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Sodium aescinate microemulsion eye drops

A technique for sodium aescinate and eye drops, which is applied in the directions of emulsion delivery, cardiovascular system diseases, organic active ingredients, etc. Improved quality stability, uniform particle size distribution, and reduced eye irritation

Inactive Publication Date: 2018-03-27
WUHAN AIMIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because sodium aescinate is highly irritating and unstable in liquid, its application in ophthalmic preparations is limited

Method used

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  • Sodium aescinate microemulsion eye drops
  • Sodium aescinate microemulsion eye drops
  • Sodium aescinate microemulsion eye drops

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024]

[0025] Preparation method: 1) Take 8g of sodium aescinate, 3g of polyethylene glycol 400, 6g of sodium chloride, 9g of borate buffer (pH7.6), 0.5g of ethylparaben, and dissolve them in water for injection to prepare water box;

[0026] 2) Heat and stir 12 g of medium-chain fatty acid triglycerides and 2 g of Tween 80 to form an oil phase;

[0027] 3) Slowly add the oil phase to the water phase, and stir while adding, until a clear solution is formed, filter through a 0.22 μm microporous membrane, sterilize, and subpackage to obtain 1000 g of microemulsion eye drops.

Embodiment 2

[0029]

[0030] Preparation method: 1) Take 12g of sodium aescinate, 2g of polyethylene glycol 600, 9g of potassium chloride, 6g of phosphate buffer (pH7.2), and 0.2g of benzalkonium bromide, dissolve them in water for injection, and make water Mutually;

[0031] 2) Heat and stir 15 g of medium-chain fatty acid triglycerides and 1 g of Tween 80 to form an oil phase;

[0032] 3) Slowly add the oil phase to the water phase, and stir while adding, until a clear solution is formed, filter through a 0.22 μm microporous membrane, sterilize, and subpackage to obtain 1000 g of microemulsion eye drops.

Embodiment 3

[0034]

[0035] Preparation method: 1) Take 6 g of sodium aescinate, 1 g of polyethylene glycol 200, 7 g of glucose, 5 g of borate buffer solution (pH8.0), and 0.8 g of benzyl alcohol, and dissolve them in water for injection to make an aqueous phase;

[0036] 2) Heat and stir 20 g of medium-chain fatty acid triglycerides and 0.8 g of Tween 80 to make an oil phase;

[0037] 3) Slowly add the oil phase to the water phase, and stir while adding, until a clear solution is formed, filter through a 0.22 μm microporous membrane, sterilize, and subpackage to obtain 1000 g of microemulsion eye drops.

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Abstract

The invention discloses sodium aescinate microemulsion eye drops, which are prepared from effective content of sodium aescinate, 0.5-3% of medium-chain triglycerides, 0.05-0.5% of polyethylene glycol,0.05-0.5% of Tween, 0.1-1% of an osmotic pressure regulator, 0.1-2% of a buffer solution, 0.01-0.1% of a preservative and the balance of water for injection. The sodium aescinate is micro-emulsifiedso as to be prepared into the eye drops according to the special properties, so that the mass stability of the sodium aescinate is effectively improved, and the eye irritation is reduced.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to sodium aescinate eye drops, in particular to sodium aescinate microemulsion eye drops. Background technique [0002] Aescin, also known as aescinic acid, is a general term for total saponins, β-aescin or isoaescin, which are extracted from the seeds of Aescinaceae Aesculus, and belongs to triterpenoid saponins. The water solubility of aescin is poor, in order to increase its solubility, it is often made into salt. Oral or injection of aescin and its salts are commonly used clinically to treat cerebral edema caused by various reasons and accompanying brain dysfunction, inflammation and swelling caused by various reasons (such as trauma, burns, surgery), and venous reflux disorder It has strong anti-inflammatory and anti-exudation effects, and can significantly reduce the exudation of acute inflammation. [0003] CN 102920722 A discloses an ophthalmic preparation containi...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K47/14A61K47/10A61K47/26A61K31/704A61P9/10A61P27/02A61P25/00
CPCA61K9/0048A61K9/1075A61K31/704A61K47/10A61K47/14A61K47/26
Inventor 石召华叶利春张洋关小羽吴灯张晓存刘享平
Owner WUHAN AIMIN PHARMA
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