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Gatifloxacin ear drop and its prepn process

A technology of gatifloxacin and ear drops, which is applied in the field of medicine, can solve the problems that there is no research or clinical application of GFLX ear drops, the incidence of side effects is low, and the phototoxicity is reduced, so as to reduce systemic adverse reactions and overcome resistance. High medicinal properties and high bioavailability

Inactive Publication Date: 2007-03-21
王廷春
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The phototoxicity is significantly reduced. So far, large-scale clinical trials have shown that the incidence of side effects of gatifloxacin is relatively small and mild. In clinical trials, less than 2.9% of patients discontinued the drug due to side effects
However, this treatment method is very inconvenient for patients
Gatifloxacin preparations have been used in internal medicine, surgery, dermatology and gynecology in China, but there is no report on the research or clinical application of GFLX ear drops

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Take 0.1g of gatifloxacin crude drug that has passed the inspection, put it in a beaker, add 25ml of 50% ethanol, and ultrasonically treat it for 10min. Add to 100ml, adjust the pH value between 5.0~6.5 with dilute hydrochloric acid, suction filter through a 0.22 μm microporous membrane, subpackage after passing the inspection to obtain the ear drops of the present invention.

Embodiment 2

[0037] Take 0.3g of gatifloxacin crude drug that has passed the inspection, put it in a beaker, add 30ml of 50% ethanol, and ultrasonically treat it for 12min. After it is completely dissolved, add 35ml of medicinal glycerin, and stir while adding. Add to 100ml, adjust the pH value between 5.0~6.5 with dilute hydrochloric acid, suction filter through a 0.22 μm microporous membrane, subpackage after passing the inspection to obtain the ear drops of the present invention.

Embodiment 3

[0039] Get qualified gatifloxacin hydrochloride crude drug 0.5g, place in the mortar, add 50% ethanol 35ml, grind for 15min, after dissolving completely, add medicinal glycerin 30ml, stir while adding, after being uniform, Add purified water to 100ml, adjust the pH value between 5.0 and 6.5 with acetic acid, filter through a 0.22 μm microporous membrane, subpackage after passing the test to obtain the ear drops of the present invention.

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PUM

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Abstract

The gatifloxacin ear drop is prepared with gatifloxacin or its salt as the main component and the supplementary materials including glycerin, ethanol and sterilized water for injection, pure water or distilled water. The present invention also discloses the preparation process of the gatifloxacin ear drop. As one fourth generation oxyquinolone type antibacterial medicine, the gatifloxacin ear drop has high bioavailability, reduced medicine taking times, less systemic untoward reaction, high patient's compliance and less drug resistance.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an externally used medicine for treating ear infection and a preparation method thereof. Background technique [0002] At present, oral and injectable antibiotics are mainly used clinically to treat ear infections, which are extremely inconvenient to use, and the drugs cannot quickly reach the ear infection site, reducing the suffering of patients. There are very few ear anti-infective drugs for external use, only chloramphenicol ear drops, ofloxacin ear drops, etc., and the application rate of old products is quite high. Long-term use of these old ear drops leads to the increasing number of drug-resistant bacteria and weakens the therapeutic effect; and it needs to be administered multiple times a day, which is not easy for patients to accept. Therefore, there is a clinical need for an external ear anti-infection drug with good antibacterial effect, broad antibacterial spectru...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/496A61P27/16A61P31/04
Inventor 王廷春
Owner 王廷春
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