润肠通便颗粒质量标准研究

Quality Standard for Runchang Tongbian Granules

目的建立润肠通便颗粒的质量控制方法。方法采用TLC法对方中决明子、当归进行定性鉴别;采用HPLC法测定样品中大黄素、大黄酚的含量。色谱条件:色谱柱为Hypersil ODS2 C18柱(150 mm×4.6 mm,5μm);流动相:甲醇-0.1%磷酸溶液(84∶16);流速:1 ml·min-1;柱温:室温;检测波长:254 nm。结果薄层定性鉴别的斑点清晰,分离效果良好;大黄素含量在1.1～44μg·ml-1的浓度范围内线性关系良好(r=0.9999),平均加样回收率为98.05%,RSD为1.2%(n=6);大黄酚含量在1.6～64μg·ml-1范围内线性关系良好(r=0.9999),平均加样回收率为98.07%,RSD为1.1%(n=6)。结论本实验简单易行,结果准确,重复性好,可作为该制剂的质量控制标准。

Objective To establish a quality standard for Runchang Tongbian granules. Methods Rhei Radix et Rhizoma and Angelicae Sinensis Radix were identified by TLC. Emodin and chrysophanol in Runchang Tongbian granules were determined by HPLC. Hypersil ODS2 Cls （ 150 mm ×4.6 mm,5 μm） column was used. The mobile phase consisted of methanol-0.1% phosphoric acid solusion （84： 16） at a flow rate of 1.0 ml ·min^-1 The detection wavelength was set at 254 nm under room temperature. Results Spots in the TLC were clear. The calibration curves were linear within the range of 1.1-44 μg ·ml^-l（ r =0. 9999） for emodin and 1.6-64 μg ·ml^-1（ r =0. 9999） for chrysophanol. The average recovery （ n =6） of emodin and chrysophanol was 98.05% with RSD 1.2% and 98.07% with RSD 1.1%, respectively. Conclusions This method is simple, accurate and repeatable, which can be used for quality control of Runchang Tongbian granules.