近红外光谱在口服固体制剂连续制造中的应用

Application of Near-Infrared Spectroscopy in Continuous Manufacturing of Oral Solid Dosage Forms

摘要

连续制造是推动制药产业从传统批次生产向智能化、连续化转型的关键模式.近红外光谱(NIRS)凭借快速、无损、多指标同步检测的优势,已成为口服固体制剂连续制造中的核心过程分析技术(PAT)工具.区别于既有综述的泛化介绍或单一单元操作聚焦,本研究以连续制药工艺单元为主线,系统梳理了NIRS在原料鉴别、结晶、混合、制粒、干燥、压片、包衣及包装等全流程关键工序中的在线监测方法与质量控制策略,并揭示了其从离线检测向在线监控、从单点测量向多属性关联、从被动监测向主动控制的演进路径.为口服固体制剂连续制造的过程质量控制提供了系统化技术参考,并为NIRS在液体制剂及中药固体制剂连续制造中的拓展应用奠定了基础.

Abstract

Continuous manufacturing is a key paradigm driving the transformation of the pharmaceutical industry from traditional batch production toward intelligent continuous operation.Near-Infrared Spectroscopy (NIRS),with its advantages of rapid,non-destructive,and simultaneous multi-attribute analysis,has become a core Process Analytical Technology (PAT) tool for the continuous manufacturing of oral solid dosage forms.Different from existing reviews that provide generalized introductions or focus on single unit operations,this paper,uses the continuous pharmaceutical process units as the main thread and systematically reviews the online monitoring methods and quality control strategies of NIRS in key unit operations throughout the entire process,including raw material identification,crystallization,blending,granulation,drying,tableting,coating and packaging.It further reveals the evolutionary pathway of NIRS from offline detection to online monitoring,from single-point measurement to multi-attribute correlation,and from passive monitoring to active control.This review provides a systematic technical reference for quality control in the continuous manufacturing of oral solid dosage forms and lays the foundation for the extended application of NIRS on the continuous manufacturing of liquid preparations and traditional Chinese medicine solid dosage forms.

关键词

近红外光谱 / 连续制造 / 口服固体制剂 / 过程分析技术

Key words

near-infrared spectroscopy / continuous manufacturing / oral solid dosage forms / process analytical technology

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基金资助

云南省基础研究计划项目(202401BE070001-002)

昆明理工大学校级本科教育教学改革研究项目(JGYF251012)