摘要
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.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2012年第13期1935-1941,共7页
China Journal of Chinese Materia Medica
基金
国际科技合作专项(2010DFB13400)
关键词
多工序多指标统计质量控制
多变量数据分析
多向主成分分析
丹参注射液
multistage multivariate statistical quality control
multivariate data analysis
multi-way principle component anal-ysis (MPCA)
Danshen injection