二至胶囊质量标准研究___

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(4.6 mm×250 mm,0.45 μm)色谱柱 甲醇-乙腈-0.2 moL• L-1乙酸铵（60∶22∶18）为流动相，流速0.8 mL• min-1 检测波长215 nm。结果：定性鉴别薄层色谱特征明显 齐墩果酸在 25.6~256 μg• 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14.4~144 μg• 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.

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