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Levetiracetam sodium chloride injection composition and preparation method thereof

A technology for sodium chloride injection and composition, which is applied in the directions of alkaline/alkaline-earth metal chloride active ingredients, drug combinations, and pharmaceutical formulations, can solve problems such as poor substance content stability, and achieve good quality, high stability, and drug use. The effect of high safety

Active Publication Date: 2016-04-13
仁合益康集团有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Aiming at technical problems such as high content of related substances and poor stability in levetiracetam sodium chloride injection, on the basis of long-term and extensive research, the applicant unexpectedly found that: levetiracetam The content of sodium chloride and sodium chloride is maintained at a certain ratio, especially the weight ratio of the two is controlled at 1:4.5~3:1, only a small amount of sodium acetate trihydrate (such as 0.01-0.05%w / v), and the pH value of the injection is controlled between 4.0-6.0, the prepared levetiracetam sodium chloride injection can achieve extremely high stability, and the content of related substances is even lower than that of listed products

Method used

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  • Levetiracetam sodium chloride injection composition and preparation method thereof
  • Levetiracetam sodium chloride injection composition and preparation method thereof
  • Levetiracetam sodium chloride injection composition and preparation method thereof

Examples

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Effect test

Embodiment 1

[0040] Embodiment 1 levetiracetam sodium chloride injection of the present invention

[0041] prescription:

[0042]

[0043]

[0044] Preparation:

[0045] Take 50-80% of the prescription amount of water for injection, add levetiracetam, sodium chloride, sodium acetate trihydrate, stir to dissolve, adjust the pH with acetic acid, phosphoric acid or hydrochloric acid, and use 0.02%-0.1% (w / v) Activated carbon adsorption for 15-30 minutes, filter to remove carbon, add water for injection to the full amount, filter through a 0.22μm microporous membrane, fill, and sterilize at 121°C for 15 minutes.

Embodiment 2

[0046] Embodiment 2 levetiracetam sodium chloride injection of the present invention

[0047] prescription:

[0048]

[0049] Preparation method: with embodiment 1.

Embodiment 3

[0050] Embodiment 3 levetiracetam sodium chloride injection of the present invention

[0051] prescription:

[0052]

[0053] Preparation method: with embodiment 1.

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Abstract

The invention provides a levetiracetam sodium chloride injection composition. The levetiracetam sodium chloride injection composition is composed of levetiracetam, sodium chloride, sodium acetate trihydrate and water for injection, wherein weight ratio of the levetiracetam to the sodium chloride is 1:4.5-3:1. The levetiracetam sodium chloride injection composition has the advantages of formula simplicity, high stability, high safety, suitableness for industrial production and the like.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a levetiracetam sodium chloride injection composition and a preparation method thereof. Background technique [0002] Levetiracetam is a new type of antiepileptic drug, its chemical name is (S)-α-ethyl-2-oxo-1-pyrrolidineacetamide, and its molecular formula is C 8 h 14 N 2 o 2 , the structural formula is as follows: [0003] [0004] Levetiracetam has the characteristics of high therapeutic index, good safety, and mild side effects. It is the only broad-spectrum antiepileptic drug with preventive effect reported so far. As an innovative high-efficiency antiepileptic drug, it has a new antiepileptic mechanism unlike other antiepileptic drugs in structure. The exact antiepileptic mechanism of levetiracetam is unknown, but it is different from traditional antiepileptic drugs in acting on ion channels or excitatory and inhibitory neurotransmitter systems. ...

Claims

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Application Information

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IPC IPC(8): A61K33/14A61K9/08A61K47/12A61P25/08A61K31/4015
CPCA61K9/0019A61K9/08A61K31/4015A61K33/14A61K47/12A61K2300/00
Inventor 牛涛涛
Owner 仁合益康集团有限公司
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