通便灵片质量标准研究

Study on the Quality Standards of Tongbianling Tablet

目的制定通便灵片的质量标准。方法采用薄层色谱法鉴别通便灵片中的番泻叶、当归,采用高效液相色谱法测定本品中大黄酸含量。结果薄层层析可鉴别出番泻叶、当归,大黄酸在0.13～1.17μg范围内呈良好的线性关系,平均回收率97.08%(RSD=1.91%,n=6)。结论方法简单可控,可有效地控制本品的质量,保证临床疗效。

Objective To establish the quality standards of Tongbianling Tablet. Methods The identification of Sennae Folium and Angelicae Sinensis Radix was performed by TLC, and the content of rhein in the tablet was determined by HPLC. Results Sennae Folium and Angelicae Sinensis Radix could be identified by TLC. The calibration curve was linear in the range of 0.13-0.17 μg of rhein （r =0.9999）. The average recovery was 97.08% （RSD=1.91%, n=6）. Conclusin The methods were simple and available for quality control of this prescription.