拉曼光谱技术在仿制药一致性评价研究中的应用

Application of Raman spectroscopy in studying consistency evaluation of generic drug

仿制药与原研药在主药/辅料晶型、粒度、处方工艺等方面保持一致,才能保证仿制药与原研药在体内药效上保持一致。而拉曼光谱对仿制药进行分析,不仅适用固体粉末、药物制剂,也适用液体药物,其产生信号主要基于药物的可极化官能团,而大多数药物都具有可极化官能团,应用拉曼光谱技术对仿制药进行研究,主要优势是:所需样品少、受水溶液影响小、无损检测,同时,药物辅料的拉曼光谱信号弱,因此可以忽略药物辅料信号干扰。本文从拉曼光谱技术在仿制药主药成分晶型、粒径、制剂组分鉴别、溶出度研究等方面对拉曼光谱技术在仿制药一致性评价研究中的应用作一综述。

It is significant to keep consistent for auxiliary materials crystal,particle size,prescription process between the generic drugs and the original drugs,so as to ensure that the generic drugs and the original drugs have the same pharmacodynamics in vivo.Raman spectroscopy can analyze the generic drugs,not only for solid powder,drug preparation,but also for liquid drugs.The signal generation is mainly based on the polarizable functional groups of drugs,and most drugs have polarizable functional groups.The main advantages of using Raman spectrum technology to study generic drugs are small samples,less affected by the aqueous solution,and nondestructive testing.At the same time,the interference of the drug excipients signal can be ignored because the drug excipients of Raman spectrum is weak.In this paper,we review the application of Raman spectroscopy in generic drug research and evaluation from the crystal shape,particle size,formulation component identification and dissolution research of the generic drugs.