养心氏片HPLC-ELSD指纹图谱的建立及6个成分的含量测定  

Establishment of HPLC-ELSD Fingerprint and Determination of 6 Components of Yangxinshi Tablets

作　　者：胡晨泽 Hu Cenze(Affiliated Hangzhou First People’s Hospital,Zhejiang Oniversity School of Medicine,Hangzhou 310000,China)

机构地区：[1]浙江大学医学院附属杭州市第一人民医院,杭州310000

出　　处：《中国药师》2022年第6期1121-1125,共5页China Pharmacist

摘　　要：目的:建立养心氏片高效液相色谱-蒸发光散射检测器(HPLC-ELSD)指纹图谱,同时测定其中6个主要成分的含量。方法:采用Agilent XDB-C_(18)色谱柱(250 mm×4.6 mm,5μm),ELSD漂移管温度120℃,载气体积流量2.0 L·min^(-1);以乙腈-0.1%甲酸水溶液为流动相,梯度洗脱;采用“中药色谱指纹图谱相似度评价系统(2012A版)”建立10批养心氏片指纹图谱并进行相似度评价,并对部分色谱峰进行鉴定。结果:10批养心氏片样品共确定共有峰19个,与对照指纹图谱的相似度均不低于0.90。通过与混合对照品比对,指认化学成分6个,分别为人参皂苷Rg_(1)、人参皂苷Re、人参皂苷Rb_(1)、人参皂苷Rd、黄芪甲苷、黄芪皂苷Ⅰ。上述6个成分在各自的质量范围内线性关系良好(r>0.9990),平均加样回收率为99.8%-106.2%,RSD为0.72%-1.61%(n=9)。10批样品中上述成分的含量分别为0.5580-1.1120 mg·g^(-1)、0.3610-0.9520 mg·g^(-1)、0.6690-1.4140 mg·g^(-1)、0.1410-0.5520 mg·g^(-1)、0.2170-0.3640 mg·g^(-1)、0.1440-0.2360 mg·g^(-1)。结论:本研究所建立的方法简便准确,为养心氏片的质量评价与控制提供了有力的技术支持。Objective:To establish the fingerprint of Yangxinshi tablets by HPLC-ELSD,and determine the contents of 6 components in the preparation.Methods:The separation was developed on a Waters Sunfire ODS C_(18) column(250 mm×4.6 mm,5μm)with gradient elution by acetonitrile-0.1%formic acid solution,the temperature of drift tube maintained at 120℃,and the flow rate of carrier gas was 2.0 L·min^(-1).The HPLC fingerprints of 20 batches of Yangxinshi tablets were analyzed by the Similarity Evaluation System for Chromatographic Fingerprint of TCM(2012A Edition),and the similarity was evaluated,as well as some chromatographic peaks were identified.Results:There were 19 common peaks in the HPLC fingerprints of 10 batches of samples,and the similarity with the control fingerprint was not lower than 0.90.By comparing with the mixed reference substances,6 components were identified,which were ginsenoside Rg_(1),ginsenoside Re,ginsenoside Rb_(1),ginsenoside Rd,astragalosideⅣand astragalosideⅠ.The above 6 components were well linearly related within their respective mass ranges(r>0.9990),the average adding sample recoveries were 99.8%-106.2%,and the RSDs were 0.72%-1.61%(n=9).In the 10 batches of samples,the contents of the above 6 components were(0.5580-1.1120)mg·g^(-1),(0.3610-0.9520)mg·g^(-1),(0.6690-1.4140)mg·g^(-1),(0.1410-0.5520)mg·g^(-1),(0.2170-0.3640)mg·g^(-1) and(0.1440-0.2360)mg·g^(-1),respectively.Conclusion:The method established in the study is simple and accurate,which provides a strong technical support for the quality evaluation and quality control of Yangxinshi tablets.

关 键 词：养心氏片 指纹图谱 高效液相色谱--蒸发光散射检测器 相似度 质量控制 含量测定 

分 类 号：TQ460.72[医药卫生—药物分析学]