中药生产多工序多指标统计质量控制(MMSQC)方法

Multistage multivariate statistic quality control(MMSQC) for monitoring production process of traditional Chinese medicines

目的:建立中药生产过程中各个工序产生的中间体质量监控方法,保证中药产品质量的批次一致性。方法:基于多变量数据分析技术,提出一种中药生产质量监控方法——多工序多指标统计质量控制(multistage multivariate statisticalquality control,MMSQC),采用Hotelling T2和SPE统计量,监控各个工序中间体的质量。以丹参注射液生产为例,介绍了MMSQC的应用方法。结果:MMSQC方法能监控多个工序产生的中间体质量,与单指标监控方法相比,更加简便、准确。结论:MMSQC方法可以推广应用于中药生产过程多工序的质量监控。

Objective： To establish a method for monitoring the quality of intermediates generated in each working procedure during the production process of traditional Chinese medicine （TCM） , in order to ensure the batch-to-batch quality consistency of TCM products. Method： The multistage multivariate statistic quality control （MMSQC） was proposed to monitor production quality of TCMs based on multivariate data analysis technique. Hotelling T^2 and SPE were adopted for monitoring the quality of intermediates generated in each working procedure. Danshen injection was taken as the example to introduce the application method of MMSQC. Result： MMSQC can monitor the quality of intermediates generated in multiple working procedures, which is simpler and more accurate com- pared with single-indicator monitoring method. Conclusion： MMSQC can be popularized to monitor quality of multistage production of TCMs.