近年來，近紅外光譜技術在中藥制造領域得到廣泛應用，已經成為中藥制造過程分析的重要技術手段。通過建立注射用益氣復脈（凍干）的質量標志物的近紅外光譜分析方法，并結合工藝特點與質量要求確定過程分析技術應用方式，介紹該制劑生產過程近紅外光譜分析系統(tǒng)的構建，詳細描述該系統(tǒng)建立過程工藝監(jiān)測點的篩選原則、檢測方式的選擇依據。同時，結合筆者工作經驗，提出了將近紅外光譜分析技術運用于中藥制造過程質量控制中需注意的問題（包括系統(tǒng)構建的前期準備、近紅外光譜分析方法開發(fā)與運行管理體系完善等）并進行討論。

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