近年来，近红外光谱技术在中药制造领域得到广泛应用，已经成为中药制造过程分析的重要技术手段。通过建立注射用益气复脉（冻干）的质量标志物的近红外光谱分析方法，并结合工艺特点与质量要求确定过程分析技术应用方式，介绍该制剂生产过程近红外光谱分析系统的构建，详细描述该系统建立过程工艺监测点的筛选原则、检测方式的选择依据。同时，结合笔者工作经验，提出了将近红外光谱分析技术运用于中药制造过程质量控制中需注意的问题（包括系统构建的前期准备、近红外光谱分析方法开发与运行管理体系完善等）并进行讨论。

In recent years, near infrared spectroscopy (NIRS) has been considered as an efficient tool for achieving process analytical technology (PAT) in the manufacture of traditional Chinese medicine (TCM) products. In this article, the NIRS based process analytical system for the production of Yiqi Fumai Lyophilized Injection (YQFM) was introduced. The design of the process analytical system was described in detail, including the selection of monitored processes and testing mode. Building the analytical methods of NIRS based on some of quality markers in YQFM, determining the application mode of PAT based on the process feature and quality requirement. Based on author's experience on PAT, some issues in the application of NIRS to the process monitoring and control in TCM production were raised and discussed. That include the preparation for production of PAT system, method development of NIRS, and improving the management of process analytical system. Finally, the prospect for the application of NIRS in the TCM industry was put forward.

R283.6;R286.0