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2. 发明授权

US4652442A Process of producing a sustained release preparation containing indomethacin or niomethacin 失效
标题翻译：制备含有吲哚美辛或尼美沙星的缓释制剂的方法
公开(公告)号：US4652442A
公开(公告)日：1987-03-24
申请号：US624591
申请日：1984-06-26
申请人： Johann Hopfgartner , Wilhelm Hurka , Otto Grablowitz , Wolfgang Kropp
发明人： Johann Hopfgartner , Wilhelm Hurka , Otto Grablowitz , Wolfgang Kropp
IPC分类号： A61K9/16 , A61K9/20 , A61K9/22 , A61K31/405 , A61K31/455 , A61K9/26 , A61K9/52
CPC分类号： A61K9/16 , A61K31/405 , A61K31/455 , A61K9/2018 , A61K9/2054
摘要： In a process of producing a sustained release preparation containing indomethacin or niomethacin, the active ingredient in the form of a powder as well as one or more food grade substances having a solubility of at least 1 gram per 10 milliliters in an aqueous liquid at any pH value from 1 to 9 and a temperature of 37.degree. C., and one or more food grade substances having a solubility of at least 1 gram per 100 milliliters in an aqueous liquid at any pH value from 1 to 9 and a temperature of 37.degree. C. are thoroughly mixed and the resulting mixture is mixed with a solution of one or more food grade substances which in an aqueous liquid have(a) a solubility below 1 gram per 1000 milliliters in an aqueous liquid at any pH value from 1 to 9 and a temperature of 37.degree. C., or(b) a solubility below 1 gram per 1000 milliliters at a pH value of 1 and a temperature of 37.degree. C.in an organic solvent which may contain water and is adapted to form a kneadable dough with the active ingredient and components A, B and C, said mixing is continued until a kneadable dough has been formed, said dough is subjected to a pressure of at least 2 bars and is granulated by an operation which may be performed during the application of pressure, and the resulting granules are dried and are subsequently brought in a conventional form for the intake of the preparation (tablets, dragees, capsules or the like).
摘要翻译：在制备含有吲哚美辛或尼美沙星的缓释制剂的过程中，粉末形式的活性成分以及一种或多种食品级物质，其在任何pH下的水溶液中的溶解度至少为10克/ 10毫升值为1至9，温度为37℃，以及在任何pH值为1至9，温度为37℃的水性液体中溶解度至少为1克/ 100毫升的一种或多种食品级物质将所得混合物充分混合，并将所得混合物与一种或多种食用级物质的溶液混合，其在水性液体中具有（a）在水溶液中的溶解度低于1克/ 1000毫升，任何pH值为1至9 温度为37℃，或（b）溶解度低于1克/ 1000毫升，pH值为1，温度为37℃，可能含有水，并适于形成可捏合的面团与活性成分和组分A，B和C，继续混合，直到形成捏合的面团，所述面团经受至少2巴的压力，并且可以通过在施加压力期间进行的操作造粒，并且得到的将颗粒干燥，随后将其置于常规形式用于摄取制剂（片剂，药剂，胶囊等）。

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