Gel for eye containing bromfenac sodium hydrate and preparation thereof

Abstract

The invention relates to an ophthalmic gel containing the active ingredient of bromfenac sodium hydrate and a preparation method thereof; the bromfenac sodium hydrate ophthalmic gel contains the active ingredient of bromfenac sodium hydrate, macromolecular hydrogel substrate, osmotic pressure regulator, bacteriostat, antioxidant, metal ion chelating agent, pH regulator and water for injection; the ophthalmic gel has convenient application and quick effect; particularly, the gel possesses certain viscosity and can stay in the eyes for a long time, thus overcoming the defect that eye drops can only stay in the eyes for a short time after being diluted by tears and achieving more effective therapeutic effect.

Description

technical field

[0001] The invention relates to an ophthalmic gel containing active ingredient bromfenac sodium hydrate and a preparation method thereof, belonging to the technical field of medicine. Background technique

[0002] Bromfenac sodium is a non-steroidal anti-inflammatory drug, a derivative of 2-amino-3-benzoylphenylacetic acid (amfenac), which mainly blocks prostaglandin inflammation regulation by inhibiting cyclooxygenase Synthesis of anti-inflammatory agents, thereby producing anti-inflammatory effects, prostaglandins, in addition to systemic effects, are also important regulators of ocular inflammation.

[0003] The chemical name of bromfenac sodium is 2-amino-3-(4-bromobenzoyl)-phenylacetate sodium sesquihydrate, and its chemical structure is as follows:

[0004]

[0005] Bromfenac sodium is easily soluble in water, almost insoluble in 0.1M hydrochloric acid solution, acetonitrile and acetone, soluble in methanol and slightly soluble in ethanol.

[0006] ...

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