【作者】 定天明； 张正行； 陈坚； 李新霞； 熊海疆； 邹华；

【Author】 DING Tian-ming~1 ZHANG Zheng-xing~(1*) CHEN Jian~2 LI Xin-xia~2 XIONG Hai-jiang~3 ZOU Hua~3 (1.Department of Pharmacy,China Pharmaceutical University,Nanjing 210009,China; 2.Department of Pharmacy,Xinjiang Medical University,Urumqi,830054,China; 3.Xinjiang FOCS Biological Technical Company,Urumqi 830022,China)

【机构】 中国药科大学药学院； 新疆医科大学药学院； 新疆富科思生物技术发展有限公司；

【摘要】 目的:在自行研制的溶出度过程分析系统上建立药物溶出度自动监测技术。方法:以分支光纤为光传输媒介,分别连接光源和检测器,光纤公共端部直接插入溶出杯实时监测格列吡嚎片及格列吡嗪控释片的溶出过程。结果:格列吡嗪在20～100μg·mL^-1范围内线性关系良好,r=0.9998,日内、日间的RSD分别为2.8%和3.2%。方法的加样回收率格列吡嗪片和控释片分别为99.0%和99.2%。经与中国药典2005年版方法对照,提取的参数无显著性差异。结论:本法获得的数据信息完整,反映了药物在体外的溶出过程,相应软件的使用实现了药物溶出度监测的智能化,替代了烦琐的传统测试方法。更多还原

【Abstract】 Objective:To establish processing analysis method for the dissolution test of glipizide tablets and glipi-zide sustained release tablets by optical-fiber chemical sensor dissolution test system.Method:Bifurcated opti-cal fiber was used to connect light source and detector and the common end was dipped in the dissolution vessel. The dissolution process can be monitored with computer.Results:The standard curve of glipizide was linear with the concentration changed from 20 to 100μg·mL^-1,r=0.9998.The RSD（n=6）of within-day and day-to -day were less than 5.0%.The recovery by FOCSDT method of glipizide tablets and glipizide sustained release tablets was 99.0% and 99.2%.The parameters obtained by FOCSDT had no significant difference compared with the method in ChP 2005（P>0.05）.Conclusion:This procession analysis can reflect the real dissolution of drug with the total information.更多还原