发明名称 NICORANDIL-CONTAINING PHARMACEUTICAL COMPOSITION
摘要 Provided is a pharmaceutical composition comprising nicorandil, mannitol, and an alkali metal salt of an organic carboxylic acid, wherein (1) the ratio of "a value of an X-ray diffraction peak of ´-form crystals of the mannitol at 9.8° ± 0.3° (2¸)"/"a value of an X-ray diffraction peak of nicorandil crystals at 10.6° ± 0.3° (2¸)" is 2.0 or less, or (2) the ratio of "an intensity of a peak of ´-form crystals of the mannitol at 1.01 THz ± 0.2 THz in a second derivative spectrum of an absorption spectrum obtained by terahertz transmission spectroscopy"/"an intensity of a peak of nicorandil crystals at 0.95 THz ± 0.2 THz in the second derivative spectrum of the absorption spectrum obtained by the terahertz transmission spectroscopy" is 1.5 or less. This pharmaceutical composition is excellent in storage stability.
申请公布号 EP2727593(A4) 申请公布日期 2014.11.26
申请号 EP20120805113 申请日期 2012.06.29
申请人 MOCHIDA PHARMACEUTICAL CO., LTD. 发明人 YURA TAKAYUKI;HASHIMOTO YUKI;KANEHIRO HIDEO
分类号 A61K31/455;A61K9/19;A61K47/10;A61K47/12;A61K47/26;A61P9/04;A61P9/10 主分类号 A61K31/455
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