Establishment of quantitative analysis of multi -components by single marker and quality evaluation of Gushen dingchuan pills / 中国药房

ABSTRACT

OBJECTIVE To establish quantitative analysis of multi -components by single marker （QAMS） method to simultaneously detect the contents of cinnamic acid ，cinnamaldehyde，plantamajoside，verbascoside，isoacteoside，calceolarioside B ， psoralen，isopsoralen，neobavaisoflavone and bavachin in Gushen dingchuan pill ，and to perform quality evaluation of Gushen dingchuan pill by combining with chemical pattern recognition . METHODS High-performance liquid chromatography was adopted . Using psoralen as internal standard ，the relative correction factors of the other 9 components were established ，and the contents of each component were calculated and compared with those determined by external standard method . Cluster analysis ，principal component analysis and partial least squares discrimination analysis were performed by the results of QAMS method ，and the qualities of 15 batches of Gushen dingchuan pills were evaluated . RESULTS The above 10 components showed a good linear relationship in their respective ranges （r＞0.999 0）. RSDs of precision ，repeatability，stability and recovery tests were all lower than 2.00%. There was no significant difference between QAMS method and external standard method （P＞0.05）. The results of cluster analysis and principal component analysi showed that 15 batches of Gushen dingchuan pills could be clustered into 3 categories. The results of partial least squares discrimination analysis showed that psoralen ，verbascoside，cinnamaldehyde and isopsoralen were the main potential markers affecting the quality of Gushen dingchuan pills . CONCLUSIONS Established QAMS method for quantitative control of multi index components and chemical pattern recognition can be used for the quality evaluation of Gushen dingchuan pills .