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Slow-release dronedarone hydrochloride capsule and preparation method thereof

A technology of dronedarone hydrochloride and sustained-release capsules, applied in the field of dronedarone hydrochloride sustained-release capsules and preparation thereof

Inactive Publication Date: 2018-05-25
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

Arrhythmia often troubles many patients and doctors, especially the clinical application of amiodarone, because it has a good effect on the control of many premature ventricular contractions, atrial fibrillation or atrial flutter, but the long-term The application of it makes its side effects a fly in the ointment, especially it causes liver, lung, thyroid and cornea etc.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Preparation of pill cores

[0019] 1. Preparation of the coating solution of the main drug: add 15 g of ethyl cellulose and 10 g of dronedarone hydrochloride accurately weighed into the 60% ethanol solution, stir evenly, and filter the resulting suspension with an 80-mesh sieve to form a solid For the coating solution with a content of 55%, keep stirring when spraying the solution.

[0020] 2. Pour 21g of sucrose blank core into the coating pan and preheat it. When the internal temperature of the sucrose blank core reaches above 45°C, adjust the speed in the coating pan to about 20rpm, turn on the peristaltic pump and spray gun to start coating, The spray flow rate is controlled at 70-80g / min. After coating the main drug, open the air exhaust and air intake valves, the coating pan rotates at 5 rpm, and the drying heating temperature is 50°C, and is dried for 5 hours, and the pellets are passed through 12-mesh and 20-mesh sieves to obtain the product.

[0021] Preparat...

Embodiment 2

[0032] Preparation of pill cores

[0033] 1. Preparation of the main drug coating solution: Add 20 g of hypromellose and 15 g of dronedarone hydrochloride into purified water, stir evenly, and filter the resulting suspension with a 80-mesh sieve to form a solid content of 50 % coating solution, keep stirring when spraying.

[0034] 2. Pour 21g of sucrose blank core into the coating pan and preheat it. When the internal temperature of the sucrose blank core reaches above 45°C, adjust the speed in the coating pan to about 20rpm, turn on the peristaltic pump and spray gun to start coating, The spray flow rate is controlled at 70-80g / min. After coating the main drug, open the air exhaust and air intake valves, the coating pan rotates at 5 rpm, and the drying heating temperature is 50°C, and is dried for 5 hours, and the pellets are passed through 12-mesh and 20-mesh sieves to obtain the product.

[0035] Preparation of isolation coating layer

[0036] 1. Add 3g of polyethylene ...

Embodiment 3

[0046] Preparation of pill cores

[0047] 1. Preparation of the main drug coating solution: Add 10 g of polyethylene glycol 4000 accurately weighed and 20 g of dronedarone hydrochloride into purified water, stir evenly, and filter the resulting suspension with an 80-mesh sieve to form a solid content of 45 % coating solution, keep stirring when spraying.

[0048] 2. Pour 21g of sucrose blank core into the coating pan and preheat it. When the internal temperature of the sucrose blank core reaches above 45°C, adjust the speed in the coating pan to about 20rpm, turn on the peristaltic pump and spray gun to start coating, The spray flow rate is controlled at 70-80g / min. After coating the main drug, open the air exhaust and air intake valves, the coating pan rotates at 5 rpm, and the drying heating temperature is 50°C, and is dried for 5 hours, and the pellets are passed through 12-mesh and 20-mesh sieves to obtain the product.

[0049] Preparation of isolation coating layer

[...

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PUM

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Abstract

The invention discloses a slow-release dronedarone hydrochloride capsule and preparation method and application thereof. A slow-release dronedarone hydrochloride pellet comprises a medicated pellet core, an isolating coating layer, a slow-release coating layer and a protective coating layer from inside to outside, wherein the medicated pellet core comprises the following specific components in percent by weight: 10-25% of dronedarone hydrochloride, 10-30% of an adhesive and 10-60% of a sucrose blank pellet core. The slow-release preparation can prolong the duration of the treatment concentration of the dronedarone hydrochloride in a body to 12 hours, reduce side effects caused by excessive fluctuation in blood drug concentration, and reduce the medicine taking times.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to dronedarone hydrochloride sustained-release capsules and a preparation method thereof. Background technique [0002] Dronedarone is a new antiarrhythmic drug developed by Sanofi-Aventis in France, registered in the United States and the European Union, and approved for clinical use in my country 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 premature ventricular contractions, atrial fibrillation or atrial flutter, but the long-term The application of it makes its side effects incur a fly in the ointment, especially it causes liver, lung, thyroid and cornea and so on. The drug has similar electrophysiological effects to amiodarone and is an alternative to the latter because it does not contain iodine. Therefore, it will not cause adverse...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/62A61K9/58A61K31/343A61P9/06
CPCA61K31/343A61K9/5026A61K9/5078
Inventor 雷林芳
Owner 佛山市弘泰药物研发有限公司
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