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Dexoxiracetam new crystal form and its preparation method and use

A crystal form and crystallization technology, applied in the field of Dexo-oxiracetam, can solve the problems that there is no crystal form of Dexo-oxiracetam, disclosure, less research on the crystal form of Dexo-oxiracetam, etc.

Active Publication Date: 2020-03-24
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there are few studies on the preparation method and crystal form of Dexoxiracetam, and there is no disclosure of the crystal form of Dexoxiracetam

Method used

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  • Dexoxiracetam new crystal form and its preparation method and use
  • Dexoxiracetam new crystal form and its preparation method and use
  • Dexoxiracetam new crystal form and its preparation method and use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036]Dissolve 30mg of dexoxiracetam (Chongqing Runze Pharmaceutical Co., Ltd.) in 6mL of n-propanol, heat at 40°C, and filter to obtain a supersaturated solution. Seal the solution and place it at -19°C for cooling and crystallization for 24 hours , separated by filtration, and dried at a temperature of 70°C and a relative humidity of 10% for about 5 hours to obtain crystals.

Embodiment 2

[0038] Dexoxiracetam crystals obtained in Example 1 were subjected to crystal parameter determination.

[0039] Powder Diffraction Determination (XRPD):

[0040] Test instrument conditions: use Bruker D2PHASER powder diffractometer to test at room temperature, the test conditions are: Cu Ka It is the light source, the voltage is 30kV, the current is 10mA, the test step is 0.014°, the scanning speed is 0.1s / step, and the scanning range is 5-40° (2θ). After testing, the D-oxiracetam crystal prepared in Example 1 has diffraction angles 2θ of 14.44±0.2°, 17.12±0.2°, 18.88±0.2°, 19.24±0.2°, 19.78±0.2°, 20.66±0.2° , 20.84±0.2°, 21.18±0.2°, 21.82±0.2°, 22.94±0.2°, 23.24±0.2°, 24.88±0.2°, 30.46±0.2°, 31.40±0.2°, 31.52±0.2° have diffraction peaks, in order For convenience, this crystal is called "dextro-oxiracetam crystal form III", and its powder diffraction pattern is shown in figure 1 , and the diffraction data are analyzed in Table 1 below.

[0041] Table 1: Powder diffraction...

Embodiment 3

[0054] Dissolve 30mg of Dexoxiracetam in 2mL of n-propanol, heat at 50°C, and filter to obtain a supersaturated solution. Seal the solution and place it at -17°C for cooling and crystallization for 15 hours, filter and separate, and store at 65°C , Drying for about 4 hours under the condition of a relative humidity of 10%, to obtain colorless sand-like crystals, identified by the method of Example 2, is the dextro-oxiracetam crystal form III.

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Abstract

The invention provides a crystal form of dextrorotation oxiracetam, the crystal form has a diffraction angle of 2 θ is There are diffraction peaks at 17.12±0.2°, 18.88±0.2°, 19.24±0.2°, 21.18±0.2°, and 24.88±0.2°. This crystal form has oxiracetam that can promote the synthesis of phosphorylcholine and o-acylethanolamine, and promote the brain Metabolism, has a stimulating effect on specific central nervous pathways through the blood-brain barrier, improves intelligence and memory, has obvious advantages on memory dysfunction, and has special biological activities in the fields of sedation and anti-epilepticus. The preparation method of the crystal form of the invention is simple and suitable for industrial production.

Description

technical field [0001] The present invention relates to dexoxiracetam, in particular to the crystal form, preparation method and application of dexoxiracetam. Background technique [0002] Oxiracetam (Oxiracetam), CAS No. 62613-82-5, was synthesized for the first time in 1974 by the Italian company Skrbechem, and it is a new generation of brain metabolism-improving drug listed in 1987, which can promote phosphorylcholine and adjacent Acetyl ethanolamine synthesis, promote brain metabolism, stimulate specific central nervous pathways through the blood-brain barrier, improve intelligence and memory. Studies have shown that its L-body has better curative effect on promoting the development of brain intelligence. In recent years, reports have shown that its dextrorotary form (dexoxiracetam) has special biological activity in the fields of sedation and antiepileptic, and its toxicity is low, and the drug safety range is large. It is expected to become an existing highly toxic an...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D207/273A61K31/4015A61P25/08
CPCC07D207/273C07B2200/13C07B2200/07A61P25/08A61K31/4015
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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