依舒佳林缓释片释放度研究

目的针对依舒佳林(isehelium)缓释片进口药品注册标准中释放度检查项下存在的问题，用溶出度仪代替原标准方法中的崩解仪。方法尸溶出度仪中的小杯法，以盐酸溶液(6—1000)为介质，取样点为2、6和10h；检测方法为高效液相色谱法。在测定溶出曲线的基础上选定取样点。结果在2．6和10h的释放量分别达到标示量的10％～30％、40％～70％和70％以上。结论新方法与原方法比较，更能反映样品的溶出过程和溶出速率，方法重现性好，结果准确。

In vitro release evaluation of dihydroergotoxine mesylate in sustained-release tablets

Objective To evaluate the in vitro release of dihydroergotoxine mesylate (Ischelium) sustained-release tablets. Methods Dihydroergotoxine mesylate release from sustained-release tablets (Ischelium) was evaluated with dissolution tester instead of the original disintegration test apparatus. The amount of dihydroergotoxine mesylate released from tablets at different time intervals (2, 6 and 10 hours) was detected by HPLC. Results and Conclusion The dissolution tester gave better results than the original disintegration method for the measurement of dihydroergotoxine mesylate released from sustained-release tablets.