复方三叶香茶菜片质量标准的改进

Quality standard improvement of Compound Isodon Rernifolia (D.Don) Kudo Tablets

目的：建立复方三叶香茶菜片中齐墩果酸和熊果酸的HPLC-ELSD含量测定方法。方法：采用高效液相色谱-蒸发光散射检测器,以齐墩果酸和熊果酸为指标成分,色谱柱为Agilent Eclipse XDB-C18（4.6 mm×250 mm,5μm）;流动相为甲醇-0.5%醋酸铵（82∶18）;流速1.0 mL/min;柱温30℃;ELSD漂移管温度85℃;雾化气体流量2.0 L/min。结果：齐墩果酸在0.45～2.69μg（r=0.999 9）、熊果酸在0.63～3.75μg（r=0.999 3）的范围内具有良好的线性关系;平均回收率齐墩果酸为100.3%（RSD=1.32%）,熊果酸为100.6%,（RSD=1.66%）。结论：所建立的方法操作简便,定量准确,专属性强,优于原有标准收载的方法。

AIM： HPLC-ELSD method was established to investigate the content of oleanolic acid and ursolic acid in Compound Isodon Rernifolia （ D. Don ） Kudo Tablets. METHODS ： The determination of oleanolic acid and ursolic acid was conducted by HPLC-ELSD using a Agilent Eclipse XDB-C18（4.6 mm ×250 mm,5 μm） column： The mobile phase consisted of methanol-0.5% ammonium acetate solution （ 82：18 ）. The flow rate was 1.0 mL/ rain. The column temperature was set at 30 ℃. The drift tube temperature was set at 85 ℃. The gas flow rate was 2.0 L/min. RESULTS ： The linear ranges of oleanolic acid and ursolic acid were 0.45-2.69 μg （ r = 0. 999 9 ） and 0.63-3.75 μg （ r = 0. 999 3 ） , respectively. The average recoveries of oleanolic acid and ursolic acid were 100.3% （RSD = 1.32% ） and 100.6% （ RSD = 1.66% ）. respectively. CONCLUSION： The method is simple, accurate, and specific which is better than the original one.