通便宁片质量标准研究

Study on quality standard for TONG Bian Ning Tablets

目的建立通便宁片质量控制方法。方法采用薄层色谱法对制剂中番泻叶、牵牛子、砂仁、白豆蔻进行定性鉴别;用HPLC法测定番泻叶干膏粉中芦荟大黄素的含量。结果薄层色谱中斑点清晰,易于识别;HPLC法精密度、重现性良好,芦荟大黄素进样量在0.1047～0.8376μg范围内线性关系良好。加样回收率为102.45%,RSD=1.53%。结论本法可有效控制通便宁片的质量。

Objective To establish the quality standard for TONG Bian Ning Tablets. Methods Folium Sennae、Semen Pharbitidis、Frutus amomi and Fructus Amomi Rotundus were identified by TLC. The content of Aloe-emodin was determined by HPLC. Results The TLC spots developed were fairly and simply identical. HPLC was accurate and reproducible. Aloe-emodin showed a good linear relationship at a range of 0.1047～0.8376 μg. The recovery was 102.45% and RSD was 1.53%. Conclusion These methods can be used for the quality control of Tongbianning Tablets effectively.