过程分析技术在流化床制粒过程中的应用进展

Application Progress of Process Analysis Technology in Fluidized Bed Granulation Process

流化床制粒是制药企业生产固体剂型的湿法制粒技术之一。自美国FDA提倡使用过程分析技术(PAT)以来,PAT被广泛用于实时分析、监测与控制流化床制粒过程。本研究主要介绍了基于流化床制粒的过程检测技术以及数据分析方法,过程检测技术主要包括近红外光谱、声发射、空间滤波、微波共振等技术;数据分析方法主要分为光谱的化学计量学分析、线性回归与非线性算法、过程实时数据建模方法。并综述了近年来PAT在流化床制粒过程中的应用,主要包括终点判断、生产过程实时分析检测与异常监控等方面,为流化床制粒工艺选取适宜的PAT技术提供了依据。

Fluidized bed granulation is one of the wet granulation technologies for pharmaceutical enterprises to produce solid dosage forms.Since U.S.Food and Drug Administration(FDA) advocated the use of process analysis technology(PAT),PAT has been widely used for real-time analysis,monitoring and control of fluidized bed granulation process.The process detection technology and data analysis method based on fluidized bed granulation are mainly introduced in this paper.The process detection technology mainly includes near-infrared spectroscopy,acoustic emission,spatial filtering and microwave resonance.The data analysis methods are mainly divided into spectral data processing method,linear and non-linear algorithm and process real-time data analysis method.And the applications of PAT in fluidized bed granulation in recent years are reviewed,mainly including endpoint judgment,real-time analysis and detection of production process and anomaly monitoring,which provides a basis for selecting appropriate PAT technology for fluidized bed granulation process.