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多通道光纤化学传感器连续在位监测固体制剂的体外溶出度

Continuous in situ monitoring of the dissolution rate of solid pharmaceutical preparation using multiple channel optical fiber chemical sensor

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【作者】 张全梅; 葛继红; 买尔旦; 粟奇志; 陈坚;

【Author】 ZHANG Quan-mei, GE Ji-hong, MAI Er-dan, SU Qi-zhi(Xinjiang Medical University, The First Affiliated Hospital, Urumqi 830000) and CHEN Jian(School of Pharmacy, Urumqi 830054), Fenxi Shiyanshi,2002,21(5):53~56

【机构】 新疆医科大学第一附属医院药剂科; 新疆医科大学药学院 乌鲁木齐830000; 乌鲁木齐830000; 乌鲁木齐830000;

【摘要】 采用基于荧光猝灭原理的多通道光纤化学传感器连续在位监测固体制剂的体外溶出度。采用自制光纤荧光溶出度监测仪与ZRS 4型智能溶出仪联用 ,连续在位监测氧氟沙星片、甲硝唑片、呋喃妥因肠溶片的体外溶出度 ,溶出曲线经微机从五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。方法的回收率分别为 97.4%~ 1 0 4 .4%、97.4%~ 1 0 3 .8%、96 .6 %~ 1 0 2 .1 %,日内、日间的RSD <5 %。经与中国药典 2 0 0 0版方法及美国药典 2 3版方法对照 ,各时间药物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 )。

【Abstract】 To continuously monitor the dissolution rate of solid pharmaceutical preparation in-time and on-line, multiple channel chemical sensor based on fluorescence multiple quenching (FOCSMQ) without filtering and sampling was used. Using the multiple channel FOCSMQ linked with computer, the dissolution rate of ofloxacin tablets, metronidazole tablets, nitrofurantoin tablets were monitored on-line. A computer was used to select the best function from five common fitting models to fit the dissolution curve. The average recovery of the FOCSMQ method was 97.4%~104.4%,97.4%~103.8%,96.6%~102.1%,respectively, the RSDs (n=6) of within-day and day-to-day were less than 5%. The results of measurement had no significant difference with ChP (2000) method and USP (23) method (P>0.05).

【基金】 国家自然科学基金资助项目 (2 9775 0 2 2 )
  • 【文献出处】 分析试验室 ,Analytical Laboratory , 编辑部邮箱 ,2002年05期
  • 【分类号】TQ460.7
  • 【下载频次】89
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