【摘要】 本研究利用冷冻透射电镜技术对脂质体的物理稳定性进行了精准原位评价。冷冻透射电镜技术无须干燥和染色，能够最大程度保留脂质体的原始形貌，清晰呈现双层膜结构及包载物的空间分布，克服了传统表征方法导致的形变、水合层干扰及探针卷积效应等问题，能够高效、直观地评估脂质体的形态、粒径及粒径分布、包载物状态等，为脂质体制剂的开发与优化提供了可靠的科学依据和质量控制标准，提高药物研发和生产的一致性和可比性，满足日益增长的临床需求。更多还原

【Abstract】 This study employs cryo-electron microscopy(Cryo-EM) to precisely evaluate the physical stability of liposomes in situ. Cryo-EM eliminates the need for drying and staining, thereby preserving the native morphology of liposomes to the greatest extent. It clearly reveals the bilayer membrane structure and the spatial distribution of encapsulated substances, overcoming issues such as deformation, hydration layer interference, and probe convolution effects associated with traditional characterization methods. Cryo-EM enables efficient and intuitive assessment of liposome morphology, particle size, size distribution, and the state of encapsulated materials. Cryo-EM provides reliable scientific evidence and quality control standards for the development and optimization of liposomal formulations. Ultimately, it enhances the consistency and comparability of drug development and production, meeting the growing clinical demands.更多还原