头孢氨苄片溶出度的光纤过程分析  

Real-time detection of cephalexin dissolution by FODT

作　　者：李欣[1] 朱瑾[2] 耿晶[1] 杨淑梅[2] 李新霞[1] 

机构地区：[1]新疆医科大学药学院,乌鲁木齐830011 [2]新疆医科大学第五附属医院药剂科,乌鲁木齐830011

出　　处：《新疆医科大学学报》2014年第8期995-997,共3页Journal of Xinjiang Medical University

基　　金：新疆医科大学科研创新基金(xjc2012114)

摘　　要：目的对头孢氨苄片体外溶出过程进行分析,建立以光纤药物溶出仪为测试仪器的药物质量评价的方法学。方法采用FODT-601型光纤药物溶出度实时测定仪检测头孢氨苄片的溶出度。结果仪器可平行、实时监测6个通道不同头孢氨苄片的溶出过程,日内、日间精密度分别为1.87%和0.85%;回收率为100.03%,RSD为3.91%;FODT法测得头孢氨苄片平均溶出度为(110.0±2.07)%,与紫外-可见分光光度法测得结果无明显差异。结论光纤药物溶出仪可实时监测片剂的体外溶出情况,实验数据可靠,在考察制剂溶出曲线、优化处方工艺上发挥重要作用。Objective To detect drug release of cephalexin in vitro,and to establish a novel drug quality evaluation methodology by this instrument.Methods Detect and monitor cephalexin tablets dissolution by fiber optic drug dissolution tester （FODT）.Results FODT could realtime detect dissolution rates of tablets in six different channels simultaneously.The within-day and betweenday precision rates were 1.87% and 0.85%,respectively.And the recovery was 100.03%,while the relative standard deviation was 3.91%. The average dissolution of cephalexin tablets measured by FODT was （110.0±2.07）%,which showed no significant difference with the UV-method.Conclusion FODT could be applied to in vitro dissolution profile study,with reliable results,and it was of great importance in process optimization of pharmaceuticals.

关 键 词：头孢氨苄片 光纤药物溶出仪 溶出度 

分 类 号：R914[医药卫生—药物化学]