A pharmaceutical composition comprising, in relation to 100% by weight of a total amount of a self-emulsifying composition, 70 to 90% by weight of eicosapentaenoic acid ethyl ester as a first medicinal component, 0.5 to 6% by weight of water, 1 to 29% by weight of polyoxyethylene sorbitan fatty acid ester (optionally further comprising polyoxyethylene castor oil) as an emulsifier, 1 to 25 parts by weight of lecithin in relation to 100 parts by weight of the eicosapentaenoic acid ethyl ester, and pitavastatin, rosuvastatin, or a salt thereof as a second medicinal component. The composition is excellent in any one of self-emulsifying property, dispersibility of the composition, emulsion stability, absorbability, and storage stability of the medicinal components and a preparation.
                            一种药物组合物,以自乳化组合物总量的 100%(重量)计,包括 70 至 90% (重量)的二十碳五烯酸
乙酯(作为第一药物成分)、0.5至6%(重量)的
水,1至29%(重量)的聚氧
乙烯山梨醇酐
脂肪酸酯(可选择进一步包含聚氧
乙烯蓖麻油)作为
乳化剂,1至25份(重量)的卵
磷脂(相对于100份(重量)的二十碳五烯酸
乙酯),以及
匹伐他汀、
洛伐他汀或其盐作为第二种药物成分。该组合物在自乳化性、组合物的分散性、乳液稳定性、可吸收性以及药物成分和制剂的储存稳定性中的任何一个方面都非常出色。