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Pranoprofen in-situ gelling eye drop and preparation method thereof

A technology of in-situ gelation and pranoprofen, applied in the field of medicine, can solve the problems of short residence time and poor stability of pranoprofen water-based eye drops

Inactive Publication Date: 2013-01-23
JIANGSU JIBEIER PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The present invention mainly solves the problems of poor stability and short residence time of pranoprofen water-based eye drops, prepares a kind of pranoprofen gelling eye drops in situ, and provides its preparation method

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Weigh 5 g of sodium alginate, add 100 mL of water for injection, stir slowly to dissolve, set aside for later use as solution ①. Weigh 0.13 g of benzalkonium chloride and 8 g of boric acid, add an appropriate amount of water for injection, heat and stir to dissolve, cool, and make solution ②. Weigh 2.3g of borax, 0.15g of EDTA-2Na, 0.025g of BHT, and 0.5g of Tween-800.5g, heat and stir to dissolve, cool, and use as solution ③. Weigh 0.5 g of pranoprofen, add it to solution ③, stir well to dissolve, and make it solution ④. Mix solution ② and solution ④ to form a uniform system, then add solution ①, add water for injection to make the final volume of the system 500mL, and stir to make the mixture uniform. Filter through a 0.22 μm microporous membrane, sterilize, and aliquot to obtain.

Embodiment 2

[0029] Weigh 10g of Poloxamer 407, add an appropriate amount of water for injection, stir well to disperse evenly, and refrigerate for more than 12 hours until the polymer is completely dissolved to form a clear and transparent solution, which is set aside for later use as solution ①. Weigh 0.13 g of benzalkonium chloride and 8 g of boric acid, add an appropriate amount of water for injection, heat and stir to dissolve, cool, and make solution ②. Weigh 2.3g of borax, 0.15g of EDTA-2Na, 0.035g of BHT, and 0.75g of Tween-800.75g, heat and stir to dissolve, cool down, and use it as solution ③. Weigh 0.5 g of pranoprofen, add it to solution ③, stir well to dissolve, and make it solution ④. Mix solution ② and solution ④ to form a uniform system, then add solution ①, add water for injection to make the final volume of the system 500mL, and stir to make the mixture uniform. Filter through a 0.22 μm microporous membrane, sterilize, and aliquot to obtain.

Embodiment 3

[0031] Weigh 8g of sodium alginate, add 100mL of water for injection, stir in a hot water bath to dissolve, let it stand for later use as solution ①. Weigh 0.10 g of benzalkonium chloride and 8 g of boric acid, add an appropriate amount of water for injection, heat and stir to dissolve, and cool to form a solution ②. Weigh 2.3g of borax and 0.15g of EDTA-2Na, heat and stir to dissolve, cool, and use as solution ③. Weigh 0.075g of BHT and 1.0g of Tween-80, heat to dissolve, and make solution ④. Mix solution ③ with solution ④, stir to make the system uniform, and obtain solution ⑤. Weigh 0.5 g of pranoprofen, add to solution ⑤, stir well to dissolve, and use it as solution ⑥. Mix solution ② and solution ⑥ to form a uniform system, then add solution ①, add water for injection to make the final volume of the system 500mL, and stir to make the mixture uniform. Filter through a 0.22 μm microporous membrane, sterilize, and aliquot to obtain.

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PUM

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Abstract

A pranoprofen in-situ gelling eye drop is disclosed. The pranoprofen in-situ gelling eye drop comprises the components by mass percent: 0.1% of pranoprofen, 1%-40% of thickening agent, 0.03%-1.0% of pH adjusting agent, 0.01%-0.03% of bacteria inhibitor, 0.005%-0.2% of antioxidant, 0.01%-0.05% of chelating agent, and 0.1%-4.0% of solubilizing agent. The pranoprofen in-situ gelling eye drop disclosed by the invention has the characteristics that a material (e.g., poloxamer 407 and sodium alginate) with good biocompatibility and having the feature of temperature sensitivity, pH sensitivity or ion sensitivity is used as a matrix, the eye drop is administered in vitro under a solution state, phase change occurs immediately at the administered site in vivo in accordance with different environments inside and outside human body, so as to form in-situ gel; and the eye drop is convenient to use, high in bioavailability and long in residence time and results in good compliance of patients. The invention further discloses a preparation method of the pranoprofen in-situ gelling eye drop.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an eye drop containing pranoprofen and a preparation method thereof. Background technique [0002] At present, after eye surgery, the combination of antibiotics and hormones is mainly used to control postoperative infection so as not to induce symptoms. Glucocorticoids are effective drugs for controlling non-infectious inflammation of the outer eye and anterior segment and inflammation after cataract surgery, but ocular use can cause adverse reactions such as glaucoma and secondary bacterial infection. Therefore, developing a drug that is effective and has few side effects has broad market prospects. [0003] Pranoprofen, whose chemical name is (RS)-2-(10-hydrogen-9-oxa-1-azanthracene-6-yl) propionic acid, is a propionic acid nonsteroidal anti-inflammatory drug, and its mechanism of action is mainly In order to inhibit the activity of cyclooxygenase (COX), block th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/436A61K47/32A61K47/34A61K47/36A61K47/44A61P27/02
Inventor 兰雪莲陈建赵雷郦红岩吴修艮
Owner JIANGSU JIBEIER PHARMA
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