复方三七片质量标准研究

Studies on quality standard of compound pseudo-Ginseng tablets

目的研究成方制剂复方三七片的质量标准。方法采用TLC对白芷、三七进行定性鉴别;采用HPLC进行主成分含量测定,色谱柱为Aglient ZORBAX C18柱(150 mm×4.6 mm,5μm),流动相为乙腈-水,梯度洗脱,流速为1.0 mL/min,检测波长为203 nm。结果 TLC可鉴别三七和白芷,HPLC测定人参皂苷Rg1、人参皂苷Rb1和三七皂苷R1,三者分别在0.048～0.384 mg、0.052 5～0.420 mg、0.011 8～0.094 4 mg范围内线性、精密度、稳定性均良好,阴性无干扰,平均加样回收率分别为100.91%(RSD=1.04%)、100.36%(RSD=1.04%)、100.29%(RSD=0.99%)。结论所建立的质量标准简便可行、重复性好,可以用来评价复方三七片的质量。

Objective To establish a quality standard for compound Pseudo-Ginseng tablets Methods Angelica dahurica and Pseudo-Ginseng were identified by thin layer chromatography.The content of Ginsenoside Rg1,Ginsenoside Rb1 and Notoginsenoside R1 were determined by High Performance Liquid Chromatography.Chromatographic conditions： Aglient ZORBAX C18 column（150 mm×4.6 mm,5 μm） was used as the stationary phase,a mixture of acetonitrile and water as the mobile phase was adopted.The flow rate was 1.0 mL/min,and the detection wavelength at 203 nm.Results The qualitative identification with TLC were specific.The linear response range was 0.048～0.384 mg/mL for Ginsenoside Rg1,0.0525～0.420 mg/mL for Ginsenoside Rb1,and 0.0118～0.0944 mg/mL for Notoginsenoside R1.The average recoveries of these compounds were 100.91%（RSD=1.04%）,100.36%（RSD=1.04%）,100.29%（RSD=0.99%）,respectively.Conclusion This method is simple,accurate and reproducible for quality control of Compound Pseudo-Ginseng Tablet.