A ophthalmic flurbiprofen ester nano-emulsion in-situ gel formulation and the preparation method thereof

A ophthalmic flurbiprofen ester nano-emulsion in-situ gel formulation and the preparation method thereof

  • CN 102,159,186 A
  • Filed: 10/30/2009
  • Published: 08/17/2011
  • Est. Priority Date: 10/30/2008
  • Status: Active Application
First Claim
Patent Images

1. Claim1st, a kind of flurbiprofen axetil eye nano-emulsion in-situ gel preparation, based on 1000 mL eye nano-emulsion in-situ gel preparations, said preparation includes following components, than ibuprofen ester 1000The g osmotic pressure regulators of 100 g emulsifying agents, 50 g thickeners 50The g of bacteriostatic agent 0-0.5PH adjusting agent purified water adds to 1000 mLc2nd, flurbiprofen axetil eye nano-emulsion in-situ gel preparation according to claim 1, wherein, the oil is the one or more in soybean oil, castor oil and three Miglyol 812s.3rd, flurbiprofen axetil eye nano-emulsion in-situ gel preparation according to claim 1, wherein, the emulsifying agent is the one or more in lecithin, polysorbate, Emulsifier EL-60 and Crodaret.4th, flurbiprofen axetil eye nano-emulsion in-situ gel preparation according to claim 1, wherein, the osmotic pressure regulator is the one or more in glycerine, glucose, mannitol and propane diols.5th, flurbiprofen axetil eye nano-emulsion in-situ gel preparation according to claim 1, wherein, the one kind of the thickener in gellan gum, sodium alginate, melon glue, pectic substance, sodium hyaluronate, hydroxypropyl methylcellulose, methylcellulose, polyvinylpyrrolidone, polyvinyl alcohol and carbomerOr it is a variety of.6th, flurbiprofen axetil eye nano-emulsion in-situ gel preparation according to claim 5, wherein, the thickener is gellan gum, sodium alginate or carbomer.7th, flurbiprofen axetil eye nano-emulsion in-situ gel preparation according to claim 5, wherein, the molecular weight of the gellan gum is 105

  • 107, its methylation<

    30 %;

    The molecular weight of the sodium alginate is I x l 06

    2.4x l 06;

    The molecular weight of the melon glue is 220,000;

    The molecular weight of the hydroxypropyl methylcellulose is 86,000;

    The molecular weight of the methylcellulose is 20,000 380,000;

    The molecular weight of the polyvinylpyrrolidone is 5,000 70,000;

    The model 934,971,974,980 or 981 of the carbomer.8th, the flurbiprofen axetil eye nano-emulsion in-situ gel preparation according to any one of claim 17, wherein, based on 1000 mL eye nano-emulsion in-situ gel preparations, said preparation Hai Jin mono- Walk include 0.1 1.2 g metal-chelator.9th, flurbiprofen axetil eye nano-emulsion in-situ gel preparation according to claim 8, wherein, the metal-chelator is the one or more in EDTA, EDTA-2Na, EDTA-Ca and EDTA-2K.10th, the preparation method of the flurbiprofen axetil eye nano-emulsion in-situ gel preparation described in claim 1, it is rapid that this method Bao includes Yi Xia Walk:

    It regard the oil dissolved with flurbiprofen axetil as oil phase;

    Appropriate purified water is added into emulsifying agent, pH adjusting agent, bacteriostatic agent and osmotic pressure regulator, aqueous phase is made;

    Oil phase is added into aqueous phase, emulsification pretreatment obtains colostrum, it is cooled to after room temperature and adjusts pH values to 5.5 or so with pH adjusting agent, and then obtain emulsion with high pressure homogenizer homogeneous, after circulator bath cooling emulsion, viscosity is adjusted with aqueous thickener solution, pH value is adjusted to 49 with pH adjusting agent, is mended with purified water to enough;

    0.45 μ

    ι

    η

    of gained emulsion filtering with microporous membrane.11st, preparation method according to claim 10, wherein, add metal-chelator during aqueous phase is prepared.

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