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 |
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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