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Azithromycin eye-drops new composition and preparation method and application thereof

A technology of azithromycin and its composition, which is applied in the field of new composition of azithromycin eye drops and its preparation, can solve problems such as not easy to dissolve, and achieve the effect of not easy to dissolve and easy to absorb

Inactive Publication Date: 2009-09-09
迈洋致达(北京)科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The researchers of the present invention have found through a large number of experimental studies that the eye drop composition containing an effective amount of azithromycin, citric acid and other suitable auxiliary materials has good stability. Shortcoming, improved the bioavailability of medicine, the researcher finds that the proportioning between azithromycin and citric acid in the composition has important influence on the pharmacological effect of eye drops of the present invention, when the proportioning of azithromycin and citric acid is 2: 1-6: 1: The eye drop preparation of the present invention has the effect of treating ophthalmic diseases; when the ratio of azithromycin and citric acid is 3:1-4:1, the eye drop preparation of the present invention has significant pharmacological effects; when the ratio of azithromycin and citric acid When it is 3.7: 1, the eye drop preparation of the present invention has the best curative effect in treating ophthalmic diseases

Method used

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  • Azithromycin eye-drops new composition and preparation method and application thereof
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  • Azithromycin eye-drops new composition and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Azithromycin:citric acid=3.7:1

[0052] (1) Weigh 0.2 g of cross-linked carbomer 980 and add it to water for injection to swell, and place it in the refrigerator for 8 hours to obtain solution A;

[0053] (2) Weigh 1g of azithromycin and 0.27g of citric acid, add water for injection and stir for 0.5 hours, and dissolve completely to obtain a saturated solution of azithromycin-citric acid; add water for injection into the saturated solution, then add 0.16g of F407 and stir to dissolve, add 10mg of Benzalkonium bromide, to obtain solution B;

[0054] (3) Weigh 0.02g EDTA-2Na and 2g mannitol into solution A, stir to obtain solution C; mix solutions B and C, stir, and add 0.4g NaCl, after all dissolve, use 2mol / L Adjust the pH to 6 with NaOH solution, and dilute to 100ml with water for injection to obtain azithromycin eye drops.

Embodiment 2

[0056] Azithromycin:citric acid=1:1

[0057] (1) Weigh 0.4g of cross-linked carbomer 980 and add it to water for injection to swell, and place it in the refrigerator for 24 hours to obtain solution A;

[0058] (2) Weigh 0.4g of azithromycin and 0.4g of citric acid, add water for injection and stir for 3 hours, and dissolve completely to obtain a saturated solution of azithromycin-citric acid; add water for injection into the saturated solution, then add 0.3g of F407 and stir to dissolve, add dropwise 15mg of benzalkonium bromide, to obtain solution B;

[0059] (3) Weigh 0.03g EDTA-2Na and 3g mannitol into solution A, stir to obtain solution C; mix solutions B and C, stir, and add 0.5g NaCl, after all dissolve, use 2mol / L Adjust the pH to 7 with NaOH solution, and dilute to 100ml with water for injection to obtain azithromycin eye drops.

Embodiment 3

[0061] Azithromycin:citric acid=2:1

[0062] (1) Weigh 0.2 g of cross-linked carbomer 980 and add it to water for injection to swell, and place it in the refrigerator for 12 hours to obtain solution A;

[0063] (2) Weigh 0.4g of azithromycin and 0.2g of citric acid, add water for injection and stir for 1 hour, and dissolve completely to obtain a saturated solution of azithromycin-citric acid; add water for injection into the saturated solution, then add 0.1g of F407 and stir to dissolve, add dropwise 10mg of benzalkonium bromide, to obtain solution B;

[0064] (3) Weigh 0.02g EDTA-2Na and 2g mannitol into solution A, stir to obtain solution C; mix solutions B and C, stir, and add 0.3gNaCl, after all dissolve, use 2mol / L NaOH The pH of the solution was adjusted to 6.3, and the volume was adjusted to 100 ml with water for injection to obtain azithromycin eye drops.

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Abstract

The invention discloses an azithromycin eye-drops new composition and a preparation method and an application thereof. The azithromycin is combined with citric acid and then is combined with a proper amount of auxiliary materials to obtain eye-drops after the experimental study by research personnel; the effect of azithromycin absorption can be better achieved by combining the azithromycin and the citric acid and the defect that the azithromycin is not easy to dissolve is overcome, and the azithromycin eye-drops new composition has remarkable pharmacological action and has obvious therapeutic effects of curing ophthalmic diseases such as conjunctivitis, ceratitis, trachoma, dacryocystitis, and the like.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a new composition of azithromycin eye drops and its preparation method and application. Background technique [0002] There are many eye diseases, mainly conjunctivitis, keratitis, trachoma, dacryocystitis, glaucoma, cataract and other ophthalmic diseases. There are several causes of eye infections, Haemophilus influenzae and Streptococcus pneumoniae being the most common causative bacteria. Because various pathogenic microorganisms widely exist in nature, and the conjunctiva is in direct contact with the outside world, pathogenic microorganisms can often spread through direct contact with media such as hands, objects, and water, causing conjunctivitis. Keratitis is a serious eye disease and one of the main causes of blindness. There are many causes of keratitis. Trauma, other ocular or systemic infectious diseases may cause corneal infection, and the pathogens that...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7052A61K9/08A61K47/12A61P27/02
Inventor 颜文革漆新国阚迎昕王立强
Owner 迈洋致达(北京)科技有限公司
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