维生素D2软胶囊溶出度测定方法的建立#br#

目的 建立维生素D2软胶囊溶出度曲线测定的方法，评价国内维生素D2软胶囊与原研之间的体外溶出行为。方法 采用桨法(沉降篮)，转速100r/min，以高效液相法测定维生素D2软胶囊在不同溶出介质中的溶出度并绘制溶出曲线。结果 在0.5mol/L NaOH-10%曲拉通X-100介质中国产维生素D2软胶囊与原研在90min溶出度均可达到80%以上。结论 该方法可用于维生素D2软胶囊的溶出度测定。

Establishment of a dissolution method of vitamin D2 soft capsules

Objective To establish a method for the dissolution curve determination of vitamin D2 soft capsules and evaluate the in vitro dissolution behavior between domestic vitamin D2 soft capsules and the original preparation. Methods Using the paddle method with a sinker, the rotate speed was set at 100r/min, and the dissolution curves testing in different media were performed by using HPLC. Results The dissolution of domestic vitamin D2 soft capsules and the original preparation were all above 80% at 90min in 0.5mol/L NaOH-10% triton X-100 medium. Conclusion The method is suitable for the dissolution determination of vitamin D2 soft