Pharmaceutical composition of bromfenac sodium

Abstract

The invention provides a pharmaceutical composition of bromfenac sodium, which comprises the following components in percentage by weight: 0.01-0.5% of bromfenac sodium sesquihydrate and pharmacologically acceptable salt thereof; 0.01%-1% by weight of a viscosity modifier dextran; 0.01%-1% by weight of a surfactant; and 0.01%-0.5% by weight of an antioxidant; and optional other auxiliary materialsacceptable in pharmacology. The bromfenac sodium eye drops have the beneficial effects that when the bromfenac sodium eye drops contain dextran 40 or dextran 70, impurities U-II can be effectively prevented from being generated, and the condition that the addition of dextran can also ensure the antibacterial effect of benzalkonium chloride, prolong the intraocular residence time and improve the drug effect can be accidentally found.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to a pharmaceutical composition of bromfenac sodium. Background technique [0002] The chemical name of bromfenac sodium: 2-amino-3-(4-bromobenzoyl)phenylacetic acid (sodium), the structural formula is as follows: [0003] [0004] Bromfenac sodium is a non-steroidal anti-inflammatory drug with anti-inflammatory activity. Its mechanism of action is to prevent the synthesis of prostaglandins by inhibiting cyclooxygenase 1 and 2. Prostaglandins are mediators of some intraocular inflammation. Prostaglandins can destroy the blood-aqueous humor barrier, dilate blood vessels, increase vascular permeability, increase leukocytes, and increase intraocular pressure. [0005] Bromfenac sodium ophthalmic solution is developed by Japanese Senju company, listed in Japan in 2000, trade name ブロナック / eye solution (BRONUCK OPHTHALMIC SOLUTION), is the 0.1% bromfenac sodium ophthalmic solution (with bromfen...

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Problems solved by technology

[0009] Through the published information and our development process of bromfenac sodium eye drops, it is found that the combination of polysorbate 80 in the original prescription and the preservative benzalkonium chloride will reduce the antibacterial effect of benzalkonium chloride, which has a certain safety risk; bromfenac sodium and thickener povidone are prone to produce a polymer impurity U-II impurity, which increases with the prolongation of imitation time and the increase of temperature. The content of this impurity in the product is about 3%

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