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

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 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.

RESULT

MMSQC can monitor the quality of intermediates generated in multiple working procedures, which is simpler and more accurate compared with single-indicator monitoring method.

CONCLUSION

MMSQC can be popularized to monitor quality of multistage production of TCMs.