金桑芪抗毒滴丸HPLC特征指纹图谱研究

摘要

目的 建立金桑芪抗毒滴丸 HPLC 特征指纹图谱,对该制剂进行质量控制.方法 采用 Waters XSELECT CSH-C18色谱柱(4.6 mm×150 mm,5 μm),以乙腈-0.1%磷酸溶液为流动相梯度洗脱,流速为1.0 mL/min,柱温为30 ℃,检测波长为260 nm.以毛蕊异黄酮葡萄糖苷、芦丁、甘草苷、金丝桃苷、槲皮素和甘草酸铵为参照物,对10批金桑芪抗毒滴丸进行相似度分析.结果 金桑芪滴丸特征图谱共有24个共有峰,比对出了贯叶连翘、桑白皮、黄芪和甘草的特征峰,各批样品的相似度均在0.9以上.结论 采用HPLC特征图谱可对金桑芪抗毒滴丸实现全面和整体的评价,为有效提高该制剂的质量控制提供参考.%Objective To establish fingerprint of Jinsangqi Kangdu Dropping Pills by HPLC; To control the quality of the preparation. Methods Waters XSELECT CSH-C18 chromatographic column (4.6 mm × 150 mm, 5 μm) was used and eluted with acetonitrile - 0.1% phosphoric acid solution gradient at the flow rate of 1.0 mL/min. The detection wavelength was 260 nm with column temperature of 30 ℃. Using calycosin-7-O-β-D-glucopyranoside, rutin, liquiritin, hyperoside, quercetin and ammonium glycyrrhizinate as the object references, ten batches of Jinsangqi Kangdu Dropping Pills were tested and analyzed by similarity comparison.Results Fringerprint spectrum of Jinsangqi Kangdu Dropping Pills had 24 common peaks in total, and characteristic spectrums of Hypericum Perforatum, Mori Cortex, Astragali Radix and Glycyrrhizae Radix et Rhizoma had been found, while similarity of HPLC fingerprint was more than 0.9 among those batches of samples. Conclusion Using HPLC fingerprint can evaluate the Jinsangqi Kangdu Dropping Pills quality totality,which can provide references for improving the quality control of the preparation.