介紹了以質(zhì)量標(biāo)志物（Q-marker）為目標(biāo)開展的注射用益氣復(fù)脈（凍干）（YQFM）質(zhì)量評價與監(jiān)測技術(shù)研究進(jìn)展，為開展全面的YQFM質(zhì)量評價與控制創(chuàng)造了必要條件，也為中藥Q-marker理論成果向制藥工業(yè)質(zhì)量控制實(shí)踐轉(zhuǎn)化提供參考。包括在藥品全生命周期內(nèi)構(gòu)建基于Q-marker的質(zhì)量評價及監(jiān)測體系技術(shù)路線，針對不同組方藥材、生產(chǎn)工藝中間體以及成品中Q-marker的分析技術(shù)研究結(jié)果；基于近紅外光譜技術(shù)的生產(chǎn)過程分析技術(shù)體系，在生產(chǎn)過程中對Q-marker實(shí)施監(jiān)控，為藥品生產(chǎn)全過程的質(zhì)量評價提供技術(shù)支撐。

The development for the researches of quality evaluation and monitoring technologies for Yiqi Fumai Lyophilized Injection (YQFM) targeting on quality marker (Q-marker) were presented, created the condition for the overall quality evaluation and control of YQFM, and provided inference for the transformation from Q-marker theory achievement to traditional Chinese medicine industrial quality control. The technical chart for the construction of quality evaluation and monitoring system in product lifecycle based on Q-marker was showed. The analytical methods of Q-markers in raw materials, intermediates, and products were introduced, which provided technical tools for quality evaluation in manufacturing process. The process quality monitoring system using near infrared spectroscopy technology was established, and quality models for determining Q-markers in critical process were developed, which were applied to monitor Q-markers in manufacture.

R286.1