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Pharmaceutical composition and preparation method of acetylglutamine powder injection for injection

A technology of acetylglutamine and composition, which is applied in the direction of drug combination, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as chemical stability

Active Publication Date: 2018-06-01
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0025] However, it is well known that acetylglutamine has significant chemical stability problems. For example, the acetylglutamine raw materials and aqueous injections recorded in the second part of the Chinese Pharmacopoeia in 2010 have strictly controlled its related substances

Method used

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  • Pharmaceutical composition and preparation method of acetylglutamine powder injection for injection
  • Pharmaceutical composition and preparation method of acetylglutamine powder injection for injection
  • Pharmaceutical composition and preparation method of acetylglutamine powder injection for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0097] Embodiment 1: Preparation of acetylglutamine freeze-dried powder injection pharmaceutical composition

[0098] formula:

[0099] Acetylglutamine 100mg,

[0100] Mannitol 166mg,

[0101] Appropriate amount of acid-base regulator,

[0102] 1ml water for injection for dosing;

[0103] Preparation method:

[0104] (a) Dissolve acetylglutamine in an appropriate amount of 2.5 times the weight of water for injection, add an appropriate amount of propylene glycol (the weight of propylene glycol added is 0.2 times the weight of acetylglutamine), stir evenly, and then add absolute ethanol (absolute ethanol The weight added is 0.4 times of the weight of acetylglutamine), stirred evenly, and left for 24 hours; continue to add absolute ethanol (the weight of absolute alcohol added is 2.5 times of the weight of acetylglutamine), so that acetylglutamine is precipitated, filtered precipitation, vacuum drying;

[0105] (b) Take the dried acetylglutamine and the freeze-dried excip...

Embodiment 2

[0108] Embodiment 2: Preparation of acetylglutamine freeze-dried powder injection pharmaceutical composition

[0109] formula:

[0110] Acetylglutamine 300mg,

[0111] Mannitol 200mg,

[0112] Appropriate amount of acid-base regulator,

[0113] 1ml water for injection for dosing;

[0114] Preparation method:

[0115] (a) Dissolve acetylglutamine in an appropriate amount of 2 times the weight of water for injection, add an appropriate amount of propylene glycol (the weight of propylene glycol added is 0.3 times the weight of acetylglutamine), stir evenly, and then add absolute ethanol (absolute ethanol The weight added is 0.5 times of the weight of acetylglutamine), stirred evenly, and left for 24 hours; continue to add absolute ethanol (the weight of absolute ethanol added is 3 times of the weight of acetylglutamine), so that acetylglutamine is precipitated, and filtered precipitation, vacuum drying;

[0116] (b) Take the dried acetylglutamine and the freeze-dried exci...

Embodiment 3

[0119] Embodiment 3: Preparation of acetylglutamine freeze-dried powder injection pharmaceutical composition

[0120] formula:

[0121] Acetylglutamine 100mg,

[0122] Mannitol 130mg,

[0123] Appropriate amount of acid-base regulator,

[0124] 1ml water for injection for dosing;

[0125] Preparation method:

[0126] (a) Dissolve acetylglutamine in an appropriate amount of 3 times the weight of water for injection, add an appropriate amount of propylene glycol (the weight of propylene glycol is 0.1 times the weight of acetylglutamine), stir evenly, and then add absolute ethanol (absolute ethanol The added weight is 0.3 times the weight of acetylglutamine), stirred evenly, and left for 24 hours; continue to add absolute ethanol (the weight of absolute ethanol added is 2 times the weight of acetylglutamine), so that acetylglutamine is precipitated, and filtered precipitation, vacuum drying;

[0127] (b) Take the dried acetylglutamine and the freeze-dried excipient mannit...

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Abstract

The invention relates to an aceglutamide powder injection medicine composition for injection and a preparation method of the medicine composition, in particular belongs to the technical field of medicines, relates to a medicine for treating brain traumatic coma, coma caused by neurosurgery, hepatic coma, hemiplegia, high paraplegia, infantile paralysis, nerve headache and lumbago, in particular relates to a medicine composition such as a freeze-dried powder injection prepared by taking aceglutamide as an active component and also relates to a preparation method of the medicine composition. In one embodiment of the invention, the aceglutamide powder injection medicine composition for injection comprises aceglutamide, a freeze-drying excipient and an acid-base regulation agent, wherein the freeze-drying excipient is selected from mannitol, glycine, lactose, saccharose, glucose and the like or the combination thereof. The aceglutamide powder injection for injection has excellent medicinal properties.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a medicine that can be used for the treatment of coma, hepatic coma, hemiplegia, high paraplegia, sequelae of poliomyelitis, nervous headache and lumbago caused by traumatic brain coma, neurosurgery, etc. A pharmaceutical composition made of acetylglutamine as an active ingredient, such as freeze-dried powder injection. The invention also relates to a preparation method of the pharmaceutical composition. Background technique [0002] Aceglutamide [0003] [0004] Chemical name N 2 -Acetyl-L-glutamine, the acetylated product of glutamine, is a classic spirit-stimulating drug, which can improve nerve cell metabolism, maintain nerve stress function and reduce blood amine, and can pass through the blood-brain barrier . Mainly used for traumatic brain injury coma, hepatic coma, hemiplegia, high paraplegia, sequelae of poliomyelitis, sequelae of traumatic brain injury, mental re...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/198A61K47/18A61K47/26A61K47/02A61K47/04A61P25/00A61P29/00A61P1/16
CPCY02A50/30
Inventor 张莲莲余茹金春花何玉祥李玉红赵东明
Owner CHENGDU TIANTAISHAN PHARMA
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