Oxiracetam injection and preparation method thereof

A technology for injection and water for injection, which is applied in the field of oxiracetam injection and its preparation, and can solve problems such as accelerating the hydrolysis of oxiracetam and increasing ionic strength

Inactive Publication Date: 2012-06-27
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the use of buffer salts will greatly increase the ionic strength of the solution, which will accelerate the hydrolysis of oxiracetam

Method used

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  • Oxiracetam injection and preparation method thereof
  • Oxiracetam injection and preparation method thereof
  • Oxiracetam injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Take 6.4L of water for injection, cool the water for injection to 30°C, add 4.0kg of oxiracetam while stirring to dissolve it completely; divide the solution into 8 equal parts, and add different amounts (as shown in Table 1) of NaH 2 PO 4 , and then use water for injection at 30°C to make up to 1.0L of the full prescription; filter the liquid medicine through a 0.22μm microporous membrane to obtain a filtrate; Seal; put the sample in the sterilizing cabinet, sterilize (temperature: 121°C, constant temperature time: 15 minutes); light inspection, get 8 finished oxiracetam injections with different prescriptions.

[0027] The finished products of the above 8 different prescriptions were stored in a sample storage box at 40°C, and samples were taken on the 30th day to investigate the pH value and total impurities of the samples. The results are shown in Table 1 below:

[0028] Table 1 NaH 2 PO 4 Effect of usage amount on solution pH and total impurities

[0029]

...

Embodiment 2

[0034] Take 30L of water for injection cooled to 30°C, add 10.0kg of oxiracetam while stirring to make it completely dissolved; adjust its pH value to 4.0 with 0.01mol / L NaOH solution; dilute to 30°C with water for injection 50L, add 50.0g activated carbon for needles, stir and adsorb for 20 minutes, filter to remove carbon; filter the medicinal solution through a 0.22μm microporous membrane to obtain a filtrate; fill the filtrate, the volume of each ampoule is 5ml, and seal it; Put the sample into a sterilizing cabinet and sterilize (temperature: 121°C, constant temperature time: 15 minutes); light inspection to obtain the finished product of oxiracetam injection.

[0035]

Embodiment 3

[0037] Take 40L of water for injection cooled to 60°C, add 10.0kg of oxiracetam while stirring to make it completely dissolved; adjust its pH value to 5.5 with 0.1mol / L NaOH solution; dilute to 5.5 with 60°C water for injection 50L; filter the liquid medicine through a 0.22μm microporous membrane to obtain the filtrate; fill the filtrate, the volume of each ampoule is 5ml, and seal it; put the sample into the sterilization cabinet and sterilize (temperature: 121°C , constant temperature time: 15 minutes); light inspection, the finished product of oxiracetam injection was obtained.

[0038]

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Abstract

The invention provides an oxiracetam injection, characterized in that 1000 ml of the injection contains 100-250 g of oxiracetam, and the pH value is adjusted to 4.0-5.5 by using 0.01-0.1 mol/L of a NaOH solution, and the balance of the injection is injection water. The invention also provides a preparation method of the oxiracetam injection. The oxiracetam injection has the advantages of low content of impurities and good stability, and can be stored at room temperature.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an oxiracetam injection and a preparation method thereof. Background technique [0002] Oxiracetam, chemical name: 4-hydroxy-2-oxo-1-pyrrolidineacetamide, is a pyrrolidone derivative firstly synthesized by the Italian ISF company, and is a new generation of brain metabolism improving drug. The dosage forms launched in Italy for the first time are oral preparations and injection preparations. The preparations that have been developed and marketed include tablets, capsules, injections, and freeze-dried powder injections. [0003] This product can promote the synthesis of phosphorylcholine and phosphorylethanolamine, increase the utilization of oxygen and glucose in the brain and the ratio of ATP / ADP, increase the synthesis of protein and nucleic acid in the brain; act on glutamate-promoting receptors, Prevent neurotoxicity caused by glutamate; can improve memory and le...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4015A61K47/04A61P25/00A61P25/28
Inventor 喻義袁璐黄兴锟张鹏宇王小霞
Owner YAOPHARMA CO LTD
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