Objective:To establish a comprehensive quality control method for Shangke Jiegu tablets based on organic and inorganic double factors by using HPLC and ICP-MS

in order to improve its quality control standard. Method:The fingerprint of 10 batches of the Shangke Jiegu tablets was established by HPLC

and their similarity was calculated with the similarity evaluation system. Semi-quantitative analysis of the inorganic elements was done for 10 batches of the Shangke Jiegu tablets by ICP-MS. In the process of data analysis

MPP software was employed for principal component analysis (PCA) to screen difference elements. Combining with related literature

full-quantitative analysis was done for the difference elements and heavy metals associated with efficacy as well as harmful elements. Result:The HPLC fingerprint of the Shangke Jiegu tablets was set up based on multi-wavelength fusion. 27 common peaks were marked and the similarity among samples was over 0.92.Combining with the results of semi-quantitative analysis and related literature

full-quantitative analysis was done for 12 inorganic elements

including common elements (Ca

Mg

K

Na)

trace elements (Fe

Zn

Mn)

and heavy metals and harmful elements (Cu

Hg

As

Pb

Cd). The quality evaluation system was set up based on organic and inorganic double factors. Conclusion:The method with good reproducibility is simple and accurate

providing foundation for the quality control of Shangke Jiegu tablets based on organic and inorganic double factors.