Rebamipide suspension eye drop containing water soluble high-molecular polymers and preparation method thereof

A technology of water-soluble polymer and rebamipide, which is applied in the field of medicine, can solve problems such as inability to make transparent and clear eye drops, poor water solubility of rebamipide, and discomfort for patients, and achieve a simple and easy-to-control production process , the source is easy to obtain, and the effect of reducing irritation

Inactive Publication Date: 2014-08-13
广州艾格生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Due to the poor water solubility of rebamipide, it is almost insoluble in water or dilute hydrochloric acid, so it cannot be made into transparent and clear eye drops
Ordinarily, rebamipide is made into ultrafine particles, and suspending agents, thickeners, etc. are added to directly prepare ophthalmic suspensions. It will gather in the middle, the particle size will become larger, and it will feel sandy and irritating when dripping into the eyes, and the patient will feel uncomfortable

Method used

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  • Rebamipide suspension eye drop containing water soluble high-molecular polymers and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0034] prescription

[0035]

[0036] Take an appropriate amount of water for injection, heat it to 80°C to 90°C, weigh carboxymethylcellulose sodium and disperse it in it, stir to dissolve, add disodium ethylenediaminetetraacetate and sodium chloride, stir to dissolve, use sodium hydroxide / hydrochloric acid to adjust the pH value to 6.5-7.5, sterilize and filter with a 0.2 μm microporous membrane, add sterile rebamipide ultrafine pulverized particles (0.1-50 μm), stir properly, mix well, add water for injection to the full amount, Shake well and dispense it into eye drop bottles under sterile conditions.

Embodiment 2

[0038] prescription

[0039]

[0040] Take an appropriate amount of water for injection, heat it to 80°C to 90°C, weigh carboxymethylcellulose sodium and disperse it in it, stir to dissolve, add disodium ethylenediaminetetraacetate and sodium chloride, stir to dissolve, use sodium hydroxide / hydrochloric acid to adjust the pH value to 6.5-7.5, sterilize and filter with a 0.2 μm microporous membrane, add sterile rebamipide ultrafine pulverized particles (0.1-50 μm), stir properly, mix well, add water for injection to the full amount, Shake well and dispense it into eye drop bottles under sterile conditions.

Embodiment 3

[0042] prescription

[0043]

[0044]

[0045]Prepare with reference to the method of Example 1.

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PUM

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Abstract

The invention provides rebamipide suspension eye drop containing water soluble high-molecular polymers and a preparation method thereof. The rebamipide suspension eye drop can be used for treating dry eyes. The main components of the eye drop comprise the water soluble high-molecular polymers, active pharmaceutical ingredients, a deflocculating agent, a pH regulator and an osmotic pressure regulator; the eye drop is prepared by sterilizing and filtering or high temperature sterilizing. The rebamipide suspension eye drop provided by the invention has the characteristics of being fine and uniform and free of settlement and agglomeration of particles, the sizes of the particles are kept to be consistent in a long term storage process, no particle is felt during eye dropping and no stimulation is generated, so that the rebamipide suspension eye drop is accepted by patients easily.

Description

technical field [0001] The invention relates to a suspending eye drop containing rebamipide and a preparation method thereof, so that the fine particles of rebamipide can be suspended in the medium for a long time, and the suspension can be kept in a suspended state for a long time. The invention is used for treating dry eye syndrome and belongs to the technical field of medicine. Background technique [0002] Dry eye syndrome (Keratoconjuetivitis sicca, KCS) refers to the absolute and relative lack of liquid components of the tear film, abnormal tear distribution on the ocular surface, and increased tear evaporation caused by various reasons such as decreased tear production, abnormal mucus secretion, and meibomian gland dysfunction. Syndromes with common features. In 1946, Wolf discovered that the structure of tear film is divided into lipid layer, water layer and mucus layer. The lipid layer can reduce tear evaporation, prevent tears from overflowing the eyelid margin, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K47/38A61K47/34A61K31/4704A61P27/02
Inventor 何盛江张现涛于江月
Owner 广州艾格生物科技有限公司
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