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Amino-acid-containing aceglutamide pharmaceutical composition for injection and application thereof

A technology of acetylglutamine and amino acids, which is applied in the field of medicine, can solve problems such as stability and effect damage, and affect product effects, and achieve clinically high safety, good resistance to high humidity, and safe and reliable ingredients

Active Publication Date: 2021-01-05
GUANGZHOU YIPINHONG PHARMA +4
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Later, it was found that when used as an injection preparation, whether it is a powder injection or an injection, it is easily affected by light, heat, etc., causing the substance to decompose or transform into other substances, and the stability and effect are damaged to varying degrees. Affect product effect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1: With reference to patent CN201610177247.X, take the prescribed amount of acetylglutamine, add an appropriate amount of water, stir well, adjust the pH value to 5.5-5.6 with 10% sodium hydroxide, then add mannitol, Stir and dissolve aspartic acid and sucrose, add 0.1% of the volume of the needle, stir and absorb with activated carbon at room temperature for 20 minutes, filter and decarbonize; add water for injection to 2000ml of the filtrate, pass through a 0.22μm microporous membrane, and measure the content of intermediates. , filled in 7ml vials, 2ml each.

[0025] 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. Prepare freeze-dried powder according to the above preparation method, w...

Embodiment 2

[0027] Example 2: 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 5.5-5.6, then add mannitol, aspartic acid and sucrose and stir Dissolve, add 0.1% of the volume of the needle, stir and absorb with activated carbon at room temperature for 20 minutes, filter and decarbonize; the filtrate is supplemented with water for injection to 2000ml, passes through a 0.22μm microporous membrane, and measures the content of intermediates. In the bottle, each 2ml.

[0028] 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. Prepare freeze-dried powder according to the preparation method of Example 1, wher...

Embodiment 3

[0030] Example 3: 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 5.5-5.6, then add mannitol, aspartic acid and sucrose and stir Dissolve, add 0.1% of the volume of the needle, stir and absorb with activated carbon at room temperature for 20 minutes, filter and decarbonize; the filtrate is supplemented with water for injection to 2000ml, passes through a 0.22μm microporous membrane, and measures the content of intermediates. In the bottle, each 2ml.

[0031] 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. Prepare freeze-dried powder according to the preparation method of Example 1, wher...

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PUM

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Abstract

The invention provides application of amino acid in improving the stability of aceglutamide for injection. It is found that in a freeze-drying protective agent containing the amino acid, when the aceglutamide composition is used as an injection product for use, the stability to light, heat and temperature can be improved. The invention further provides the aceglutamide composition containing the amino acid, mannitol and cane sugar. The aceglutamide composition comprises the following components of, in parts by weight, 50-100 parts of aceglutamide, 60-100 parts of amino acid, 80-160 parts of mannitol, 80-160 parts of cane sugar and a proper amount of pH regulator, wherein the amino acid is one or more of glutamic acid or aspartic acid. The aceglutamide for injection is high in stability, and can exert the original effect and ensure the curative effect when being subsequently used as a powder injection or an injection.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to an acetylglutamine composition containing amino acids and its application as an injection acetylglutamine preparation. Background technique [0002] 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. Current research has found that acetylglutamine has been used as a nutritional support during recovery from high-intensity training. Acetylglutamine promotes amino acid transport and enhances intracellular glutathione and DNA synthesis. [0003] At present, the commonly used dosage forms of acetylglutamine are injections, including powder injections and injections. Compared with injection, acetylglutamine ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K9/08A61K31/197A61K47/10A61K47/18A61K47/26A61P25/00A61P25/28
CPCA61K31/197A61K47/183A61K47/10A61K47/26A61K9/0019A61K9/19A61K9/08A61P25/28A61P25/00Y02A50/30
Inventor 李捍雄黄涌澜
Owner GUANGZHOU YIPINHONG PHARMA
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