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

Haoshu Xiong, Ying Fu, Jing Nie, Haibin Qu

College of Pharmaceutical Science, Zhejiang University, Hangzhou 310058, China.

Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica 2012 Jul

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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. The multistage multivariate statistic quality control (MMSQC) was proposed to monitor production quality of TCMs based on multivariate data analysis technique. Hotelling T2 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. MMSQC can monitor the quality of intermediates generated in multiple working procedures, which is simpler and more accurate compared with single-indicator monitoring method. MMSQC can be popularized to monitor quality of multistage production of TCMs.

Citation

Haoshu Xiong, Ying Fu, Jing Nie, Haibin Qu. Multistage multivariate statistic quality control (MMSQC) for monitoring production process of traditional Chinese medicines]. Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica. 2012 Jul;37(13):1935-41