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Enoxacin ocular sustained release gelata and preparation thereof

A slow-release gel and ophthalmic technology, applied in the field of medicine, can solve the problems of patients' reluctance to use, low bioavailability, poor compliance, etc., to maintain effective drug concentration, long residence time, and good compatibility Effect

Inactive Publication Date: 2004-11-10
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Eye drops are the most commonly used dosage form in ophthalmology. After administration, they are diluted to 0.1% of the original concentration by tears within a few minutes, and the bioavailability is low, only 1%-10%. Therefore, the frequency of eye drops needs to be increased, and it is inconvenient for patients to use. Poor compliance and may cause systemic toxicity
Although the release of eye ointment is slow, patients are not willing to use it because of its strong greasy feeling and easy to cause "blurred vision" due to the base of Vaseline

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Take 39kg of deionized water, add 0.15kg of enoxacin, stir to dissolve. Take 2kg of sodium alginate and sprinkle it into the above solution. Let stand overnight, then add 0.001 kg of benzalkonium bromide and 0.4 kg of sodium chloride, and stir to dissolve. Use 10% NaOH solution to adjust the pH to 7.4, dissolve and pass through a 0.22um microporous membrane, and add water from the filter to a total of 50kg. Sampling is carried out for quality identification, and after passing the test, it is subpackaged in eye drop bottles under a sterile environment, and then packaged to obtain the product.

Embodiment 2

[0028] Take 39kg of deionized water, add 0.15kg of enoxacin, stir to dissolve. Take 1.5 kg of hydroxypropyl methylcellulose (HPMC F4M) and sprinkle it into the above solution. Let stand overnight, then add 0.001 kg of benzalkonium bromide and 0.4 kg of sodium chloride, and stir to dissolve. Adjust the pH to 7 with boric acid, dissolve and pass through a 0.22um microporous membrane, and add water from the filter to a total of 50kg. Sampling is carried out for quality identification, and after passing the test, it is subpackaged in eye drop bottles under a sterile environment, and then packaged to obtain the product.

Embodiment 3

[0030] Take 39kg of deionized water, add 0.15kg of enoxacin, stir to dissolve. Take 2kg of methylcellulose and sprinkle it into the above solution. Let stand overnight, then add 0.001 kg of benzalkonium bromide and 0.4 kg of sodium chloride, and stir to dissolve. Use 10% NaOH solution to adjust the pH to 7, dissolve and pass through a 0.22um microporous filter membrane, and add water from the filter to a total of 50kg. Sampling is carried out for quality identification, and after passing the test, it is subpackaged in eye drop bottles under a sterile environment, and then packaged to obtain the product.

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PUM

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Abstract

The invention relates to an eye use Enoxacin slow release gelling agent and its preparation method, which comprises the following constituents (by weight proportions), Enoxacin 0.1-1, and thickening agent 0.1-40, preservative agent 0.001-3, isotonic conditioning agent 0.1-10, pH=4.5-9 of pH modifier, and balancing water. The preparation process comprises dissolving the Enoxacin into water, adding thickening agent and stewing, charging preservative agent, isotonic conditioning agent, stirring to dissolve, regulating pH=4.5-9 with pH modifier, subjecting the solution to filtration by microporous filtering film, watering to total amount from the filter.

Description

Technical field: [0001] The invention relates to the technical field of medicine, in particular to an enoxacin ophthalmic sustained-release gel and a preparation method thereof. Background technique: [0002] According to statistics, more than 80% of the patients who go to see a doctor in ophthalmology are ocular infections. Ophthalmic infections include conjunctivitis, keratitis, and global inflammation; divided from pathogenic bacteria, including bacterial infections and fungal infections. Anti-infective drugs can be used for bacterial infection, but due to the existence of the blood-ocular barrier, the drugs cannot fully penetrate into the eye, and the drug concentration in the intraocular tissue is low. Therefore, the anti-infective drugs used in ophthalmology are those with good permeability, such as tobramycin, cleomycin and chloramphenicol. In recent years, the application of quinolones in ophthalmology has grown rapidly, such as ofloxacin, levofloxacin, norfloxacin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/496A61P27/02A61P31/04A61P31/10
Inventor 潘卫三刘志东王思玲
Owner SHENYANG PHARMA UNIVERSITY
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