宫血宁胶囊HPLC指纹图谱研究

HPLC fingerprint of Gongxuening Capsules

目的本研究建立宫血宁胶囊(重楼)的HPLC指纹图谱分析方法,为宫血宁胶囊内在质量评价积累数据。方法采用RP-HPLC方法,以Agilent Series SB-AQ C18色谱柱(4.6 mm×250 mm,5μm);流动相为乙腈(A)-水(B),梯度洗脱程序为5～50 min2,0%～42%A;50～70 min4,2%～44%A;70～100 min4,4%～80%A;100～120 min,80%～95%A;洗脱时间为120 min;检测波长203 nm;体积流量1.0 mL/min;柱温30℃;进样量10μL,进行指纹图谱研究。结果建立宫血宁胶囊指纹图谱,以重楼皂苷H色谱峰为参照峰,确定12个共有峰,测定了60批样品,样品指纹图谱相似度均大于0.99。结论本法操作简便、分离效果好、稳定性高、重现性好,可应用于宫血宁胶囊的质量控制及真伪品鉴别。

AIM To establish the HPLC fingerprint of Gongxuening Capsules（Paris polyphylla Smith var.yunnanensis（Franch.） Hand.-Mazz） and accumulate data for evaluation of its quality.METHODS The chromatographic fingerprints were determined with reversed-phase HPLC on an Agilent Series SB-AQ C18（4.6 mm×250 mm,5 μm）with the gradient solvent system consisting of acetonitrile（A）and water（B）,5-50 min,20%-42% A;50-70 min,42%-44% A;70-100 min,44%-80% A;100-120 min,80%-95% A,The flow rate was 1 mL/min,the detection wavelength was set at 203 nm,and the column temperature was maintained at 30 ℃.To deal with the data by ＂ similarity of software of Chinese traditional medicine fingerprints＂.RESULTS Based on the peaks of paris saponin H as reference peaks,measured value of sixty batches revealed that there were twelve common peaks and high similarity between samples of fingerprints.CONCLUSION This method is easy to handle and has good separation effect,reproducibility and high stability,and can be applied to quality control and product identifieation of Gongxuening Capsules.