中文摘要：

制剂一致性研究中如何提高效率、充分保障仿制制剂与原研药一致,亟待发展新的技术和方法。对于具有结构特征的固体制剂、微粒分散体系,结构是其特定处方与工艺技术的结果,决定其递送药物的释放行为及其体内药代动力学行为。传统表征技术不能对结构进行定量,而同步辐射成像等新一代结构定量表征技术,在揭示制剂内部结构方面展现了前所未有的能力,能定量表征制剂的静态结构和动态结构,实现制剂工艺的逆向工程剖析和制剂间结构异同的甄别。本团队建立了方法学,采用该技术实现了在静态结构（原辅料粉体结构、颗粒单元结构、片剂结构和膜结构等）和水化等动态结构、固体制剂工艺甄别等方面的应用,将制剂的结构划分为从剂型到制剂中间体、动态结构、分子结构等四级结构,提出了基于制剂结构的药物一致性评价新策略。在制剂释药行为一致的基础上,制剂内部精细结构的一致更有助于确保制剂的一致性。

英文摘要：

Strategies and techniques are extremely important to improve the evaluation efficiency and fully guarantee the consistency of dosage forms. For preparations with a structural feature as solid dosage forms and particulate dispersion systems, the structures of dosage forms are the outcome of the specific formulation and production process, which determine the drug delivery behaviors as well as the pharmacokinetics of the dosage forms. Conventional techniques failed to quantitatively determine the structures of dosage forms. Synchrotron radiation micro-computed tomography is a new generation of structural quantitative characterization technology in revealing the internal structure of dosage forms with unprecedented capability for quantitative characterization of the static and dynamic structures of dosage forms, enabling to reversely analyze the production process and identify the structure differences between the generics and brand products. Based on synchrotron radiation micro-computed tomography methodology researches and applications in static structures （powders, particulate systems, tablets, films, membranes, etc.）, dynamic structures （hydration） and de-formulation of production process, we have classified the structures of dosage forms into four levels from macro-scope to molecular level as dosage forms, granular intermediates for formulation, dynamic structure and molecular structures, and proposeddosage form structure based new strategy for consistency evaluation. Along with conventional dissolution/ release behavior similarity, the internal structure consistency ensures high consistency between the brand product and the generics.