小艾飞蜜膏质量标准研究

Quality standards analysis for Xiaoaifei Preparation

目的建立小艾飞蜜膏（荜茇、高良姜）的质量分析方法。方法采用薄层色谱法（TLC）对小艾飞蜜膏中的胡椒碱和高良姜素进行定性鉴别；采用高效液相色谱法（HPLC）分别测定胡椒碱、高良姜素的含量。结果薄层色谱鉴别均斑点清晰，阴性对照无干扰；定量测定中胡椒碱在24～144μg浓度范围内与峰面积呈良好线性关系（r=0．9999），平均回收率为100．09％，RSD为1．04％（n=6）。高良姜素在2．16～12．96／xg浓度范围内与峰面积呈良好线性关系（r=0．9999），平均回收率为100．06％，RSD为1．17％（n=6）。结论所建立的方法操作简单，专属性和重复性良好，可作为该制剂的质量控制方法之一。

Objective To establish the quality standard for Xiaoaifei Preparation （Piperis longi Fructus, AI- pinae officinarum Rhizoma）. Methods Piperine and Galangin in Xiaoaifei Preparation were identified by TLC and the contents of Piperine and Galangin were determined by HPLC. Results The TLC spots devel oped were fairly clear, and the blank test showed no interference. For Piperine, the linearity was good （r =0.999 9） in the range of 24-144μg and the average recovery was 100.09% with a suitable RSD. For Galangin, the linearity was good （r =0.999 9） in the range of 2.16-12.96μg and the average recovery was 100.06μ with a suitable RSD. Conclusion The method is simple, reliable and accurate, which can be applied as a quantity control method of Xiaoaifei Preparation.