公开(公告)号：US4769381A

公开(公告)日：1988-09-06

申请号：US3036

申请日：1987-01-13

申请人： Kouji Ishihara ,  Mika Sanada ,  Naoki Matsuo ,  Yoshimitsu Iida ,  Yoshinori Matsuoka ,  Junko Matsuo

发明人： Kouji Ishihara ,  Mika Sanada ,  Naoki Matsuo ,  Yoshimitsu Iida ,  Yoshinori Matsuoka ,  Junko Matsuo

IPC分类号： A61K9/00 ,  A61K9/14 ,  A61K9/19 ,  A61K31/455 ,  A61K47/12 ,  A61K31/44

CPC分类号： A61K9/0019 ,  A61K31/455 ,  A61K47/12 ,  A61K9/19 ,  Y10S514/97

摘要： A non-liquid type preparation for injection that has improved stability contains N-(2-hydroxyethyl)-nicotinamide nitrate ester (generally known as nicorandil) and an inorganic or organic acid and/or an alkaline metal salt thereof. These ingredients, together with an excipient that is pharmaceutically acceptable, may be dissolved in a solvent, sterilized by filtration and freeze-dried to obtain a freeze-dried preparation, or may be dissolved in a solvent under an aseptic condition and recrystallized to obtain an injectable powder. Nicorandil preparations according to the present invention are very stable and useful in clinical applications.

摘要翻译： 具有改进的稳定性的非液体型注射用制剂包含N-（2-羟乙基） - 烟酰胺硝酸酯（通常称为尼可地尔）和无机或有机酸和/或其碱金属盐。 这些成分与药学上可接受的赋形剂一起可以溶解在溶剂中，通过过滤灭菌，冷冻干燥，得到冷冻干燥制剂，或者可以在无菌条件下溶解于溶剂中，重结晶，得到 可注射粉末 根据本发明的尼可地尔制剂在临床应用中非常稳定和有用。