固体辅料物化表征研究概况

Research on Physico-chemical Characterization of Solid Excipients

整理固体辅料各项物化参数的表征方法与应用,为辅料研究开发提供有价值的参考。检索、查阅国内外相关研究文献与著作,概述固体辅料流动性、粒度与粒度分布、熔点、黏度、旋光度、结晶度、晶型的表征方法,并对这些表征方法在固体辅料研究中的具体应用进行分析总结。对固体辅料各物化参数的表征应综合考虑选用或联用合适的表征方法,且趋向于利用新技术新方法,使更加全面有效地表征该辅料的各物化参数。联合运用合适的表征方法对固体辅料各项物化参数进行表征能够有效地控制辅料的质量,且为固体辅料的研究开发提供参考。

To provide valuable reference for excipient research and development,review characterization methods and applications of the solid excipients physico-chemical parameters.The monographs and literatures in characterization methods of the solid excipients powder flow,melting temperature,viscosity,particle size and particle size distribution,optical rotation,crystallinity,crystal type were retrieved and consulted.The characterization and specific application in solid excipients research was analyzed and summarized.The physicochemical parameters of solid excipients characterization were comprehensively considered or combined with a suitable choice of characterization methods,and tend to take advantage of new technologies and new ways to more fully and effectively characterize the physico-chemical parameters of the excipients.Joint use appropriate characterization of the physico-chemical parameters of the solid excipients could effectively control the quality of the excipients,and the solid excipients research and development to provide a reference.