口腔崩解片体外崩解评价方法探讨  

Study on Disintegrating Method for Orally Disintegrating Tablets

作　　者：姚方耀[1] 刘欢[1] 刘衡[1] 张鹏威[1] 阎卉[1] 王春龙[1] 

机构地区：[1]天津药物研究院制剂中心,天津300193

出　　处：《中国药学杂志》2007年第4期276-279,共4页Chinese Pharmaceutical Journal

摘　　要：目的改进设计口腔崩解片体外崩解的评价方法。方法制备了利培酮口腔崩解片和茶苯海明口腔崩解片,改进设计了4种口腔崩解片体外崩解的测定方法。分别采用这些方法测定了两种口崩片的体外崩解,并且考查了体内外相关性。结果对于利培酮口崩片,采用滴定管液滴法测定崩解具有较好的重现性和较好的体内外崩解时间相关性,而且砂砾感(粒度)控制准确;对于茶苯海明口崩片,则以日本药典(JP)溶出度改良法较为适合。结论用于口崩片体外崩解评价,滴定管液滴法和JP溶出度改良法为两种可取的方法。OBJECTIVE To design and improve disintegrating equipments for orally disintegrating tablets （ODT）. METHODS Risperidone ODT and dimenhydrinate ODT were prepared. They were respectively tested with four kinds of disintegrating equipments. Then the relationship between in vivo and in vitro disintegrating results of these two ODT was studied. RESULTS Buret - liquid droplet disintegrating method is suitable for testing risperidone ODT with good reproducibility, in vivo -in vitro relationship and effective control of particle size. Improved-JP dissolution disintegrating method was optimum for the measurement dimenhydrinate ODT. CONCLUSION Buret - liquid droplet disintegrating method and improved-JP dissolution disintegrating method are good disintegrating methods to evaluate ODT.

关 键 词：利培酮 茶苯海明 口腔崩解片 崩解测定 

分 类 号：R944.4[医药卫生—药剂学]