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Ciclosporin eye gel and preparation method thereof

A technology of cyclosporine and gel, which is applied in the field of medicine, can solve the problems of short corneal retention time, low bioavailability, and intolerance of patients, and achieve long corneal retention time, high bioavailability, and low damage Effect

Active Publication Date: 2014-04-23
ZHAOKE GUANGZHOU OPTHALMIC DRUG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, cyclosporine A is mixed with oily solvents to make various vegetable oil eye drops at home and abroad, but these oily eye drops have poor mucous membrane adhesion and short retention time in the cornea, so the bioavailability is very low and the effect is poor.
At the same time, oily solvents are irritating to the eyes, and patients usually cannot tolerate them

Method used

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  • Ciclosporin eye gel and preparation method thereof
  • Ciclosporin eye gel and preparation method thereof
  • Ciclosporin eye gel and preparation method thereof

Examples

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preparation example Construction

[0048] The present invention also provides a method for preparing the cyclosporin eye gel, which specifically comprises mixing the aqueous gel matrix with water to prepare the gel matrix, and then mixing the cyclosporin A with a nonionic surfactant and a wetting agent It is uniformly mixed and stirred evenly with the prepared gel matrix, pH regulator is added to adjust the pH to 5.0-8.0, sterilized, and then sterilized into eye drop bottles to obtain cyclosporine eye gel.

[0049] Sterilization refers to the use of physical or chemical methods to kill all microorganisms, including pathogenic and non-pathogenic microorganisms and spores, so that they can reach the level of sterility protection. The sterilization of the present invention is preferably autoclaving.

[0050] Autoclave sterilization is a method of heating with saturated steam with a pressure greater than normal pressure in a closed sterilization container for sterilization. The autoclave sterilization method of the pre...

Embodiment 1

[0054] Example 1: The cyclosporine eye gel of the present invention

[0055] prescription:

[0056] An eye gel containing 0.01% cyclosporine A, the specific prescription is as follows:

[0057] Cyclosporine A 0.01% by weight, Tween 802% by weight, Carbomer 0.01% by weight, Propylene glycol 5% by weight, appropriate amount of sodium hydroxide, add water for injection to 100g, and make a 100g specification containing 0.01% cyclosporin eye gel .

[0058] Preparation:

[0059] 1) Preparation of gel matrix

[0060] Take the prescribed amount of water for injection into a beaker, and spread the prescribed amount of carbomer on the surface of the above-mentioned water for injection, and let it swell at rest.

[0061] 2) Preparation of cyclosporin A solution

[0062] Accurately weigh cyclosporin A, add Tween 80 to dissolve cyclosporin A, add propylene glycol, and stir well.

[0063] 3) Mixing and post-processing

[0064] Take the gel matrix prepared in step (1) and the drug solution prepared in ste...

Embodiment 2

[0069] prescription:

[0070] An eye gel containing 0.04% cyclosporine A, the specific prescription is as follows:

[0071] Cyclosporin A 0.04% by weight, castor oil 10% by weight, carbomer 0.2% by weight, propylene glycol 30% by weight, appropriate amount of sodium hydroxide, add water for injection to 100g, make a 100g specification containing 0.04% cyclosporin A eye gel glue.

[0072] Preparation:

[0073] 1) Preparation of gel matrix

[0074] Take the prescribed amount of water for injection into a beaker, and spread the prescribed amount of carbomer on the surface of the above-mentioned water for injection, and let it swell at rest.

[0075] 2) Preparation of cyclosporin A solution

[0076] Accurately weigh cyclosporin A, add castor oil to dissolve cyclosporin A, add propylene glycol, and stir well.

[0077] 3) Mixing and post-processing

[0078] Take the gel matrix prepared in step (1) and the drug solution prepared in step (2), mix and stir uniformly, add a pH regulator to adjust th...

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Abstract

The invention belongs to the field of medicines, and discloses ciclosporin eye gel and a preparation method thereof. The ciclosporin eye gel is water-based eye gel which is prepared from the raw materials: ciclosporin A, a nonionic surfactant, a water-based gel matrix, a wetting agent, a pH modifier and water. The ciclosporin A of the ciclosporin eye gel has high solubility in water, and the corneal permeability of the ciclosporin A is good. Meanwhile, the ciclosporin eye gel is the water-based eye gel, the adhesiveness of a mucous membrane is good, the corneal retention time is long, and the bioavailability of ciclosporin A is high. In addition, the ciclosporin eye gel does not contain an oil-based solvent and a preservative and has slight irritation to eyes and low damage to the ocular surface. The preparation method of the ciclosporin eye gel is simple for operation and is suitable for large scale production.

Description

Technical field [0001] The invention belongs to the field of medicine, and specifically relates to a cyclosporin eye gel and a preparation method thereof, in particular to a cyclosporin aqueous eye gel and a preparation method thereof. Background technique [0002] Dry eye is one of the common ocular surface diseases. It refers to the instability of the tear film and the damage of the ocular surface caused by abnormal quality or quantity of tear fluid, or abnormal tear fluid dynamics, resulting in eye discomfort and other symptoms A type of disease. The symptoms of dry eye usually manifest as dryness, foreign body sensation, burning sensation, itching sensation, blurred vision, red eyes, contact lens intolerance and so on. In recent years, with the widespread use of video terminals and the popularization of air-conditioning facilities in residential and office environments, dry eye has become a global epidemic. Due to the lack of large-scale, multi-center dry eye epidemiologica...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K38/13A61P27/02A61P37/06
Inventor 戴向荣李小羿张国辉凌娟周冠群
Owner ZHAOKE GUANGZHOU OPTHALMIC DRUG
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