目的：建立顽痹清丸高效液相色谱（HPLC）指纹图谱评价体系，为顽痹清丸的质量控制提供依据。方法以Agilent C18柱（4.6 mm×250 mm，5μm）为色谱柱，以乙腈-0.1%磷酸水溶液为流动相梯度洗脱，流速1.0 mL/min，检测波长258 nm，进样量20μL。对10批顽痹清丸样品进行测定，采用《中药色谱指纹图谱相似度评价系统（2004 A）》建立顽痹清丸的标准指纹谱，并计算各批样品的相似度。结果所建立的顽痹清丸指纹图谱共确定20个共有峰，相似度不低于0.98，5个峰得到化学确认。结论建立的HPLC指纹图谱方法稳定易行，重复性好，可用于顽痹清丸的质量评价。%Objective To establish an evaluation system of HPLC fingerprint of Wanbiqing Pills; To provide references for the quality control ofWanbiqing Pills.Methods Wanbiqing Pills were analyzed with HPLC method. Analysis was performed on Agilent C18 column (4.6 mm×250 mm, 5μm) with the mobile phase of acetonitrile- 0.1%H3PO4 water gradient elution at the flow rate of 1.0 mL/min. The detection wavelength was 258 nm. Sample injection was 20μL. Standard fingerprint ofWanbiqing Pills was established based on Similarity Evaluation System for Chromatographic Fingerprint of TCM (Version 2004 A). The similarity ofWanbiqing Pills from different batches was computed.Results A standard HPLC fingerprint procedure was developed forWanbiqing Pills with 20 common peaks. The similarity of 10 batches ofWanbiqing Pills was not lower than 0.98. Five peaks received chemical confirmation.Conclusion The HPLC method is stable and feasible and with good repeatability, which can be used for the quality control ofWanbiqing Pills.
展开▼
