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Fleroxacin freeze-dry emulsion and production method thereof

A technology of fleroxacin and freeze-dried emulsion, which is applied to the freeze-dried emulsion of quinolone antibiotic drug fleroxacin and its preparation field, can solve the problems of large pH value change, high irritation, yellowish solution color and the like, and achieves irritation to human body. Small, low toxicity, anti-oxidative hydrolysis effect

Inactive Publication Date: 2009-12-30
HAINAN MEIDA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Fleroxacin listed preparations include injections and freeze-dried products. The preparation methods are to dissolve fleroxacin by adding lactic acid, acetic acid, etc., and then sterilize or freeze-dry. After long-term storage, the color of the solution turns yellow and the pH value changes greatly. Moreover, lactic acid and acetic acid are very irritating to the human body.

Method used

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  • Fleroxacin freeze-dry emulsion and production method thereof
  • Fleroxacin freeze-dry emulsion and production method thereof
  • Fleroxacin freeze-dry emulsion and production method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Fleroxacin 100g

[0039] Soy Lecithin 300g

[0040] Mannitol 100g

[0041] Oleic acid 50g

[0042] Glycerin 50g

[0043] Vitamin E 20g

[0044] Citric acid 5g

[0045] Water for injection 2000ml

[0046] Preparation Process

[0047] (1) Dissolve 100g of fleroxacin and 20g of vitamin E in an appropriate amount of chloroform, add 1000g of soybean lecithin and mix evenly to form an oil phase;

[0048] (2) Dissolve 50 g of oleic acid and 50 g of glycerin in an appropriate amount of water for injection, and adjust the pH value to 5.1 with citric acid solution to form an aqueous phase;

[0049] (3) Slowly add the oil phase into the high-speed stirring water phase, use a tissue masher, a magnetic stirrer or an electromagnetic stirrer to prepare colostrum, and then repeatedly homogenize the emulsion through a high-pressure homogenizer to obtain a finely dispersed emulsion , remove the organic solvent under reduced pressure;

[0050] (4) Add 1000g of mannitol, remove mo...

Embodiment 2

[0052] Fleroxacin 200g

[0053] Cholesterol 2000g

[0054] Glucose 1000g

[0055] Sodium deoxycholate 100g

[0056] Glycerin 100g

[0057] Vitamin C 30g

[0058] Sodium dihydrogen phosphate 12g

[0059] Water for injection 4000ml

[0060] The preparation process prepared the dried fleroxacin freeze-dried emulsion according to Example 1.

Embodiment 3

[0062] Fleroxacin 300g

[0063] Polysorbate 80 5000g

[0064] Sucrose 3000g

[0065] Cholic acid 150g

[0066]Glycerin 150g

[0067] Anhydrous sodium sulfite 40g

[0068] Hydrochloric acid 20g

[0069] Water for injection 6000ml

[0070] The preparation process prepared the dried fleroxacin freeze-dried emulsion according to Example 1.

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Abstract

The invention discloses a fleroxacin freeze-dry emulsion and a production method thereof. The production method comprises the following steps: firstly, making fleroxacin into a finely dispersed emulsion; and then freezing and drying the emulsion. The invention improves the water solubility of the fleroxacin, avoids the accumulation and the separation of medicines, lessens irritation to human bodies, prevents the fleroxacin from being oxidized and hydrolyzed in an injection of a solution type and more stabilizes the physicochemical property thereof. The invention has the advantages of long-term stability, convenient storage and transportation, and the like.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a freeze-dried emulsion of quinolone antibiotic drug fleroxacin and a preparation method thereof. Background technique [0002] Fleroxacin is a quinolone antibacterial drug, its chemical name is: 6,8-difluoro-1-(2-fluoroethyl)-1,4-dihydro-7-(4-methyl-1-piperazine) -4-Oxo-3-quinolinecarboxylic acid, molecular formula C 17 h 18 N 3 o 3 f 3 . Gram-negative bacteria, including Escherichia coli, Klebsiella pneumoniae, Proteus, Salmonella typhi, Salmonella paratyphi, Shigella, Enterobacter cloacae, Enterobacter puerpera, 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. It is mainly bact...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K9/19A61K31/496A61P31/04
Inventor 邱民
Owner HAINAN MEIDA PHARMA