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Sitafloxacin hydrate injection and preparation method thereof

A technology for sitafloxacin and injection, applied in the field of medicine, can solve the problems of technical difficulties of injection, unstable aqueous solution, low solubility, etc., and achieve the effects of reducing impurities, increasing stability and improving curative effect

Active Publication Date: 2010-02-03
WUHAN WUYAO SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the publication date is March 18, 2009, the invention patent with the publication number CN101385716 discloses sitafloxacin granules and its preparation method, but the injection belongs to the clinical intravenous administration and belongs to the liquid preparation. Granules are completely different
At present, there are no patents and documents related to sitafloxacin injection at home and abroad, and the solubility of sitafloxacin in water is low, the aqueous solution is unstable, and there are considerable technical difficulties in making injections

Method used

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  • Sitafloxacin hydrate injection and preparation method thereof
  • Sitafloxacin hydrate injection and preparation method thereof
  • Sitafloxacin hydrate injection and preparation method thereof

Examples

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Effect test

example 1

[0028] prescription:

[0029] Sitafloxacin 50g

[0030] Sodium Benzoate 40g

[0031] Sodium chloride 10g

[0032] Polyvinyl alcohol 0.4g

[0033] Sodium metabisulfite 10g

[0034] EDTA-2Na 0.75g

[0035] Phosphate buffer saline

[0036] Add water for injection to 1000ml

[0037]

[0038] Made into 500 pieces, 2ml / piece, 100mg / piece

example 2

[0040] prescription:

[0041] Sitasalate 50g

[0042] Sodium Salicylate 15g

[0043] Propylene glycol alginate 0.5g

[0044] Glucose 100g

[0045] EDTA-NaCa 0.75g

[0046] Vitamin C 1g

[0047] Add water for injection to 1000ml

[0048]

[0049] Made into 500 pieces, 2ml / piece, 100mg / piece

example 3

[0051] prescription:

[0052] Sitafloxacin 40g

[0053] Sodium Salicylate 12g

[0054] Sodium chloride 9g

[0055] Cremophor RH40 1.3g

[0056] Glutathione 3g

[0057] EDTA-2Na 0.68g

[0058] Phosphate buffer saline

[0059] Add water for injection to 1000ml

[0060]

[0061] Made into 200 pieces, 5ml / piece, 200mg / piece

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PUM

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Abstract

The invention discloses a sitafloxacin hydrate injection and a preparation method thereof. Each product contains 1-50mg of sitafloxacin hydrate per ml, 0.5-30mg of antioxygens, 0.1-0.75 mg of metal complexing agent, 2-20mg of complex solubilizer, 6-100mg of osmotic pressure modifier, and 0.1-1mg of surface active agent. The sitafloxacin hydrate injection is prepared by the preparation method of the invention can obviously reduce generated impurities, increases the stability, is not only beneficial to increase the quality of the product and but also can increase the curative effect.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a novel fluoroquinolone antibacterial preparation, in particular to a sitafloxacin injection and a preparation method thereof. Background technique [0002] Sitafloxacin is a broad-spectrum fluoroquinolone antibacterial agent developed by Daiichi Sankyo, Japan, with a chemical name of 7-[(7S)-7-amino-5-azaspiro[ 2.4] Hept-5-yl]-8-chloro-6-fluoro-1-[(1R,2S)-cis-2-fluorocyclopropyl]-1,4-dihydro-4-oxo-3- Quinoline carboxylic acid, molecular formula C 19 h 18 CIF 2 N 3 o 3 , the molecular weight is 409.81, and the structural formula is as follows: [0003] [0004] Sitafloxacin belongs to N-1-fluorinated cyclopropyl quinolones. The research of in vitro antibacterial activity proves that it has broad-spectrum antibacterial effect, not only has antibacterial activity against Gram-negative bacteria, but also has antibacterial activity against Gram-positive bacteria (formazan-resi...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/19A61K31/4709A61P31/04
Inventor 耿海明黄璐杨欣方春梅杨若
Owner WUHAN WUYAO SCI & TECH
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