利咽合剂的质量标准研究

摘要

目的:建立利咽合剂的质量标准.方法:采用薄层色谱(TLC)法对制剂中的玄参、西青果、甘草进行鉴别;采用高效液相色谱法测定制剂中绿原酸的含量.色谱柱为Agilent Eclipse Plus C18,流动相为甲醇-0.2%磷酸(18:82,V/V),流速为1.0 ml/min,检测波长为327 nm,柱温为30℃,进样量为20μl.结果:玄参、西青果、甘草的TLC图斑点清晰,分离度好,阴性对照无干扰.绿原酸检测进样量线性范围为0.16~1.6μg(r=0.999 9);精密度、稳定性、重复性的RSD<1.0%,加样回收率为96.9%~101.4%,RSD为1.17%(n=9).结论:该方法操作简单、重复性好,可用于利咽合剂的质量控制.%OBJECTIVE:To establish the quality standard of Liyan mixture. METHODS:TLC was conducted to identify the Scrophularia ningpoensis,Terminalia chebula and Glycyrrhiza uralensis;HPLC was conducted to determine the content of chloro-genic acid. The column was Agilent Eclipse Plus C18 with mobile phase of methanol-0.2% phosphoric acid (18:82,V/V) at flow rate of 1.0 ml/min,the detection wavelength was 327 nm,column temperature was 30 ℃ and the injection volume was 20 μl. RE-SULTS:TLC showed S. ningpoensis,T. chebula and G. uralensis had clear spots and good separation. There was no interference for negative control. The linear range of chlorogenic acid was 0.16-1.6 μg(r=0.999 9);RSDs of precision,stability and reproduc-ibility tests were lower than 1.0%,recovery was 96.9%-101.4%(RSD=1.17%,n=9). CONCLUSIONS:The method is simple and reproducible,and can be used for the quality control of Liyan mixture.