光纤药物溶出/释放度原位过程监测仪监测甲硝唑口腔粘贴片释放过程  

The process monitoring of the release rate of metronidazole oral sticking tablets with fiber-optic medicine dissolution/release rate process test system

作　　者：丁晓萍 陈坚[2] 熊海江 

机构地区：[1]新疆维吾尔自治区药物研究所,乌鲁木齐830002 [2]新疆医科大学药学院,乌鲁木齐830054 [3]新疆富科思生物技术公司,乌鲁木齐830022

出　　处：《药物分析杂志》2006年第3期355-357,共3页Chinese Journal of Pharmaceutical Analysis

基　　金：科技型中小企业技术创新基金(№03C26216500443);新疆维吾尔自治区高技术发展计划资助项目(№200311110)

摘　　要：目的:考察一种光纤传感实时、原位过程监测甲硝唑口腔粘贴片体外释放度测定方法的可行性并与药品标准测定方法进行比较。方法:采用 FODT-601型光纤药物溶出/释放度原位过程监测仪,同时监测6片甲硝唑口腔粘贴片的药物释放过程,双波长法(320/450 nm)消除赋形剂干扰,计算机处理数据、实时显示药物释放曲线及打印结果。结果:方法回收率为99.0%～103.8%,日内、日间精密度均小于2%。本系统在1、2、4h 测定的甲硝唑口腔粘贴片药物累积释放百分率与药品标准方法测定结果无显著差异(P>0.05)。结论:光纤药物溶出/释放度过程监测法能够有效的测定药物的释放度。免除了补液、过滤、稀释等过程,减少了人为操作误差,结果准确。Objective： To examine the feasibility of a real time and process monitoring method of the release rate of metronidazole oral sticking tablets, and compared with medicine standard test method. Method： The release procession of six metronidazole oral sticking tablets were determinated simultaneously with FODT - 601 fiber - optic medicine dissolution/release rate process monitoring system. The interference of adjuvants was cancelled by two wavelengths（320/450 nm）. Data handled and experiment report printed and release curve lines shown were completed by computer. Results： The recovery of this way was 99.0% - 103.8%, the RSD （n = 5） of within - day and day - to - day was less than 2%. The cumulation realase rate of metronidazole oral sticking tablets measured by this test system at 1, 2 and 4 hours respectively had no significant difference compared with the test results of medicine criterion method （P 〉 0.05）. Conclution： Fiber - optic medicine dissolution/release rate process monitoring method can determine effectively the release rate of medicine, avoid the procedure of sampling, filter and dilute et al, and reduce the artificial error. Test results are accurate.

关 键 词：释放度过程监测 甲硝唑口腔粘贴片 

分 类 号：R917[医药卫生—药物分析学]