Ophthalmic composition as well as preparation method and application thereof

An ophthalmic composition and drug technology, applied in the field of medicine, can solve problems affecting drug compliance, prolong treatment time, accelerate wound healing, etc., achieve the effects of shortening treatment and recovery time, improving comfort, and increasing drug compliance

Active Publication Date: 2021-01-26
湖北远大天天明制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Chondroitin sulfate is an acidic mucopolysaccharide extracted and purified from animal tissues. It is the main component of the intercellular matrix, which can accelerate wound healing, reduce scar tissue, and facilitate the migration of corneal epithelial cells, thus promoting the healing of corneal trauma. Healing, often used in the treatment of keratitis, corneal ulcer, and corneal injury, but during the treatment, patients often complain that when using chondroitin sulfate eye drops, there is a stinging sensation in the eyes, which affects drug compliance and leads to prolonged treatment time , even fails

Method used

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  • Ophthalmic composition as well as preparation method and application thereof
  • Ophthalmic composition as well as preparation method and application thereof
  • Ophthalmic composition as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] (1) Preparation of ophthalmic composition

[0035] Step S1, uniformly mixing sodium citrate, sodium chloride and water for injection to prepare a mixed solution I;

[0036] Step S2, adding chondroitin sulfate and olopatadine hydrochloride to water for injection, and stirring homogeneously at 3000r / min for 10min to prepare mixed solution II;

[0037] Step S3, mixing the mixed solution I and the mixed solution II evenly, adding water for injection, filtering through a 0.22 μm filter element, and filling to obtain an ophthalmic composition with the following composition based on the total weight of the ophthalmic composition:

[0038] and the remainder of

[0039] Water for Injection;

[0040] The mass ratio of chondroitin sulfate and olopatadine hydrochloride in the ophthalmic composition is 0.34:1;

[0041] The ratio of the amount of water for injection in step S1, the amount of water for injection in step S2 and the amount of water for injection in step S3 is 3:3:4...

Embodiment 2

[0049] (1) Preparation of ophthalmic composition

[0050] Step S1, uniformly mixing borax, potassium chloride and water for injection to prepare mixed solution I;

[0051] Step S2, adding chondroitin sulfate and olopatadine hydrochloride to water for injection, and stirring homogeneously at 4500r / min for 15min to prepare mixed solution II;

[0052] Step S3, mixing the mixed solution I and the mixed solution II evenly, adding water for injection, filtering through a 0.22 μm filter element, and filling to obtain an ophthalmic composition with the following composition based on the total weight of the ophthalmic composition:

[0053] and the remainder of

[0054] Water for Injection;

[0055] The mass ratio of chondroitin sulfate and olopatadine hydrochloride in the ophthalmic composition is 0.28:1;

[0056] The ratio of the amount of water for injection in step S1, the amount of water for injection in step S2 and the amount of water for injection in step S3 is 2:5:3.

[00...

Embodiment 3

[0063] (1) Preparation of ophthalmic composition

[0064]The preparation method of the ophthalmic composition of this embodiment is the same as that of Example 1, the difference is that the osmotic pressure regulator is glycerin, and the pH regulator is citric acid, and the following formula is obtained based on the total weight of the ophthalmic composition: Composition of the ophthalmic composition:

[0065] and the remainder of

[0066] Water for Injection;

[0067] The mass ratio of chondroitin sulfate to olopatadine hydrochloride in the ophthalmic composition is 0.41:1.

[0068] (2) Performance analysis of eye drops

[0069] The ophthalmic composition prepared in Example 3 was used as eye drops, and the accelerated stability inspection was carried out according to the 2015 edition of "Chinese Pharmacopoeia" 9001 preparation stability inspection principles, and the inspection was carried out according to the indicators under the 0105 ophthalmic preparation general rul...

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Abstract

The invention relates to an ophthalmic composition which comprises chondroitin sulfate and olopatadine hydrochloride. The invention further relates to a preparation method of the ophthalmic composition. The preparation method comprises the following steps: S1, mixing a pH regulator, an osmotic pressure regulator and injection water to obtain a mixed solution I; S2, homogeneously stirring and mixing chondroitin sulfate, olopatadine hydrochloride and injection water for 10-15 minutes at 3000-4500 r/min to obtain a mixed solution II; and S3, mixing the mixed solution I and the mixed solution II with the injection water, and filtering the mixture to obtain the ophthalmic composition. Furthermore, the invention relates to application of the ophthalmic composition in preparation of medicines forimproving eye stimulation symptoms caused by treatment of corneal diseases. The ophthalmic composition serving as eye drops can be used for effectively relieving eye irritation caused by chondroitinsulfate at conventional dosage for corneal disease treatment, so that the medication compliance of a patient can be improved, and the treatment time of the patient can be effectively shortened.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an ophthalmic composition and its preparation method and application. Background technique [0002] Chondroitin sulfate is an acidic mucopolysaccharide extracted and purified from animal tissues. It is the main component of the intercellular matrix, which can accelerate wound healing, reduce scar tissue, and facilitate the migration of corneal epithelial cells, thus promoting the healing of corneal trauma. Healing, often used in the treatment of keratitis, corneal ulcer, and corneal injury, but during the treatment, patients often complain that when using chondroitin sulfate eye drops, there is a stinging sensation in the eyes, which affects drug compliance and leads to prolonged treatment time , or even fail. [0003] Therefore, the problem at present is to provide an ophthalmic composition and its preparation method and application that can reduce eye irritation s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/12A61K47/02A61K31/737A61K31/335A61P27/02
CPCA61K9/0048A61K9/08A61K47/12A61K47/02A61K31/737A61K31/335A61P27/02A61K2300/00
Inventor 王超付欢胡梦琳尹传忠徐玉梅郭欢
Owner 湖北远大天天明制药有限公司
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