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Method for producing dronedarone hydrochloride

A technology of dronedarone hydrochloride and dronedarone, applied in the field of medicine, can solve the problems of difficult control, low yield, easy stratification, etc., and achieve the effects of reducing energy consumption of enterprises, high yield and simple operation

Active Publication Date: 2014-12-03
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method ensures the safety of the reaction, the reaction is very easy to separate, difficult to control, and the yield is low, and the reaction time is as long as 5 hours
[0012] In view of the above, there is a lack of an excellent industrial method for producing dronedarone hydrochloride in the prior art, which can reduce production costs, improve production safety, and ensure higher reaction yield and quality

Method used

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  • Method for producing dronedarone hydrochloride

Examples

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Effect test

Embodiment 1

[0033] Under stirring at 20°C, dissolve 9.5kg dronedarone in 28L ethyl acetate, stir for 30min until dissolved, filter, add 3.1kg 33% ethanol hydrochloric acid solution dropwise to the filtrate (volume of ethanol is about 2.5L, HCl 1.6 equivalent) , after stirring for 1 hour, a solid was precipitated, filtered, the filter cake was recrystallized with acetone, filtered with suction, washed with acetone, dried in vacuum, and crushed to obtain 9.05 kg of white solid powder (mass yield 95.3%).

Embodiment 2

[0035] Under stirring at 20°C, dissolve 9.5kg dronedarone in 28L ethyl acetate, stir for 30min until dissolved, filter, add 3.1kg 33% ethanol hydrochloric acid solution dropwise to the filtrate (volume of ethanol is about 2.5L, HCl 1.6 equivalent) , after stirring for 1 h, a solid precipitated, filtered, washed the filter cake with acetone, dried the obtained product in vacuum, and pulverized to obtain 9.4 kg of white solid powder (mass yield 99.3%).

Embodiment 3

[0037]Under stirring at 25°C, dissolve 9.5kg dronedarone in 28L ethyl acetate, stir for 30min until dissolved, filter, add 6.4kg 20% ​​ethanol hydrochloric acid solution dropwise to the filtrate (ethanol volume is about 6.3L, HCl 2 equivalent) , after stirring for 1 hour, a solid was precipitated, filtered, the filter cake was recrystallized with acetone, filtered with suction, washed with acetone, dried in vacuum, and crushed to obtain 8.69kg of white solid powder (mass yield 91.4%).

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Abstract

The invention relates to a method for producing dronedarone hydrochloride, which is used for solving the technical problems of high energy consumption and poor safety in the existing dronedarone hydrochloride production technique. In ethyl acetate, a hydrochloric acid ethanol solution is utilized to treat dronedarone to obtain the dronedarone hydrochloride. Due to the use of the hydrochloric acid ethanol solution, the invention ensures the low production cost and high industrial safety, so that the reaction is carried out under mild conditions, thereby obtaining the high-yield high-quality dronedarone hydrochloride.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a method for producing dronedarone hydrochloride. Background technique [0002] Dronedarone hydrochloride, the chemical name is N-[2-n-butyl-3-[4-[3-(di-n-butylamino)propoxy]phenoxy]-5-benzofuranyl]methanol Sulfonamide hydrochloride is a new antiarrhythmic drug developed by Sanofi-Aventis in France. Clinical trials have shown that dronedarone hydrochloride can significantly reduce the morbidity and mortality of patients with atrial fibrillation / atrial flutter. Dronedarone hydrochloride was approved by the FDA on July 1, 2009 and launched in the United States. It is a very potential drug for the treatment of arrhythmia. Its structural formula is shown in the following formula (2): [0003] . [0004] Dronedarone hydrochloride is produced by the reaction of dronedarone free base and HCl. Regarding the preparation method of dronedarone hydrochloride, the disclosures in t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D307/80
Inventor 王丙林胡永亮于普刘磊娜郭小丰刘媛媛
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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