发明名称 |
EVALUATION METHOD AND INDEX MATERIAL OF PREPARATION CONTAINING LULICONAZOLE |
摘要 |
PROBLEM TO BE SOLVED: To provide an evaluation method of stability for a preparation containing luliconazole and the preparation excellent in stability.SOLUTION: An evaluation method of stability for a preparation containing luliconazole measures a generation amount of the SE form of the luliconazole, a generation amount of the Z form of the luliconazole, and a generation amount of the amido form of the luliconazole represented by the following formula (1) when being stored under a severe condition or an acceleration condition. When the generation amount of the SE form, the generation amount of the Z form, and the generation amount of the amido form are respectively 5 mass% or less of the blending amount of the luliconazole, the preparation is determined to have the high stability. And a preparation conforming to the evaluation method is provided. |
申请公布号 |
JP2015113341(A) |
申请公布日期 |
2015.06.22 |
申请号 |
JP20140063175 |
申请日期 |
2014.03.26 |
申请人 |
POLA PHARMA INC;NIPPON NOHYAKU CO LTD |
发明人 |
MASUDA TAKAAKI;YAMAGUCHI HIROSHI |
分类号 |
A61K31/4178;A61K9/08;A61K47/10;A61K47/14;A61K47/22;A61K47/34;A61P31/10;C07D409/06 |
主分类号 |
A61K31/4178 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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