Pranoprofen eye drops containing sulfobutyl ether-β-cyclodextrin and preparation method thereof

A technology containing sulfobutyl ether and sulfobutyl ether, which can be used in pharmaceutical formulations, non-active ingredients of polymer compounds, sensory diseases, etc., can solve the problems of strong irritation and low bioavailability, and achieve the goal of improving stability Effect

Active Publication Date: 2018-03-30
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to overcome the shortcomings such as strong irritation and low bioavailability that common pranoprofen eye drops have, it is urgent to develop a new type of pranoprofen eye drops, which has good appearance, nontoxicity, Non-irritating, can improve patient compliance and other characteristics

Method used

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  • Pranoprofen eye drops containing sulfobutyl ether-β-cyclodextrin and preparation method thereof
  • Pranoprofen eye drops containing sulfobutyl ether-β-cyclodextrin and preparation method thereof
  • Pranoprofen eye drops containing sulfobutyl ether-β-cyclodextrin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1: prepare 0.1% pranoprofen eye drops with 1% SBE-β-CD solution and 0.1% HPMC as solubilizer and stabilizer

[0022]

[0023] Preparation method: Dissolve the prescription amount of SBE-β-CD in 90mL of water for injection, add boric acid to dissolve, heat in a water bath to 60°C, add 0.1g of pranoprofen, stir until completely dissolved, add other excipients in turn, stir to make After it is completely dissolved, adjust the pH value to 7.5, and add water for injection to 100ml. Filter through a 0.22μm microporous membrane, fill in divided doses into ampoules, and obtain the product.

Embodiment 2

[0024] Embodiment 2: prepare 0.1% pranoprofen eye drops with 5% SBE-β-CD solution and 0.1% HPMC as solubilizer and stabilizer

[0025]

[0026] Preparation method: Dissolve the prescription amount of SBE-β-CD in 90mL of water for injection, add boric acid to dissolve, heat in a water bath to 60°C, add 0.1g of pranoprofen, stir until completely dissolved, add other excipients in turn, stir to make After it is completely dissolved, adjust the pH value to 7.5, and add water for injection to 100ml. Filter through a 0.22μm microporous membrane, fill in divided doses into ampoules, and obtain the product.

Embodiment 3

[0027] Embodiment 3: prepare 0.1% pranoprofen eye drops with 10% SBE-β-CD solution and 0.1% HPMC as solubilizer and stabilizer

[0028]

[0029] Preparation method: Dissolve the prescription amount of SBE-β-CD in 90mL of water for injection, add boric acid to dissolve, heat in a water bath to 60°C, add 0.1g of pranoprofen, stir until completely dissolved, add other excipients in turn, stir to make After it is completely dissolved, adjust the pH value to 7.5, and add water for injection to 100ml. Filter through a 0.22μm microporous membrane, fill in divided doses into ampoules, and obtain the product.

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PUM

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Abstract

The invention belongs to the technical field of medicine, and discloses a pranoprofen eye drop containing sulfobutyl ether-β-cyclodextrin, which comprises active ingredient pranoprofen, solubilizer sulfobutyl ether-β-cyclodextrin Essence, stabilizer, pH regulator, bacteriostatic agent and osmotic pressure regulator; The stabilizer is macromolecular polymer polyethylene glycol, polyvinyl alcohol, povidone, polyvinylpyrrolidone, sodium hyaluronate, povidone One of loxamer, hypromellose or a mixture thereof. The preparation method of the present invention is to dissolve SBE-β-CD in water for injection, add pranoprofen under heating at 60°C, and after it is completely dissolved, add other auxiliary materials in turn, stir until completely dissolved, and cool to room temperature. Adjust the pH value, add water for injection to the full amount, and filter through a 0.22 μm microporous membrane to obtain the product. The pranoprofen eye drops containing sulfobutyl ether-β-cyclodextrin reduces the irritation to the eyes during use, and significantly improves the stability of the pranoprofen eye drops.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a pranoprofen eye drop and a preparation technology thereof, in particular to a pranoprofen eye drop containing sulfobutyl ether-β-cyclodextrin and a preparation method thereof. Background technique [0002] At present, the commonly used drugs for clinical treatment of various eye inflammation and allergic symptoms are antihistamines, anticongestants, corticosteroids, mast cell stabilizers and non-steroidal anti-inflammatory agents. Long-term use of antihistamines, anticongestants, corticosteroids, and mast cell stabilizers may lead to a decline in adrenal cortex function and induce serious adverse reactions. Non-steroidal anti-inflammatory drugs have no adverse reactions of corticosteroids, and have anti-inflammatory, analgesic and anti-allergic effects, so they are widely used in ophthalmology. [0003] Pranoprofen eye drops are the eye drops of propionate non-steroidal anti...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/436A61K47/40A61P27/02
Inventor 王永军薛鹏王晶何仲贵
Owner SHENYANG PHARMA UNIVERSITY
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