基于HPLC指纹图谱的浙贝母质量评价  

Quality Evaluation of Fritillariae Thunbergii Bulbus by HPLC Fingerprint

作　　者：秦建平[1] 李家春[1] 吴建雄[1] 吴素素[1] 黄文哲[1] 王振中[1] 萧伟[1] 

机构地区：[1]江苏康缘药业股份有限公司中药制药过程新技术国家重点实验室,江苏连云港222001

出　　处：《中国实验方剂学杂志》2015年第19期34-36,共3页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家"重大新药创制"科技重大专项(2011ZX09201-201-20)

摘　　要：目的:建立浙贝母药材HPLC指纹图谱,为其质量控制提供比较全面的评价方法。方法:Welch XtimateTMC18色谱柱(4.6 mm×250 mm,5μm);流动相乙腈-10 mmol·L-1乙酸铵溶液(氨水调p H至10.0),梯度洗脱;流速0.8 m L·min-1,柱温25℃,蒸发光散射检测器。利用化学计量学方法,包括相似度分析、聚类分析、主成分分析,对色谱数据进行分析。结果:该方法精密度、稳定性、重复性良好。测定了16批浙贝母药材,提取7个色谱峰作为指纹图谱共有峰,采用相似度评价、聚类分析和主成分分析等方法,对所收集的16批样品进行系统比较与归类,16批样品分为2类。结论:该法重复性好,简便可靠,可以为浙贝母的质量控制和评价提供依据。Objective： To estabilish an HPLC fingerprint of Fritillariae Thunbergii Bulbus to provide a comprehensive evaluation for its quality control. Method： Welch XtimateTM C18 （4.6 mm × 250 mm, 5μm） column was used and eluted with a mobile phase of acetonitrile-10 mmol . L-1 ammonium acetate solution （ pH 10.0） in a gradient mode, the flow rate was 0.8 mL .min-1 , the column temperature was 25 ℃. An evaporated light scattering detector was used to determine the fingerprint. The fingerprint was further evaluated by chemometric methods, including similarity analysis （SA）, hierarchical clustering analysis （HCA） and principal component analysis （PCA）. Result： The precision, stability and repeatability of the method were favorable. Seven chromatographic peaks were extracted as the common peaks of fingerprint, and 16 batches of samples were compared and classified with such methods as SA, HCA and PCA, and then divided into 2 clusters by their quality difference. Conclusion： The method is reproducible, simple and reliable and can be used for the quality control and evaluation of Fritillariae Thunbergii Bulbus.

关 键 词：浙贝母 高效液相色谱-蒸发光散射 指纹图谱 化学计量学 质量评价 

分 类 号：R284.1[医药卫生—中药学]