改变药典规定测试波长实现替硝唑片溶出度的过程分析  

Processing analysis on dissolution rate of Tinidazole Tablets

作　　者：李新霞[1] 邹华 熊海疆 陈坚[1] 

机构地区：[1]新疆医科大学药学院,新疆乌鲁木齐830054 [2]新疆富科思生物技术发展有限公司,新疆乌鲁木齐830011

出　　处：《新疆医科大学学报》2003年第6期521-522,共2页Journal of Xinjiang Medical University

基　　金：新疆维吾尔自治区高技术发展计划资助项目(200311110)

摘　　要：目的:在自制溶出度过程分析仪上建立固体制剂溶出度过程分析技术。方法:将分支光纤分别连接光源和检测器,光纤公共端部直接插入溶出杯中,监测药物溶出度,通过改变药典规定替硝唑的测试波长,实现溶出度过程分析。结果:方法学考察替硝唑在264 nm处,浓度在120～560μg/ml范围内吸收度与浓度成线性r=0.999 9,日内日间精密度为0.8％和1.1％(n=6),平均回收率97.8％。实时监测替硝唑的溶出度,可直接从溶出曲线上提取相关参数,与药典方法测定相比差异无统计学意义(P>0.05)。结论:本法通过改变替硝唑测试波长,不经过滤稀释,获得药物在体外的溶出曲线,数据信息完整。Objective: To establish processing analysis method for the dissolution test of Tinidazole Tablets by Fiber-Optieal Chemical Sensor Dissolution Test system. Methods: Bifurcated optical fiber was used to connect light source and detector and the common end was dipped in the dissolution vessel. The dissolution procession can be monitored through computer. Results: The standard curve of Tinidazole was linear with the concentration changed from 120 to 560 μg/ml-1, r =0. 999 9. The recovery by FOCSDT method was 97. 8%. The RSD (n =6) of within-day and day-to-day were 0. 8% and 1. 1%. The parameters obtained by FOCSDT had no significant difference compared with the method in Ch. P 2000 ( P > 0. 05). Conclusion: This procession analysis can reflect the real dissolution of drug and obtain the total information.

关 键 词：光导纤维 原位监测 药物溶出度 替硝唑 

分 类 号：R978.1[医药卫生—药品] R917[医药卫生—药学]