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Crystal form of n-methyl-2-pyridylethylamine dihydrochloride and preparation method thereof

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

Active Publication Date: 2017-05-17
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 of n-methyl-2-pyridylethylamine dihydrochloride and preparation method thereof
  • Crystal form of n-methyl-2-pyridylethylamine dihydrochloride and preparation method thereof

Examples

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Effect test

Embodiment 1

[0021] Heat 1g of N-methyl-2-pyridylethylamine dihydrochloride in 5ml of ethanol to 78°C to dissolve it completely, stand for crystallization at 25°C, filter, and dry to obtain 0.82g of white solid, which is The crystal form of the N-methyl-2-pyridylethylamine dihydrochloride.

Embodiment 2

[0023] Heat 1g of N-methyl-2-pyridineethylamine dihydrochloride in 60ml of isopropanol to 80°C to dissolve it completely, stand for crystallization at 30°C, filter, and dry to obtain 0.78g of white solid , which is the crystal form of the N-methyl-2-pyridylethylamine dihydrochloride.

Embodiment 3

[0025] Heat 1g of N-methyl-2-pyridineethylamine dihydrochloride in 2ml of methanol to 60°C to dissolve it completely, stand for crystallization at -10°C, filter, and dry to obtain 0.87g of white solid. It is the crystal form of the 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 10.9 DEG, 12.4 DEG, 14.7 DEG, 15.5 DEG, 18.0 DEG, 19.5 DEG, 21.6 DEG, 22.9 DEG, 23.7 DEG, 24.7 DEG, 24.9 DEG, 26.0 DEG, 26.2 DEG, 26.4 DEG, 26.6 DEG, 28.1 DEG, 29.6 DEG, 34.3 DEG, 35.9 DEG, 37.8 DEG and 38.2 DEG. The present invention further discloses the preparation method of the crystal form, wherein the preparation method can adopt any one of the following schemes: scheme 1: heating and dissolving N-methyl-2-pyridine ethylamine dihydrochloride in a solvent, cooling, and crystallizing; and scheme 2: 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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Patent Type & Authority Patents(China)
IPC IPC(8): C07D213/38
CPCC07B2200/13C07D213/38
Inventor 蒋敏张福利潘林玉裘鹏程宋品徐静王海翠
Owner CHINA NAT MEDICINES GUORUI PHARMA
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