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痔疮栓质量标准的研究

Study on Quality Standard for Haemorrhoids Suppository

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【作者】 周道年阮金兰赵钟祥

【Author】 ZHOU Dao-nian,RUAN Jin-lan,ZHAO Zhong-xiang (School of Pharmacy,Tongji Medical College of Huanzhong University of Science and Technology,Wuhan 430030,China)

【机构】 华中科技大学同济医学院药学院华中科技大学同济医学院药学院 武汉430030武汉430030

【摘要】 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。

【Abstract】 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.

  • 【文献出处】 医药导报 ,Herald of Medicine , 编辑部邮箱 ,2006年03期
  • 【分类号】R286
  • 【下载频次】157
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