L-ofloxacin lactate slow release gels for eye and its preparing method

A technology of levofloxacin lactate and sustained-release gel, which is applied in the field of medicine, can solve the problems that patients are reluctant to use, low bioavailability, poor compliance, etc., and achieves maintaining effective drug concentration, long residence time, and good compatibility. Effect

Inactive Publication Date: 2005-01-12
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

[0027] Get 39kg of deionized water, add 0.15kg of levofloxacin lactate, and stir to dissolve. Take 2kg of sodium alginate and sprinkle it into the above solution. After standing overnight, add 0.005 kg of benzalkonium bromide, 0.4 kg of sodium chloride, and 1.5 kg of hydroxypropyl-β-cyclodextrin, and stir to dissolve. Use 10% NaOH solution to adjust the pH to 7.4, pass the solution 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

[0029] Get 39kg of deionized water, add 0.15kg of levofloxacin lactate, and stir to dissolve. Take 1.5kg of hydroxypropyl methylcellulose and sprinkle it into the above solution. After standing overnight, add 0.005 kg of benzalkonium bromide, 0.4 kg of sodium chloride, and 1.5 kg of hydroxypropyl-β-cyclodextrin, and stir to dissolve. Adjust the pH to 7 with boric acid, pass the solution 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

[0031] Get 39kg of deionized water, add 0.15kg of levofloxacin lactate, and stir to dissolve. Take 2kg of methylcellulose and sprinkle it into the above solution. After standing overnight, add 0.005 kg of benzalkonium bromide, 0.4 kg of sodium chloride, and 1.5 kg of hydroxypropyl-β-cyclodextrin, and stir to dissolve. Adjust the pH to 7 with 10% NaOH solution, pass the solution 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.

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PUM

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Abstract

A slowly-releasing ocular gel of levoofloxacin lactate for treating eyelid inflammation, stye, conjunctivitis, dacryocystitis, keratitis, corneol ulcer and trachoma is prepared from levoofloxacin lactate, thickeing agent, antiseptic, isotonic regulator, osmotic regulator, pH regulator and water. Its preparing process is also disclosed.

Description

Technical field: [0001] The invention relates to the technical field of medicine, in particular to a levofloxacin lactate 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 enoxacin, ofloxacin, nor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/5383A61P27/02
Inventor 潘卫三刘志东
Owner SHENYANG PHARMA UNIVERSITY
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