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Fluconazole ear drops and preparation method thereof

A fluconazole ear drop and fluconazole technology are applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, medical preparations containing active ingredients, etc. The effect of suitable fluidity and simple preparation method

Inactive Publication Date: 2018-03-30
博济医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The medicinal ingredient of the drops of this invention is the combined use of fluconazole and tinidazole, and the solvent of its dosage form is water, which is inconvenient to use as ear drops
In the prior art, there is no fluconazole ear drops with good drug effect, stable dosage form and suitable fluidity, which is more suitable for animals and children

Method used

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  • Fluconazole ear drops and preparation method thereof
  • Fluconazole ear drops and preparation method thereof
  • Fluconazole ear drops and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Fluconazole ear drops comprises the following components in weight percentage: 0.1% of fluconazole, 0.2% of hypromellose (HPMCE4M), 0.0025% of benzalkonium chloride and 8% of propylene glycol, and the balance is water for injection, pH is 3.5.

[0033] The preparation method of fluconazole ear drops comprises the steps:

[0034] (1) Dissolving the formulated amount of hypromellose in an appropriate amount of water for injection at 70°C and stirring to form a transparent solution to obtain solution A;

[0035] (2) Mix fluconazole and propylene glycol in the prescribed amount, stir and dissolve at 50°C, add an appropriate amount of water for injection, and adjust the pH to 3.5 with 0.5mol / L hydrochloric acid solution to obtain solution B;

[0036] (3) Mix solution A and solution B evenly, add benzalkonium chloride in the prescribed amount, stir evenly, adjust the pH to 3.5 with hydrochloric acid solution, add water for injection to the full amount, stir evenly, let stand...

Embodiment 2

[0038] Fluconazole ear drops, which comprises the following components in weight percentage: 1.0% fluconazole, 1.0% hypromellose (HPMCE4M), 0.01% benzalkonium chloride and 18% propylene glycol, and the remainder is water for injection , pH 4.5.

[0039] A preparation method of fluconazole ear drops, the method may further comprise the steps:

[0040] (1) Dissolving the formulated amount of hypromellose in an appropriate amount of water for injection at 90°C and stirring to form a transparent solution to obtain solution A;

[0041] (2) Mix fluconazole and propylene glycol in the prescribed amount, stir and dissolve at 50°C, add an appropriate amount of water for injection, and adjust the pH to 4.5 with 0.5mol / L hydrochloric acid solution to obtain solution B;

[0042] (3) Mix solution A and B solution evenly, add benzalkonium chloride in the formula amount, stir evenly, adjust the pH to 4.5 with hydrochloric acid solution, add water for injection to the full amount, stir evenl...

Embodiment 3

[0044] Fluconazole ear drops comprises the following components in weight percentage: 0.8% of fluconazole, 0.6% of hypromellose (HPMCE4M), 0.005% of benzalkonium chloride and 8% of propylene glycol, and the balance is water for injection, pH is 4.0.

[0045] The preparation method of fluconazole ear drops comprises the steps:

[0046] (1) Dissolving the formulated amount of hypromellose in an appropriate amount of water for injection at 80°C, stirring to form a transparent solution to obtain solution A;

[0047] (2) Mix the formulated amount of fluconazole and propylene glycol, stir and dissolve at 50°C, add an appropriate amount of water for injection, and adjust the pH to 4.0 with 0.5mol / L hydrochloric acid solution to obtain solution B;

[0048](3) Mix solution A and B solution evenly, add benzalkonium chloride in the formula amount, stir evenly, adjust the pH to 4.0 with hydrochloric acid solution, add water for injection to the full amount, stir evenly, let stand, filter...

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Abstract

The invention relates to a pharmaceutical preparation and a preparation method thereof and in particular relates to a fluconazole ear drop preparation and a preparation method and application thereof.The fluconazole ear drops comprise the following components in percentage by weight: 0.1-1.0% of fluconazole, 0.2-1.0% of hydroxypropyl methylcellulose, 0.0025-0.01% of benzalkonium chloride, 0-18% of propylene glycol and the balance of water for injection, wherein the pH value is 3.5-4.5. The fluconazole ear drops disclosed by the invention are excellent in effect of treating otomycosis externa,stable in dosage form and appropriate in liquidity and are particularly applicable to children and animals. The condition that a solution with low viscosity is frequently and inconveniently applied can be avoided. With the adoption of filtration and bacteria removal, the preparation method is simple.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and its preparation method and application, in particular to a fluconazole ear drop preparation and its preparation method and application. Background technique [0002] Fungal otitis externa is a relatively common disease among ear diseases. The common pathogenic bacteria of external auditory canal mycosis include yeast, candida, blastomyces, aspergillus, mucormycetes, actinomycetes, penicillium and so on. The fungus mainly invades the stratum corneum of the skin of the external auditory canal, causing a large amount of epithelial shedding, ear itching, discomfort, and stuffy feeling. For example, the scab composed of exfoliated epithelium and mycelium in the ear canal blocks the external auditory canal or contacts the tympanic membrane, resulting in tinnitus and hearing loss . Combined with bacterial infection, obvious earache, ear odor, etc. may appear. In severe cases, otomestoiditis may also...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4196A61K47/38A61K47/10A61K47/18A61P31/10A61P27/16
CPCA61K9/0046A61K9/08A61K31/4196A61K47/10A61K47/18A61K47/38
Inventor 王廷春田玉婷谭舜徐丽王栋
Owner 博济医药科技股份有限公司
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