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Drug release system, azithromycin eye preparation containing drug release system, and preparation method of drug release system

A technology for azithromycin and ophthalmic preparations, which is applied in the field of drug release system and azithromycin ophthalmic preparations including its components, and can solve the problems of inability to stay active ingredients, lack of sustained-release effect, and increase the pain of patients, and achieve good intraocular Penetration, easy availability of raw materials, and the effect of improving safety

Inactive Publication Date: 2018-06-29
广州君博医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, only azithromycin ophthalmic preparations produced in the United States are in-situ gelling eye drops, which lack sustained release and have low mucoadhesiveness. The effect of the drug increases the pain of the patient to a certain extent

Method used

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  • Drug release system, azithromycin eye preparation containing drug release system, and preparation method of drug release system
  • Drug release system, azithromycin eye preparation containing drug release system, and preparation method of drug release system
  • Drug release system, azithromycin eye preparation containing drug release system, and preparation method of drug release system

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preparation example Construction

[0028] A preparation method of a release system of azithromycin ophthalmic preparation, the steps are: take water for injection, add polycarbophil solution under stirring, after swelling, take water for injection, add citric acid to dissolve citrate Sodium citrate, poloxamer 407, stir to dissolve, mix with the above polycarbophil solution, adjust the pH value to 6.0-6.5, stir well, steam sterilize at 121°C, and cool to room temperature.

[0029] Table 1 Preparation of Azithromycin Ophthalmic Preparations Drug Release System Raw Material Components and Consumption

[0030]

[0031] A slow-release azithromycin ophthalmic preparation comprising a drug delivery system for azithromycin ophthalmic preparations, which uses azithromycin as a medicinal raw material, and uses the drug delivery system polymer of the azithromycin ophthalmic preparation as a mucoadhesive polymer drug delivery system, Every 100 parts by weight of the preparation contains 0.5-2 parts by weight of azithrom...

Embodiment 13-18

[0050] Table 3 Example 13-18 Preparation of Sustained-release Azithromycin Ophthalmic Gel Raw Material Components and Consumption

[0051]

[0052]

[0053] The preparation method is as follows: take 2 / 5 of the prescribed amount of water for injection, add the prescribed amount of polycarbophil under stirring, let it swell for more than 2 hours, then take a small amount of water for injection, add the prescribed amount of citric acid to dissolve sodium citrate, poirot Sham 407, stir to dissolve, mix with the above polycarbophil solution, add 2mol / L sodium hydroxide solution, adjust the pH value to 6.0-6.5, stir well, steam sterilize at 121°C for 20 minutes, and cool to room temperature Add the prescribed amount of azithromycin; take a small amount of water for injection to dissolve the thickener and let it disperse and let it cool; and dissolve the prescribed amount of complexation stabilizer and bacteriostat with water for injection, stir to dissolve and then add the dis...

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Abstract

The invention relates to a drug release system, an azithromycin eye preparation containing the drug release system, and a preparation method of the drug release system. According to the preparation method, the mucosa adhesive polymer drug release system is prepared taking Azithromycin as a drug effect raw material; the weight ratio of polycarbophil, poloxamer 407, citric acid, and sodium citrate is controlled to be 1:0.1-1.0:0.1-1.0:0.1-0.8; an eye local acceptable pharmaceutical accessory material is adopted to prepare the slow release preparation; the weight ratio of Azithromycin to the drugrelease system polymer is controlled to be 1:1-2. The azithromycin eye preparation can be prepared into eye drop, ophthalmic gel, eye ointment, or any pharmaceutical dosage form suitable for eye local external use. The preparation method is capable of solving problems of Azithromycin such as poor water dissolvability and stability, prolonging retention time of active drugs on eye surfaces, and increasing the antibacterial activity on target tissues.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and more specifically relates to a drug delivery system, an azithromycin ophthalmic preparation comprising the composition and a preparation method thereof. Background technique [0002] Eyes are the window for human beings to perceive the world, and they are also important organs of the human body. Many eye diseases, such as glaucoma, keratitis, conjunctivitis, etc., if not treated in time and effectively, will eventually lead to serious consequences of blindness. On the one hand, because the eyes have very effective protection mechanisms such as tearing and blinking reflex, the liquid medicine dripped into the eye can be quickly eliminated from the precorneal area. The biggest disadvantage of traditional ophthalmic preparations lies in their short residence time and low bioavailability. Very low, only 1%-10% of the administered dose. On the other hand, the biological barrier functio...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K47/10A61K47/32A61K47/12A61K31/7052A61P27/02A61P31/04
CPCA61K9/0048A61K9/06A61K31/7052A61K47/10A61K47/12A61K47/32
Inventor 谭上彬王志军陈宇明黄俊杰崔明
Owner 广州君博医药科技有限公司
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