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该文将近红外光谱作为过程分析技术的工具,研究并建立了丹参多酚酸大孔吸附树脂柱色谱过程监测方法。采用7个正常操作批次建立柱色谱过程的多变量统计过程控制(MSPC)模型,以2个测试批次(包括1个正常操作批次和1个异常操作批次)验证模型的监测性能。结果显示,MSPC模型对柱色谱过程具有良好的监测能力。同时,采用偏最小二乘(PLS)建立了柱色谱过程中迷迭香酸、紫草酸和丹酚酸B 3个关键质量指标的近红外光谱定量校正模型,验证结果显示模型具有满意的预测性能。将以上2种模型相结合应用,能够有效地实现对丹参多酚酸大孔吸附树脂柱色谱过程的实时监测,并对关键质量指标进行在线分析。该研究所建立的过程监测方法可以为中药制药过程分析技术的开发提供参考。
In this paper, near-infrared spectroscopy as a tool for process analysis technology, research and establish a method of monitoring the process of chromatography of macroporous resin of salvia miltiorrhiza polyphenols. A multivariate statistical process control (MSPC) model of the column chromatography was established with seven normal operation batches and the monitoring performance of the model was verified in two test batches, including one normal operation batch and one abnormal operation batch. The results show that the MSPC model has good monitoring ability for column chromatography. At the same time, the quantitative correction model of near infrared spectra of 3 key quality indexes of rosmarinic acid, lithocholic acid and salvianolic acid B in column chromatography was established by partial least squares (PLS). The results show that the model has satisfactory predictive performance . The combination of the above two models can effectively realize the real-time monitoring of the chromatographic process of the macroporous adsorption resin of Salvia miltiorrhiza, and analyze the key quality indicators online. The method of process monitoring established by this institute can provide a reference for the development of Chinese traditional medicine process analysis technology.