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Aceglutamide composition for injection and preparing method thereof

A technology of acetoglutamine and preparation, applied in the field of medicine, can solve problems such as inability to carry out industrialized production, reduction of acetoglutamine yield, poor reproducibility of operation process and the like

Active Publication Date: 2016-07-27
GUANGZHOU YIPINHONG PHARMA +4
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the strict control of the process parameters not only increases the operating cost, but also has poor reproducibility of the operating process, so that the above method cannot be industrialized, which limits the practical application of acetylglutamine preparations
[0009] In addition, it is well known that activated carbon is required for decolorization during the preparation of injections. In the methods disclosed in the above-mentioned documents, activated carbon has a certain adsorption effect on acetylglutamine, thereby reducing the yield of acetylglutamine and improving pharmaceutical costs.

Method used

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  • Aceglutamide composition for injection and preparing method thereof
  • Aceglutamide composition for injection and preparing method thereof
  • Aceglutamide composition for injection and preparing method thereof

Examples

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Embodiment 1

[0030]

[0031] Take the prescribed amount of acetylglutamine, add an appropriate amount of water, stir well, adjust to dissolve with 10% sodium hydroxide, and adjust the pH value to 5.6, then add mannitol, dextran and sucrose and stir to dissolve, add 0.1% of the volume of The needles were stirred and adsorbed with activated carbon at room temperature for 20 minutes, and decarbonized by filtration; the filtrate was supplemented with water for injection to 2000ml, and passed through a 0.22μm microporous membrane to measure the content of intermediates. After passing the test, it was filled in 7ml vials, 2ml each.

[0032] The filled sample is half-filled with butyl rubber stoppers, placed in a plate, placed in a freeze dryer, freeze-dried, cooled to -40°C, and kept warm for 2 hours, then raised at a rate of about 1°C / hour, and slowly raised to -5°C Sublimation and drying at ~0°C, then heating to 35°C, and keeping the temperature for 5 hours.

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Abstract

The invention provides aceglutamide freeze-dried powder for injection.The powder is prepared from 1-10 parts by weight of aceglutamide, 0.5-20 parts by weight of freeze-drying protective additive and a proper amount of pH modifier.Preferably, the freeze-drying protective additive is the composition of mannitol, dextran and saccharose in the proportion of 1:1:1.

Description

technical field [0001] The invention relates to an acetylglutamine pharmaceutical composition, in particular to a freeze-dried preparation of acetylglutamine for injection, which belongs to the field of medicine. Background technique [0002] Acetyl glutamine, also known as acetate glutamine or amide glutaric acid amine acetate glutamine, chemical name: N-acetyl-L-glutamine, its physical and chemical properties are: white crystalline powder, odorless, tasteless, soluble In water, slightly soluble in ethanol. [0003] Acetylglutamine is a central nervous system stimulant, which can directly enter the central nervous system through the blood-brain barrier, participate in the information transmission of the central nervous system, improve nerve cell metabolism, increase cell vitality, maintain nerve stress ability, and improve brain function. [0004] Further current research has found that acetylglutamine has been used as a nutritional support during high-intensity training r...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/198A61P25/00A61P39/00
CPCA61K9/0019A61K9/19A61K31/198A61K47/36
Inventor 李捍雄杨冬玲佟妍
Owner GUANGZHOU YIPINHONG PHARMA
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