甲磺酸二氢麦角碱_

依舒佳林缓释片释放度研究

http://www.100md.com 《广东药学院学报》 2005年第3期

甲磺酸二氢麦角碱,,甲磺酸二氢麦角碱；高效液相色谱法；崩解仪；溶出度仪；小杯法,1仪器与试药,2色谱条件的确定,3线性试验和溶出曲线的测定,4方法与结果,5讨论,参考文

     摘要:目的针对依舒佳林(ischelium)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。方法用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10 h；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10 h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。

    关键词:甲磺酸二氢麦角碱；高效液相色谱法；崩解仪；溶出度仪；小杯法

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

    LIANG Guanghua，PAN Jinglan

    (Guangzhou Institute for Drug Control, Guangzhou 510160, China)

    Abstract: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. ......

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