三七接骨丸中三七的质量控制标准研究

摘要

目的：建立三七接骨丸中三七的快速检测方法及含量测定方法。方法采用薄层色谱法快速检测三七接骨丸中的三七药材，采用HPLC法测定三七中主要成分人参皂苷Rb1、人参皂苷Rg1及三七皂苷R1的含量：采用 Hibar ODS C18（4.6×250mm，5μm）色谱柱，流动相为乙腈-水，梯度洗脱，流速1.0mL· min 1，柱温30℃，检测波长203nm。结果人参皂苷 Rb1、人参皂苷 Rg1、三七皂苷 R1分别在0.01270mg· mL 1～0.4064mg· mL 1（r＝0.9997）、0.01416mg· mL 1～0.4530mg· mL 1（r＝0.9998）、0.0054mg· mL 1～0.1742mg· mL 1（r＝0.9999）范围内线性关系良好，平均回收率分别为人参皂苷Rb195.41％（RSD＝0.78％，n＝6）、人参皂苷Rg195.32（RSD＝0.39％，n＝6）、三七皂苷 R194.74％（RSD＝0.82％，n＝6）。结论该方法准确有效、重复性好，可作为三七接骨丸中三七的质量控制方法。%OBJECTIVE To establish a rapid detection method and a HPLC method for determination of Notog-inseng in Sanqi Jiegu Pills.METHODS Notoginseng was identified rapidly by TLC method ,and Ginsenoside Rb 1、Ginsenoside Rg1 and Notoginsenoside R1 in Notoginseng were determined by HPLC.Hibar ODS C18(4.6 ×250mm, 5μm) column was used ,with the mobile phase consisting of acetonitrile-water,gradient elution ,the volume of flow of 1.0mL· min-1 ,column temperature of 30℃ and detection wavelength of 203nm.RESULTS The linear ranges of Ginsenoside Rb1、Ginsenoside Rg1、Notoginsenoside R1 were 0.01270mg· mL-1 ~0.4064mg· mL-1(r=0.9997)、0.01416mg· mL-1 ~0.4530mg· mL-1(r=0.9998)、0.0054mg· mL-1 ~0.1742mg· mL-1(r=R=0.9999), respectively.The average recoveries of 95.41%(RSD=0.78%,n=6)for Ginsenoside Rb1,95.32(RSD=0.39%,n=6) for Ginsenoside Rg1 and Notoginsenoside R1 94.74%(RSD=0.82%,n=6) was obtained.CONCLUSION The method is accurate and effective ,and with good reproducibility.It can be used for the quality control of Notogin-seng in Sanqi Jiegu Pills.