吸入制剂用原料药中无定型含量的定量方法研究进展

Research Progress on Quantification Methods of Amorphous Content of Bulk Drugs for Inhaled Preparation

吸入制剂尤其是吸入粉雾剂的快速发展,凸显了对微粉化原料药中无定型含量的定量需求。文章简述了目前广泛使用的7种定量方法(PXRD法、DSC法、动态蒸汽吸附法、微量热法、溶解量热法、IR法和拉曼光谱法),及其限度和相应的检测仪器,并基于吸入制剂用原料药的常见无定型含量限度要求,列举了一些研究实例,分析了不同方法的优缺点,以期为相关研究提供参考。

The rapid development of inhaled products,especially dry powder for inhalation,highlights the quantitative demands for the amorphous content of micronized bulk drugs.This review briefly describes seven widely used quantitative methods,named PXRD,DSC,dynamic vapor adsorption,microcalorimetry,solution calorimetry,IR and Raman spectroscopy methods,as well as their limitations and corresponding detection instruments.And based on the common limit requirements of amorphous content for inhaled bulk drugs,some examples are provided.The advantages and disadvantages of different methods are analyzed to provide some references for related researches.