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Oxiracetam injection composition and preparation method thereof

A technology of oxiracetam and injection, applied in the field of medicine, can solve problems such as poor stability, and achieve the effect of high stability

Active Publication Date: 2013-08-14
HEBEI RENHE YIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the inevitability of metal iron ions, the product has disadvantages such as poor stability

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-5

[0047] Example 1-5 Oxiracetam Injection

[0048] Prescription:

[0049]

[0050] Wherein, among the embodiment 1-3 calcium sodium edetate, glycine and vitamin B 6 The weight content is equal, edetate calcium sodium, glycine and vitamin B in the embodiment 4-5 6 The weight content varies.

Embodiment 1-5）

[0052] Take 80-90% of the total amount of water for injection at 80-90°C, add the prescribed amount of sodium dihydrogen phosphate, calcium sodium edetate, glycine and vitamin B 6 , dissolve; add the prescription amount of oxiracetam, dissolve; adjust the pH value; add 0.1% (g / mL) activated carbon of the total volume of the solution for adsorption, and filter to remove carbon; add water for injection to the full amount; filter through a 0.22 μm microporous membrane , packaged, and sterilized with damp heat at 121°C for 20 minutes. After testing, the concentrations of metal iron ions in Examples 1, 2, 3, 4, and 5 were 0.5 ppm, 0.3 ppm, 0.6 ppm, 0.8 ppm, and 0.7 ppm, respectively.

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PUM

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Abstract

The invention relates to an oxiracetam injection composition and a preparation method thereof. The oxiracetam injection provided by the invention comprises 0.1-0.3 g of oxiracetam, 0.2-0.4 mg of sodium dihydrogen phosphate, 0.02-0.04 mg of sodium calcium edetate, 0.02-0.04 mg of glycine, 0.02-0.04 mg of vitamin B6, a pH value regulator (for regulating the pH value to the range from 4.5 to 5.0) and water for injection per 1 ml. The oxiracetam injection provided by the invention has the advantages of good quality and high stability.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an oxiracetam injection and a preparation method thereof. Background technique [0002] Oxiracetam is a pyrrolidone-like brain metabolism-improving drug that can be used to improve the memory and learning abilities of patients with senile dementia and memory impairment. It was first developed and marketed by the Italian ISF company in 1987. The chemical name of oxiracetam is 4-hydroxy-2-oxo-1-pyrrolidineacetamide and the molecular formula is C 6 h 10 N 2 o 3 , the structural formula is as follows: [0003] [0004] Oxiracetam has two situations where the hydroxyl and carbonyl are located on the same side and the opposite side of the pyrrole ring, and it is difficult to separate the two spatial conformations of oxiracetam. When the hydroxyl group and the carbonyl group are located on the same side of the pyrrole ring, it is easy to form intramolecular hydrogen bonds, whic...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/22A61P25/00A61P25/28A61K31/4015
Inventor 刘淑景
Owner HEBEI RENHE YIKANG PHARMA
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