宣肺止咳合剂的高效液相指纹图谱

HPLC fingerprints of Xuanfeizhike mixture

目的:建立宣肺止咳合剂的高效液相指纹图谱,为宣肺止咳合剂的质量控制和评价提供依据。方法:采用Agilent Zorbax SB-C18(4.6 mm×250 mm,5μm)色谱柱,在254 nm检测波长下以乙腈-0.1%甲酸水为流动相梯度洗脱,以葛根素为参照物,在相同的色谱条件下测定10批宣肺止咳合剂,并运用国家药典委员会中药色谱指纹图谱相似度评价系统(2004A)对10批宣肺止咳合剂进行相似度评价,并对组方中6味药材进行了相关性分析。结果:建立了宣肺止咳合剂的HPLC指纹图谱,10批样品的相似度在0.995~0.999之间,标定了28个共有指纹峰,其中26个归属到各药材,3个已确认成分。结论:该方法具有良好的精密度、重复性、稳定性,为宣肺止咳合剂的质量评价与质量控制提供了科学依据。

OBJECTIVE To establish the method of HPLC fingerprint analysis for Xuanfeizhike mixture and provide the basis for the control and evaluation of quality of commercially available Xuanfeizhike mixtures.METHODS HPLC method was used with Agilent Zorbax SB-C18（4.6 mm×250 mm,5μm）,at 254 nm detection wavelength,gradient eluted by acetonitrile-0.1%formic acid.By taking as the reference substance,the fingerprints of 10 batches of Xuanfeizhike mixture were analyzed under the same chromatographic conditions.The Similarity Evaluation System for Chromatographic Fingerprint of Chinese Materia Medica（version 2004A）was used to evaluate the similarity of 10 batches of Xuanfeizhike mixture,and to analyze the correlations of 6 ingredients in Xuanfeizhike mixture.RESULTS the common mode of HPLC fingerprint of Xuanfeizhike mixture was established,the similarity of 10 batches of Xuanfeizhike mixture was in the range of 0.995-0.999.Twenty eight common peaks weie identified,26 peaks of them were assigned to herbs,and 3 peaks were identified.CONCLUSION The method has good precision,repeatability,stability.The study provides a scientific foundation for quality evaluation and quality control standards for Xuanfeizhike mixture.