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目的:建立二至胶囊的质量控制方法。方法:采用TLC法鉴别二至胶囊中女贞子、墨旱莲;采用HPLC法测定齐墩果酸、熊果酸含量。色谱条件:Agilent ZORBAXSB-C18(4.6mm×250mm,0.45μm)色谱柱;甲醇-乙腈-0.2moL.L-1乙酸铵(60:22:18)为流动相,流速0.8mL.min-1;检测波长215nm。结果:定性鉴别薄层色谱特征明显;齐墩果酸在25.6～256μg.mL-1线性关系良好(r=0.9997),平均回收率为99.25%,RSD为1.24%;熊果酸在14.4～144μg.mL-1线性关系良好(r=0.9991),平均回收率为99.20%,RSD为0.97%。结论:本法可以准确地进行定性、定量检测,有效地控制该制剂的质量。
Objective: To establish the quality control method of Erzhi capsule. Methods: The Fructus Ligustri Lucidi and Eclipta in Erzhi capsules were identified by TLC. The contents of oleanolic acid and ursolic acid were determined by HPLC. Chromatographic conditions: Agilent ZORBAXSB-C18 (4.6mm × 250mm, 0.45μm) column; methanol-acetonitrile-0.2moL.L-1 ammonium acetate (60:22:18) as mobile phase at a flow rate of 0.8mL.min-1; Detection wavelength of 215nm. Results: The qualitative identification of TLC was obvious. Oleanolic acid showed good linearity (r = 0.9997) at 25.6 ~ 256μg.mL-1 with an average recovery of 99.25% and RSD of 1.24% mL-1 (r = 0.9991). The average recovery was 99.20% and the RSD was 0.97%. Conclusion: This method can accurately carry out qualitative and quantitative tests, and effectively control the quality of the preparation.