Bromfenac sodium eye drops and preparation method thereof

A technology of bromfenac sodium and eye drops, which can be used in pharmaceutical formulations, sensory diseases, non-central analgesics, etc., can solve the problems of short adhesion time, change the viscosity of eye drops, etc., and achieve increased safety and efficiency. Effectiveness, improvement of polymer impurities, effect of prolonging residence time

Inactive Publication Date: 2015-04-22
山东辰欣佛都药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But it also has its disadvantages. Because the viscosity of water is very low, the attachment time around the eyeball is short, and the tears secreted after the eye drops are applied to the eyes and other factors make the concentration of the drug dilute, and it is difficult to achieve a long time around the eyeball. For the purpose of maintaining a high concentration, an excipient is often added to the eye drops as a thickener to change the viscosity of the eye drops and regulate the residence time of the drug in the eye

Method used

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  • Bromfenac sodium eye drops and preparation method thereof
  • Bromfenac sodium eye drops and preparation method thereof
  • Bromfenac sodium eye drops and preparation method thereof

Examples

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Effect test

Embodiment 1

[0019] Prescription: bromfenac sodium 5g, molecular weight range 1.5×10 6 About 5g of sodium hyaluronate, 27.9g of boric acid, 52.5g of borax, 0.5g of benzalkonium bromide, 0.5g of anhydrous sodium sulfite, 0.5g of disodium edetate, and 5000ml of water for injection were added to make 1000 sticks.

[0020] The preparation method is as follows: 1) disperse the prescribed amount of sodium hyaluronate in an appropriate amount of water for injection at 40°C to 50°C, and make it swell to form a transparent solution; Add disodium sulfite and benzalkonium bromide, and add 1), heat to boil, boil for 30 minutes, cool to 30-40°C, add anhydrous sodium sulfite and bromfenac sodium respectively, stir for 15 minutes to dissolve, add injection Add water to the full volume, mix for 15 minutes, and adjust the pH to 8.3 with sodium hydroxide. Filter cycle for 15 minutes. After taking samples to measure the content and pH, they were filled and sealed in 5ml plastic bottles for eye drops cleane...

Embodiment 2

[0022] Prescription: Bromfenac Sodium 5g, Hydroxypropyl Methylcellulose 1g, Carbomer 1g, Sodium Citrate 27.9g, Disodium Hydrogen Phosphate 52.5g, Methylparaben 0.2g, Methylparaben Propyl Add 0.3g, 0.2g p-hydroxytert-butanol anisole, 0.3g propyl gallate, 0.4g triethanolamine, 0.2g tryptophan, and water for injection to 5000ml, and make 1000 tubes in total.

[0023] The preparation method is as follows: 1) Disperse the prescribed amount of hydroxypropyl methylcellulose and carbomer in an appropriate amount of water for injection at 40°C to 50°C to swell to form a transparent solution; 2) Add the prescription water under stirring Amount of sodium citrate, disodium hydrogen phosphate, triethanolamine, tryptophan, paraben, methyl paraben propyl, add 1), heat to boiling, after boiling for 30 minutes, cool to 30-40°C , add p-hydroxytert-butanol anisole, propyl gallate, and bromfenac sodium respectively, stir for 15 minutes to dissolve, add water for injection to the full amount, mix ...

Embodiment 3

[0025] Prescription: bromfenac sodium 5g, molecular weight range 1.2×10 6 About 8g of sodium hyaluronate, 27.9g of boric acid, 52.5g of borax, 0.5g of benzalkonium bromide, 0.5g of anhydrous sodium sulfite, 0.5g of disodium edetate, and water for injection were added to 5000ml, and a total of 1000 tubes were prepared.

[0026] The preparation method is as follows: 1) disperse the prescribed amount of sodium hyaluronate in an appropriate amount of water for injection at 40°C to 50°C, and make it swell to form a transparent solution; Add disodium sulfite and benzalkonium bromide, and add 1), heat to boil, boil for 30 minutes, cool to 30-40°C, add anhydrous sodium sulfite and bromfenac sodium respectively, stir for 15 minutes to dissolve, add injection Add water to the full volume, mix for 15 minutes, and adjust the pH to 8.3 with sodium hydroxide. Filter cycle for 15 minutes. After taking samples to measure the content and pH, they were filled and sealed in 5ml plastic bottles...

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Abstract

The invention belongs to the technical field of medicine preparation, and particularly relates to bromfenac sodium eye drops and a preparation method thereof. The eye drops comprise, by mass, 0.05-0.5% of bromfenac sodium, 0.03-0.2% of a thickening agent, 0.01-0.1% of bacteriostatic agents, 0.05-0.5% of antioxidant, 0.005-0.1% of complexing agents, and the balance water for injection, and the pH value is adjusted to 8.3 through a pH regulator. Compared with the prior art, acid mucopolysaccharide sodium hyaluronate which commonly exists in biological bodies is selected as the thickening agent by the bromfenac sodium eye drops, the water solution of the acid mucopolysaccharide sodium hyaluronate has good biocompatibility and high viscosity elasticity, due to the fact that the eye drops have the high viscosity elasticity, the residence time of drops in the eyes is prolonged, the problem that polymer impurities are prone to being generated when povidone serves as the thickening agent of an original product is solved, and the using safety and efficiency of the bromfenac sodium eye drops are increased.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a bromfenac sodium eye drop and a preparation method thereof. Background technique [0002] Bromfenac sodium is one of the derivatives of 2-amino-2-benzoylphenylacetic acid. Its structure is similar to ketoprofen and diclofenac. It is the most effective cyclooxygenase inhibitor with strong anti-inflammatory and analgesic effects. 10 times stronger than other NSAIDs. Bromfenac Sodium Eye Drops was developed by Senju Corporation of Japan and was launched in Japan in 2000 under the trade name Xibrom TM It was listed in the United States in early March 2005, and in October 2009 in China under the trade name Pronacle. It is mainly used for the symptomatic treatment of inflammatory diseases of the outer eye and anterior eye, such as blepharitis, conjunctivitis, scleritis (preserved episcleritis), postoperative inflammation, etc. Compared with other non-stero...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/196A61K47/36A61P27/02A61P29/00
Inventor 王绍同李中井薛晓霞张宇丽谢海梁
Owner 山东辰欣佛都药业股份有限公司
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