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    • 6. 发明公开
    • METHOD OF PRODUCING ENTERIC-COATED SEAMLESS SOFT CAPSULE
    • 生产肠溶包衣的无胶软胶囊的方法
    • EP3205339A1
    • 2017-08-16
    • EP15848818.9
    • 2015-10-06
    • Fuji Capsule Co., Ltd.
    • MASUDA, KojiNISHIMURA, NaokiHAYANO, AkihikoSHIMOKAWA, YoshiyukiKATO, Kenji
    • A61K9/52A61K47/10A61K47/36A61K47/42
    • A61K9/4833A61K9/4825A61K9/4866A61K31/202A61K47/10A61K47/36A61K47/42
    • An object is to provide a method of manufacturing a seamless soft capsule that is enteric and excellent in formulation properties. An enteric seamless soft capsule is manufactured by the following steps (a) and (b): (a) preparing an enteric capsule shell liquid comprising gelatin and low methoxy pectin having a degree of esterification of 0 to 40% and a degree of amidation of 0 to 25%, the enteric capsule shell liquid having a viscosity at 50°C of 60 to 127 mPa•s; and (b) encapsulating capsule fills with the enteric capsule shell liquid prepared in the step (a) by dripping. Preferably, the jelly strength of the gelatin is 180 to 330 Bloom, an aqueous solution of the low methoxy pectin at a concentration of 2 mass% has a viscosity at 35°C of 8 to 15 mPa•s, and the enteric capsule shell liquid comprises 10 to 20 parts by mass of the low methoxy pectin per 100 parts by mass of gelatin.
    • 一个目的是提供一种制造无肠软胶囊的方法,所述无胶软胶囊是肠溶的且具有优异的制剂性质。 通过以下步骤(a)和(b)制备肠溶无缝软胶囊:(a)制备包含明胶和低甲氧基果胶的肠溶胶囊壳液,其酯化度为0至40%,酰胺化度为 0至25%,所述肠溶胶囊壳液在50℃下的粘度为60至127mPa·s; 和(b)用步骤(a)中制备的肠溶胶囊壳液滴下胶囊填充物。 优选明胶的凝胶强度为180〜330Bloom,浓度2质量%的低甲氧基果胶的水溶液的35℃下的粘度为8〜15mPa·s,肠溶胶囊壳液 相对于100质量份明胶,含有10〜20质量份低甲氧基果胶。