作者报告了以生物表面活性剂——胆酸盐溶液对油性药物制剂进行溶出试验,此法是通过20mM甘氨鹅去氧胆酸钠溶液在搅拌下完成,即所谓“胆酸盐法”。但软胶囊制剂崩解后药物和植物油飘浮在试验溶液的表面,难以测定其实际溶出情况。本文介绍改进的搅拌试验装置来进行软胶囊制剂溶出试验的方法——“珠法”,并讨论了溶出速率的影响因素。 The authors report that the bio-surfactant-cholate solution is used for the dissolution test of oily pharmaceutical preparations by the 20 mM glycylcinodeoxycholate solution with stirring, the so-called “cholate method.” However, after the preparation of the soft capsule disintegrated, the drug and the vegetable oil floated on the surface of the test solution, and it was difficult to measure the actual dissolution thereof. This article describes an improved stirring test device for the dissolution of soft capsule formulations test method - “bead method” and discusses the dissolution rate of the factors.