金沙牛化石片高效液相色谱指纹图谱研究

HPLC fingerprint of jinshaniu huashi tablets

目的建立金沙牛化石片高效液相色谱(HPLC)法指纹图谱,为科学评价金沙牛化石片质量及其生产工艺稳定性提供依据。方法采用Agi Lent ZORBAX SB-C_(18)色谱柱(4.6 mm×150 mm,5μm),以0.2%磷酸-乙腈为流动相进行梯度洗脱,流速为1.0 m L·min^(-1),检测波长为254 nm,柱温为25℃。采用国家药典委员会"中药色谱指纹图谱相似度评价系统(2012版)"对10批金沙牛化石片进行相似度评价。结果以夏佛塔苷为参照峰,初步建立了金沙牛化石片HPLC指纹图谱,确定了18个共有峰,10批金沙牛化石片样品指纹图谱相似度均在0.9以上。结论该方法简便、准确、重复性好,可用于金沙牛化石片质量控制。

Objective To establish HPLC fingerprints of jinshaniu huashi tablets,to provide basis for the scientific assessments of jins-haniu huashi tablets’quality and stability of the production process.Methods The separation was performed on a ZORBAX SB-C18 column（4.6 mm ×150 mm,5 μm）with 0.2% phosphoric acid-acetonitrile as the mobile phase in a gradient elution at a flow rate of 1.0 mL·min -1 .The detection wavelength was set at 254 nm,and the column temperature was set at 25 ℃.Fingerprint Similarity Eval-uation Software（edition 2012）of Chinese Pharmacopoeia Commission was used to evaluate the similarity of the 10 batches of Jinshaniu Huashi Tablets.Results The common mode for the HPLC fingerprint was set up with schaftoside as the reference peak.Eighteen co-processing peaks were selected as the fingerprint peaks of jinshaniu huashi tablets.Good similarities with correlation coefficients higher than 0.9 were found between 10 batches of jinshaniu huashi tablets and the standard fingerpint.Conclusions The method is simple, accurate,and reproducible,which could be used for quality control of jinshaniu huashi tablets.