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Azithromycin gel eye drops and preparation process thereof

A technology of azithromycin and eye drops, which can be applied to medical preparations without active ingredients, medical preparations containing active ingredients, organic active ingredients, etc., can solve the problem of low bioavailability, poor drug absorption, and short retention time. problem, to achieve the effect of reducing drug loss, delaying drug release, and increasing residence time

Active Publication Date: 2013-07-31
北京乐维生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The invention discloses azithromycin gel-type eye drops and a preparation process thereof, aiming at providing clinically practical, convenient and reliable ophthalmic preparations for treating bacterial conjunctivitis, and solving the problem of eye drop-type drugs in the eyes. Short residence time, poor drug absorption, low bioavailability, etc.

Method used

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  • Azithromycin gel eye drops and preparation process thereof
  • Azithromycin gel eye drops and preparation process thereof
  • Azithromycin gel eye drops and preparation process thereof

Examples

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Embodiment 1

[0031] Embodiment 1: Take by weighing 0.15g of azithromycin, stir and dissolve with appropriate amount of citric acid-sodium citrate buffer solution, then add 4.0g of sodium chloride, 0.1g of disodium edetate, and 0.05g of thimerosal solution into the above-mentioned drug solution, replenish Add an appropriate amount of water for injection and ultrasonically dissolve; add 0.01g polycarbophil, and shear with high-shear equipment at 10,000r / min for 1 minute to make polycarbophil fully swell and disperse; after polycarbophil is completely swelled and dispersed, cool to room temperature, adjust the pH to 6.0-6.5 with 1M sodium hydroxide solution; add 0.1 g of poloxamer 407 to the solution, and then transfer the solution to 4°C to completely dissolve poloxamer 407 and obtain clarification After the solution, add the full amount of water for injection, filter, subpackage; store at 2-8°C.

Embodiment 2

[0032]Example 2: Weigh 1.06g of azithromycin, 8.0g of mannitol, 0.1g of disodium edetate, and 0.05g of benzalkonium chloride solution, and dissolve them ultrasonically with an appropriate amount of citric acid-sodium citrate buffer and water for injection; add 0.05g polycarbophil, cut for 1 minute with high-shear equipment at 10000r / min to make polycarbophil fully swell and disperse; after polycarbophil is completely swollen and dispersed, cool to room temperature and oxidize with 1M Mix solution of sodium and potassium hydroxide (1:1 molar ratio) to adjust the pH to 6.0-6.5; add 15g of carbomer to the solution, and then transfer the solution to 4°C to completely dissolve the carbomer and obtain clarification After the solution, add water for injection to the full amount, filter, subpackage; store at 2-8°C.

Embodiment 3

[0033] Example 3: Weigh a mixture of 5.0 g of azithromycin, 2.4 g of glycerin, 6.0 g of disodium edetate, paraben A, B, C, and butyl ester (mass ratio is 70:10:10:10) 2.0 g, ultrasonically dissolve with an appropriate amount of citric acid-sodium citrate buffer and water for injection; add 2.5g of polycarbophil, and shear with high-shear equipment at 10000r / min for 2 minutes, so that the polycarbophil is fully swollen and dispersed; After the polycarbophil is completely swollen and dispersed, cool to room temperature, and adjust the pH to 6.0-6.5 with 1M sodium hydroxide solution; add 10.0 g of poloxamer 407 to the solution, and then transfer the solution to 4°C. Completely dissolve the poloxamer 407 to obtain a clear solution, add water for injection to the full amount, filter and sub-package; store at 2-8°C.

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Abstract

The invention discloses azithromycin gel eye drops and a preparation process thereof. The eye drops are prepared from a main medicine, namely azithromycin and excipients such as an adhesive, a gel matrix, an isotonic regulator, a preservative, an antioxidant, a buffering agent and the like. The adhesive, namely polycarbophil in the eye drops can increase the biological adhesion of the eye drops, so that the detention time of medicines in eyes is further prolonged. The invention provides a practical, convenient and reliable ophthalmic preparation for treating bacterial conjunctivitis, and solves the problems that the detention time of medicines in an eye drop formulation in the eyes is short, the medicines are not easy to absorb, the bioavailability is low and the like.

Description

technical field [0001] The invention relates to an eye drop and a preparation process thereof, in particular to a gel-type eye drop containing azithromycin and a preparation process thereof, and belongs to the technical field of production of ophthalmic pharmaceutical preparations. Background technique [0002] Bacterial conjunctivitis is the most frequently encountered eye disease in daily ophthalmology first visits. Although bacterial conjunctivitis is considered a self-limiting disease, it is usually treated with antibiotic water-soluble eye drops. As an outstanding representative of a new generation of antibiotics, azithromycin is the only 15-membered ring macrolide antibiotic that has been marketed in the world. Its antibacterial spectrum is similar to that of erythromycin but its antibacterial effect is stronger. It has been widely used in China in recent years. [0003] [0004] Azithromycin structural formula [0005] Its mechanism of action is to interfere with...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K31/7052A61K47/32A61K47/34A61K47/36A61K47/38A61P31/04A61P27/02
Inventor 薛泉
Owner 北京乐维生物技术有限公司
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