痔疮栓质量标准的研究

Study on Quality Standard for Haemorrhoids Suppository

目的制定痔疮栓的质量标准。方法采用薄层色谱法对栓剂中的大黄、柿蒂进行定性鉴别；采用化学法对栓剂中的冰片、芒硝进行定性鉴别；采用高效液相色谱外标法对大黄素进行含量测定。结果样品浓度在4～20μg·mL^-1范围内，浓度与峰面积有良好的线性关系，重现性RSD=0．35％，稳定性RSD=0．50％，平均加样回收率为99．19％（n=6）。结论该方法简单、方便、准确，可作为痔疮栓质量控制的方法。

Objective To establish a quality standard for haemorrhoids suppository. Methods Radix et rhizoma rhei and calyx kaki in haemorrhoids suppository were identified by thin-layer chromatography （TLC）. Camphol and sodiam sulfate in the Suppository were qualitativerly identified with chemical methods. The content of Rheum emodin was determined by HPLC. Results Within the range of sample concentration 4 - 20 μg·mL^-1, there was a good linear relationship between the concentration and the peak area; the RSD of reproducibility and stability were 0.35%, 0.50% respectively, and the average recovery rate was 99.19% （n = 6）. Conclusion This method is easy, convenient and precise, so it can serve as a quality control method for haemorrhoids suppository.