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Aceglutamide injection with good stability and preparation method of aceglutamide injection

A technology for acetoglutamine and injection, applied in the field of acetoglutamine injection and preparation thereof, can solve the problems of decreased content, increased pH value, affecting the popularization and application of acetylglutamine injection, etc. Stable, stable drug quality effect

Inactive Publication Date: 2018-01-16
江西省子轩科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the presence of acetylated amide bonds in the chemical structure of acetylglutamine, it is easy to be decomposed in aqueous solution, resulting in an increase in pH and a decrease in content, which affects the clinical application of acetylglutamine injection.

Method used

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  • Aceglutamide injection with good stability and preparation method of aceglutamide injection

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Experimental program
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Effect test

Embodiment 1

[0015] Embodiment 1: the formula of the acetylglutamine injection of every 10000ml is as follows:

[0016] Acetylglutamine 500g, sodium hydroxide 90g, lactose 4.6g, mannitol 7.5g, nicotinamide 10.5g, meglumine 4.2g, water for injection to 10000ml;

[0017] Its preparation method is as follows:

[0018] (1) Add sodium hydroxide and lactose to water for injection at 75°C respectively to form a 6.2 mol / L sodium hydroxide solution and a 3.4% lactose solution by mass percentage, then mix them and stir evenly to obtain a mixed solution a;

[0019] (2) Dissolve mannitol, nicotinamide, and meglumine with 500ml of 45°C water for injection, and let it stand for 3 hours to obtain mixed solution b;

[0020] (3) Dissolve acetylglutamine in 6500ml of water for injection with a water temperature of 75°C, then add mixed solution a and mixed solution b, then add water for injection to the full amount, and stir evenly at 75°C to obtain a medicinal solution;

[0021] (4) The liquid medicine is...

Embodiment 2

[0023] Embodiment 2: the formula of the acetylglutamine injection of every 10000ml is as follows:

[0024] Acetylglutamine 500g, sodium hydroxide 90g, lactose 1.2g, mannitol 4.5g, nicotinamide 7.5g, meglumine 2.4g, water for injection to 10000ml;

[0025] Its preparation method is as follows:

[0026] (1) Add sodium hydroxide and lactose to water for injection at 70°C respectively to form a 5.5 mol / L sodium hydroxide solution and a 2.1% lactose solution by mass percentage, and mix them evenly to obtain a mixed solution a;

[0027] (2) Dissolve mannitol, nicotinamide, and meglumine with 400ml of 40°C water for injection, and let it stand for 2 hours to obtain mixed solution b;

[0028] (3) Dissolve acetylglutamine in 6000ml of water for injection with a water temperature of 70°C, then add mixed solution a and mixed solution b, then add water for injection to the full amount, and stir evenly at 70°C to obtain a medicinal solution;

[0029] (4) The liquid medicine is first pass...

Embodiment 3

[0031] Embodiment 3: the formula of the acetylglutamine injection of every 10000ml is as follows:

[0032] Acetylglutamine 500g, sodium hydroxide 90g, lactose 5.9g, mannitol 10.5g, nicotinamide 12.3g, meglumine 5.6g, add water for injection to 10000ml;

[0033] Its preparation method is as follows:

[0034] (1) Add sodium hydroxide and lactose to water for injection at 80°C respectively to form a 7.2 mol / L sodium hydroxide solution and a 4.6% lactose solution by mass percentage, then mix them and stir evenly to obtain a mixed solution a;

[0035] (2) Dissolve mannitol, nicotinamide, and meglumine with 600ml of 50°C water for injection, and let it stand for 4 hours to obtain mixed solution b;

[0036] (3) Dissolve acetylglutamine in 7000ml of water for injection with a water temperature of 80°C, then add mixed solution a and mixed solution b, then add water for injection to the full amount, and stir evenly at 80°C to obtain a medicinal solution;

[0037] (4) The liquid medici...

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Abstract

The invention provides an aceglutamide injection with good stability and a preparation method of the aceglutamide injection. By means of reasonable proportioning of auxiliary materials such as lactose, mannitol, niacinamide and meglumine, the stability of the aceglutamide injection can be improved, and content reduction of aceglutamide in a storage process can be reduced; meanwhile, it is discovered that after addition of the auxiliary materials, related substances in the aceglutamide injection are increased obviously, standard requests of Chinese pharmacopoeia cannot be met, while after adoption of the specific process, the related substances in the aceglutamide injection are reduced, acceleration tests prove that the pharmacopeia standards are met, and clinical medication efficacy is guaranteed.

Description

technical field [0001] The invention relates to an acetylglutamine injection and a preparation method thereof, in particular to an acetylglutamine injection with good stability and a preparation method thereof. Background technique [0002] Acetylglutamine for injection is the acetylated product of glutamine, which can improve the metabolism of brain nerve cells, maintain the ability of nerve stress and reduce blood ammonia, and can pass through the blood-brain barrier. Clinically, it is mainly used to treat hepatic coma, traumatic brain injury, brain neuroma, coma caused by neurosurgery, paralysis, mental retardation, memory impairment, sequelae of polio, nervous headache and low back pain, etc. At present, the commonly used acetylglutamine preparations mainly include injections. Due to the presence of acetylated amide bonds in the chemical structure of acetylglutamine, it is easy to be decomposed in aqueous solution, resulting in an increase in pH value and a decrease in ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/198A61K47/26A61K47/22A61P25/00A61P1/16A61P25/28A61P29/00
Inventor 俞金香
Owner 江西省子轩科技有限公司
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