光纤药物在位溶出度/释放度监测仪实时监测复方卡托普利片体外溶出度

Real-time FOCSDT Detection Method and Conditions for Dissolution Test of Compound Captopril Tablets

目的:采用光纤化学传感技术实时、在位监测固体制剂体外溶出度的测定并与中国药典2000年版方法比较。方法:分支光纤一端连接光源,公共端部探头浸入溶出液,另一端连接检测器,计算机记录并处理数据。结果:本法监测药物溶出的全过程,显示药物实时溶出曲线图,直接提取相关参数,与药典方法比较,无统计学差异(p>0.05)。结论:光纤化学溶出度过程监测法能够有效的测定固体药物的体外溶出度,并能真实地反映药物溶出的全过程。

Objective： To study a method which can monitor the dissolution rate of drug on - line - fiber optic chemical sensor dissolution test（FOCSDT） ,and compare the difference of this method with that described in ChP （2000）. Method：Bifurcated optical fiber was used to connect light source and detector and the common end was dipped in the dissolution vessel. The dissolution procession could be monitored through computer. Result：This process had ysis ion analysis can test the whole process of drug and no significant difference compared with the method get dissolution graph. The parameters obtained by FOCSDT in ChP 2000 （p 〉 0. 05 ）. Conclution ： This procession analcan reflect the real dissolution of drug and obtain the total information.