复方姜黄片质量标准研究

Study on Quality Standard for Fufangjianghuang Tablets

目的建立复方姜黄片的质量标准。方法采用TLC法对制剂中姜黄、川芎、胡椒进行定性鉴别;以HPLC法测定制剂中姜黄素的含量,采用Kromasil C_(18)色谱柱(250mm×4.6mm,5.0μm),以乙腈-1%醋酸溶液(55∶45)为流动相,检测波长为430nm。结果制剂中姜黄素、川芎嗪、胡椒碱的薄层鉴别具有较好的专属性;姜黄素在14.62~292.74μg·ml^(-1)范围内线性关系良好,线性方程为Y=74 159 X-200 122,r=0.9999,平均加样回收率与RSD分别为98.38%、0.59%。结论所建立的标准科学合理,可用于该制剂的质量控制。

Objective To establish a quality standard for Fufangjianghuangtablets.Methods Curcumin,ligustrazine,and pepper in the preparation was identified by TLC,respectively.And HPLC was used to determine the contents of curcumin.The analytical column was Kromasil C_（18） column（250 mm×4.6 mm,5.0μm）.The mobile phase was composed of acetonitrile-1% glacial acetic acid（55∶45）,and the detection wavelength was set at 430 nm.Results The TLCs of Curcumin,ligustrazine,and pepper have good specificity,respectively.Curcumin regression equation was Y =74 159 X-200 122 and r =0.9999 in the concentration range of 14.62-292.74μg·ml^-1.And average recovery was 98.38%,and its RSD was 0.59%.Conclusion The standard can be used for the preparation of quality control.