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目的:概述我国光纤药物溶出度研究进展。方法:通过查阅国内外相关文献资料,对光纤药物溶出仪的基本结构、工作原理、特点及其在药物固体制剂溶出度监测方面的应用做一综述。结果:由于光纤药物溶出度具有原位、在线、实时监测的特点,适用于药物口服固体制剂的溶出度测定,尤其对缓控释制剂、肠溶制剂和复方制剂的溶出度监测具有明显的优势。结论:光纤药物溶出度研究,填补了我国药物溶出度过程分析的空白。
Objective: To summarize the progress of research on dissolution of optical fiber drugs in our country. Methods: The basic structure, working principle and characteristics of optical fiber drug dissolution apparatus and its application in the monitoring of drug solid preparation dissolution were reviewed by referring to relevant literature at home and abroad. Results: Because of the in-situ, on-line and real-time monitoring of the dissolution rate of optical fiber drugs, it is suitable for the determination of dissolution of oral solid preparations, especially for the dissolution monitoring of controlled-release, enteric and compound preparations . Conclusion: The study of optical fiber drug dissolution has filled the gap in the analysis of the process of drug dissolution in China.