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Levetiracetam-sodium chloride injection composition and preparation method thereof

A technology of sodium chloride injection and composition, which is applied in the direction of drug combination, drug delivery, and medical formula, which can solve the problems of poor stability of substance content and achieve the effects of good quality, high stability, and improved drug safety

Inactive Publication Date: 2016-03-30
HEBEI RENHE YIKANG PHARMA
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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 to 3:1, and only a small amount of phosphate (such as 0.01-0.05% w / v) is added , 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 the marketed product

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

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Experimental program
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Embodiment 1

[0039] Embodiment 1 levetiracetam sodium chloride injection of the present invention

[0040] prescription:

[0041]

[0042]

[0043] Preparation:

[0044] Take 50-80% of the prescribed amount of water for injection, add levetiracetam, sodium chloride, phosphate, stir to dissolve, adjust the pH with acetic acid, phosphoric acid or hydrochloric acid, and use 0.02%-0.1% (w / v) activated carbon Adsorb 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

[0045] Embodiment 2 levetiracetam sodium chloride injection of the present invention

[0046] prescription:

[0047]

[0048] Preparation method: with embodiment 1.

Embodiment 3

[0049] Embodiment 3 levetiracetam sodium chloride injection of the present invention

[0050] prescription:

[0051]

[0052] 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 comprises levetiracetam, phosphate, sodium chloride and injection water according to a weight content ratio of levetiracetam to sodium chloride of 1: 4.5-3: 1. The levetiracetam-sodium chloride injection composition has the advantages of simple formula, high stability, high safety and industrial production feasibility.

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): A61K9/08A61K31/4015A61K47/02A61P25/08
CPCA61K31/4015A61K9/0019A61K9/08A61K47/02
Inventor 牛涛涛
Owner HEBEI RENHE YIKANG PHARMA
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