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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 (the following formula) which excellently acts on fungus, and is widely used as a medicine for foot trichophytosis and tinea corporis.;SOLUTION: An evaluation method of a preparation measures a generation amount of the product material (amido form) by hydrolysis of a cyano group when being stored under a severe condition (at 60°C for three weeks) or an acceleration condition (at 40°C fro six months). When the generation amount is 0.5 mass% or less, or preferably 0.2 mass% or less of the blending amount of the luliconazole, the preparation is determined to have the high stability.;COPYRIGHT: (C)2015,JPO&INPIT
机译:解决的问题:提供一种含有卢立康唑(下式)的制剂的稳定性的评价方法,该制剂对真菌具有优异的作用,并被广泛用作足癣,脚癣的药物。当在严酷条件下(在60°C下保存三周)或在加速条件下(在40°C下保存六个月)时,氰基水解可测量氰基水解产生的产物材料(酰胺形式)的生成量。当产生量为卢立康唑的共混量的0.5质量%以下,或优选0.2质量%以下时,确定该制剂具有高稳定性。;版权所有:(C)2015,JPO&INPIT

著录项

  • 公开/公告号JP2015113343A

    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JP20140193668

  • 发明设计人 MASUDA TAKAAKI;YAMAGUCHI HIROSHI;

    申请日2014-09-24

  • 分类号A61K31/4178;A61K47/08;A61K47/10;A61K47/14;A61K47/22;A61P31/10;

  • 国家 JP

  • 入库时间 2022-08-21 15:34:36

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