Long-lasting release nifedipine preparation
    8.
    发明授权
    Long-lasting release nifedipine preparation 失效
    持久释放硝苯地平制剂

    公开(公告)号:US5861173A

    公开(公告)日:1999-01-19

    申请号:US755381

    申请日:1996-11-21

    CPC分类号: A61K9/209 A61K31/4422

    摘要: This invention provides a long-lasting release solid nifedipine preparation which exhibits clinically sufficient effect when administered once per day. A press coated tablet whose core and shell each contains nifedipine, the dissolution rate of nifedipine from said tablet being (a) in the dissolution test using a sinker according to method 2 of the dissolution test method as prescribed by the Pharmacopoeia of Japan, after 2 hours 10-40% after 4 hours 30-65% after 6 hours at least 55%, and (b) in the dissolution test according to the disintegration test method as prescribed by the Pharmacopoeia of Japan, after 3 hours 20-45% after 4 hours 30-65%.

    摘要翻译: 本发明提供了一种持久释放固体硝苯地平制剂,其每天施用一次时显示临床上足够的效果。 一种压制包衣片,其核心和外壳各自含有硝苯地平,硝苯地平从所述片剂的溶出速率为(a)根据日本药典根据日本药典规定的溶出试验方法的方法2,使用沉降片进行溶解试验 4小时后10-40%,6小时后30-65%至少55%,(b)根据日本药典按照日本药典规定的崩解试验方法进行溶解试验后,3小时后20-45% 4小时30-65%。