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Method for preparing ranitidine hydrochloride

A technology of ranitidine hydrochloride and methyl group, applied in the field of preparing ranitidine hydrochloride, can solve the problems of complicated steps, low yield and high processing cost, and achieve the effects of simple steps, high yield and low processing cost

Inactive Publication Date: 2011-04-13
JIANGSU HI STONE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, for the preparation of ranitidine hydrochloride in the prior art, the steps are cumbersome, the yield is low and the processing cost is high, so it is not suitable for mass production

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] 1, the preparation of ranitidine

[0023] Get 200kg of ethanol, 2-[[[5-(dimethylamino)methyl-2-furan]methyl]sulfanyl]ethylamine 17.0kg in a reaction tank, add N-methyl-1-methanol therein Sulfuryl-2-nitroethyleneamine 12.3kg. After the addition is complete, slowly raise the temperature to 40°C to dissolve and react, and maintain it for 8-10 hours.

[0024] After the reaction is complete, cool the reaction solution to 4°C and keep it for 36 hours to fully separate the crystals, then filter, wash the crystals twice with cold ethanol (20ml / time), drain the crystals, and dry the crystals in vacuum (temperature 30°C, time 4 hours) , 21.09 kg of off-white ranitidine crystals were obtained.

[0025] 2. Preparation and refining of ranitidine hydrochloride

[0026] Take 50L of ethanol and 20.0kg of ranitidine, stir to dissolve them, control the temperature at 30±2°C, add hydrochloric acid ethanol solution dropwise until the pH is 6 (about 8L of hydrochloric acid ethanol soluti...

Embodiment 2

[0028] 1, the preparation of ranitidine

[0029] Get 200kg of ethanol, 2-[[[5-(dimethylamino)methyl-2-furan]methyl]sulfanyl]ethylamine 17.0kg in a reaction tank, add N-methyl-1-methanol therein Sulfuryl-2-nitroethyleneamine 12.3kg. After the addition, slowly raise the temperature to 42°C to dissolve and react, and maintain it for 8-10 hours.

[0030] After the reaction is complete, cool the reaction solution to 6°C and keep it for 36 hours to fully separate out the crystals, then filter, wash the crystals twice with cold ethanol (20ml / time), drain the crystals, and dry the crystals in vacuum (temperature 30°C, time 4 hours) 21.04 kg of off-white ranitidine crystals were obtained.

[0031] 2. Preparation and refining of ranitidine hydrochloride

[0032] Take 50L of ethanol and 20.0kg of ranitidine, stir to dissolve them, control the temperature at 30±2°C, add hydrochloric acid ethanol solution dropwise until the pH is 6.2 (about 8L of hydrochloric acid ethanol solution is ne...

Embodiment 3

[0034] Get 200kg of ethanol, 2-[[[5-(dimethylamino)methyl-2-furan]methyl]sulfanyl]ethylamine 17.0kg in a reaction tank, add N-methyl-1-methanol therein Sulfuryl-2-nitroethyleneamine 12.3kg. After the addition is complete, slowly raise the temperature to 45°C to dissolve and react, and maintain it for 8-10 hours.

[0035] After the reaction is complete, cool the reaction solution to 8°C and keep it for 36 hours to fully separate out the crystals, then filter, wash the crystals twice with cold ethanol (20ml / time), drain, and dry the crystals in vacuum (temperature 30°C, time 4 hours) , 21.09 kg of off-white ranitidine crystals were obtained.

[0036] 2. Preparation and refining of ranitidine hydrochloride

[0037] Take 50L of ethanol and 20.0kg of ranitidine, stir to dissolve them, control the temperature at 30±2°C, add hydrochloric acid ethanol solution dropwise until the pH is 6.5 (about 8L of hydrochloric acid ethanol solution is required), continue stirring for 10 minutes,...

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Abstract

The invention relates to a method for preparing ranitidine hydrochloride, comprising the following steps of: (1) mixing ethanol with 2-[[[5-(dimethylamino)methyl-2-furyl]methyl]thio]ethylamine; (2) adding N-methyl-1-methylthio-2-nitro-vinylamine in reaction liquid; (3) cooling reaction liquid, and fully precipitating crystallize; (4) filtering reaction liquid, and washing, pumping and drying crystals to obtain almost white ranitidine; (5) agitating and mixing ethanol and ranitidine; (6) adding ethanol hydrochloride solution until pH value is 6-6.5, and agitating; (7) immediately adding activated carbon to decolor after the pH value becomes stable; (8) filtering reaction liquid, and cooling filtrate to 4-8 DEG C; and (9) continuously filtering, and washing, pumping and drying crystals to obtain white solid ranitidine hydrochloride. The method for preparing ranitidine hydrochloride has the advantages of simple steps, high yield and low processing cost, and is suitable for large scale production.

Description

technical field [0001] The invention relates to a method for preparing ranitidine hydrochloride, which belongs to the technical field of medicine. Background technique [0002] Ranitidine hydrochloride, English name: Ranitidine Leinitiding Piam, its pharmacology has the effect of competitively blocking the combination of histamine and H2 receptors, inhibiting the action of gastric acid, which is 5 to 12 times that of cimetidine in moles, so It is a potent H2 receptor blocker. It is mainly used for the treatment of duodenal ulcer, gastric ulcer, reflux esophagitis, Zollinger-Ellison syndrome and other diseases with high gastric acid secretion. [0003] At present, the prior art for the preparation of ranitidine hydrochloride has cumbersome steps, low yield and high processing cost, and is not suitable for mass production. Contents of the invention [0004] In view of the above problems, the present invention provides a preparation method with simple steps, high yield and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D307/52
Inventor 王多平
Owner JIANGSU HI STONE PHARMA
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