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.
作者
韩晴雯
周斌
李玉平
顾志华
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)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2020年第7期1300-1308,共9页
Chinese Journal of Pharmaceutical Analysis
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
Shenlian capsules
HPLC fingerprint
similarity analysis
cluster analysis
discriminant analysis of partial least squares
quality control
