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Oxiracetam compound and pharmaceutical composition thereof

A compound, alpha ray technology, applied in the field of medicine, can solve the problems of poor quality stability, decreased dissolution, and increased impurity content, and achieves the effects of good stability, good stability and high purity

Inactive Publication Date: 2014-10-01
朗天药业(湖北)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Chinese patent CN200410023403.4 discloses a dispersible oxiracetam tablet and its preparation method. The prescription consists of 10-90% oxiracetam, 2-90% disintegrant, and 0-20% lubricant and glidant , binder 0-20%, the preparation can disintegrate rapidly into uniformly dispersed fine particles after oral administration, it is convenient to take, can be taken orally after being dispersed with water, and can also be contained in the mouth for sucking or swallowing, but the patent No mention of formulation stability issues
This patent only tested the influence factors of high temperature and light on the oxiracetam preparation, and did not investigate its long-term storage stability
[0007] After research and analysis, it was found that the above-mentioned disclosed oxiracetam oral solid preparation product has shortcomings in terms of quality stability: the quality stability of the product is poor, and during long-term storage, the content of active ingredients is significantly reduced, and the content of impurities is significantly increased , the dissolution rate drops significantly, and the quality is not stable enough, which is not conducive to ensuring the safety of clinical medication

Method used

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  • Oxiracetam compound and pharmaceutical composition thereof
  • Oxiracetam compound and pharmaceutical composition thereof
  • Oxiracetam compound and pharmaceutical composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] 1) Completely dissolve 50g of oxiracetam in a mixed solvent of 600ml of tetrahydrofuran and 300ml of ethylene glycol, stir until it is completely dissolved, adjust the pH value of the liquid to 5 with acetic acid, then add activated carbon, stir for adsorption, filter to remove carbon Bacteria, to obtain a clear solution, move the clear solution into a pressure vessel, and under the condition that the pressure in the pressure vessel is 1Mpa and the temperature of the clear solution in the pressure vessel is 60°C, slowly add 300ml of isopropyl ether to produce a white precipitate, filter , washed successively with methanol and deionized water, and dried under reduced pressure to obtain the oxiracetam compound in the form of white microcrystalline powder;

[0049] 2) Add the oxiracetam crystals obtained in step 1) into toluene and heat up to 65°C, heat it for 8 hours and filter while it is hot, and then fine-filter the filtrate with a 0.45 μm microporous membrane;

[0050...

Embodiment 2

[0059] 1) Completely dissolve 50 g of oxiracetam in a mixed solvent of 675 ml of tetrahydrofuran and 225 ml of ethylene glycol, adjust the pH value of the liquid to 6.5 with acetic acid, then add activated carbon, stir for adsorption, filter for decarburization and sterilize to obtain a clear solution, Move the clarified solution into a pressure vessel, and slowly add 250ml of isopropyl ether under the condition that the pressure in the pressure vessel is 1Mpa and the temperature of the clarified solution in the pressure vessel is 70°C, to produce a white precipitate, filter it, and then use methanol, then remove Washing with deionized water and drying under reduced pressure to obtain the white microcrystalline powder oxiracetam compound;

[0060] 2) Add the oxiracetam crystals obtained in step 1) into toluene and heat up to 80°C, keep warm for 3 hours and filter while it is hot, and then fine filter the filtrate with a 0.45um microporous membrane;

[0061] 3) Collect the filt...

Embodiment 3

[0067] Completely dissolve 50g of oxiracetam in a mixed solvent of 500ml of tetrahydrofuran and 400ml of ethylene glycol, adjust the pH value of the liquid to 5.5 with acetic acid, then add activated carbon, stir for adsorption, filter for decarbonization and sterilization, and obtain a clear solution. Move the solution into a pressure vessel, and under the condition that the pressure in the pressure vessel is 1Mpa and the temperature of the clarified solution in the pressure vessel is 65°C, slowly add 350ml of isopropyl ether to produce a white precipitate, filter it, and wash it with methanol and deionized water successively. Wash and dry under reduced pressure to obtain the oxiracetam compound in the form of white microcrystalline powder;

[0068] 2) Add the oxiracetam crystals obtained in step 1) into toluene and heat up to 70°C, heat it for 5 hours and filter it while it is hot, and then fine filter the filtrate with a 0.45um microporous membrane;

[0069] 3) Collect the ...

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Abstract

The invention belongs to the technical field of medicine, and provides an oxiracetam compound and a pharmaceutical composition thereof. The X-ray powder diffraction of the oxiracetam compound by Cu-Kalpha ray measurement has characteristic peaks when 2theta is 12.2 degrees, 14.4 degrees, 18.1 degrees, 19.6 degrees, 20.0 degrees, 21.8 degrees, 22.7 degrees, 24.6 degrees or 25.1 degrees. The oxiracetam compound has high crystal purity, and the related substance content is lower than 0.05%. The oxiracetam has favorable stability, and the moisture absorption weight gain does not exceed 0.5% even under high-humidity conditions. The tablet prepared by the pharmaceutical composition containing the oxiracetam has favorable stability, and the total impurity content is lower than 0.2% after the tablet is stored for 24 months. The injection prepared by the pharmaceutical composition containing the oxiracetam has favorable stability, and the total impurity content is lower than 0.2% after the injection is stored for 24 months.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to oxiracetam compounds and pharmaceutical compositions containing oxiracetam. Background technique [0002] Oxiracetam (oxiracetam, CAS62613-82-5), developed by ISF S.P.A in Italy, is a new generation of anti-hypoxic nootropics, which belongs to the cyclic derivative of GABOB. Oxiracetam can selectively act on the cerebral cortex and hippocampus, and has the functions of activating, protecting and promoting the functional recovery of nerve cells, but it has no direct vascular activity and no central excitatory effect. It is a long-lasting effect on the improvement of learning and memory. promotion. Oxiracetam can improve brain metabolism and is clinically used to treat brain damage caused by various physical and chemical factors, various cerebral hypoxia and chronic cerebral insufficiency. It has a certain curative effect on dementia, shock, senile mental decline syn...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D207/273A61K9/08A61K9/20
CPCA61K9/0019A61K9/2054C07D207/273
Inventor 蔡翔符耿哲黎翩
Owner 朗天药业(湖北)有限公司
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