Sitafloxacin medicament composition for injection and preparation method thereof

A technology of sitafloxacin and its compounds, which is applied in the field of sitafloxacin drug composition, preparation and its preparation process, can solve the problems of discoloration, sensitivity, degradation, etc., prolong the rate of bottle blowing, reduce cross-contamination, and improve product yield. rate effect

Inactive Publication Date: 2012-05-30
JIANGSU CAREFREE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] New quinolone antibiotics are more sensitive to light due to their chemical structure, and conventional preparation methods are easy to cause degradation and discoloration

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Preparation of sitafloxacin freeze-dried powder injection (50mg specification) by common method

[0016] prescription

[0017] Sitafloxacin: 50g

[0018] Mannitol: 300g

[0019] Add water for injection to: 10000mL

[0020] Total production: 1000 bottles

[0021] Take sitafloxacin and put it in a container, add 80% of water for injection, stir to dissolve and mix evenly, then add mannitol, stir to dissolve and mix evenly, measure the content of intermediates, and dilute to The whole amount, under sterile conditions, was filtered with a 0.22 μm microporous membrane until clarified, the filtrate was filled in a sterile 25mL vial, partly plugged with a butyl rubber stopper, packed into a plate, sent to a freeze dryer, and finally dried The stable product temperature is 35°C. After maintaining this temperature for 3 hours, the bottle is cork-pressed, out of the box, and crimped, and the rate of bottle frying is 25.8%.

Embodiment 2

[0023] Preparation of sitafloxacin freeze-dried powder injection by improved method

[0024] prescription

[0025] Sitafloxacin: 50g

[0026] Mannitol: 100g

[0027] Sodium chloride: 20g

[0028] Sodium hydroxide: 417g

[0029] Add water for injection to: 10000mL

[0030] Total production: 1000 bottles

[0031] Put sitafloxacin in a container, add 80% water for injection, stir to dissolve and mix evenly, then add mannitol, sodium chloride and sodium hydroxide, stir to dissolve and mix evenly, measure the intermediate content, Fill it in a 25mL vial under aseptic conditions, partially plug it with a butyl rubber stopper, put it into a plate, send it into a freeze dryer, close the door, and finally dry at a product temperature of 35°C. After maintaining this temperature for 3 hours, The rate of plugging, boxing, crimping and bottle blowing is 0.2%.

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Abstract

The invention relates to a stable sitafloxacin medicament composition. The medicament composition comprises a therapeutically effective amount of a novel oral quinolone antibiotic medicine selected from sitafloxacin, and pharmaceutically acceptable auxiliary materials of mannitol and the like. The medicament composition of the invention can be used to treat single or mixed bacterial infection of the respiratory tract, the urogenital tract, the abdominal cavity, soft skin tissues and the like.

Description

Technical field [0001] The invention is a pharmaceutical project, which involves the composition of antibacterial agents and its preparation process, especially involving the composition, preparation and preparation process of Westsstar drugs.The mechanism of drug action is to inhibit the normal protein synthesis of sensitive bacteria, which has a good antibacterial effect on most Gram -positive bacteria and Gram -based negative bacteria. Background technique [0002] In recent years, the average annual growth rate of the world's antibiotic market has been about 8%, of which the market share of antibiotics is about 25 billion to 26 billion US dollars.At present, the global anti -infective drug market is facing a key change from brand drugs to non -special medicines, which has also led to a slight decrease of 1.8%in 2006 that the market sales revenue in 2006 was about 6.5%from the previous year.The year will increase at a rate of 5%to 6%, and the growth rate will decrease slightly...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4709A61K47/04A61K47/26A61P31/04
Inventor 严洁黄欣
Owner JIANGSU CAREFREE PHARM CO LTD
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