Fleraxacin for injection and preparation method thereof

A fleroxacin and injection technology, which is applied in the field of fleroxacin freeze-dried powder for injection and its preparation field, can solve the problems of inconvenience in injection use, turbidity, etc. Effect

Inactive Publication Date: 2008-12-24
HAINAN JINRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In the prior art of fleroxacin injection, the injection is placed for a long time, the solution is no longer

Method used

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  • Fleraxacin for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] prescription:

[0044] Fleroxacin 206.08g

[0045] Mannitol 100g

[0046] Lactic acid 85.42ml

[0047] Add water for injection to 2000ml

[0048]

[0049] Total 1000 bottles

[0050] Preparation process: Add 206.08g of fleroxacin and 100g of mannitol into 1600mL of water for injection, stir, then dropwise add 85.42mL of lactic acid to the above mixture, stir until fleroxacin is completely dissolved, then add 0.6g of Activated carbon, stirred at room temperature for 30 minutes, filtered through a 0.45 μm microporous membrane to remove the activated carbon, then added water for injection to 2000 mL, stirred thoroughly for 20 minutes to mix the solution evenly, and the obtained mixture was sterilized by filtering through a 0.22 μm microporous membrane, and the filtrate was placed in Slowly cool to -30°C in the tray of the freeze dryer, and maintain -30°C for 3 hours, then quickly cool to -55°C, vacuumize, heat up to 2°C within 14 hours, and...

Embodiment 2

[0052] prescription:

[0053] Fleroxacin 206.08g

[0054] Mannitol 82.5g

[0055] Lactic acid 80.31ml

[0056] Add water for injection to 2000ml

[0057]

[0058] Total 1000 bottles

[0059] Preparation process: Add 206.08g of fleroxacin and 82.5g of mannitol into 1600mL of water for injection, stir, then dropwise add 80.31mL of lactic acid to the above mixture, stir until fleroxacin is completely dissolved, then add 0.68g of Activated carbon, stirred at room temperature for 30 minutes, filtered through a 0.45 μm microporous membrane to remove the activated carbon, then added water for injection to 2000 mL, stirred thoroughly for 20 minutes to mix the solution evenly, and the obtained mixture was sterilized by filtering through a 0.22 μm microporous membrane, and the filtrate Put it in the tray of the freeze dryer, cool slowly to -32°C, and maintain the initial freezing at -32°C for 2.5 hours, then quickly cool to -50°C, vacuumize, and rai...

Embodiment 3

[0061] prescription:

[0062] Fleroxacin 206.08g

[0063] Mannitol 123g

[0064] Lactic acid 68.35ml

[0065] Add water for injection to 2000ml

[0066]

[0067] Total 1000 bottles

[0068] Preparation process: Add 206.08g of fleroxacin and 123g of mannitol into 1600mL of water for injection, stir, then dropwise add 68.35mL of lactic acid to the above mixture, stir until fleroxacin is completely dissolved, then add 0.53g of Activated carbon, stirred at room temperature for 30 minutes, filtered through a 0.45 μm microporous membrane to remove the activated carbon, then added water for injection to 2000 mL, stirred thoroughly for 20 minutes to mix the solution evenly, and the obtained mixture was sterilized by filtering through a 0.22 μm microporous membrane, and the filtrate was placed in In the lyophilizer tray, cool slowly to -35°C, and maintain -35°C for 2.5 hours, then quickly cool to -45°C, vacuum, and heat up to -5°C within 12 hours, ...

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Abstract

The invention provides injection fleroxacin which is composed of fleroxacin, mannite and lactic acid; the invention also provides a preparation method of the fleroxacin freeze-dried powder: fleroxacin and mannite are added into water, then lactic acid is also dropped into the water, and the solution is stirred until the fleroxacin is dissolved completely; active carbon is added into the mixed solution which then is filtered; the filtrate is placed in a material disc of a freezedryer to be cooled slowly to 30DEG below zero to 60DEG below zero and be kept the prelimitary freezing for 2.5 to 3 hours at 30DEG below zero to 60DEG below zero, then is rapidly cooled to about 45DEG below zero to 55DEG below zero to be pumped to vacuum, is heated to 5DEG below zero to 5DEG for 12 to 15 hours and is kept at 5DEG below zero to 5DEG for 4 to 6 hours, is heated to 25DEG to 30DEG within 3 to 5 hours and is kept at 25DEG to 30DEG for 5 to 7 hours so that the fleroxacin freeze-dried powder is obtained. The obtained fleroxacin freeze-dried powder has simple components, favorable stability and resolubity and low water content.

Description

technical field [0001] The invention relates to a freeze-dried fleroxacin powder for injection and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Fleroxacin is a third-generation quinolone antibacterial drug, which has the characteristics of broad antibacterial spectrum, strong antibacterial effect, wide distribution, and long half-life. Against Gram-negative bacteria, including Escherichia coli, Klebsiella pneumoniae, Proteus, Salmonella typhi, Salmonella paratyphi, Shigella, Enterobacter cloacae, Enterobacter aerogenes, Citrobacter, marcescens Serratia, Pseudomonas aeruginosa, Neisseria meningitidis, Haemophilus influenzae, Morakata, Legionella pneumophila, Neisseria gonorrhoeae, etc. all have strong antibacterial effects. It also has moderate antibacterial effect on Gram-positive cocci such as Staphylococcus and hemolytic streptococcus. [0003] The chemical name of fleroxacin is 6,8-difluoro-1-(2-fluor...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/496A61K47/10A61K47/12A61P31/04
Inventor 王小树
Owner HAINAN JINRUI PHARMA
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