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Dronedarone hydrochloride slow-release tablets and preparation method thereof

A technology for dronedarone hydrochloride and sustained-release tablets, which is applied in the field of pharmaceutical preparations and its preparation, can solve the problems of unseen glycerol monostearate, etc., and achieve the effects of expanded production, good sustained-release effect, and simple process

Inactive Publication Date: 2018-05-11
佛山市弘泰药物研发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the matrix materials of sustained-release tablets, there are no reports on glyceryl monostearate and glyceryl palmitate stearate

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1: Preparation of dronedarone hydrochloride sustained-release tablets

[0035] Weigh 1g dronedarone hydrochloride, 2.5g glyceryl palmitate stearate, 5g microcrystalline cellulose, mix them evenly according to the same volume addition method, pass through an 80 mesh sieve, 2.5g waxy melt (0.5g white beeswax , 1g palm wax and 1g PEG6000 plus ethanol are melted at 85°C and then dried to remove ethanol) Add the main drug, microcrystalline cellulose and stearic acid palmitate to the mixture of PVPK30 ethanol solution (concentration is 5%wt.) Used as a binder (10g of solution) to make soft materials, granulate on a 30-mesh sieve, dry at 60°C for 1 hour, and then size the 30-mesh sieve, add 0.2g of magnesium stearate and 0.3g of silicon dioxide, mix well, and press .

Embodiment 2

[0036] Example 2: Preparation of dronedarone hydrochloride sustained-release tablets

[0037] Weigh 1.2g dronedarone hydrochloride, 5g glyceryl palmitate stearate, and 2.5g microcrystalline cellulose, mix them evenly according to the same volume addition method, pass through an 80 mesh sieve, 2.5g waxy melt (0.5g white Beeswax, 1g palm wax and 1g PEG6000 plus ethanol are melted at 85°C and dried to remove ethanol) are added to the mixture of the main drug, microcrystalline cellulose and glyceryl palmitate stearate, and the ethanol solution of PVPK30 (concentration of 5% wt. ) Used as a binder (10g of solution) to make soft materials, granulate with 30 mesh sieve, dry at 60°C for 1 hour, and after granulation on 30 mesh sieve, add 0.2g magnesium stearate and 0.3g silicon dioxide, mix and press sheet.

Embodiment 3

[0038] Example 3: Preparation of dronedarone hydrochloride sustained-release tablets

[0039] Weigh 1.5g dronedarone hydrochloride, 0.5g glyceryl monostearate, 2.5g microcrystalline cellulose, mix them evenly according to the same volume addition method, pass through an 80 mesh sieve, 2g waxy molten liquid (1.5g white beeswax And 0.5g of PEG2000 and ethanol are melted at 85°C and dried to remove the ethanol) is added to the mixture of the main drug, microcrystalline cellulose and glyceryl palmitate stearate, and the ethanol solution of PVPK30 (concentration of 2%wt.) is used as the adhesive (10g of solution amount) to make soft material, granulate with 30 mesh sieve, dry at 60°C for 1 hour, after granulation on 30 mesh sieve, add 0.1g magnesium stearate, mix well, and compress.

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PUM

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Abstract

The invention belongs to the field of medicine preparations and discloses dronedarone hydrochloride slow-release tablets and a preparation method thereof. The slow-release tablets are prepared from, in percentage by mass, 10%-35% of dronedarone hydrochloride, 50%-90% of a hydrophobic framework material, 1%-5% of a binder and 0.5%-5% of a lubricant. The slow-release tables are prepared from the hydrophobic framework material and the like, medicine release can be well controlled, the process is simple, and expanded production is facilitated.

Description

Technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to a dronedarone hydrochloride sustained-release tablet and a preparation method thereof. Background technique [0002] Dronedarone (Dronedarone) is a new anti-arrhythmic drug. It was developed by Sanofi-Aventis of France and registered in the United States and the European Union. my country was approved for clinical use in July 2006. Arrhythmia often troubles many patients and doctors, especially the clinical application of amiodarone, because it has a good effect on the control of many ventricular premature contractions, atrial fibrillation or atrial flutter, but it has a large amount for a long time. The application of it causes its side effects to cause deficiencies, especially it causes liver, lung, thyroid and cornea. The drug has an electrophysiological effect similar to amiodarone (amiodarone) and is an alternative newer drug for the latter because...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K47/38A61K47/14A61K47/44A61K31/343A61P9/06
CPCA61K9/2054A61K9/2013A61K31/343
Inventor 雷林芳
Owner 佛山市弘泰药物研发有限公司
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