热毒宁注射液金银花提取过程轨迹研究

Study on Extraction Process Trajectory for In-line Monitoring of Extraction Process of Lonicera Japonica of Re-Du-Ning Injection

目的:建立热毒宁注射液金银花提取过程轨迹,实现对提取过程的全程在线监控,为中药生产批次间质量控制提供参考。方法:收集多批次金银花提取过程的近红外光谱(NIRs)数据,并使用多元统计过程控制技术(MSPC)建立提取过程轨迹,实现对提取过程的全程监控。结果:建立的热毒宁注射液金银花提取过程的主成分得分,Hotelling T2和DMod X轨迹图能够检测到过程的异常情况。结论:基于近红外光谱数据和MSPC技术建立的过程轨迹图可以反应中药生产的过程变化,可以用于对中药生产的全程监控。

This study was aimed to develop in-line monitoring of extraction process of Lonicerajaponica in the extraction process trajectory of Re-Du-Ning （RDN） injection. Several batches of near-infrared （NIR） spectrum dates were collected and multivariate statistical process control （MSPC） method was in conjunction with. The results showed that using score,Hotelling T2 and DModX control chart, various normal and abnormal behaviors of the test batches were detected in time by comparison with the extraction process trajectory. It was concluded that the process trajectory for in-line quality control based on NIR spectrum dates and MSPC could indicate the changes of process. It was a feasible technology tool of the total process quality control during traditional Chinese medicine （TCM） manufacturing process.