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More stable aceglutamide compound and medicinal composition thereof

A technology of acetylglutamine and compounds, which is applied in the field of preparation of pharmaceutical compounds, can solve the problems of greater than 0.2%, and achieve the effects of long storage period, low impurity content, and good crystal shape

Inactive Publication Date: 2012-02-22
河北三禾实创生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the prior art uses 95% ethanol as the recrystallization solvent. Although the content of acetylglutamine after recrystallization is greater than 99%, the content of a related impurity with an unknown structure is greater than 0.2%.

Method used

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  • More stable aceglutamide compound and medicinal composition thereof
  • More stable aceglutamide compound and medicinal composition thereof
  • More stable aceglutamide compound and medicinal composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Add 45g of the purchased crude product acetylglutamine to 450ml of a mixed solution of methanol and acetone with a volume ratio of 2:1, then add 22g of activated carbon, heat to reflux for 2 hours, cool and place in a 4-degree refrigerator for 12 hours to precipitate crystals, and filter Crystals were obtained, and the above recrystallization steps were repeated to obtain 40 g of white crystals with a purity of 99.80%. Each impurity content is less than 0.1%.

Embodiment 2

[0039]

[0040] Its preparation method is as follows:

[0041] Take 100g of acetylglutamine, mix and grind it with PEG-400, dissolve the ground product of acetylglutamine and PEG-400 with 8000ml of absolute ethanol, add 0.5% activated carbon, heat to 80°C and maintain it for 15 minutes, filter to remove carbon, and then Add sodium bisulfite and edetate disodium, stir to dissolve, add absolute ethanol to 10000ml, add 0.5% activated carbon, boil, fine filter with 0.45μm microporous membrane, and use 0.20μm microporous filter The membrane is sterilized and filtered, canned, sterilized, and labeled, and the product is obtained.

Embodiment 3

[0043]

[0044] Its preparation method is as follows:

[0045] Take 60g of acetylglutamine, mix and grind it with PEG-400, dissolve the ground product of acetylglutamine and PEG-400 with 8000ml of absolute ethanol, add 0.5% activated carbon, heat to 80°C and maintain it for 15 minutes, filter to remove carbon, and then Add sodium bisulfite and edetate disodium, stir to dissolve, add absolute ethanol to 10000ml, add 0.5% activated carbon, boil, fine filter with 0.45μm microporous membrane, and use 0.20μm microporous filter The membrane is sterilized and filtered, canned, semi-sealed, placed in a freeze-drying box, freeze-dried, sealed, labeled, and packaged.

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PUM

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Abstract

The invention relates to more stable aceglutamide compound and a medicinal composition. The more stable aceglutamide compound is prepared by the following steps of: recrystallizing crude aceglutamide by 1-3 times with a mixed solvent prepared by mixing methanol with acetone in the ratio 2:1; and decolorizing with active carbon to obtain a white crystal, wherein the ratio of the crude aceglutamideto the mixed solvent is 1:10; and the using amount of the active carbon is 5 percent of the solution volume.

Description

Technical field: [0001] The invention relates to the preparation of a pharmaceutical compound, in particular to the preparation of an acetylglutamine compound and its preparation. Background technique: [0002] Acetylglutamide, also known as: acetic glutamine, English name: Aceglutamide, structural formula is: [0003] [0004] [Pharmacological action] Improve nerve cell metabolism, maintain good stress function; reduce blood ammonia, used for hepatic coma, traumatic brain coma; alcohol and drug dependence; organic mental disorders, intellectual and memory loss; paralysis; sequelae of polio . [0005] [Indications] For brain trauma coma, hepatic coma, hemiplegia, high paraplegia, sequelae of poliomyelitis, nervous headache, low back pain, etc. [0006] At present, acetylglutamine small-capacity water injections and freeze-dried injections are already on the market. In the prior art, acetylglutamine contains glutamine, an impurity that is easily oxidized, resulting in po...

Claims

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Application Information

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IPC IPC(8): C07C237/22C07C231/24A61K31/198A61P25/00A61P25/04A61P25/28A61P1/16A61P9/10
Inventor 贺金凤
Owner 河北三禾实创生物科技有限公司
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