目的：建立复方抗感灵颗粒的质量标准。方法采用薄层色谱法对制剂中金银花、连翘进行定性鉴别。采用高效液相色谱法对制剂中绿原酸的含量进行测定,采用 Diamonsil C18柱分离,以乙腈-0.4%磷酸(20∶80,V/V)为流动相,流速为1.0 mL/min。结果通过薄层鉴别,分别检出金银花中的绿原酸、连翘中的连翘苷。通过高效液相色谱法测得制剂中绿原酸的线性关系为A＝30461C-5938.8,r＝0.9998,RSD＝1.01%,表明绿原酸在10.2～102.0μg/mL 范围内有良好的线性关系。结论该方法准确、快速、稳定、可靠,重复性好,可用于该复方制剂的质量控制及评价。%Objective To establish the quality standard of Compound Kangganling Granules. Methods TLC method was used for qualitative identification of Lonicerae Japonicae Flos and Forsythiae Fructus, and HPLC method was used for determination of chlorogenic acid in the preparation. The HPLC separation was performed on Diamonsil C18 column. The mobile phase was consisted of acetonitrile-0.4%phosphoric acid (20∶80, V/V), and the flow rate was 1.0 mL/min. Results TLC identified chlorogenic acid in Lonicerae Japonicae Flos and phillyrin in Forsythiae Fructus. The linear relationship of chlorogenic acid in the preparation measured by HPLC was A=30461C-5938.8, r=0.9998, RSD=1.01%, showing that the linear range of chlorogenic acid was 10.2-102.0μg/mL. Conclusion The method is accurate and rapid, with good stability, reliability and reproducibility, and can be used for the quality control and evaluation of the preparation.
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