指纹图谱联合多元统计分析的百合地黄汤物质基准质量评价及量值传递规律研究OACSTPCD

Objective:To explore the preparation process of Baihe Dihuang Decoction(BDD)substance reference,establish a BDD sub-stance reference fingerprint,and conduct quality evaluation,elucidating the quantity transfer law of the main components of BDD in the drug material decoction substance reference.Method:Optimize the standard preparation process of lily substances to establish the stand-ard preparation method for BDD substances;Establish a reference fingerprint of BDD substances using high-performance liquid chro-matography(HPLC)method;Using a similarity evaluation system for traditional Chinese medicine chromatographic fingerprints to cali-brate and identify common peaks and chromatographic peaks;Based on multivariate statistical analysis(cluster analysis,partial least squares discriminant analysis)methods,identify the main chemical components that cause differences in the baseline quality of BDD substances from different batches,and conduct content measurements;Study the quantity transfer law of BDD substance reference based on the transfer rate of main chemical components.Results:(1)The standard preparation method for BDD substances is to soak 280 g of fresh lilies for 10 hours,remove the floating foam,add 400 mL of water,and fry the whole process without covering the fire(boiling with fire until boiling,then turning to low heat and keeping slightly boiling)until 200 mL,then add 200 mL of fresh Rehmannia juice and fry to 300 mL,pass through a 100 mesh filter to obtain the BDD decoction,concentrate(heated in a 60℃water bath),and freeze dry.(2)Fifteen batches of BDD substance reference HPLC fingerprint spectra(S1-S15)were established,with similarity greater than 0.9.A total of 21 common peaks were calibrated,and four chromatographic peaks were identified(8 peaks Zichun,13 peaks Dihuang glycoside D,17 peaks Wangbaicalin A,and 20 peaks Wangbaicalin B).(3)The results of multivariate statistical analysis showed that S1,S2,S3,S7,S8,S9,S10,S14,and S15 clustered into one group,while other batches clustered into one group.Moreover,peak 8 Zichun and peak 17 Wangbaicalin A had a significant impact on clustering discrimination.(4)Among the 15 batches of BDD substance standards,the content ranges of Zichun,Dihuangoside D,and Wanglilianoside A are(21.77-46.41)mg·g-1,(1.8-3.66)mg·g-1,and(0.34-1.09)mg·g-1,respectively.(5)Among the 15 batches of BDD substance standards,the transfer rates of decoction substance standards for Zichun,Dihuang glycoside D,and Wanglilide A ranged from 66.23%to 97.64%,41.19%to 89.06%,and 71.91%to 94.01%,respectively.Conclusion:This study optimized the preparation process of BDD substance reference,established HPLC finger-print of BDD substance reference,identified the main chemical components that caused differences in different batches,and found that the main chemical components of BDD substance reference can be stably transferred in the herbal decoction substance reference,laying a solid foundation for the development of new BDD formulations.