HPLC指纹图谱技术结合模式识别分析评价参莲胶囊的质量  

Quality evaluation of Shenlian capsules by HPLC fingerprint and pattern recognition

作　　者：韩晴雯 周斌[2] 李玉平[1] 顾志华[1] HAN Qing-wen;ZHOU Bin;LI Yu-ping;GU Zhi-hua(The Pharmacy Department of Shanghai Lung Hospital,Shanghai 200433,China;The Pharmacy Department of Shanghai Shuguang Hospital,Shanghai 200021,China)

机构地区：[1]上海市肺科医院药剂科,上海200433 [2]上海中医药大学附属曙光医院药剂科,上海200021

出　　处：《药物分析杂志》2020年第7期1300-1308,共9页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立参莲胶囊高效液相色谱(HPLC)指纹图谱,结合系统聚类分析和偏最小二乘法-判别分析(PLS-DA),为参莲胶囊的质量控制提供一种新方法。方法:选择5个制药厂家生产的25个批次参莲胶囊样品。采用HPLC法,以乙腈(A)-0.05%磷酸水溶液(B)为流动相进行梯度洗脱,流速1.0 mL·min-1,分段检测波长254 nm(0~19 min)、210 nm(19~90 min),柱温35℃,进样量20μL,建立参莲胶囊的指纹图谱,用中药色谱指纹图谱相似度评价系统(2012A版)建立指纹图谱共有模式和相似度计算,并用SIMCA14.0软件建立PLS-DA模型进行统计分析。结果:建立了参莲胶囊的HPLC指纹图谱,确定了28个共有峰,相似度计算结果在0.929~0.991之间,通过对照品比对指认出氧化苦参碱、苦参碱、粉防己碱、防己诺林碱、苦杏仁苷、齐墩果酸、熊果酸、补骨脂素、异补骨脂素9个成分。PLS-DA分析显示5个制药厂家25批参莲胶囊样品成分较为一致,但28个共有成分含量存在差异,且与生产厂家呈较好相关性。结论:所建立的指纹图谱方法专属性强,高效快速,可为参莲胶囊的质量控制提供参考。Objective:To establish the HPLC fingerprint of Shenlian capsules,and to provide a new method for the quality control of Shenlian capsules through cluster analysis combining discriminant analysis of partial least squares(PLS-DA).Methods:A total of 25 batches of Shenlian capsules supplied by 5 pharmaceutical manufacturers were used in this study.HPLC analysis was performed with acetonitrile(A)-0.05%phosphoric acid aqueous solution(B)as the mobile phase at a flow rate of 1.0 mL·min-1.The wavelength switching technology was used(0-19 min,254 nm;19-90 min,210 nm)and the column temperature was 35℃.The injection volume was 20μL.The fingerprint common pattern and similarity calculation were established using traditional Chinese medicine chromatographic fingerprint similarity evaluation system(2012 version A).The PLS-DA model was established using SIMCA 14.0 software to perform statistical analysis.Results:HPLC fingerprint of Shenlian capsules was established and 28 common peaks were identified in this study.The similarities ranged from 0.929 to 0.991.Nine components were identified as oxymatrine,matrine,tetrandrine,fangchinoline,amygdalin,oleanolic acid,ursolic acid,psoralen and angelicin.PLS-DA indicated components in 25 batches of Shenlian capsules from 5 pharmaceutical manufacturers were consistent.However,there were differences in the contents of the 28 common components among different sample,and the contents of components were correlated with the pharmaceutical manufacturers.Conclusion:The established fingerprint method is specific,efficient and rapid,which can be used as a reference for the quality control of Shenlian capsules.

关 键 词：参莲胶囊 HPLC指纹图谱 相似度分析 聚类分析 偏最小二乘法-判别分析 质量控制 

分 类 号：R917[医药卫生—药物分析学]