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Injection composition containing oxiracetam and preparation method and application thereof

A technology for injection and composition, which is applied in the field of small-volume injection preparations, can solve the problems of reducing related substances, and achieve the effects of low content of related substances, reducing the possibility of hydrogen bond formation, and simple formula

Active Publication Date: 2013-07-24
北京爱力佳医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The object of the present invention is to find a reasonable and effective oxiracetam-containing injection formulation and process to overcome the existing problems of the existing preparations, expecting to produce oxiracetam injection preparations with stable and controllable quality, including water injection and frozen For dry powder injection, the present invention especially solves the problems of stable quality of water injection dosage form and reduction of related substances.

Method used

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  • Injection composition containing oxiracetam and preparation method and application thereof
  • Injection composition containing oxiracetam and preparation method and application thereof
  • Injection composition containing oxiracetam and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Add 1kg of oxiracetam to 4L of water for injection, stir to dissolve it; adjust the pH value to 4.8 with 0.5mol / L (ie 0.5N) sodium hydroxide solution; dilute the volume of water for injection to 5L; Microporous membrane filtration, filling filtrate 5ml / bottle, 1g / bottle, melting and sealing; sterilization (temperature: 121°C, constant temperature time: 15 minutes); lamp inspection, ready to use. The preparation should be protected from light, sealed and stored at a storage temperature below 20°C.

[0052] Stability study plan:

[0053] (1) Destructive test: acid, alkali, heat, oxidation test

[0054] (2) Accelerated test: take three batches of pilot test samples of this product, and place them in conditions A and B respectively, A: temperature 40°C±2°C, relative humidity 75%±5% temperature and humidity control box, B: 30 ℃ ± 2 ℃, relative humidity 65% ​​± 5% in the temperature and humidity control box to take samples regularly, measure the properties, pH, color of the s...

Embodiment 2

[0057] Take 30L water for injection cooled to room temperature, add 10.0kg oxiracetam, stir to dissolve completely; adjust the pH value to 4.7 with 0.51mol / L sodium hydroxide solution; dilute to 50L with water for injection, add 50.0 g needle with activated carbon, stirred and adsorbed for 20 minutes, filtered to remove carbon; filtered the medicinal solution through a 0.22 μm microporous membrane, filled with filtrate, and the filling capacity of each ampoule was 5ml, and sealed; the sample was sterilized (121°C , 15 minutes); lamp inspection, to obtain the injection preparation of oxiracetam.

Embodiment 3

[0059] Add 10.0kg of oxiracetam to 40L of water for injection, stir to dissolve it; adjust the pH value to 4.8 with 0.49mol / L sodium hydroxide solution; adjust the volume of water for injection to 50L; filter the liquid through a 0.22μm microporous filter Membrane filtration, filled with filtrate 5ml / bottle, melted and sealed; sterilized (temperature: 121°C, constant temperature time: 15 minutes); light inspection, ready to use.

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Abstract

The invention provides an injection composition containing oxiracetam and a preparation method and an application thereof. The composition contains sodium hydroxide. The invention further provides a preparation method and an application of the medicinal composition. The composition is mainly used for improving memory and the memory learning function of a mentally retarded patient, and is suitablefor memory and amentia caused by symptoms such as mild or moderate vascular dementia, senile dementia, brain trauma and the like, or is taken as an auxiliary treatment medicament.

Description

technical field [0001] The invention relates to pharmaceutical preparations in the field of medicine, in particular to the formulation, preparation process and application of an injection composition containing oxiracetam, and the injection composition generally refers to a small-volume injection preparation. Background technique [0002] Oxiracetam, chemical name: 4-hydroxy-2-oxo-1-pyrrolidineacetamide, is a new generation of brain metabolism improving drug, which is effective for cerebrovascular disease, brain injury, brain tumor (postoperative), intracranial infection , dementia, brain degenerative diseases, etc. have good curative effect. It can selectively act on the cerebral cortex, stimulate specific neural pathways in the hippocampus, activate, protect and repair brain nerve cells, and has high safety. Oxiracetam is a pyrrolidone derivative first synthesized by the Italian ISF company. The dosage forms launched in Italy for the first time are oral preparations and ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K9/19A61K31/4015A61K47/04A61P9/10A61P25/28A61P25/00
Inventor 陈先武
Owner 北京爱力佳医药科技有限公司
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