Antimycotic pharmaceutical composition

摘要

In a pharmaceutical composition for external use containing a compound such as luliconazole and/or a salt thereof, comprised are a higher alcohol which is in a liquid state at 1 atm and 25° C. and/or a diester of a dibasic acid, provided that a diester carbonate is excluded, and a polyoxyethylene alkyl ether and/or a polyoxyethylene alkenyl ether. Provided is a preparation using a solvent other than crotamiton, propylene carbonate, and N-methyl-2-pyrroridone as a solvent for solubilization and steric stabilization and having the following properties: 1) when a compound represented by the general formula (1) and/or a salt thereof has a stereoisomer, the amount of the stereoisomer of the compound and/or a salt thereof produced under a preservation condition of 60 degrees C. for 3 weeks is 1% by mass or less with respect to the total mass of the compound and/or a salt thereof at the beginning of preservation; 2) the preparation is in a clear liquid state when preserved at a constant temperature of 20° C. immediately after manufacture; and 3) no crystal is deposited when the preparation is preserved at 5° C. for 2 weeks after manufacture.

主权项

1. A pharmaceutical composition for external use, comprising:
1) luliconazole of the following general formula (1) and/or a salt thereof; 2) at least one kind selected from a higher alcohol which is in a liquid state at 1 atm and 25° C. and a diester of a dibasic acid, provided that a diester carbonate is excluded; and 3) 5 to 20% by mass with respect to a total amount of the pharmaceutical composition of at least one polyoxethylene alkyl ether selected from polyoxyethylene lauryl ether and polyoxyethylene cetyl ether; wherein R1 and R2 represents a chlorine atom.