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将近红外光谱分析技术与多变量数据分析技术相结合,建立注射用益气复脉(冻干)组方药材五味子提取过程的在线监测方法。采用生产上5个正常批次建立了五味子提取过程的多变量统计过程控制(multivariate statistical process control,MSPC)模型,并利用PC scores,DModX和Hotelling T~23种控制图对2个测试批次进行监测。结果显示,MSPC模型对提取过程具有良好的监测性能。将所建立的MSPC模型应用到实际生产中,能够有效地实现对五味子提取过程的在线监测,并实时反映生产过程中物料属性的变化。该文建立的监测方法为过程分析技术在中药注射剂生产过程质量控制领域的应用提供了参考。
The combination of near-infrared spectroscopy and multivariate data analysis techniques was used to establish an on-line monitoring method for the extraction of Schisandra sphenantherae for injection. Multivariate statistical process control (MSPC) model of Schisandra sphenanthera extraction was established with five normal batches on production and two control batches were tested using PC scores, DModX and Hotelling T ~ 23 control charts monitor. The results show that the MSPC model has good monitoring performance for the extraction process. The MSPC model is applied to the actual production, which can effectively monitor the extraction process of Schisandra chinensis and reflect the change of material properties in the production process in real time. The monitoring method established in this article provides a reference for the application of process analysis technology in the field of quality control of TCM injection manufacturing process.