公开(公告)号：US5378462A

公开(公告)日：1995-01-03

申请号：US109051

申请日：1993-08-19

申请人： Bernd Boedecker ,  Friederike Henninges ,  Klaus-Juergen Koelln ,  Guenther Kuhnow ,  Guenter-Josef Peschke ,  Manfred Rehburg ,  Alwin Sobe ,  Berthold Stemmle

发明人： Bernd Boedecker ,  Friederike Henninges ,  Klaus-Juergen Koelln ,  Guenther Kuhnow ,  Guenter-Josef Peschke ,  Manfred Rehburg ,  Alwin Sobe ,  Berthold Stemmle

IPC分类号： A61J3/07 ,  A61K9/16 ,  A61K9/36 ,  A61K9/50 ,  A61K38/46 ,  A61K38/54 ,  A61K37/62 ,  A01N25/34 ,  C12N11/08 ,  C12N11/18

CPC分类号： A61K9/1694 ,  A61K9/1641 ,  A61K9/5042

摘要： Pancreatin-containing micropellet cores which can be coated with a gastric juice-resistant film are prepared by extruding a mixture containing pancreatin, polyethylene glycol 4000 and a lower alcohol such as propan-2-ol to produce extrudates which break by themselves into fragments, rounding the fragments with the addition of highly liquid paraffin and drying. Propan-2-ol may be present with the paraffin during rounding. The micropellet cores contain 65-85% pancreatin, and have a bulk density of 0.6 g/ml to 0.85 g/ml, a spherical to ellipsoidal shape with a minor axis in the range of 0.7-1.4 mm and a particle size distribution in which at least 80% of the micropellet cores have a minor axis to major axis ratio in the range from 1:1 to 1:2.

摘要翻译： 通过挤压含有胰酶，聚乙二醇4000和低级醇如丙-2-醇的混合物制备可涂覆有耐胃酸膜的含胰蛋白酶的微丸芯，制备出自己断裂成碎片的挤出物 片中加入高度液体石蜡并干燥。 丙烯醇可能在四舍五入期间与石蜡一起存在。 微丸芯含有65-85％的胰酶，其体积密度为0.6g / ml至0.85g / ml，球形至椭圆形的短轴为0.7-1.4mm，粒径分布为 至少80％的微芯线芯具有在1：1至1：2的长轴比的短轴。