中文摘要：

固体药物制剂的结构研究是实现优化给药的基础，也是给药系统创新的重要内容。同步辐射显微CT （synchrotron radiation X-ray microtomography, SR-μCT）技术，不仅能够在微米、亚微米级分辨率上展示药剂粉体、微粒给药系统、片剂类固体剂型等三维静态形貌特征，而且能够连续观察缓控释制剂释药过程中的动态变化，揭示释药速率的关键结构因素，为新型给药系统的设计、质量控制提供依据和新方法。综述了同步辐射显微CT在药物制剂结构研究方面的国内外进展。我国新近应用该技术开展了药剂粉体颗粒的表征、制剂微观结构及基于结构的释放动力学研究，在药物的晶型研究、颗粒混合及分层的评价、制剂复杂结构的分形特征、难溶性药物凝胶骨架片的水化动力学和渗透泵三维立体释放动力学研究方面取得了一系列进展。

英文摘要：

As the element of innovation for the drug delivery system, the architecture of the solid pharmaceutical dosage forms is the ground work to have an optimized drug delivery. With the high resolution of micron and sub- micron, the synchrotron radiation X-ray microtomography （SR-μCT） technique can show the static three- dimensional morphology and the structural characteristics of the solid dosage forms, such as powders, particulate drug delivery systems and tablets. Furthermore, the SR-pCT can correlate the dynamic structure transformation of the pharmaceutical dosage forms during the drug release phase with the drug release kinetics. Therefore, it＇s possible to identify the significant structural factors governing the drug release rate of the controlled/sustained release systems, which can provide new measure and novel methodologies for the design and quality control of drug delivery systems. This article reviews the advances and applications in characterization of pharmaceutical preparations. China has commenced the SR-gCT researches in structural characterization of powders, internal and microstructure of pharmaceutical preparations and structure based drug release kinetics, e.g., the identification of crystal polymorphs, quantitative profiling of mixing and segregation of granules, fractal analysis of complicated structure, the hydration dynamic characteristics of poorly water-soluble drugs in gel forming matrix tablets and the three dimensional release kinetics of monolith osmotic pump tablets.