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Dronedarone hydrochloride self-microemulsion preparation and preparing method thereof

A technology of dronedarone hydrochloride and nedarone self-degradation, which is applied in the field of medicine and achieves the effects of high yield, easy availability of raw materials, and promotion of lymphatic transport.

Inactive Publication Date: 2018-05-18
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] Example 1: Preparation of dronedarone hydrochloride self-microemulsion soft capsule

[0019] Dronedarone hydrochloride

1g

Linoleic acid monoglyceride

100g

Caprylic acid capric acid polyethylene glycol glyceride

50g

Diethylene glycol monoethyl ether

50g

[0020] Preparation Process:

[0021] Add dronedarone hydrochloride to linoleic acid monoglyceride and stir to dissolve it, then add caprylic acid capric acid polyethylene glycol glyceride and diethylene glycol monoethyl ether successively, stir to mix evenly, and then fill Available in soft capsules.

Embodiment 2

[0022] Example 2: Preparation of dronedarone hydrochloride self-microemulsion soft capsule

[0023] Dronedarone hydrochloride

1g

Oleic acid polyethylene glycol glyceride

100g

Ethyl oleate

50g

Tween 80

25g

Propylene Glycol

25g

[0024] Preparation Process:

[0025] Add dronedarone hydrochloride to polyethylene glycol oleate and stir to dissolve it, then add ethyl oleate, Tween-80, and propylene glycol in sequence, stir to make it evenly mixed, and fill it into a soft capsule. Got.

Embodiment 3

[0026] Example 3: Preparation of dronedarone hydrochloride self-microemulsion soft capsule

[0027] Dronedarone hydrochloride

1g

Polyethylene glycol 15-hydroxystearate

75g

Caprylic acid triglyceride

50g

Oleic acid

25g

Polyoxyethylene 35 castor oil

25g

Polyethylene glycol 400

25g

[0028] Preparation Process:

[0029] Add dronedarone hydrochloride to polyethylene glycol 15-hydroxystearate and stir to dissolve it, then add caprylic acid capric acid triglyceride, oleic acid, polyoxyethylene 35 castor oil, and polyethylene glycol 400 in sequence. After stirring to make it evenly mixed, fill it in a soft capsule to get it.

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PUM

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Abstract

The invention discloses a dronedarone hydrochloride self-microemulsion preparation and a preparing method thereof. A liquid self-microemulsion preparation is prepared from dronedarone hydrochloride, an oil phase, an emulsifier and a co-emulsifier, or a solid self-microemulsion preparation is further prepared from the obtained liquid self-microemulsion preparation and an excipient.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a dronedarone hydrochloride self-microemulsion preparation and a preparation method thereof. Background technique [0002] Dronedarone (Dronedarone) is a new anti-arrhythmic drug. It was developed by the French Sanofi-Aventis company 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 electrophysiological effects similar to amiodarone (amiodarone), and is an alternative newer drug for the latter because it d...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K9/48A61K9/20A61K31/343A61K47/44A61K47/14A61K47/12A61K47/10A61P9/06
CPCA61K9/1075A61K9/1617A61K9/2013A61K9/4858A61K31/343A61K47/10A61K47/12A61K47/14A61K47/44
Inventor 雷林芳
Owner 佛山市弘泰药物研发有限公司
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