基于近红外光谱技术和多变量统计过程控制的五味子提取生产过程监测方法  

Monitoring method of extraction process for Schisandrae Chinensis Fructus based on near infrared spectroscopy and multivariate statistical process control

作　　者：徐敏 张磊[2,3] 岳洪水 庞洪伟 叶正良 丁黎[1] XU Min ZHANG Lei YUE Hong-shui PANG Hong-wei YE Zheng-liang DING Li(Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China Tianjin Tasly Pride Pharmaceutical Co. , Ltd. , Tianjin 300402, China Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections, Tianjin 300402, China)

机构地区：[1]中国药科大学药物分析教研室,江苏南京210009 [2]天津天士力之骄药业有限公司,天津300402 [3]天津市中药注射剂安全性评价企业重点实验室,天津300402

出　　处：《中国中药杂志》2017年第20期3906-3911,共6页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2012ZX09101202)

摘　　要：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。To establish an on-line monitoring method for extraction process of Schisandrae Chinensis Fructus, the formula medicinal material of Yiqi Fumai lyophilized injection by combining near infrared spectroscopy with multi-variable data analysis technology. The multivariate statistical process control （MSPC） model was established based on 5 normal batches in production and 2 test batches were monitored by PC scores, DModX and Hotelling T2 control charts. The results showed that MSPC model had a good monitoring ability for the extraction process. The application of the MSPC model to actual production process could effectively achieve on-line monitoring for extraction process of Schisandrae Chinensis Fructus, and can reflect the change of material properties in the production process in real time. This established process monitoring method could provide reference for the application of process analysis technology in the Droeess aualitv control of traditional Chinese medicine iniections.

关 键 词：多变量统计过程控制 近红外光谱分析技术 五味子提取过程 注射用益气复脉(冻干) 

分 类 号：R284.1[医药卫生—中药学]