Bromfenac sodium hydrate thermosensitive in-situ gel eye drops and preparation method thereof

Abstract

The invention discloses bromfenac sodium hydrate thermosensitive in-situ gel eye drops which comprise, by weight, 0.05%-0.15% of active component bromfenac sodium hydrates, 1%-30% of themosensitive gel materials and auxiliary materials acceptable in pharmacy; the pH value of the eye drops is regulated to 6.5-9.0, and the osmotic pressure is set at 286-310 mOsmol / k. The invention further provides a preparation method of the bromfenac sodium hydrate thermosensitive in-situ gel eye drops. Compared with the prior art, the bromfenac sodium hydrate thermosensitive in-situ gel eye drops and the preparation method thereof have the advantages that the problems that traditional eye drops are short in stay time in the eyes and low in bioavailability are solved, the defects that the viscosity of traditional eye gel is high and transfer in the producing and using process is difficult are overcome, and the compliance of a patient is improved.

Description

technical field [0001] The invention relates to the field of preparation of eye drops, in particular to bromfenac sodium hydrate heat-sensitive in-situ gel eye drops and a preparation method thereof. Background technique [0002] Bromfenac sodium (Bromfenacsodium) is one of the derivatives of 2-amino-3-benzoylphenylacetic acid, the chemical name is 2-amino-3-(4-bromobenzoyl)sodium phenylacetate, and its structure is similar to Fen and diclofenac are similar. Bromfenac sodium was developed by A.H.Robins Company of the United States. It applied for a US patent in 1978 and was authorized in 1980. The patent number is US4182774. Later, the patent right was transferred to Wyeth-Ayerst Company of the United States and jointly developed with Senju Company of Japan. [0003] Structural formula: [0004] [0005] Molecular formula: Molecular weight: 383.17 [0006] Bromfenac sodium can inhibit the synthesis of prostaglandin inflammatory mediators mediated by cyclooxygenase, a...

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Problems solved by technology

[0009] In view of the above-mentioned defects, the technical problem solved by the present invention is to provide a bromfenac sodium hydrate heat-sensitive in-situ gel eye drop and a preparation method thereof, which solves the problem that the traditional eye drops stay in the eye for a short time, and the bioavailability There is no problem of low viscosity, and it does not have the disadvantages of high viscosity like traditional ophthalmic gels and difficult transfer during production and use, which improves patient compliance

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