清燥润肺合剂质量标准研究

Study on the Quality Standard for Qingzao Runfei Mixture

目的建立清燥润肺合剂的质量标准。方法采用薄层色谱法对制剂中桑叶、甘草、北沙参、麦冬、枇杷叶进行定性鉴别;采用高效液相色谱法对制剂中甘草酸含量进行测定。结果薄层色谱中阴性无干扰,专属性强;甘草酸在0.2031～1.6921μg范围内线性关系良好,r=0.9998,平均回收率为98.24%,RSD=2.62%。结论本试验建立的方法简便、快捷,重复性好,可用于清燥润肺合剂的质量控制。

Objective To establish quality control method for Qingzao Runfei Mixture. Methods Mulberry Leaves, Glycyrrhiza, Radix Glehniae, Ophiopogon Japonicus and Loquat Leaves were identified by TLC. Glycyrrhizic Acid was determinated by HPLC. Results The negative sample of TLC had no interference. The specifity was good. Glycyrrhizic acid showed a good linear relationship in the range of 0.203 1-1.692 1 μg, r=0.9998. The average recovery was 98.24%, and RSD was 2.3%. Conclusion The established methods axe simple, quick and with good reproducibility. This study provides methods for the quality control of Qingzao Runfei Mixture.