阿司匹林肠溶片溶出度的在线过程分析  

On-line-fiber optic dissolution test of aspirin enteric-coated tablets

作　　者：阿依吐伦.斯马义 陈坚[2] 李新霞[1] 

机构地区：[1]新疆医科大学药学院药化/有机教研室,新疆乌鲁木齐830054 [2]新疆医科大学药学院分析/药分教研室,新疆乌鲁木齐830054

出　　处：《新疆医科大学学报》2005年第6期528-529,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:研究一种实时、在位监测药物固体制剂体外溶出度的测定方法———光纤药物溶出度过程实验(FODT)。方法:采用FODT检测了阿司匹林肠溶片溶出度,并与国家药品标准溶出度测定结果进行了比较。FODT是将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,由计算机记录并处理数据。结果:FODT监测阿司匹林肠溶片溶出的全过程,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溶出参数,与2002年国家药品标准溶出度测定方法比较,溶出参数Td、T50及累积溶出百分率差异均无统计学意义(P>0.05)。结论:FODT能够有效地测定阿司匹林肠溶片的体外溶出度,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 sensor dissolution test (FODT). And compare the difference of this method with Ch.P dissolution (Ch.P 2002). 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 can be monitored through computer. Results: This procession analysis can test the whole process of drug and get dissolution graph. The parameters obtained by FODT had no significant difference compared with the method in Ch.P 2002 (P>0.05). Conclusions: Through comparing FODT of aspirin enteric-coated tablets dissolution with standard test method, this procession analysis can test efficiently the dissolution of solid drug, FODT can reflect the real dissolution of drug and obtain the total information.

关 键 词：光纤溶出度过程实验 国家药品标准溶出度测定 阿司匹林肠溶片 

分 类 号：R971.1[医药卫生—药品] R917[医药卫生—药学]