结构是缓控释给药系统的核心与灵魂，是其发挥良好临床疗效的关键，研究缓控释制剂释放过程中的动态变化是解析其释放机理的前提。限于常规方法仅能给出二维和表面的特征，纳米~微米~毫米尺度的制剂三维结构尤其是动态结构的研究几乎是被忽略的领域。近年来，本团队依托上海光源强大的结构解析能力，与先进国家同步开展制剂结构的探索性研究，初步建立基于同步辐射光源成像的制剂结构研究方法，为考察制剂的静态内部结构、物质空间分布，处方、工艺因素及药剂学性质之间的关系提供了一种全新的研究手段。本课题将专注于基于同步辐射的超快速高分辨动态显微CT成像技术的方法学研究，实现凝胶骨架片、渗透泵释放过程中动态结构的原位实时高精度的测定，同时发展大规模四维结构数据分析的新方法，将结构药剂学理论扩展至更高的维度，关注缓控释制剂研究的核心基本问题即释放动力学的驱动机制，揭示决定释药速率的关键结构因素，明确缓控释制剂的控释机理。

The structure of dosage forms is the important primary property which determines the releasing process and therapeutic efficacy. Investigating the dynamic changing structures of Sustained/Controlled release preparations during release is one of the premises for the research of release mechanism. Synchrotron radiation computed micro-tomography is the most powerful available technique which can satisfy the demands of quantitative structure analysis, whereas the common microscope and electron microscope can’t provide multi-dimensional and multi-scale quantitative micro-structure from nanometer to millimeter. The applicants have firstly worked on the quantitative analysis of pharmaceutical structures by using Shanghai Synchrotron Radiation Facility (SSRF), and realized the great-leap-forward development for the pharmaceutical fine structure research from 2D imaging to micro-CT. Meanwhile, we carry out a series of explorative researches of pharmaceutics structures in competition with other leading countries, and have preliminarily established the theory and method of pharmaceutics structures based on synchrotron radiation imaging. Based on the above, this project is to optimize and develop new techniques and methods of pharmaceutics structure study, including ultra-fast high-resolution X-ray dynamic CT and protocols for the analysis of huge four dimensional structural data. Being mainly focused on the typical Sustained/Controlled release systems, we are to systematically investigate the hydro-gel matrix tablet and osmotic pump tablet based on synchrotron radiation micro-CT, to utilize the unique advantages of synchrotron radiation imaging technique on revealing the releasing mechanism of dosage forms, to demonstrate the multi-dimensional and multi-scale dynamic pharmaceutics structures and the rules of the influences on drug release, and to provide theoretical and methodological supporting for development of innovative drug delivery systems, which can greatly deepen the fundamental researches on theories of pharmaceutics.