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Production method of bromhexine hydrochloride

A technology of bromhexine hydrochloride and a production method, which is applied in the field of bromhexine hydrochloride raw material drug production, can solve problems such as synthesis reaction equipment being difficult to meet production needs, harsh synthesis reaction conditions, poor reaction quality and the like, and achieve sealing and environmental protection effects Good, simple structure, few reaction steps

Inactive Publication Date: 2013-01-30
HONGYI SCI & TECH CO LTD NANCHANG
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The current bromhexine hydrochloride production process has harsh synthesis reaction conditions, the synthesis reaction equipment is difficult to meet the production needs, the reaction quality is poor, the yield is low, and the environmental pollution is serious

Method used

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  • Production method of bromhexine hydrochloride
  • Production method of bromhexine hydrochloride
  • Production method of bromhexine hydrochloride

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Experimental program
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Embodiment Construction

[0023] 1. Preparation of N-(2-nitrobenzyl)-N-methylcyclohexylamine (intermediate I)

[0024] Take 149g of 2-nitrobenzyl bromide, 80g of N-methylcyclohexylamine (about 99%), and 500ml of absolute ethanol in a multifunctional reactor equipped with a special bottom valve, and heat and reflux for 5h together. The reaction solution was evaporated to dryness under reduced pressure to remove ethanol. Add 100ml of water to dissolve the evaporated matter, add 2mol / L sodium hydroxide to adjust the pH to 10, extract 3 times with 50ml of chloroform, wash the organic layer 3 times with 30ml of water, dry with 50g of anhydrous sodium sulfate for more than 8 hours, filter and wash with 30ml of chloroform for 2 First, chloroform was distilled off under reduced pressure to obtain an oily residue, and then dried under reduced pressure at 116°C to 119°C and 8.0 Pa to obtain N-(2-nitrobenzyl)-N-methylcyclohexylamine oil (Intermediate I) 145 g. Yield 84.7%.

[0025] 2. Preparation of N-(2-amino...

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Abstract

The invention discloses a production method of bromhexine hydrochloride, which uses a multi-function reaction kettle with a special kettle bottom valve as the reaction vessel, uses a special filter as the purifier, uses 2-nitrobenzyl bromide and N-methyl cyclohexylamine as the starting materials, enables the product generated by the reaction under the condition of normal temperature and pressure to the react with hydrazine hydrate under the catalysis of Raney's nickel, and produces the bromhexine hydrochloride by brominating substitution reaction, chlorine hydride salification reaction, purification and drying. Compared with the disclosed production process of bromhexine hydrochloride and the bromhexine hydrochloride produced by the current synthesis device, the production method of the invention has the advantages of less reaction steps, moderate reaction condition, convenient purification and simple operation; the used special device has the advantages of good heat insulation, oxidation resistance, air tightness and environmental protection effects and thorough reaction; and the reaction device has the advantages of simple structure, convenient operation, easy disassembly / assembly and cleaning, high filter efficiency, reaction quality and yield, and stable product quality.

Description

technical field [0001] The invention relates to the field of medicine and chemical industry, and more specifically, relates to a production method of bromhexine hydrochloride crude drug. Background technique [0002] The English name of bromhexine hydrochloride is Bromhexine Hydrochloride, which was the earliest active ingredient of Indian folk expectorant and cough medicine Duckbill flower. It was first synthesized by Keck in 1963 and developed by BoehringerInger Company. It was listed in 1965 and sold in Germany and Italy. , Britain, France and other countries, it was produced in my country in 1973 and recorded in the Chinese Pharmacopoeia. [0003] Bromhexine hydrochloride is a derivative of Vasicine, its chemical name is N-methyl-N-cyclohexyl-2-amino-3,5-dibromobenzylamine hydrochloride, and its structural formula is HCl, the molecular formula is C 14 h 20 Br 2 N 2 • HCl, molecular weight 412.60. [0004] Bromhexine hydrochloride has a strong mucolytic effect. It ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07C211/52C07C209/68B01J19/18B01F13/08
Inventor 穆正义廖新华刘孝乐
Owner HONGYI SCI & TECH CO LTD NANCHANG
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