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Azithromycin ophthalmic gel preparation composition and preparation and application thereof

A technology of azithromycin and ophthalmic gel, which is applied in the field of medicine, can solve the problems of azithromycin being difficult to dissolve, achieve good pharmacological effects, improve therapeutic effects, and exert therapeutic effects

Inactive Publication Date: 2008-08-06
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] After a large number of experimental studies, the researchers of the present invention combined azithromycin with citric acid and then combined with suitable auxiliary materials to make ophthalmic gel preparations; the present invention can better achieve the effect of azithromycin absorption by combining azithromycin with citric acid, and solve the problem of azithromycin The disadvantage of not being easy to dissolve, at the same time, it can be made into a gel preparation, which can make the drug act on the lesion for a long time to achieve the effect of full absorption. After a large number of animal experiments, it was found that when the weight ratio of azithromycin to citric acid is 2:1-6: 1 ophthalmic gel preparation of the present invention has good pharmacological effect; When the weight ratio of azithromycin and citric acid is 3.7: 1, the pharmacological effect of the ophthalmic gel preparation of the present invention is most remarkable, has obvious treatment conjunctivitis, keratitis, Trachoma, dacryocystitis ophthalmic diseases

Method used

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  • Azithromycin ophthalmic gel preparation composition and preparation and application thereof
  • Azithromycin ophthalmic gel preparation composition and preparation and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Azithromycin:citric acid=5:1

[0049] (1) Weigh 1g of glycerin and 0.01g of EDTA-2Na into water for injection, add 5mg of benzalkonium bromide after dissolving to obtain solution A; weigh 0.2g of cross-linked carbomer 980 into solution A to dissolve, and place in the refrigerator 8 hours, to obtain matrix B;

[0050] (2) Weigh 0.5g of azithromycin and 0.1g of citric acid, add them into 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, Adjust the pH to 6 with 2mol / L NaOH to obtain solution C;

[0051] (3) Use 2mol / L NaOH to adjust the pH to 5.5 for matrix B, then autoclave for 0.5 hours, mix matrix B with solution C, adjust the pH to 6 with 2mol / L NaOH, add water for injection to adjust and stir Obtain 100 g of azithromycin ophthalmic gel.

Embodiment 2

[0053] Azithromycin:citric acid=1:1

[0054] (1) Weigh 3g of glycerin and 0.03g of EDTA-2Na into water for injection, add 15mg of benzalkonium bromide after dissolving to obtain solution A; weigh 0.5g of cross-linked carbomer 980 into solution A to dissolve, and place in the refrigerator After 24 hours, matrix B was obtained;

[0055] (2) Take by weighing 0.4g azithromycin and 0.4g citric acid, add in water for injection and stir for 3 hours, dissolve completely, obtain azithromycin-citric acid saturated solution, add water for injection in the saturated solution, then add 0.2g F407 and stir to dissolve, Adjust the pH to 7 with 2mol / L NaOH to obtain solution C;

[0056] (3) Adjust the pH of matrix B to 6.5 with 2mol / L NaOH, then autoclave for 1 hour, mix matrix B with solution C, adjust the pH to 7 with 2mol / L NaOH, add water for injection to adjust and stir Obtain 100 g of azithromycin ophthalmic gel.

Embodiment 3

[0058] Azithromycin:citric acid=2:1

[0059] (1) Weigh 1.5g glycerin and 0.02g EDTA-2Na into water for injection, add 10mg benzalkonium bromide after dissolving to obtain solution A; Stand for 12 hours to obtain matrix B;

[0060] (2) Weigh 1g azithromycin and 0.5g citric acid, add in water for injection and stir for 2 hours, dissolve completely, obtain azithromycin-citric acid saturated solution, add water for injection in saturated solution, then add 0.15g F407 and stir to dissolve, use 2mol / L NaOH adjusted the pH to 6.5 to obtain solution C;

[0061] (3) Use 2mol / L NaOH to adjust the pH to 6 for matrix B, then autoclave for 0.5 hours, mix matrix B with solution C, adjust the pH to 6.5 with 2mol / L NaOH, add water for injection to adjust and stir Obtain 100 g of azithromycin ophthalmic gel.

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Abstract

The invention discloses a novel composition of an ophthalmic Azithromycin gel preparation, a preparation method thereof and applications thereof. The researcher of the invention combines appropriate auxiliary materials with the combination of Azithromycin and citric acid to prepare the ophthalmic Azithromycin gel preparation; the combination of the Azithromycin and the citric acid in the invention can achieve better absorption of the Azithromycin, which resolves the problem that the Azithromycin is difficult to dissolve; meanwhile, the manufactured gel preparation can ensure that the drug have prolonged effects on lesion location to realize full absorption of the drug. The ophthalmic Azithromycin gel preparation of the invention has obvious pharmacological action and outstanding effects on treatment of such ophthalmic diseases as conjunctivitis, keratitis, trachoma, dacrocystitis, etc.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a new composition of azithromycin ophthalmic gel preparation, its preparation method and application. Background technique [0002] There are many eye diseases, mainly conjunctivitis, keratitis, trachoma, dacryocystitis, glaucoma, cataract and other ophthalmic diseases. Conjunctivitis is a common disease in ophthalmology, but its incidence has not yet been determined. Since most of the conjunctiva is in direct contact with the outside world, it is easily stimulated by infectious (such as bacteria, viruses, and chlamydia, etc.) and non-infectious factors (trauma, chemical substances, and physical factors, etc.) in the surrounding environment. Lymphatic tissue is abundant, and it is easy to be sensitized by self and external antigens. Keratitis refers to the inflammation of corneal tissue. Typical symptoms that patients will experience include burning eyes, stinging ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/7052A61P27/02
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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