扶正抗流感胶囊质量标准研究

摘要

目的 建立扶正抗流感胶囊的质量控制方法.方法 采用TLC法对方中金银花、黄芪和黄芩进行定性鉴别；采用HPLC法测定样品中绿原酸的含量.色谱条件:色谱柱为Hypersil ODS2 C18柱(150 mm×4.6 mm,5μm)；流动相:乙腈-2％冰醋酸液(1∶20)；流速:1 ml/min;柱温:室温；检测波长:326 nm.结果 薄层定性鉴别的斑点清晰,分离效果良好；绿原酸含量在5.0 ～ 160.0 μg/ml范围内线性关系良好(r=0.9999),平均加样回收率为100.61％,RSD为1.57％(n＝6).结论 本方法操作简单,结果准确,重复性好,可作为该制剂的质量控制标准.%Objective To establish a quality standard for fuzhengkangliugan capsules. Methods Flos lonicerae, Radix astragali and Radix scutellariae were identified by TLC. The chlorogenic acid in fuzhengkangliugan capsules was determined by HPLC. The Hypersil ODS2 C18(150 mm ×4.6 mm,5 μm) column was used. The mobile phase consisted of methyl cyanide-2% glacial acetic acid (1: 20) at a flow rate of 1. 0 ml/min. The detection wavelength was set at 326 nm under room temperature. Results The spots in the thin layer chromatography were clear. The chlorogenic acid showed a good linear relationship within the range of 5.0-160.0 μg/ml ( r =0.9999). The average recovery was 100.61% with RSD 1.57%. Conclusion This method is simple, accurate and repeatable, which can be used for quality control of fuzhengkangliugan capsules.