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Ophthalmic composition and preparation method thereof

A composition and ophthalmology technology, applied in the direction of drug combination, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve unfavorable treatment of dry eye, damage to ocular surface cells, tear film instability, etc. problem, achieve the effect of protecting ocular surface cells, reducing tear evaporation, and relieving visual fatigue

Active Publication Date: 2020-07-14
BLOOMAGE BIOTECHNOLOGY CORP LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to ensure the sterility of the eye drops, preservatives such as benzalkonium bromide are added to the eye drop composition of the above-mentioned patent, but the addition of preservatives will damage the ocular surface cells and cause the tear film to be unstable and cause dry eyes syndrome, which is very unfavorable for the treatment of dry eye syndrome

Method used

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  • Ophthalmic composition and preparation method thereof
  • Ophthalmic composition and preparation method thereof
  • Ophthalmic composition and preparation method thereof

Examples

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preparation example Construction

[0058] The application provides a preparation method of an ophthalmic composition, comprising the following steps:

[0059] Step 1: Dissolve hyaluronic acid salts of different molecular weights in water under heating conditions, add sodium chloride and stir evenly, adjust the pH to alkaline with inorganic alkali or salt, and obtain compound hyaluronic acid through alcohol precipitation, washing and drying salt powder;

[0060] Step 2: Dissolving the compounded hyaluronate powder in water, and then adding zinc hyaluronate, ectoine or ectoine derivatives to obtain a mixed solution;

[0061] Step 3: adjust the pH of the mixed solution, and filter or autoclave to obtain an ophthalmic composition.

[0062] In the method described in this application, the compounded hyaluronate in step 1 has a macromolecular network structure, and the zinc hyaluronate and ectoine or ectoine derivatives in step 2 can be embedded in the macromolecular network structure. The macromolecular network op...

Embodiment 1

[0112] Take 80 mg of high-molecular-weight sodium hyaluronate with a molecular weight of 70wDa and 20 mg of low-molecular-weight sodium hyaluronate with a molecular weight of 6wDa, dissolve them in water under heating at 60°C, add 2 mg of sodium chloride and stir evenly, and oxidize with hydroxide Adjust the pH to 9.5 with sodium, add dropwise 2 times the volume of 95% ethanol under stirring, the precipitate is completely precipitated, wash the precipitate 4 times with 85% ethanol, and dry in vacuum to obtain a compound sodium hyaluronate powder; the obtained compound hyaluronate Dissolve the sodium bicarbonate powder in water, stir well to dissolve it, add 1g of ectoine and 500mg of zinc hyaluronate (8kDa), stir well, add water for injection to a volume close to 100ml, adjust the pH of the solution to 7.0 with sodium citrate buffer , continue to add water for injection to make the volume to 100ml, filter and sterilize with a filter membrane with a pore size of 0.22 μm to obtai...

Embodiment 5

[0122] The compound sodium hyaluronate prepared in Example 5 has a regular network structure after being dissolved in water, and the results are as follows: figure 1 .

[0123] 2. Antibacterial effect

[0124] Take the preserved strains of Staphylococcus aureus, Pseudomonas aeruginosa, and Pseudomonas aeruginosa, and culture them under sterile conditions for 18-24 hours to obtain samples of bacteria in the exponential growth phase, and configure 10 6 The bacterial suspension of CFU / mL is ready for use.

[0125] Take 18 sterilized petri dishes and pour 20mL medium into each petri dish on the ultra-clean workbench. Liquid coated 6 Petri dishes.

[0126] Cut the filter paper sheet into a disc with a diameter of 10mm, put the sterilized filter paper sheet with sterile tweezers on the ultra-clean workbench and put it into the container equipped with the above-mentioned Example 1-Example 9 and Comparative Example 1-Comparative Example 5. Soak in the sterilized petri dish of the ...

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Abstract

The present application discloses a preparation method for an ophthalmic composition. The method includes the following steps: dissolving a high-molecular-weight hyaluronate and a low-molecular-weighthyaluronate in water under heating conditions, adding sodium chloride, performing uniform stirring, adjusting the pH to be alkaline by using an inorganic alkali or salt, performing alcohol precipitation, performing washing, and performing drying to obtain compound hyaluronate powder; dissolving the compound hyaluronate powder in water, and adding zinc hyaluronate, tetrahydropyrimidine or a tetrahydropyrimidine derivative to obtain a mixed solution; and adjusting the pH of the mixed solution, and performing filter sterilization or heat press sterilization to obtain the ophthalmic composition.The present application also provides the ophthalmic composition. The ophthalmic composition provided in the present application contains the compounded sodium hyaluronate, the zinc hyaluronate and the tetrahydropyrimidine, does not contain preservatives, the sodium hyaluronate, the zinc hyaluronate and the tetrahydropyrimidine have synergistic effects, and the composition has the effects of reducing tear evaporation, protecting ocular surface cells, stabilizing tear films, and relieving visual fatigue.

Description

technical field [0001] The application relates to the technical field of ophthalmic medicines, in particular to an ophthalmic composition and a preparation method thereof. Background technique [0002] In recent years, with the penetration of display terminals such as computers and mobile phones into daily life, eye problems such as visual fatigue and dry eye syndrome have become more and more common. Discomfort symptoms such as vision loss have brought great distress and influence to people's work and life. The use of eye drops relieves this discomfort to a large extent, but the active ingredients of commonly used eye drops are glycerin, chitosan, cellulose derivatives, etc., which often cannot achieve satisfactory results due to their insufficient therapeutic effect or side effects. satisfactory results. [0003] The systematic name of ectoine is 2-methyl-1,4,5,6-tetrahydropyrimidine-4-carboxylic acid and the systematic name of hydroxy ectoine is 5-hydroxy-2-methyl-1,4, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/30A61K9/08A61K9/06A61K47/36A61P27/02A61P29/00A61K31/505A61K31/728
CPCA61K33/30A61K31/728A61K31/505A61K9/0048A61K47/36A61K9/08A61K9/06A61P27/02A61P29/00A61K2300/00
Inventor 耿凤邵萌王静郭学平
Owner BLOOMAGE BIOTECHNOLOGY CORP LTD
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