The present invention is that the fine particle-containing composition stable poorly soluble drug which is not affected by the storage environment conditions and a manufacturing method thereof. In accordance with the present invention, there is provided a composition in which fine particles of a poorly soluble drug, a surfactant and consists of a cyclic oligosaccharide, a fine particle-containing composition, wherein the average particle size of the fine particles is 50nm or 1000nm less provide. The mixing step of obtaining a mixed solution (I) a poorly soluble drug, a surfactant and a mixture of anti-solvent, the present invention, miniaturization and refined in a wet disperser (II) the mixture to obtain a fine particle dispersion I discloses a process for the production of a fine-particle-containing composition comprising the step of drying process, the fine particle dispersion liquid containing a (IV) wherein the cyclic oligosaccharide and addition step for adding a cyclic oligosaccharide (III) the fine particle dispersion.本発明は、保存環境条件の影響を受けない安定な難溶性薬物の微粒子含有組成物およびその製造方法を提供することである。本発明によれば、難溶性薬物の微粒子、界面活性剤および環状オリゴ糖からなる組成物であって、前記微粒子の平均粒子径が50nm以上1000nm以下であることを特徴とする微粒子含有組成物を提供する。また、本発明は、(I)難溶性薬物、界面活性剤および貧溶媒を混合し混合液を得る混合工程、(II)前記混合液を湿式分散機で微細化し、微粒子分散液を得る微細化工程、(III)前記微粒子分散液に環状オリゴ糖を添加する添加工程および(IV)前記環状オリゴ糖を含む微粒子分散液を乾燥する乾燥工程を含む微粒子含有組成物の製造方法を開示する。
