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目的:建立丹红注射液提取过程轨迹并用于提取过程质量在线监控。方法:采用近红外(near-infrared,NIR)光谱仪在线采集过程光谱数据,结合多变量数据分析技术,建立提取过程轨迹,并采用主成分得分、Hotelling T2和DModX监控图实时监控提取过程质量。结果:应用建立的丹红注射液提取过程轨迹,能及时发现提取过程异常情况。结论:基于NIR光谱技术的过程轨迹在线质量监控方法为实现中药生产全程质量控制提供了技术。
Objective: To establish the trace of extraction process of Danhong injection and to monitor the quality of extraction process online. Methods: The near-infrared (NIR) spectrometer was used to acquire the process spectrum data online. The multivariate data analysis technique was used to establish the trace of the extraction process. The quality of the extraction process was monitored by using the principal components scores, Hotelling T2 and DModX charts. Results: The process of extraction of Danhong injection was established, and the anomalies in the extraction process could be detected in time. Conclusion: The on-line quality monitoring method of process trajectory based on NIR spectroscopy provides technology for the quality control of traditional Chinese medicine production.