铁箍膏巴布剂质量标准研究

Study on Quality Standard of Tiegugao Cataplasm

目的建立铁箍膏巴布剂的质量控制方法。方法采用薄层色谱法对大黄、黄连、冰片进行鉴别。采用反相高效液相色谱法对大青叶中的活性成分靛玉红进行含量测定,色谱柱为Symmetry C18柱(4.6 mm×250 mm,5μm),以甲醇-水(75∶25)为流动相,流速为1.0 mL/min,检测波长290 nm。结果薄层色谱法具有良好的重复性、专属性。大青叶在0.012 3～0.123 2μg范围内线性关系良好(r=0.999 9,n=5),平均回收率为98.64%,RSD=0.92%(n=6)。结论本方法简便、准确,可作为铁箍膏巴布剂的质量控制方法。

Objective To establish the method for quality control of Tiegugao Cataplasm.Methods Rhubarb,Coptis chinensis and borneol in the preparation were identified by TLC.The content of indirubin,the effective substance of the preparation,was determined by HPLC.Symmetry C18 column（4.6 mm×250 mm,5 μm） was used with methanol-water as mobile phase,the flow rate was 1.0 mL/min and the detective wavelength was 290 nm.Results Medicines could be detected by TLC.The linear relationship of indirubin was good in the range of 0.012 3-0.123 2 μg（r=0.999 9,n=5）.The recovery was 98.64% and RSD=0.92%（n=6）.Conclusion The method is simple and feasible,and can be applied to control the quality of Tiegugao Cataplasm.