体外圆窗膜实验装置的建立与质量控制  

Creating the in vitro Experimental Apparatus for Round Window Membrane and the Quality Control

作　　者：刘娅[1] 孙建军[2] 孔维佳[1] 姜伟[2] 江平[2] 

机构地区：[1]华中科技大学同济医学院附属协和医院耳鼻咽喉科,武汉430022 [2]北京海军总医院全军耳鼻咽喉科中心,北京100037

出　　处：《华中科技大学学报（医学版）》2006年第2期250-252,261,共4页Acta Medicinae Universitatis Scientiae et Technologiae Huazhong

基　　金：首都医学发展基金资助项目(2002-2012)

摘　　要：目的制备体外圆窗通透实验装置,并进行质量控制,为经中耳-内耳间跨膜药理学研究提供技术基础。方法模拟中耳腔及鼓阶外淋巴腔环境,构建由活体豚鼠的圆窗膜组织、Franz扩散池(玻璃/聚乙烯组件)组成的体外圆窗通透实验装置;检测该装置有无渗漏;以亚甲基蓝为模型药物,检测3 h内的药物通透量。结果本研究设计并构建的圆窗通透实验装置符合药理学实验的基本要求,检测该装置性能良好、无渗漏。经连续3 h观察,亚甲基蓝的累积释放量符合零级释放方程。结论成功构建的体外圆窗通透实验装置符合药学实验质控标准。本装置的建立为中耳-内耳之间的跨膜给药研究提供了实验基础。Objective To design an in vitro experimental apparatus for round window membrane （RWM） and explore the quality control in order to provide in vitro data for inner ear pharmaceutical study in tropical drug delivery. Methods The apparatus was designed by simulating the environment of middle ear and Scala tympani, consisting of supplying cell, receiving cell and the round polyethylene slice with RWM from guinea pigs. Its quality was controlled by leakage prevention. With the help of the apparatus, methyl blue was used as representative drugs and its pharmacokineties in 3 h was detected. Results After careful operation and strict test, the apparatus without leakage could be produced. The cumulate release amount in 3 h fitted the zero release order. Conclusion The device is credible and can contribute to the research of inner ear drug delivery.

关 键 词：FRANZ扩散池 释放量 圆窗膜 

分 类 号：R764[医药卫生—耳鼻咽喉科]