Methanesulfonic acid pazufloxacin gel droplet for ear and its preparation

A technology of pazufloxacin mesylate and rubber ear drops, applied in the field of medicine, can solve problems such as inconvenience in use, inability to quickly relieve pain of patients, etc., and achieves prolonging the administration interval, reducing systemic adverse reactions, and improving medication compliance. sexual effect

Active Publication Date: 2009-05-27
广州博济新药临床研究中心有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For eye and ear infections, if you use injection-type anti-infective drugs, the drugs will reach the lesion site slowly, so you can't relieve the patient's pain quickly, and it is extremely inconvenient to use, so we have developed a topical Pazusa Star Gel Ear Drops not only utilizes the advantages of Pazufloxacin’s wide antibacterial spectrum and good antibacterial effect, but also fully utilizes the characteristics of strong adhesion of the gel dosage form for external use

Method used

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  • Methanesulfonic acid pazufloxacin gel droplet for ear and its preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Take 1.0g of carbomer, add 200ml of glycerin and mix, stir to dissolve; take 0.4g of sodium hydroxide and dissolve in distilled water; add the prepared sodium hydroxide solution to the carbomer glycerin solution, stir while adding, and stir evenly Obtain a transparent gel matrix; take 0.5 g of pazufloxacin mesylate, dissolve it with distilled water, add 50ml of propylene glycol, stir to mix evenly, and make a mixed solution; combine the pazufloxacin mesylate solution with the gel Mix and grind the matrix until it is uniform, add distilled water to 1000ml; adjust the pH to between 5.5 and 6.5 with dilute hydrochloric acid or sodium hydroxide solution; filter with a 0.22μm microporous filter membrane; test the above-mentioned liquid after suction filtration, After passing the test, filling is performed to obtain the ear drops of the present invention.

Embodiment 2

[0035] Take 5.0g of carbomer, add 250ml of glycerin and mix, stir to dissolve; take 2.0g of sodium hydroxide and dissolve in distilled water; add the prepared sodium hydroxide solution to the carbomer glycerin solution, stir while adding, and stir evenly Obtain a transparent gel matrix; take 3.5 g of pazufloxacin mesylate, dissolve it with distilled water, add 65.0ml of propylene glycol, stir to mix evenly, and make a mixed solution; combine the pazufloxacin mesylate solution with the gel Mix and grind the gum matrix until it is uniform, add distilled water to 1000ml; adjust the pH value to between 5.5 and 6.5 with dilute hydrochloric acid or sodium hydroxide solution; filter with 0.22μm microporous membrane; test the above-mentioned liquid after suction After passing the test, filling is performed to obtain the ear drops of the present invention.

Embodiment 3

[0037] Take 10.0g of carbomer, add 300ml of glycerin to mix, stir to dissolve; take 4.0g of sodium hydroxide and dissolve in distilled water; add the prepared sodium hydroxide solution to the carbomer glycerin solution, stir while adding, and stir evenly Obtain a transparent gel matrix; take 7.0g of pazufloxacin mesylate, dissolve it with distilled water, add 80.0ml of propylene glycol, stir to mix evenly, and make a mixed solution; Mix and grind the gum matrix to uniformity, add distilled water to 1000ml; adjust the PH value to between 5.5 and 6.5 with dilute hydrochloric acid or sodium hydroxide solution; suction filtration with 0.22μm microporous membrane: test the above-mentioned liquid after suction filtration After passing the test, filling is performed to obtain the ear drops of the present invention.

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Abstract

The invention discloses a ethanesulfonic acid Pazufloxacin ad aurem gel auristilla, which take ethanesulfonic acid Pazufloxacin for the major components, and is produced complemented by Carbomer, glycerin, sodium hydroxide, propanediol and sterile water for injection or purified water or distilled water. The invention also discloses the preparation method of the said ethanesulfonic acid Pazufloxacin ad aurem gel auristilla. The invention of this medicine is a new generation quinolone synthesis antibacterial drugs, with high bioavailability, can reduce the dosage in clinical application, dosage interval extension, reduction the adverse reactions of systemic absorption, helping improving patients medication compliance. Meanwhile, the invention of the drug overcomes the resistance which the old varieties drugs bring to patients, solves the need of new medicines for the clinical treatment of ear infections diseases.

Description

Technical field [0001] The invention relates to the technical field of medicine, in particular to an external medicine for treating ear infections and a preparation method thereof. Background technique [0002] Quinolone antibacterial drugs are synthetic antibacterial drugs that began to be researched and developed in the 1970s. Because they have strong bactericidal effects against Gram-negative bacteria, positive bacteria, chlamydia, mycoplasma, and ribobacteria, they have good stability. It can be made into a variety of dosage forms for clinical use and has attracted wide attention. Among them, enoxacin, ciprofloxacin and ofloxacin have become widely used clinical antibacterial drugs. Pazufloxacin mesylate is a new injectable quinolone antibacterial drug developed by Toyama Chemical Crop. after the above-mentioned drugs. It was approved to be marketed in Japan for the first time in April 2002. The dosage is 300mg or 500mg, clinically mainly used to treat respiratory system, uri...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K31/5365A61K47/30A61P31/02
Inventor 王廷春
Owner 广州博济新药临床研究中心有限公司
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