近年來，近紅外光譜技術(shù)在中藥制造領(lǐng)域得到廣泛應(yīng)用，已經(jīng)成為中藥制造過程分析的重要技術(shù)手段。通過建立注射用益氣復(fù)脈（凍干）的質(zhì)量標(biāo)志物的近紅外光譜分析方法，并結(jié)合工藝特點(diǎn)與質(zhì)量要求確定過程分析技術(shù)應(yīng)用方式，介紹該制劑生產(chǎn)過程近紅外光譜分析系統(tǒng)的構(gòu)建，詳細(xì)描述該系統(tǒng)建立過程工藝監(jiān)測點(diǎn)的篩選原則、檢測方式的選擇依據(jù)。同時(shí)，結(jié)合筆者工作經(jīng)驗(yàn)，提出了將近紅外光譜分析技術(shù)運(yùn)用于中藥制造過程質(zhì)量控制中需注意的問題（包括系統(tǒng)構(gòu)建的前期準(zhǔn)備、近紅外光譜分析方法開發(fā)與運(yùn)行管理體系完善等）并進(jìn)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