[关键词]
[摘要]
目的 建立玉泉丸HPLC指纹图谱,并同时测定玉泉丸中6种成分含量,为玉泉丸质量控制提供科学依据。方法 采用HPLC法,Symmetery C18色谱柱(250 mm×4.6 mm,5 μm),以乙腈-0.1%磷酸水溶液为流动相梯度洗脱,体积流量1.0 mL/min,柱温30℃。建立11批玉泉丸HPLC指纹图谱,用中药色谱指纹图谱相似度评价系统软件(2012A版)、聚类分析及主成分分析进行评价,同时测定葛根素、大豆苷元、毛蕊花糖苷、五味子醇甲、甘草酸及甘草苷的含量。结果 建立了玉泉丸的HPLC指纹图谱,标定了共有峰12个,各批相似度均在0.9以上。多成分定量分析条件通过方法学考察,6个成分加样回收率均在92.06%~109.34%,RSD均在0.22%~2.76%。11批玉泉丸中葛根素、大豆苷元、毛蕊花糖苷、五味子醇甲、甘草酸及甘草苷含量范围分别为0.838~2.777、0.550~1.014、0.312~0.618、0.023~0.092、1.154~1.674、0.035~0.052 mg/g。结论 HPLC指纹图谱结合多成分同时测定的方法,快速、简便、重复性好,可为玉泉丸的质量控制提供方法学参考。
[Key word]
[Abstract]
Objective In order to provide a scientific basis for the quality control of Yuquan Pills (YP), HPLC fingerprint strategy was established and six components were determined. Methods The HPLC analysis was performed on Symmetery C18 column (250 mm×4.6 mm, 5 μm), using acetonitrile and 0.1% phosphoric acid solution as the mobile phase at a flow rate of 1.0 mL/min, and the column temperature was 30℃. The fingerprints of 11 batches of YP were established and evaluated by the similarity evaluation system of TCM (version 2012A), clustering analysis and principal component analysis. Furthermore, the content of puerarin, daidzein, verbascoside, schisandrin, glycyrrhizic acid, and glycyrrhizin was determined. Results The HPLC fingerprint with 12 common peaks of YP was established, and the similarities of samples were over 0.9. After validating the multiple component quantitative analysis condition through methodology, the average recoveries (n=9) were between 92.06% and 109.34%, and the RSD were in the range of 0.22%-2.76%. The content of puerarin, daidzein, verbascoside, schisandrin, glycyrrhizic acid, and glycyrrhizin in 11 batches of YP were in the range of 0.838-2.777, 0.550-1.014, 0.312-0.618, 0.023-0.092, 1.154-1.674, 0.035-0.052 mg/g, respectively. Conclusion The combination methods of HPLC fingerprint and simultaneous determinations of multiple components are rapid, simple and reproducible, which can provide methodological reference for the quality control of YP.
[中图分类号]
R286.02
[基金项目]
国家自然科学基金面上项目(81573560);河北省科技支撑项目(No.13226805D)