利咽合剂的质量标准研究  

Study on the Quality Standard of Liyan Mixture

作　　者：景霞[1] 徐进[1] 孙芳[1] 湛雯[1] 

机构地区：[1]南京医科大学附属南京儿童医院,南京210008

出　　处：《中国药房》2015年第36期5141-5143,共3页China Pharmacy

基　　金：南京医科大学科技发展基金项目(No.2012NJMU068)

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.

关 键 词：利咽合剂 质量标准 玄参 西青果 甘草 薄层色谱法 绿原酸 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学] R927.11[医药卫生—药学]