残黄片质量标准的研究

Studies on the Quality Standard for Canhuang Tablets

目的建立残黄片的质量标准。方法采用薄层色谱法对黄连、青黛药材进行定性鉴别;采用高效液相色谱法测定残黄片中小檗碱的含量。Luna C18(250 mm×4.6 mm,5μm)反相硅胶柱;流动相:乙腈-0.05 mol/L磷酸二氢钾溶液(50∶50)(每100 ml中加十二烷基硫酸钠0.4 g,磷酸调节pH值为4.0);流速:1 ml/min;检测波长:345 nm;柱温:30℃。结果薄层色谱斑点清晰,专属性强;盐酸小檗碱在浓度0.6054～1.4126μg范围内呈良好的线性关系,线性方程为Y=35.2256X-32.0299,r=0.9999,平均加样回收率为101.09%,RSD为2.02%。结论本方法简单、结果准确、重复性好,可有效控制残黄片的质量。

Objective To establish a quality control standard for Canhuang Tablets.Methods The thin layer chromatography was used to identify Coptis Chinensis Franch.and Naturalis Indigo.The high performance liquid chromatography method was applied to determine the content of berberine hydrochloride in Canhuang Tablets,based on a Luna C18(250 mm×4.6 mm,5 μm) with an elution solvent system composed of acetonitrile-0.05 mol/L potassium dihydrogen phosphate(50∶ 50) at a flow rate of 1ml/min.The detection wavelength was set at 345 nm and the column temperature was 30℃.Results The two natural drugs were identified by this standard with high specificity.The calibration curve of berberine hydrochloride was linear within the range of 0.6054-1.4126 μg and the correlation coefficient was 0.9999.The average recovery and relative standard deviation were 101.09% and 2.02%,respectively.Conclusion This quality standard is simple,user-friendly,accurate,and reproducible,which can be used for quality control of Canhuang Tablets.