Stable and safe oxiracetam pharmaceutical composition for injection

A composition and technology for injection, applied in the field of medicine, can solve the problems of non-over-sterilization, poor quality, and high requirements for storage conditions

Inactive Publication Date: 2012-06-27
TIANJIN HANRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0020] The biggest shortcoming of conventionally prepared oxiracetam pharmaceutical compositions for injection is that the sterilization conditions are non-over-sterilized and cannot reach 121°C for 20 minutes or 115°C for 40 minutes. The related substances are high and the quality is poor. The process requires high storage conditions and needs to be stored in a cool and dark place

Method used

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  • Stable and safe oxiracetam pharmaceutical composition for injection
  • Stable and safe oxiracetam pharmaceutical composition for injection
  • Stable and safe oxiracetam pharmaceutical composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Oxiracetam 1000g

[0055] Sodium chloride 45g

[0056] Citric acid 5g

[0057] Add water for injection to 5L

[0058] Made 1000 pieces

[0059] The preparation method is:

[0060] In the clean area, first add the prescribed amount of citric acid and sodium chloride into an appropriate amount of water for injection, stir to dissolve, then add the prescribed amount of oxiracetam, stir until completely dissolved, adjust the pH value to 3.0-4.0, take Add 0.1%-0.5% (W / V) of activated carbon to the total amount of the solution, add appropriate amount of water for injection, stir well, add water for injection until full brightness, stir and circulate for more than 15 minutes, first decarbonize by coarse filtration, and then pass through microporous membrane (such as 0.22um filter membrane) fine filtration, after fine filtration by microporous membrane, the fine filtrate can be taken for content, pH value, endotoxin, visible foreign matter and other items to test, after pas...

Embodiment 2

[0062] Oxiracetam 400g

[0063] Sodium chloride 18g

[0064] Citric acid 2g

[0065] Add water for injection to 2L

[0066] Made 1000 pieces

[0067] The preparation method is:

[0068] In the clean area, first add the prescribed amount of citric acid and sodium chloride into an appropriate amount of water for injection, stir to dissolve, then add the prescribed amount of oxiracetam, stir until completely dissolved, adjust the pH value to 3.0-4.0, take Add 0.1%-0.5% (W / V) of activated carbon to the total amount of the solution, add appropriate amount of water for injection, stir well, add water for injection until full brightness, stir and circulate for more than 15 minutes, first decarbonize by coarse filtration, and then pass through microporous membrane (such as 0.22um filter membrane) fine filtration, after fine filtration by microporous membrane, the fine filtrate can be taken for content, pH value, endotoxin, visible foreign matter and other items to test, after pass...

Embodiment 3

[0070] Oxiracetam 200g

[0071] Sodium chloride 9g

[0072] Citric acid 1g

[0073] Add water for injection to 1L

[0074] Made 1000 pieces

[0075] The preparation method is:

[0076] In the clean area, first add the prescribed amount of citric acid and sodium chloride into an appropriate amount of water for injection, stir to dissolve, then add the prescribed amount of oxiracetam, stir until completely dissolved, adjust the pH value to 3.0-4.0, take Add 0.1%-0.5% (W / V) of activated carbon to the total amount of the solution, add appropriate amount of water for injection, stir well, add water for injection until full brightness, stir and circulate for more than 15 minutes, first decarbonize by coarse filtration, and then pass through microporous membrane (such as 0.22um filter membrane) fine filtration, after fine filtration by microporous membrane, the fine filtrate can be taken for content, pH value, endotoxin, visible foreign matter and other items to test, after passi...

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Abstract

The invention relates to a stable and safe oxiracetam pharmaceutical composition for injection and a preparation method thereof, especially to an oxiracetam pharmaceutical composition for treating brain damage and neurological deficit caused by the brain damage as well as impediment of anamnesis and aptitude. Preferred are injections and lyophilized powders. The oxiracetam pharmaceutical composition provided by the invention mainly contains active components of oxiracetam, sodium chloride and citric acid. The oxiracetam pharmaceutical composition for injection has stable pH values and low impurity content. By the adoption of the preparation method, curative effects of the product are effectively raised, side effects are minimized, and simultaneously the yield is raised, cost is reduced, and higher benefits are created.

Description

[0001] technical field [0002] The invention belongs to the technical field of medicine, and in particular relates to a stable and safe oxiracetam pharmaceutical composition for injection and a preparation method thereof. Background technique [0003] Generic name: Oxiracetam; [0004] English name: Esomeprazole Sodium; [0005] Chemical name: 4-hydroxy-2-oxo-1-pyrrolidineacetamide; [0006] Its structural formula is as follows: [0007] [0008] Molecular formula: C 6 h 10 N 2 o 3 ; [0009] Molecular weight: 158.16; [0010] Indications: It is used for the treatment of brain injury and the resulting neurological function loss, memory and intellectual impairment. [0011] Type of pharmacological action: Oxiracetam is a cholinergic nootropic drug acting on the central reticular structure. [0012] Pharmacological mechanism: Oxiracetam can promote the synthesis of phosphorylcholine and phosphorylethanolamine, increase the ratio of ATP / ADP in the brain, and incre...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4015A61K47/12A61P25/28
Inventor 严洁黄欣
Owner TIANJIN HANRUI PHARMA
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