复方肿节风清咽合剂质量标准研究

Study on the Quality Standard of Compound Sarcandrae herba Qingyan Mixture

目的:建立复方肿节风清咽合剂的质量控制方法。方法:采用薄层色谱法鉴别该制剂中肿节风、麦冬和红花;采用HPLC-DAD测定复方肿节风清咽合剂中反丁烯二酸含量,色谱柱为DIKMA Dia-monsil~C_(18)(5μm,4.6mm×250mm),乙腈-0.1%磷酸溶液(2∶98)为流动相,DAD扫描范围:190～360nm,柱温:30℃,流速:1.0mL/min。结果:鉴别方法专属性强,斑点分离清晰,且阴性无干扰;反丁烯二酸线性范围在0.015 184～0.379 6μg,(R^2=0.999 8),平均回收率92.73%,RSD为1.02%。结论:该方法简便、准确、重现性好,可用于该制剂的质量控制。

Objective:To establish a method for the quality control of compound Zhongjiefeng Qingyan mixture.Methods:Thin layer chromatography(TLC)was used to identify Sarcandrae herba,Ophiopogonis ridix and Carthami flos in the preparation;HPLCDAD was used to determine the content of fumaric acid in the compound Sarcandrae herba Qingyan mixture.The column was DIKMA DiamonsilC18(4.6 mm×250 mm 5μm),Acetonitrile-0.1% phosphoric acid solution(2∶98)as the mobile phase.DAD scan range:190-360 nm,column temperature:30°C,flow rate:1.0 mL/min.Results:The TLC identification method was characterized by strong specificity,the speckle separation was clear,and the negative was negative;The linear relationship between the intake of fumaric acid in the range of 0.015184-0.3796 g was good(R^2=0.9998),the average recovery rate was 92.73%,and RSD was 1.02%.Conclusion:The method is simple,accurate and reproducible,and can be used for the effective quality control of the preparation.