二至胶囊质量标准研究

Study on the quality control standard of Erzhi capsules

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 standard for Erzhi capsules.Method： Fructus ligustri lucidi,Eclipta prostrata in this preparation were identified by TLC.The content of and in Erzhi capsules were determined by HPLC with was performed on an Agilent Zorbaxsb C18（4.6 mm×250 mm,0.45 μm）column with a mobile phase of methanol-acetonitrile -0.2 mol/mL-1.The wavelength of detector was set at 215 nm.Result：Characteristics of identification were very obviously.The linear range of ranged from 25.6 μg/mL-1 to 256 μg/mL-1（r=0.9997） and the average recovery was 99.25% （RSD=1.24%）.The linear range of ranged from 14.4 μg/mL-1 to 144 μg/mL-1（r=0.9991） and the average recovery was 99.20%（ RSD=0.97%）.Conclustion：The method of qualitative and quantitative analysis are accurate and suitable for effectively quality control of the preparation.