利用多通道光纤化学传感器在线检测呋喃妥因肠溶片的溶出度

Studies on dissolution rate of nitrofurantoin tablets using multiple ch annel fiber-optic chemical sensor

目的 基于荧光多猝灭的原理 ,采用多通道光纤化学传感器在线检测呋喃妥因肠溶片的体外溶出度。方法 用自制光纤荧光溶出度检测仪与ZRS 4型智能溶出仪联用 ,在线检测呋喃妥因肠溶片的溶出度 ,溶出曲线经微机从 5种常用数学模型中根据相关系数r值 ,优选最佳模型进行拟合。结果 方法的回收率为 96 .6 %～ 1 0 2 .1 % ,日内、日间的RSD均小于 5 %。经与美国药典 2 3版方法对照 ,各时间呋喃妥因肠溶片累积溶出量和拟合后提取的参数均无显著性差异 (P >0 .0 5)。结论 本法简便 ,快速 ,结果准确 ,可靠 。

OBJECTIVE: To continuously monitor the dissolution rate of nitrofurantoin tablets in-time and on-line using multiple channel fiber-optic chemical sensor based on fluorescence multiple quenching (FOCSMQ) without filtering and sampling. METHODS: The multiple channel FOCSMQ was used and linked with computer to continuously monitor the dissolution rate of nitrofurantoin tablets on-line. A computer was used to select the best function from five common fitting models to fit the dissolution curve. RESULTS: The recovery of the FOCSMQ method was 96.6% - 102.1%, the RSD(n = 6) of within-day and day-to-day was less than 5 %. The parameters of the dissolution and all results of measurement using the instrument had no significant difference compared with the method in USP X X III (P < 0. 05). CONCLUSION: The method is simple, rapid and reliable.