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Gel for eye containing bromfenac sodium hydrate and preparation thereof

A technology of bromfenac sodium and ophthalmic gel, applied in the field of medicine, can solve problems such as short residence time

Inactive Publication Date: 2013-01-16
ZHEJIANG SHENGBOKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, bromfenac sodium ophthalmic gel is to mix bromfenac sodium in the aqueous gel matrix, by adjusting the pH value in the alkaline range to ensure the stability of the active ingredient, and by adjusting the osmotic pressure range through the osmotic pressure regulator. Prepared ophthalmic preparation, in order to facilitate ophthalmic absorption and reduce ophthalmic drug to ocular mucous membrane stimulation, also further increase the stability of gel by antibacterial agent, antioxidant and metal ion complexing agent; And bromine The preparation of fenac sodium hydrate into ophthalmic gel is convenient to use, especially the gel has a certain viscosity and stays in the eye for a long time, which improves the dilution of eye drops by tear fluid and leads to low drug concentration and low concentration in the eye. The shortcoming of staying time is to play a continuous and effective therapeutic effect

Method used

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  • Gel for eye containing bromfenac sodium hydrate and preparation thereof
  • Gel for eye containing bromfenac sodium hydrate and preparation thereof
  • Gel for eye containing bromfenac sodium hydrate and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Bromfenac sodium hydrate: 0.1g

[0040] Carbomer: 15.0g

[0041] Thimerosal: 0.5g

[0042] Boric acid: 10.0g

[0043] Borax: 5.0g

[0044] Sodium carbonate solution: appropriate amount

[0045] Add water for injection to 1000g

[0046] Prepared 1000g

[0047]Preparation method: add carbomer, thimerosal, boric acid and borax to part of the water for injection, stir to make it fully swell, and make a blank gel, add bromfenac sodium hydrate to the blank gel, and stir evenly , adjust the pH to about 8.0 with sodium carbonate solution, add water for injection to the preparation amount, stir until the gel is uniform, sterilize with radiation, filter, and obtain bromfenac sodium hydrate ophthalmic gel.

Embodiment 2

[0049] Bromfenac Sodium Hydrate: 10.00g

[0050] Methylcellulose: 10.00g

[0051] Sodium Hyaluronate: 10.00g

[0052] Benzalkonium bromide: 0.25g

[0053] Edetate sodium salt 1.0g

[0054] Sodium chloride: 9.00g

[0055] 0.1mol / L sodium hydroxide solution: appropriate amount

[0056] Add water for injection to 1000g

[0057] Prepared 1000g

[0058] Preparation method: Add methyl cellulose, sodium hyaluronate, benzalkonium bromide, edetate sodium salt and sodium chloride to part of the water for injection, stir to make it fully swell, and prepare a blank gel. Dissolve fenac sodium hydrate in part of the water for injection, add it to the blank gel after dissolving, stir evenly, adjust the pH to about 8.0 with 0.1mol / L sodium hydroxide solution, add water for injection to the preparation amount, and stir until uniform gel, sterilized by dry heat, and filtered to obtain bromfenac sodium hydrate ophthalmic gel.

Embodiment 3

[0060] Bromfenac Sodium Hydrate: 10.00g

[0061] Hypromellose: 14.00g

[0062] Benzalkonium bromide: 0.25g

[0063] Edetate Disodium 1.0g

[0064] Sodium chloride: 9.00g

[0065] 0.1mol / L sodium hydroxide solution: appropriate amount

[0066] Add water for injection to 1000g

[0067] Prepared 1000g

[0068] Preparation method: Add benzalkonium bromide, edetate disodium and sodium chloride to part of the water for injection, stir, adjust the pH to about 8.0 with 0.1mol / L sodium hydroxide solution, add hydroxypropyl methylcellulose Stir to make it fully swell to prepare a blank gel, add bromfenac sodium hydrate to the blank gel, stir evenly, add water for injection to the preparation amount, stir until the gel is uniform, sterilize with moist heat, filter, and obtain Bromfenac Sodium Hydrate Ophthalmic Gel.

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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)-sodium phenylacetate 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]...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K31/196A61K47/32A61K47/38A61P27/02
Inventor 宛六一邢旺兴王文娟
Owner ZHEJIANG SHENGBOKANG PHARMA CO LTD
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