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Liranaftate ointment and preparation method thereof

A technology of liranaphtate and ointment, which is applied in the field of pharmaceutical preparations, can solve problems such as inability to ensure drug uniformity, non-compliant particle size, and affect the efficacy of preparations, and achieve the effects of easy quality control, uniform content, and fewer types

Active Publication Date: 2013-12-18
江苏小林制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The 2010 edition of the "Chinese Pharmacopoeia" added particle size detection requirements for creams, but because the oil phase and water phase in the existing liranaphtate creams are easy to separate, and the oil phase aggregates into bundles on the surface of the water phase, the preparation products Poor stability during placement, resulting in non-compliant particle size, thus affecting the efficacy of the preparation
The problem with this technology is that it is difficult to mix evenly when oil and water are mixed, and the drug has a high solubility in the oil phase. Therefore, even after the oil phase and the water phase are mixed, most of the drugs are still dispersed in the oil phase. The drug is mixed evenly within the preparation, but the uniformity of the drug during the storage of the preparation cannot be guaranteed

Method used

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  • Liranaftate ointment and preparation method thereof
  • Liranaftate ointment and preparation method thereof
  • Liranaftate ointment and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0029] Embodiment 1 liranaphtate ointment prescription and preparation technology

[0030]

[0031] Preparation Process:

[0032] Add liranaphtate into poloxamer 124, stir to dissolve, and use it as the internal oil phase; mix isopropanol, water and benzyl alcohol evenly, and use it as the water phase; mix the internal oil phase and the water phase to obtain a uniform Drug-containing solution: heat and melt glycerol monostearate at 80°C as the outer oil phase, mix the outer oil phase with the drug-containing solution, and stir evenly to obtain the product.

Embodiment 2

[0033] Embodiment 2 liranaphtate ointment prescription and preparation technology

[0034]

[0035] Preparation Process:

[0036] Add liranaphtate into poloxamer 124, stir to dissolve, and use it as the internal oil phase; mix isopropanol, water and sodium benzoate evenly, and use it as the water phase; mix the internal oil phase and the water phase to obtain a uniform Drug-containing solution: heat and melt glycerol monostearate at 75°C as the outer oil phase, mix the outer oil phase with the drug-containing solution, and stir evenly to obtain the product.

Embodiment 3

[0037] Embodiment 3 liranaphtate ointment prescription and preparation technology

[0038]

[0039] Preparation Process:

[0040] Add liranaphtate into poloxamer 124, stir to dissolve, and use it as the internal oil phase; mix isopropanol, water and sodium benzoate evenly, and use it as the water phase; mix the internal oil phase and the water phase to obtain a uniform Drug-containing solution: heat and melt glycerol monostearate at 75°C as the outer oil phase, mix the outer oil phase with the drug-containing solution, and stir evenly to obtain the product.

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PUM

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Abstract

The invention discloses a liranaftate ointment and a preparation method thereof. The ointment is prepared from an inner oil phase, an outer oil phase and a water phase, wherein the inner oil phase is composed of liranaftate and poloxamer 124; the outer oil phase is glycerin monostearate meltwater; the water phase is composed of isopropanol, water, and a preservative. The ointment disclosed by the invention has the advantages of uniform drug dispersion, uniform content and stable quality, therefore, the liranaftate ointment is beneficial for long-term storage and transportation.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a pharmaceutical preparation for external use, in particular to a liranaftate ointment and a preparation method thereof. Background technique [0002] Liranaftate (CAS: 88678-31-3, liranaftate) is a new type of thiocarbamate antifungal drug jointly developed by Japan Tosoh Corporation and Zenyaku Kogyo Company. It was launched in Japan in 2000. The structure of liranaftate is similar to that of tolnaftate, and its chemical name is N-(6-methoxy-2-pyridyl)-N-methylcarbamoic acid (5,6,7,8-tetrahydro)- 2-naphthyl ester, the molecular formula is C18H20N2O2S, and the molecular weight is 328.44. Liranaftate is a squalene epoxidase inhibitor and a cell wall synthesis inhibitor. It inhibits the synthesis of ergosterol, a cell component, by inhibiting the squalene epoxidation reaction of fungal cells, thereby exerting antifungal activity. The antifungal ac...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/44A61P31/10
Inventor 邓建华殷雨林王福东赵亚美焦日红
Owner 江苏小林制药有限公司
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