摘要
目的:以美国Lilly上市的奥氮平口崩片作为参比制剂,考察分析在不同pH值溶出介质中自研制剂与参比制剂体外溶出数据的相似性。方法:首先测定出自研制剂与参比制剂的溶出曲线;再利用f_2相似因子法对所测定溶出曲线的相似性来进行分析评价。结果:在15min以内,发现在不同pH值溶出介质中自研制剂与参比制剂的溶出量均大于85%。结论:自研制剂和参比制剂的溶出数据相似。
Objective： To investigate the dissolution behavior similarity between self-made praeparatum and reference praeparatum in different pH menstruum by using the Olanzapine Orally Disintegrating Tablets listed in abroad as the reference praeparatum. Methods： The dissolution curve of olanzapine in self-made praeparatum and reference praeparatum was measured, and the similarity of the dissolution curve was evalued by f 2 similar factor. Results： The single-point dissolution of both self-made praeparatum and reference praeparatum within 15 min was more than 85%. Conclusion： Self-made praeparatum and reference praeparatum are similar in dissolution behavior.
作者
樊好飞
陈才奇
肖文礼
杨贵方
王俊
杨波
刘启兵
易国辉
FAN Hao-fei;CHEN Cai-qi;XIAO Wen-li;YANG Gui-fang;WANG Jun;YANG Bo;LIU Qi-bing;YI Guo-hui(College of Basic Medicine and Life Science,Hainan Medical College,Haikou 571199,China;Center for Experimental Science,Hainan Medical College,Haikou 571199,China)
出处
《海南医学院学报》
CAS
2018年第18期1627-1630,1634,共5页
Journal of Hainan Medical University
基金
海南省重点科技计划项目(ZDYF2018154)
海口市重点科技计划项目(2017-010)~~
关键词
奥氮平
口崩片
溶出曲线
相似因子
Olanzapine；Orally disintegrating tablets；Dissolution curve；f 2 similarity factor
