复方板蓝根颗粒HPLC指纹图谱研究

Study on HPLC Fingerprint of Compound Banlangen Granule

目的:建立复方板蓝根颗粒的HPLC指纹图谱的分析方法,用于复方板蓝根颗粒的质量控制。方法:采用Kromasil C_(18)色谱柱(4.6 mm×250 mm,5μm),以甲醇-水为流动相进行梯度洗脱,流速为0.8 mL·min^(-1),检测波长254 nm,柱温为25℃,对指纹图谱进行共有峰标定,以R,S-告依春为参照峰计算各共有峰的相对保留时间和峰面积比值,采用2012年版《中药色谱指纹图谱相似度评价系统》软件对10批复方板蓝根颗粒进行相似度评价。结果:复方板蓝根颗粒HPLC指纹图谱分析方法的专属性、精密度、重现性和稳定性均良好;10批复方板蓝根颗粒指纹图谱与对照指纹图谱的相似度值均>0.90,相似度良好。结论:所建立的HPLC指纹图谱能够表达复方板蓝根颗粒中多组分的整体特征,为复方板蓝根颗粒的质量控制提供了方法依据。

Objective To establish the High Performance Liquid Chromatography(HPLC)method for fingerprint of Compound Banlangen Granule,which can be used for the quality control of Compound Banlangen Granule.Methods The separation was developed on a Kromasil C_(18) column(4.6 mm×250 mm,5μm)by gradient elution with methanol-water as the mobile phase,flow rate at 0.8 mL·min^(-1),detection wavelength at 254 nm and column temperature at 25℃.(R,S)-goitrin was used as reference.The chromatographic fingerprint similarity evaluation system software(version 2012)was used for fingerprints comparison and similarity evaluation for 10 batches of Compound Banlangen Granule.Results The HPLC method for fingerprint of Compound Banlangen Granule was specific,precise,re-producible and stable.The similarities between reference and 10 batches of Compound Banlangen Granule were all great than 0.90.Conclusions The established HPLC fingerprint can express the overall characteristics of the multi-components in the Compound Banlangen Granule and provide a tool for its quality control.