多角度光散射在药物质量控制中的应用

Application of Multi-angle Light Scattering in the Quality Control of Drugs

多角度光散射(MALS)技术是目前直接测定大分子药物相对分子质量及其分布的重要手段,在药物质量研究中的应用受到越来越多研究者的关注。本研究归纳总结了MALS的原理、特点及其在药物质量控制中的应用,主要包括采用MALS测定大分子药物、中药、药用辅料等的相对分子质量及其分布、粒径(水动力学半径)、均方根旋转半径、构象、聚集状态和支化度。MALS具有准确度高、测定范围广等优点,可为药物的质量控制和标准的建立及修订提供可靠的技术支持。

At present,multi-angle light scattering(MALS)technique is an important method to directly determine the relative molecular weight and its distribution of macromolecular drugs.Its application in drug quality research has received more and more attention from researchers.The principles,characteristics and applications of MALS in drug quality control are summarized,including the uses of MALS for determination of the relative molecular weight and its distribution,particle size(hydrodynamic radius),root mean square radius of rotation,conformation,aggregation state,and degree of branching in macromolecular drugs,traditional Chinese medicines,and pharmaceutical excipients.MALS has the advantages of high accuracy and wide measurement range,which can provide a reliable technical support for the quality control of drugs and the establishment and revision of standards.