Establishment of HPLC Fingerprints ，Content Determination and Chemical Pattern Recognition Analysis of Yuebi Jiazhu Decoction / 中国药房

ABSTRACT

OBJECTIVE：To establish the HPLC fingerprints of Yuebi jiazhu decoction ，determine the contents of ephedrine hydrochloride and pseudoephedrine hydrochloride and carry out chemical pattern recognition analysis. METHODS ：Using ammonium glycyrrhizinate as control ，HPLC fingerprint of 10 batches of Yuebi jiazhu decoction was established and the similarity was evaluated with Similarity Evaluation System for TCM Chromatographic Fingerprint （2012 edition），and common peaks were identified in combination with mixed control. HPLC method was used to determine the contents of ephedrine hydrochloride and pseudoephedrine hydrochloride. SPSS 26.0 software was used for cluster analysis ；SIMCA 13.0 software was used for principal component analysis and partial least squares discriminant analysis ；the differential components affecting the quality were screened. RESULTS：There were 20 common peaks in the fingerprint of Yuebi jiazhu decoction ，and the similarities with control fringerprint were all greater than 0.92. Two peaks were identified ，which were liquiritin （peak 11）and ammonium glycyrrhizate （peak 18）. The linear range of ephedrine hydrochloride and pseudoephedrine hydrochloride were 0.98-48 μg/mL（r＝0.999 9）and 1.02-51 μg/mL （r＝0.999 2），respectively. RSDs of precision ，reproducibility and stability tests （24 h）were all less than 2％. The average recoveries were 105.67％（RSD＝2.88％，n＝9）and 104.15％（RSD＝2.02％，n＝9），respectively. The contents of ephedrine hydrochloride and pseudoephedrine hydrochloride were 0.008 1-0.014 3，0.002 5-0.011 8 mg/mL. Results of cluster analysis showed that among the 10 batches of Yuebi jiazhu decoction ，S1 was clustered into one class ，S3 was clustered into one class ，and S2，S4-S10 were clustered into one class. The results of principal component analysis showed that S 3 was located at the far right side of the scoring plot ，S1 at the right side of the scoring plot ，and S 2，S4-S10 at the middle of the scoring plot. The results of partial least squares discriminant analysis were basically consistent with the results of cluster analysis and principal component analysis. The variable importance projection values of peak 9，peak 3，peak 12，peak 8，peak 19，peak 18 （ammonium glycyrrhizinate），peak 13，peak 20 and peak 11（liquiritin）were greater than 1. CONCLUSIONS ：Established HPLC fingerprint and the method for content determination are simple and accurate. Combined with chemical pattern recognition ，they can be used for the quality control of Yuebi jiazhu decoction. Nine components such as peak 9 are the differential components affecting the quality of Yuebi jiazhu decoction.