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Flurbiprofen axetil eye nano-emulsion in-situ gel preparation and preparation method thereof

A technology of in situ gel and nanoemulsion, applied in polymer solution containing nanoemulsion, preparation of flurbiprofen axetil ophthalmic nanoemulsion-in situ gel preparation, flurbiprofen axetil ophthalmic nanoemulsion- In the field of in situ gel preparations, the effect of prolonging the residence time, easy to use and easy for industrial production

Inactive Publication Date: 2009-03-18
SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is no ophthalmic preparation listed at home and abroad at present.

Method used

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  • Flurbiprofen axetil eye nano-emulsion in-situ gel preparation and preparation method thereof
  • Flurbiprofen axetil eye nano-emulsion in-situ gel preparation and preparation method thereof
  • Flurbiprofen axetil eye nano-emulsion in-situ gel preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Table 1 embodiment 1~6 flurbiprofen axetil nanoemulsion-in situ gel preparation composition and process parameter

[0032] Example 1 Example 2 Example 3 Example 4 Example 5 Example 6 flurbiprofen axetil 100mg 300mg 500mg 400mg 200mg 400mg

[0033] Example 1 Example 2 Example 3 Example 4 Example 5 Example 6 Osmolality regulation

[0034] PI: is the polydispersity coefficient of the particle size, which is measured by a particle size analyzer.

Embodiment 2

[0039] Test Example 2 Ophthalmic Safety Test of Flurbiprofen Axetil Ophthalmic Nanoemulsion-In Situ Gel Preparation

[0040] 1. Test materials and conditions:

[0041] Test drug: the flurbiprofen axetil ophthalmic nanoemulsion-in situ gel preparation prepared in Example 1, each administration dose is 100 μl;

[0042] Experimental animals: 4 clean New Zealand white rabbits, half male and half male, weighing 2-3 kg (purchased from Shanghai Heping Special Animal and Plant Breeding Farm);

[0043] Animal feeding environment: Room temperature: 20°C

[0044] Humidity: 30%-70%

[0045] Lighting: artificial light, 12 hours daylight, 12 hours dark

[0046] 2. Test method:

[0047] The rabbit's conjunctival sac was gently pulled open, and 100 μl of the test drug was dropped into the conjunctival sac of the right eye, and normal saline was given to the left side as a control. After administration, the eyes are passively closed for 5-10 seconds (the movement...

Embodiment 3

[0053] Test Example 3 Ocular retention evaluation of flurbiprofen axetil ophthalmic nanoemulsion-in situ gel preparation

[0054] 1. Test materials and conditions:

[0055] Experimental animals: 4 clean New Zealand white rabbits, half male and half male, weighing 2-3 kg (purchased from Shanghai Heping Special Animal and Plant Breeding Farm);

[0056] Animal feeding environment: Room temperature: 20°C

[0057] Humidity: 30%-70%

[0058] Lighting: artificial light, 12 hours daylight, 12 hours dark

[0059] Test drug:

[0060] (1), ethyl rhodamine B-labeled flurbiprofen axetil ophthalmic nanoemulsion-in situ gel preparation

[0061] According to the preparation method of Example 1, 100 mg of flurbiprofen axetil, 1 g of soybean lecithin and 0.1 g of ethyl rhodamine B were dissolved in 5 g of soybean oil, and mixed uniformly at 60 ° C to make an oil phase; 20 g of propylene glycol was dissolved in 800 ml Stir and dissolve in purified water at 60°C t...

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Abstract

The invention relates to an ophthalmic flurbiprofen ester nano emulsion-in situ gel preparation and a preparation method thereof. The ophthalmic flurbiprofen ester nano-emulsion in situ gel preparation is made from oil, an emulsifier, a thickener, an osmoregulator, a bacteriostatic agent and purified water; and is characterized in that one or a plurality of safe and non-irritating lecithin, Tween60, Tween80, polyoxyethylene castor oil and polyoxyethylene hydrogenated castor oil are taken as the emulsifier; and a high molecular material with ion sensitivity characteristic is taken as the thickener. The ophthalmic flurbiprofen ester nano emulsion-in situ gel preparation is low-viscosity fluid with good fluidity in vitro, and rapidly forms hydrogel after being dropped in eyes. The ophthalmic flurbiprofen ester nano emulsion in-situ gel preparation has the advantages of increasing the residence time of the drug in eyes and increasing bioavailability, has no irritability or other toxic side effect to eyes, and has good biocompatibility and the like.

Description

technical field [0001] The present invention relates to a novel ophthalmic preparation of flurbiprofen axetil—specifically, to a flurbiprofen axetil ophthalmic nanoemulsion-in-situ gel preparation, more specifically, it is a high-density gel containing nanoemulsion Molecular solution, after administration in the form of eye drops, quickly forms a gel on the surface of the cornea, thereby achieving the purpose of delaying the elimination of drugs, improving ocular residence time and local bioavailability. The invention also relates to a preparation method of the flurbiprofen axetil ophthalmic nanoemulsion-in-situ gel preparation. Background technique [0002] Flurbiprofen is a clinically widely used non-steroidal anti-inflammatory drug, which has anti-inflammatory, analgesic and antipyretic effects, and is used for the treatment of pain or inflammatory diseases. In 1998, my country approved the listing of flurbiprofen raw materials and tablets of Shanghai Sanwei Pharmaceutic...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/10A61K31/192A61P27/02
CPCA61K9/0048A61K9/06A61K31/192A61P27/02
Inventor 甘勇甘莉朱春柳
Owner SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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