长循环脂质体药物制剂技术的复杂性以及对制剂认识的有限性使得现阶段我国的脂质体药物研发实力与世界先进水平相比仍有一定差距。除了需要对脂质体药物进行药学方面研究外，也需要针对可影响疗效的关键制剂属性——脂质体药物结构进行深入的研究。目前，脂质体药物的一些关键的体外测试指标对于方法学的要求很高，现阶段还不具可操作性，而依托同步辐射SAXS技术，通过弱散射信号优化采集可建立起有效的表征手段。本课题以制药企业实际分析需求为切入点，选取最为典型的脂质体纳米药物——多柔比星长循环脂质体——为模型药物，开展有关PEG化脂膜结构、包载药物状态等关键粒子属性的结构研究，通过优化PEG化脂膜、载药脂质体分析模型，完善和建立长循环脂质体纳米药物SAXS分析方法，将仿制药与原研药进行结构比对，为脂质体药物研发及工艺优化提供依据。

Because of the complexity and limited cognition of PEGylated liposomal pharmaceutical preparation technology, there is still a gap for the research and development capability between our country and the world advanced level at this stage. In-depth structural studies on the key characteristics of liposomal drugs which are considered critical to ensure the efficacy are also needed in addition to the pharmaceutical research. The experimental methodology to determine some key in-vitro properties is not accessible for the moment. However, an effective characterization method can be established by the optimized acquisition of weak scattering signal with the help of synchrotron radiation SAXS .This project will start with the actual requirements of pharmaceutical enterprises and choose PEGylated liposomal doxorubicin as an example to illustrate our study on the structures of liposomal drugs. The key characteristics of liposomal drugs, which will be studied, include PEGylated lipid membrane structure, state of encapsulated drug and so on. The optimized analysis model and SAXS analysis method of PEGylated liposomal drugs will be established. And structural comparisons between reference list drug and its generic drugs will provide a reference for the development and optimization of liposomal drugs.