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作 者:韩亚亮[1] 古今[1] 何新荣[1] 张飞燕[2] 吉铁凤[3]
机构地区:[1]解放军总医院药品保障中心中药房,北京100853 [2]大理医学院,云南大理671000 [3]解放军总医院内科临床部肿瘤内一科,北京100853
出 处:《中国药物应用与监测》2015年第5期268-271,共4页Chinese Journal of Drug Application and Monitoring
基 金:军队医疗机构制剂标准提高科研专项课题计划重点项目(13ZJZ22)
摘 要:目的:建立高效液相色谱法测定血塞通软胶囊中三七皂苷R1、人参皂苷Rg1、Re、Rb1含量的方法,为制定该制剂质量标准提供参考。方法:采用HPLC法,选用ZORBAX SB-Aq色谱柱(250 mm×4.6 mm,5μm);流动相为乙腈-水梯度洗脱;流速:1.0 m L·min-1;检测波长:203 nm;柱温:25℃。结果:三七皂苷R1、人参皂苷Rg1、人参皂苷Re和人参皂苷Rb1分别在0.32-3.20μg、0.72-7.20μg、0.21-2.10μg、0.92-9.20μg范围内呈良好线性关系;相关系数分别为1.000 0、1.000 0、0.999 9、1.000 0;平均加样回收率(n=9)分别为100.22%、100.62%、100.02%、100.33%,且RSD分别为0.99%、1.18%、2.02%、0.97%。结论:该方法简便可行、准确、可靠,重现性好,结果稳定,可为血塞通软胶囊的质量控制方法提供参考。Objective: To establish the method for determining the notoginsenoside R1, ginsenoside Rg1, ginsenoside Re and ginsenoside Rb1 in Xuesaitong soft capsules by HPLC. Methods: The separation was performed on ZORBAX SB-Aq column(250 mm × 4.6 mm, 5 μm). The mobile phase consisted of acetonitrile-water with linear gradient elution. The flow rate was 1.0 m L·min-1. The detection wavelength was 203 nm and the column temperature was 25 ℃. Results: The calibration curves showed good linearity in the range of 0.32 – 3.20 μg(notoginsenoside R1, r = 1.000 0), 0.72 – 7.20 μg(ginsenoside Rg1, r = 1.000 0), 0.21 – 2.10 μg(ginsenoside Re, r = 0.999 9), 0.92 – 9.20 μg(ginsenoside Rb1, r = 1.000 0). The average recoveries(n = 9) were 100.22%, 100.62%, 100.02%, 100.33% respectively, and RSD were 0.99%, 1.18%, 2.02%, 0.97% respectively. Conclusion: The method is convenient, rapid, economical and accurate, which is suitable for quality control of Xuesaitong soft capsules.
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