A duloxetine enteric-coated pharmaceutical composition includes a core, a drug-loaded layer encapsulating the core, an intermediate controlled-release layer encapsulating the drug-loaded layer, and an enteric-coated controlled-release layer.The drug-loaded layer contains duloxetine or a pharmaceutically acceptable salt thereof and a hydrophilic polymer. The intermediate controlled release layer contains ethyl cellulose (EC) and a sugar or derivatives thereof, wherein the weight of ethyl cellulose in the intermediate controlled release layer ranges from 15.0 %~58 %. The enteric-coated controlled-release layer contains hydroxypropyl methylcellulose phthalate (HPMCP). The present invention discloses a well protected duloxetine enteric-coated pellet comprising an intermediate controlled-release layer.一種度若西汀腸衣醫藥組合物,包括:一核心、包覆核心的一載藥層、包覆載藥層的一中間控釋層、以及包覆中間控釋層的一腸衣控釋層。載藥層包括度若西汀或其藥學上可接受之鹽類及至少一親水性聚合物。中間控釋層包含乙基纖維素及醣類或其衍生物,其中乙基纖維素佔中間控釋層重量百分比之15.0%~58%。腸衣控釋層包含羥丙基甲基纖維素鄰苯二甲酸,本發明可藉由腸衣控釋層及中間控釋層以具有腸衣效果,並達到保護及控釋之作用。1‧‧‧核心2‧‧‧載藥層3‧‧‧中間控釋層4‧‧‧腸衣控釋層
