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Eye drops containing hyaluronic acid or its salts and propylene glycol

A technology of hyaluronic acid and sodium hyaluronate, which is applied to medical preparations containing active ingredients, medical preparations with non-active ingredients, organic active ingredients, etc. It can solve the problems of no record and insufficient preservation effect

Active Publication Date: 2016-05-11
SANTEN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in fact, if the preservative concentration in the eye drops is reduced, sufficient preservation effect cannot be obtained when using in a multi-dose form, and the compounding ingredients are changed along with the reduction of the preservative, so it is also There is concern that the physicochemical properties of the eye drops will be different from those of the existing sodium hyaluronate eye drops
[0008] In addition, although Japanese Patent Application Publication No. 2004-359629 (Patent Document 1), Japanese Patent Application Publication No. 2009-196903 (Patent Document 2), and Japanese Patent Application Publication No. 2009-161454 (Patent Document 3) disclose An eye drop containing sodium hyaluronate, benzalkonium chloride, and propylene glycol has sufficient preservation efficacy even though the concentration of benzalkonium chloride in the eye drop is 0.0025% or less, and has the same effect as the existing There is no record of the same physical and chemical properties of sodium hyaluronate eye drops

Method used

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  • Eye drops containing hyaluronic acid or its salts and propylene glycol
  • Eye drops containing hyaluronic acid or its salts and propylene glycol
  • Eye drops containing hyaluronic acid or its salts and propylene glycol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0072] [preservation effectiveness test]

[0073] In order to confirm the effect of propylene glycol on the preservation efficacy of hyaluronic acid eye drops, a preservation efficacy test was conducted.

[0074] (sample preparation)

[0075]

[0076] Dissolve sodium hyaluronate 0.3g, sodium chloride 0.7g, potassium chloride 0.15g, ε-aminocaproic acid 0.2g, edetate sodium hydrate 0.01g and benzalkonium chloride (C12) 0.0025g in water, Set the volume to 100mL, add dilute hydrochloric acid and / or sodium hydroxide, use the liquid with pH 6.0 as comparative formula 1, and use the liquid with pH 7.0 as comparative formula 2.

[0077]

[0078] Except the addition amount of benzalkonium chloride (C12) being 0.002 g, it prepared similarly to said comparative formulation 1 and 2.

[0079]

[0080] Dissolve sodium hyaluronate 0.3g, sodium chloride 0.7g, propylene glycol 0.25g, ε-aminocaproic acid 0.2g, edetate sodium hydrate 0.01g and benzalkonium chloride (C12) 0.001g in water,...

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PUM

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Abstract

The present invention relates to an eye drop, which is an aqueous eye drop containing hyaluronic acid or its salt at a concentration of 0.03 to 0.5% (w / v) and propylene glycol at a concentration of 0.1 to 1.0% (w / v), Wherein, the eye drops contain benzalkonium chloride at a concentration of 0.001 to 0.002% (w / v) as the only preservative, and contain ionic acid, etc. penetrating agent.

Description

technical field [0001] The present invention relates to an aqueous eye drop containing hyaluronic acid or its salt at a concentration of 0.03 to 0.5% (w / v) and propylene glycol at a concentration of 0.1 to 1.0% (w / v). The eye drop contains 0.001 Benzalkonium chloride is used as the only preservative at a concentration of ~0.002% (w / v), and an ionic isotonizing agent is contained at a concentration that makes the osmotic pressure ratio of the eye drops 0.9-1.1. In addition, the present invention also relates to a method for improving the preservation efficacy of eye drops containing sodium hyaluronate at a concentration of 0.1 or 0.3% (w / v) and containing benzalkonium chloride as the sole preservative, and This method makes the kinematic viscosity of the eye drops reach 3.0-4.0 or 17-30mm 2 / s, and prevent dripping of the eye drops, the method includes: sodium hyaluronate in an amount of 0.1 or 0.3% (w / v) in the eye drops, the eye drops Benzalkonium chloride in an amount of 0...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/10A61K47/18A61K47/36
CPCA61K9/0048A61K47/10A61K47/186A61K9/08A61K47/36A61K31/728A61P27/02A61P27/04A61K47/18A61K47/08
Inventor 稻垣孝司小川敏弘堀部吉伟堂田敦义长野敬中村雅胤中田雄一郎
Owner SANTEN PHARMA CO LTD
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