腹可安片的质量标准研究

Studies on the Quality Standard of Fuke'an Pians

目的：采用高效液相色谱法测定东莨菪内酯、没食子酸的含量,建立腹可安片质量标准,以控制产品质量。方法：通过薄层色谱法对扭肚藤、车前草、石榴皮、火炭母进行薄层鉴别。东莨菪内酯使用C18色谱柱;乙腈-水-冰醋酸（V∶V∶V=13∶87∶1）为流动相,检测波长为345 nm;没食子酸使用C18色谱柱,以甲醇-0.5%冰醋酸（V∶V=7∶93）为流动相,检测波长为270 nm。结果：薄层鉴别中东莨菪内酯和没食子酸得到很好的分离,当东莨菪内酯在3.44-41.28μg/ml浓度范围内呈线性关系（r=0.999 9,n=5）,加样回收率为（100.6±1.07）%（n=9）;当没食子酸在10.52-63.12μg/ml浓度范围内呈线性关系（r=0.999 93,n=6）,加样回收率为（99.73±0.52）%（n=9）。结论：本法简便、准确、可靠、专属性强、重现性好,可作为腹可安片的质量标准。

OBJECTIVE： The HPLC method was adopted to determined the content of scopoletin and gallic acid,the method for the quality control of Fuke＇an pills was developed,so as to control the product quality. METHODS： The thin-layer of Jasminum elongatum,Plantago asiatica L.,Pericarpium granati and Chinese knotweed herb were determined by TLC. The scopoletin used C18 column,acetonitrile-water-ice-acetid acid（ V∶ V∶ V = 13∶ 87∶ 1） was set as mobile phase,and the wavelength of detector was set at 345 nm. The gallic acid used C18 column,methanol- 0. 5% ice-acetid acid（ V∶ V = 7∶ 93） was set as mobile phase,and the wavelength of detector was set at 270 nm.RESULTS： Scopoletin and gallic acid had been separated well in the thin-layer identification. When the line range of scopoletin was 3. 44 μg / ml - 41. 28 μg / ml（ r = 0. 999 9,n = 5）,the average recovery was [（ 100. 6 ± 1. 07） %（ n =9） ]. When the line range of gallic acid was 10. 52 μg / ml - 63. 12 μg / m（ r = 0. 999 93,n = 5）,the average recoverywas [（ 99. 73 ± 0. 52%）（ n = 9） ]. CONCLUSIONS： The method is simple,accurate,reliable with good specificity and reproducibility,it can be used as the quality standard of Fuke＇an pills.