PROBLEM TO BE SOLVED: To provide an oral solid composition having light stability by conveniently preventing light-induced discoloration and decomposition of amlodipine or a pharmacologically acceptable salt thereof.SOLUTION: The invention relates to an oral solid composition which contains (a) amlodipine besylate, (b) iron oxide, and (c) at least one excipient selected from the group consisting of reduced starch syrup and reduced palatinose, the composition having no coating layer and a method for producing the oral solid composition characterized by compounding iron oxide in preparing the oral solid composition which contains amlodipine besylate and at least one excipient selected from the group consisting of reduced starch syrup and reduced palatinose.SELECTED DRAWING: NoneCOPYRIGHT: (C)2016,JPO&INPIT【課題】アムロジピンまたはその薬学上許容される塩の光による変色及び分解を簡便に防止し、光安定化した経口固形組成物を提供すること。【解決手段】(a) ベシル酸アムロジピン、(b) 酸化鉄、並びに(c) 還元澱粉糖化物及び還元パラチノースからなる群より選ばれる少なくとも一つの賦形剤を含有し、かつ被覆層を有しない経口固形組成物、並びに、ベシル酸アムロジピンと還元澱粉糖化物及び還元パラチノースからなる群より選ばれる少なくとも一つの賦形剤とを含有する経口固形組成物の調製に際して、酸化鉄を配合することを特徴とする、経口固形組成物の製造方法。【選択図】なし
