Compounded ophthalmic preparation and preparation method thereof

A compound preparation and ophthalmic technology, which is applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, drug combinations, etc., can solve problems such as poor stability, short storage time, and poor adhesion of active ingredients. To achieve the effect of overcoming deliquescence, reducing usage, and overcoming corruption

Active Publication Date: 2020-05-29
AFFILIATED HOSPITAL OF WEIFANG MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] In order to overcome the defects of poor stability, short storage time and poor adhesion of active components of traditional eye washing solutions, the pr

Method used

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  • Compounded ophthalmic preparation and preparation method thereof
  • Compounded ophthalmic preparation and preparation method thereof

Examples

Experimental program
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Example Embodiment

[0073] Example 1

[0074] Preparation of chondroitin sulfate cross-linked modified carboxylated β-cyclodextrin

[0075] 1) After dissolving 10mmol of monocarboxylated β-cyclodextrin (each molecule of cyclodextrin contains a single carboxylated group unit) and 12mmol N-hydroxysuccinimide in 50mL of distilled water, add 12mmol EDC, ice bath conditions Stir the reaction for 2h; then slowly add the chondroitin sulfate aqueous solution with amine units (including the chondroitin sulfate content 18mmol), slowly stir for 1h under ice bath conditions, then heat the water bath to 35℃, keep warm and slowly stir for 12h;

[0076] 2) After the reaction is completed, the reaction solution is concentrated, and the concentrated solution is divided into a dialysis bag for dialysis pretreatment for 16 hours to remove unreacted small molecule materials, and then purified by silica gel column chromatography to obtain the carboxylated β-ring modified by chondroitin sulfate Dextrin; the purification par...

Example Embodiment

[0079] Example 2

[0080] Preparation of ophthalmic compound preparation 1

[0081] (1) Preparation of component A

[0082] S1-1: Weigh 3g of sodium hyaluronate and 2g of trehalose into 65ml of distilled water, stir and swell for 30min in a water bath at 80°C, fully dissolve and reduce the temperature to room temperature; add 0.6g of betaine under stirring, and keep stirring To dissolve, then add 1g of alanylglutamine, continue to stir and dissolve, add distilled water to the total weight of the solution 100g, as the base liquid;

[0083] S1-2: Immerse 10g of the above-prepared chondroitin sulfate cross-linked modified cyclodextrin into the above base liquid, heat it to 45°C in a water bath, stir slowly for 30min, then treat it under 100W ultrasound for 3min; leave it at 4°C for 6h Then, it was frozen at -80°C for 6 hours, and then vacuum freeze-dried to obtain about 17g of solid component A.

[0084] After the obtained solid is sterilized by ultraviolet radiation, it is divided into ...

Example Embodiment

[0089] Example 3

[0090] Preparation of ophthalmic compound preparation 2

[0091] (1) Preparation of component A

[0092] S1-1: Weigh 2g of sodium hyaluronate and 1.5g of trehalose into 60ml of distilled water, stir and swell for 30min in a water bath at 80°C, and after fully dissolving, reduce the temperature to room temperature; add 0.5g of betaine under stirring, constantly Stir to dissolve, then add 1.2g of alanylglutamine, continue to stir to dissolve, add distilled water until the total weight of the solution is 100g, as the base liquid;

[0093] S1-2: Immerse 8g of the above-mentioned chondroitin sulfate crosslinked modified cyclodextrin into the above-mentioned base liquid, heat it to 45℃ in a water bath, stir slowly for 30min, and then treat it under 150W ultrasound for 3min; leave it at 4℃ for 6h and then Freeze at -80°C for 6h, and obtain solid component A by vacuum freeze-drying.

[0094] After the obtained solid is sterilized by ultraviolet radiation, it is divided into...

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Abstract

The invention discloses a compounded ophthalmic preparation which comprises a solid component A and a component B, wherein the component B is used as a buffer isotonic solution; the component A comprises a chondroitin sulfate cross-linking modified carboxylated beta-cyclodextrin carrier as well as components, namely sodium hyaluronate, trehalose, glycine betaine and alanyl glutamine matrix which are carried by the carrier; and the component B as the buffer isotonic solution comprises povidone, taurine, glycerinum and/or a sodium chloride isotonic agent, an antibacterial agent, a pH value adjusting agent and injection water. The preparation disclosed by the invention is used for alleviating asthenopia and relieving xerophthalmia symptoms, has very high stability and can be preserved for a long time without a preservative.

Description

technical field [0001] The invention belongs to the field of ophthalmology, and in particular relates to an eye rinse solution combination preparation for improving and / or alleviating dry eye syndrome and visual fatigue and a preparation method thereof. Background technique [0002] In the field of ophthalmology, eye cleaning or washing is one of the effective means to relieve dry eye syndrome. In recent years, with the reduction of air quality and the increase in the frequency of use of electronic terminals, there are more and more patients with dry eye syndrome, and the potential sub-symptom patients are also increasing year by year. [0003] Patients with sub-dry eye symptoms are usually accompanied by visual fatigue in daily life. As people spend more and more time on electronic terminals and wear contact lenses (contact lenses) for a long time, it is easy to cause initial symptoms such as eye dryness, foreign body sensation, and visual fatigue. Decreased tear film sta...

Claims

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Application Information

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IPC IPC(8): A61K31/728A61K31/7016A61K31/205A61K31/198A61K47/40A61K47/36A61P27/02A61P27/04
CPCA61K9/0048A61K31/198A61K31/205A61K31/7016A61K31/728A61K47/36A61K47/40A61P27/02A61P27/04A61K2300/00
Inventor 牟亚男牟莹莹王良艳
Owner AFFILIATED HOSPITAL OF WEIFANG MEDICAL UNIV
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