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Crystal form and preparation method of N-methyl-2-pyridine ethylamine dihydrochloride

A technology of pyridineethylamine dihydrochloride and crystal form, which is applied in the field of crystal form of N-methyl-2-pyridineethylamine dihydrochloride and its preparation, can solve problems such as poor stability, and achieve easy storage, The effect of simple preparation method and strong flexibility

Active Publication Date: 2015-02-11
CHINA NAT MEDICINES GUORUI PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The crystal form of the N-methyl-2-pyridineethylamine dihydrochloride overcomes the hygroscopicity of the amorphous state in the N-methyl-2-pyridineethylamine dihydrochloride raw material and preparations in the prior art. The defects of strong and poor stability are beneficial to the storage of raw materials and the preparation of preparations, and to the improvement of drug quality and stability

Method used

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  • Crystal form and preparation method of N-methyl-2-pyridine ethylamine dihydrochloride
  • Crystal form and preparation method of N-methyl-2-pyridine ethylamine dihydrochloride

Examples

Experimental program
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Effect test

Embodiment 1

[0019] Heat 1g of N-methyl-2-pyridineethylamine dihydrochloride in 10ml of ethanol containing 0.1% water to 60°C to dissolve it completely, add it dropwise to 100ml of anti-solvent xylene, and statically dissolve it at 25°C place, filter, and dry to obtain 0.71 g of white solid, which is the crystal form of N-methyl-2-pyridylethylamine dihydrochloride.

Embodiment 2

[0021] Heat 1g of N-methyl-2-pyridineethylamine dihydrochloride in 5ml of ethanol containing 0.5% water to 78°C to dissolve it completely, add it dropwise to 75ml of anti-solvent xylene, and let it stand at 0°C place, filter, and dry to obtain 0.69 g of white solid, which is the crystal form of N-methyl-2-pyridylethylamine dihydrochloride.

Embodiment 3

[0023] Heat 1g of N-methyl-2-pyridineethylamine dihydrochloride in 5ml of ethanol containing 1% water to 78°C to dissolve it completely, add it dropwise to 25ml of anti-solvent toluene, and let it stand at 0°C , filtered, and dried to obtain 0.70 g of a white solid, which is the crystal form of N-methyl-2-pyridylethylamine dihydrochloride.

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Abstract

The present invention discloses a crystal form and a preparation method of N-methyl-2-pyridine ethylamine dihydrochloride, wherein the crystal form has the characteristic absorption peaks when the diffraction angle 2[theta] is 12.4 DEG, 12.7 DEG, 24.6 DEG, 25.6 DEG, 26.5 DEG, 28.9 DEG, 38.8 DEG and 41.9 DEG in the X-ray powder diffraction spectrum adopting Cu-K[alpha] as a radiation source. The present invention further discloses the preparation method of the crystal form, wherein the preparation method comprises: heating and dissolving N-methyl-2-pyridine ethylamine dihydrochloride in a solvent, mixing with an anti-solvent, cooling, and crystallizing. With the crystal form, the stability of the bulk drug can be increased, and the bulk drug storage and the formulation preparation are easily achieved.

Description

technical field [0001] The invention relates to a crystal form of N-methyl-2-pyridineethylamine dihydrochloride and a preparation method thereof. Background technique [0002] N-methyl-2-pyridylethylamine dihydrochloride is a histamine drug, the common name is betahistine hydrochloride, and its structural formula is as follows: [0003] [0004] Betahistine hydrochloride is a diamine oxidase inhibitor. It is a weak agonist of histamine H1 receptor and a strong antagonist of H3 receptor. It has obvious expansion effect on cerebrovascular, cardiovascular, especially vertebral-basilar artery system , can improve blood circulation, increase cochlear and vestibular blood flow, thereby eliminating inner ear vertigo, tinnitus and ear closure sensation, can also improve internal auditory artery blood supply, increase capillary permeability, promote the absorption of extracellular fluid, and eliminate lymphatic edema . Betahistine hydrochloride can also resist the vasoconstricti...

Claims

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Application Information

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IPC IPC(8): C07D213/38
CPCC07D213/38
Inventor 蒋敏张福利潘林玉裘鹏程王震宇姚磊陈辉
Owner CHINA NAT MEDICINES GUORUI PHARMA
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