigh 100kg of drug-containing pellet cores and put them in the fluidized bed, and spray the above-mentioned coating prescription A or B liquid through a spray gun in a fluidized state. Coating parameters: fan frequency 30, material temperature 25°C, liquid s...

Embodiment 2

[0038] Preparation of drug-containing pill core: get 20% febuxostat, 30% microcrystalline cellulose, 5% carboxymethyl starch sodium, and 45% lactose in a mixer and mix evenly, add an appropriate amount of 5% hypromellose sodium solution as The adhesive is used to make a soft material, which is extruded through a 0.6-0.8mm sieve, rolled into a ball, and then boiled and dried to obtain a pill core.

[0039] Preparation of pellets with different coating weight gains:

[0040] Coating weight gain A prescription: Eudragit NE 30D water dispersion 20kg, HPMC 1kg, talcum powder 3kg, triethyl citrate 0.1kg.

[0041] Coating weight gain B prescription: Eudragit NE 30D aqueous dispersion 60kg, HPMC 3kg, talcum powder 9kg, triethyl citrate 0.3kg.

[0042] Weigh 100kg of drug-containing pellet cores and put them in the fluidized bed, and spray the above-mentioned coating prescription A or B liquid through a spray gun in a fluidized state. Coating parameters: fan frequency 35, material te...

Embodiment 3

[0045] Preparation of drug-containing pill core: get 30% febuxostat, 20% microcrystalline cellulose, 5% carboxymethyl starch sodium, and 45% starch and mix them uniformly in a mixer, add an appropriate amount of 5% hypromellose sodium solution as The adhesive is used to make a soft material, which is extruded through a 0.6-0.8mm sieve, rolled into a ball, and then boiled and dried to obtain a pill core.

[0046] Preparation of pellets with different coating weight gains:

[0047]Coating weight gain A prescription: Eudragit NE 30D aqueous dispersion 20kg, HPMC 1kg, titanium dioxide 1kg, magnesium stearate 2kg, triethyl citrate 0.1kg.

[0048] Coating weight gain B prescription: Eudragit NE 30D aqueous dispersion 60kg, HPMC 3kg, titanium dioxide 3kg, magnesium stearate 6kg, triethyl citrate 0.3kg.

[0049] Weigh 100kg of drug-containing pellet cores and put them in the fluidized bed, and spray the above-mentioned coating prescription A or B liquid through a spray gun in a fluid...

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PUM

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Abstract

The invention discloses microporous membrane controlled-release coated febuxostat pellets and a preparation method thereof. Each microporous membrane controlled-release coated febuxostat pellet sequentially comprises a pill core and a controlled-release coating layer from inside to outside. According to the microporous membrane controlled-release coated febuxostat pellets disclosed by the invention, not only can a bitter taste be coated, but also effective components can be dissolved out, constancy and long acting of blood concentration are ensured, and the defect that medicine is defecated together with excrement before the medicine is completely released is avoided.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations for animals, and more specifically relates to a microporous membrane controlled-release coated febuxostat pellet and a preparation method thereof. Background technique [0002] 1. Listing situation abroad [0003] Febuxostat was first applied for listing in Japan by Japan's Teijin Corporation in early 2004, and it was applied for listing in the United States at the end of the year, and IPSEN applied for listing in Europe. Febuxostat is a new generation of xanthine oxidase inhibitors, which can selectively inhibit xanthine oxidase (XO). This drug is clinically used to treat hyperuricemia (gout). [0004] 2. Mechanism of action [0005] Gout is caused by the deposition of crystalline uric acid in the joints, causing an inflammatory response. The goal of treatment is to reduce the serum uric acid level to below 6 mg / dL. The current standard treatment drug is allopurinol, which belongs to...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/426A61K47/38A61K47/36A61K47/26A61K47/32A61K47/02A61P19/06
CPCA61K9/5084A61K9/0002A61K9/5026A61K31/426A61K47/26A61K47/36A61K47/38
Inventor 王雪峰
Owner FOSHAN TENGRUI MEDICINE TECH CO LTD
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