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EVALUATION METHOD AND INDEX MATERIAL OF PREPARATION CONTAINING LULICONAZOLE

机译:含氟康唑的制剂的评价方法及指标材料

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.;COPYRIGHT: (C)2015,JPO&INPIT
机译:解决的问题:提供一种含有卢立康唑的制剂的稳定性的评价方法和稳定性优异的制剂。解决方案:含有卢立康唑的制剂的稳定性的评价方法测定了卢立康唑,在严苛条件或加速条件下储存时,卢立康唑的Z形式的产生量和下式(1)表示的卢立康唑的酰胺形式的产生量。当SE形式的产生量,Z形式的产生量和酰胺基形式的产生量分别为卢立康唑的混合量的5质量%以下时,确定制剂具有高稳定性。并提供了符合评价方法的制剂。版权所有:(C)2015,日本特许厅

著录项

  • 公开/公告号JP2015113341A

    专利类型

  • 公开/公告日2015-06-22

    原文格式PDF

  • 申请/专利权人 POLA PHARMA INC;NIPPON NOHYAKU CO LTD;

    申请/专利号JP20140063175

  • 发明设计人 MASUDA TAKAAKI;YAMAGUCHI HIROSHI;

    申请日2014-03-26

  • 分类号A61K31/4178;A61K47/10;A61K47/14;A61K47/22;A61K47/34;A61K9/08;A61P31/10;C07D409/06;

  • 国家 JP

  • 入库时间 2022-08-21 15:34:36

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