Fingerprint establishment ，chemical pattern recognition analysis and content determination of Kangfuyan capsules / 中国药房

ABSTRACT

OBJECTIVE To establish the fingerprints of Kangfuyan capsules and carry out chemical pattern recognition analysis，and simultaneously determine the contents of five components so as to promote the quality standard of the drug. METHODS High performance liquid chromatography （HPLC）fingerprints of 11 batches of Kangfuyan capsules （S1-S11）were established by Similarity Evaluation System of TCM Chromatographic Fingerprint （2012 edition）；identification and attribution analysis of chromatographic peaks were carried out by comparison with the chromatograms of the reference substance and the decoction pieces of single ingredient. SPSS 26.0 and SIMCA 14.1 software were used for cluster analysis and principal component analysis. HPLC method was used to determine the contents of matrine ，phellodendrine chloride ，rutin，forsythoside A and berberine hydrochloride. RESULTS There were 29 common peaks in the fingerprints for 11 batches of samples ，and the similarity was higher than 0.99. A total of 5 chromatographic peaks were identified ，which are matrine （peak 3），phellodendron chloride （peak 14），rutin （peak 20），forsythiaside A （peak 22） and berberine hydrochloride （peak 28）. The results of cluster analysis and principal component analysis showed that S 1-S9 were clustered into one category ，and S 10 and S 11 were clustered into another category. The contents of above 5 components were 29.320 5-60.144 3，0.621 6-1.076 6，1.025 9-2.830 5，2.899 3-6.212 7 and 4.425 1-8.581 6 mg/g， respectively. CONCLUSIONS The established fingerprint and content determination method are stable and reliable ，and can provide reference for the quality control of the preparation in combination with chemical pattern recognition analysis.