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目的:为控制玄丹巴布剂质量标准,保证药物安全有效,对玄丹巴布剂中三七皂苷R1和人参皂苷Rg1进行了含量测定方法的研究。方法:高效液相色谱条件:十八烷基硅烷键合硅胶色谱柱:kromasilM C18(250mm×4.6mm,5μm);流动相为乙腈-0.05%磷酸溶液梯度洗脱,0～10min,24%乙腈;10～40min,24%乙腈～27%乙腈;检测波长为203nm;柱温35℃,流速1.0mL·min-1。结果:三七皂苷R1的回归方程为Y=321822.5X-8203.2,r=0.9993(n=5),线性范围为0.135～0.676μg;人参皂苷Rg1回归方程为Y=363982.7X-82277.6,r=0.9995(n=5),线性范围为0.866～4.332μg。样品的平均回收率分别为95.3%,97.8%,RSD分别为2.8%,2.6%(n=5)。结论:本方法简便可靠,结果稳定,重复性好,可准确测定玄丹巴布剂中三七皂苷R1和人参皂苷Rg1的含量。
OBJECTIVE: To control the quality standard of Xuandan Babu agent and ensure the safety and effectiveness of the drug. The content determination methods of notoginsenoside R1 and ginsenoside Rg1 in Xuandan Babu was studied. Method: HPLC conditions: octadecylsilane bonded silica gel column: kromasil M C18 (250mm×4.6mm, 5μm); mobile phase was acetonitrile-0.05% phosphoric acid solution gradient elution, 0～10min, 24% acetonitrile ; 10 ~ 40min, 24% acetonitrile ~ 27% acetonitrile; detection wavelength is 203nm; column temperature 35 °C, flow rate 1.0mL · min-1. Results: The regression equation of notoginsenoside R1 was Y=321822.5X-8203.2, r=0.9993 (n=5), the linear range was 0.135～0.676μg; the regression equation of ginsenoside Rg1 was Y=363982.7X-82277.6, r=0.9995. (n=5) The linear range is 0.866 to 4.332 μg. The average recoveries of the samples were 95.3% and 97.8%, respectively, and the RSDs were 2.8% and 2.6% (n=5), respectively. Conclusion: The method is simple and reliable, the result is stable, and the repeatability is good. The content of notoginsenoside R1 and ginsenoside Rg1 in Xuandan Babu agent can be accurately determined.