转筒膜法测定外用胶囊体外溶出度的考察

Determination the Dissolution of Exterior Capsule by Method of Rotating Cylinder with Millipore Membrane

目的:应用"转筒膜法"测定外用胶囊溶出度。方法:自行设计制备"转筒",采用孔径较大的微孔膜固定转筒底部,以氨苄西林为模型药物进行试验。结果:"转筒膜法"测定外用胶囊溶出度,综合测定栓剂溶出度常用的"转篮法"和"膜法"的优点,得到了满意的结果。结论:"转筒膜法"测定外用胶囊溶出度可以明显反映出制剂间的差异,体内外试验结果有良好的相关性,满足评价体外溶出度测定可行性的2项重要要求,为制订体外质控标准提供了依据。

Objective： To determination the dissolution of exterior capsule by the method of rotating cylinder with Millipore mem- brane. Method： Fair sized aperture Millipore membrane was fixed rotating cylinder bottom, ampicillin capsule was examed by it. Re- suit： Dissolution of suppository was determinated by the method with advantages of both ＂rotating basket＂ and ＂membrane method＂. Conclusion： ＂Rotating cylinder with Millipore membrane＂ determine dissolution of exterior capsule which can apparently reflex the difference of preparations, approved correlation was gained from experimentation in vivo and in vitro, it can meet two important requirement of evaluating exterior dissolution and can supply basis for quality control criterion of exterior preparations.