绞股蓝总苷片的指纹图谱及含量测定  

UPLC fingerprint and content determination of Jiaogulan Zonggan tablet

作　　者：辛祎 李山姗 王淼[1] 王一男[1] 赵春杰[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]沈阳市第一二0中学,辽宁沈阳110000

出　　处：《沈阳药科大学学报》2016年第3期208-214,共7页Journal of Shenyang Pharmaceutical University

摘　　要：目的采用超高效液相色谱法建立中药制剂绞股蓝总苷片的指纹图谱,并同时测定其中人参皂苷Rb1和绞股蓝皂苷XLIX的含量。方法采用Kromat Universil XB C18色谱柱（150 mm×2.1mm,3μm）,以乙腈-水为流动相进行梯度洗脱,流速为0.2mL·min-1,检测波长为203nm,柱温为30℃;建立绞股蓝总苷片指纹图谱,运用中国药典委员会＂中药色谱指纹图谱相似度评价系统软件＂对10批制剂进行相似度评价,并对其中2个色谱峰进行指认及含量测定。结果 10批绞股蓝总苷片指纹图谱中标定了17个共有色谱峰,相似度值为0.983~0.995。人参皂苷Rb1和绞股蓝皂苷XLIX质量浓度分别在4.2~42.0mg·L-1和9.4~94.0mg·L-1内与峰面积呈良好的线性关系,平均回收率分别为98.5%和99.4%。结论用该方法所建立的皂苷类指纹图谱方法,结合有关成分的含量测定能更好地控制其质量,对提高绞股蓝总苷片的整体质量控制提供参考依据。Objective To establish the UPLC fingerprint and a method for content determination of Jiaogulan Zonggan tablet,and a method to simultaneously determine the content of ginsenoside Rb1 and gypenoside XLIX in Jiaogulan Zonggan tablet.Methods The separation was performed on a Kromat Universil XB C18 column（150 mm×2.1 mm,3μm）with acetonitrilewater as the mobile phase by gradient elution at the flow rate of 0.2 mL·min-1.The detection wavelength was 203 nm and the column temperature was 30℃.An UPLC fingerprint of Jiaogulan Zonggan tablet was set up and the quality of 10 batches of Jiaogulan Zonggan tablet was evaluated by similarity assay.Furthermore,the two peaks were identified and the content was determinated.Results The fingerprint chromatogram had17 common peaks,and the similarity of 10 batches of Jiaogulan Zonggan tablet was about 0.983 to 0.995.The linear range of ginsenoside Rb1 and gypenoside XLIX were 4.2-42.0 mg·L-1 and 9.4-94.0 mg·L-1,respectively.The average recoveries were 98.5% and 99.4%,respectively.Conclusions The established method of UPLC fingerprint of Jiaogulan Zonggan tablet is simple,reproducible and specific,which can be used for evaluating the guality of Jiaogulan Zonggan tablet combining with the content determination method.

关 键 词：绞股蓝总苷片 指纹图谱 含量测定 

分 类 号：R917[医药卫生—药物分析学]