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Freeze-dried dextro-oxiracetam preparation for injection and preparation method thereof

A technology for freeze-dried preparations and injections, which is applied in the field of dexoxiracetam freeze-dried preparations for injection and its preparation, and can solve problems such as the lack of technical disclosure of dexoxiracetam freeze-dried preparations

Inactive Publication Date: 2019-10-11
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Upon inquiry, there is currently no technical disclosure of the lyophilized formulation of Dexoxiracetam

Method used

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  • Freeze-dried dextro-oxiracetam preparation for injection and preparation method thereof
  • Freeze-dried dextro-oxiracetam preparation for injection and preparation method thereof
  • Freeze-dried dextro-oxiracetam preparation for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022]Dissolve D-Oxiracetam in formic acid with a mass concentration of ≥ 85%, the weight ratio of formic acid and D-Oxiracetam is 5:1, keep stirring at a stirring speed of 300 r / min, and heat up to 90 °C for insulation 45min, add activated carbon to decolorize, filter, adjust the pH of the filtrate to 6.0 with an aqueous sodium hydroxide solution with a mass concentration of 20%, crystallize at 0 ~ 5 ℃, suction filtration, collect the filter residue, at 30 ℃, the relative humidity is 70% Dry under conditions for 4h. Test equipment conditions: use Bruker D2PHASER powder diffractometer for room temperature test, 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 crystals prepared in Example 1 have diffraction angles 2θ of 10.54±0.2°, 13.76±0.2°, 14.14±0.2°, 16.64±0.2°, 17.76±0.2°, 18.72±0.2° , 20.16±0.2°, 21...

Embodiment 2

[0024] Dissolve D-Oxiracetam in formic acid with a mass concentration of ≥ 85%, the weight ratio of formic acid and D-Oxiracetam is 3:1, keep stirring at a stirring speed of 100 r / min, and heat up to 88 °C for insulation 55min, add activated carbon to decolorize, filter, adjust the pH of the filtrate to 5.8 with an aqueous sodium hydroxide solution with a mass concentration of 10%, crystallize at 0 ~ 5 ℃, suction filtration, collect the filter residue, at 20 ℃, the relative humidity is 60% Dry under conditions for 3h. Referring to the determination method of crystal form in Example 1, the results show that the crystal prepared in Example 2 is the same crystal form as that in Example 1.

Embodiment 3

[0026] Dissolve D-Oxiracetam in formic acid with a mass concentration of ≥ 85%, the weight ratio of formic acid and D-Oxiracetam is 6:1, keep stirring at a stirring speed of 400 r / min, and heat up to 100 °C for insulation 35min, add activated carbon to decolorize, filter, adjust the pH of the filtrate to 6.4 with an aqueous sodium hydroxide solution with a mass concentration of 30%, crystallize at 0 ~ 5 °C, suction filtration, collect the filter residue, at 40 °C, the relative humidity is 90%. Dry under conditions for 5h. Referring to the determination method of crystal form in Example 1, the results show that the crystal prepared in Example 2 is the same crystal form as that in Example 1.

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Abstract

The invention provides a freeze-dried dextro-oxiracetam preparation. freeze-dried dextro-se oxiracetam crystal compounds with diffraction peaks at the diffraction angles 2theta of 17.76+ / -0.2 degrees,20.16+ / -0.2 degrees, 21.20+ / -0.2 degrees, 24.17+ / -0.2 degrees and 25.88+ / -0.2 degrees, which are subjected to X powder diffraction through Cu Ka radiation, are adopted as active ingredients to be subjected to freeze drying with a freeze-drying excipient by means of a specific freeze-drying technology to obtain the free-dried dextro-se oxiracetam preparation which has high purity, low impurity content and high stability and can be stored for a long time without deterioration. The preparation has the advantages that a preparation technology is simple, convenient, feasible and high in repeatability, industrial large-scale production is easily realized, and considerable economic and social benefits can be generated.

Description

technical field [0001] The invention relates to a dexoxiracetam composition, in particular to a freeze-dried preparation of dexoxiracetam for injection and a preparation method thereof. Background technique [0002] Oxiracetam, the chemical name is 4-hydroxy-2-oxo-1-pyrrolidine acetamide, is a nootropic drug first synthesized by the Italian company Scribble in 1974. Aminobutyric acid (GABOB) derivatives, a central nervous system drug that can promote learning, enhance memory, and protect damaged nerve cells. CN102552125A announced that it improves memory and memory and learning function of mentally retarded patients; it is also suitable for memory and mental retardation caused by mild to moderate vascular dementia, senile dementia and brain trauma or as an adjuvant therapeutic drug. Studies have shown that the dextrorotate of oxiracetam (dexoxiracetam) is less effective in treating cognitive dysfunction and improving learning and memory; however, it has anti-epileptic pharm...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/26A61K31/4015A61P25/00A61P25/28
CPCA61K9/0019A61K9/19A61K31/4015A61K47/26A61P25/00A61P25/28
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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