【摘要】 目的:研究一种实时、在位监测固体制剂体外溶出度的测定方法——光纤化学溶出度过程临测法,考察本法与2000版《中国药典》溶出度测定方法的差异。方法:双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,同时显示完整的药物溶出曲线图,从原始数据中可直接提取相关参数,与药典方法比较,两种测定方法差异无统汁学意义(P>0.05)。结论:光纤化学溶出度过程监测法能够有效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。更多还原

【Abstract】 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 Ch. P (2000). 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 could be monitored through computer. Result: This procession analysis can test the whole process of drug and get dissolution graph . The parameters obtained by FOCSDT had no significant difference compared with the method in Ch. P 2000 ( P >0. 05) . Conclution : This procession analysis can reflect the real dissolution of drug and obtain the total information.更多还原