感冒热毒清合剂质量标准提高研究

Study on Improvement of Quality Standards for Ganmao Reduqing Mixture

目的:改进医院制剂感冒热毒清合剂的质量标准。方法:采用薄层色谱法对纯中药制剂感冒热毒清合剂的中药组分知母、蒲公英、金银花进行定性鉴别,改进感冒热毒清合剂中绿原酸含量的高效液相色谱测定方法,色谱柱为Diamonsil C18(250 mm×4.6 mm,5μm);流动相为甲醇-1%冰醋酸(20∶80);检测波长327 nm,流速1.0 mL/min,外标法定量。结果:在供试品薄层色谱中,与对照药材知母、蒲公英和金银花的相应位置上有相同斑点,分离效果良好;绿原酸在20.32μg/mL~101.60μg/mL浓度范围内线性关系良好,r=0.9992,平均加样回收率为97.27%。结论:建立的知母、蒲公英和金银花的薄层色谱鉴别,绿原酸的高效液相色谱含量测定方法结果准确可靠,重复性好,操作方便,适用于感冒热毒清合剂的质量控制。

Objective:To improve the quality standard of Ganmao Reduqing mixture Methods:The chief components of in Ganmao Reduqing mixture,Anemarrhenae rhizoma,Taraxaci herba,Lonicerae japonicae flos were identified by thin-layer chromatogram(TLC).The content of chlorogenic acid was determined by HPLC with Diamonsil C18(250 mm×4.6 mm,5μm),methanol-1%HAc(20∶80)was used mobile phase,and flow rate was 1.0 mL/min,the detection wavelength was 327 nm.Results:The resolution and specificity of TLC identification were good,Lonicerae japonicae,Anemarrhenae rhizoma and Taraxaciherba were identifiable with clear spots and free of disturbance by TLC.The standard curve for chlorogenic acid was linear in the range of 20.32μg/mL-101.60μg/mL(r=0.9992),while the average recovery was 97.27%.Conclusions:The TLC identification of Anemarrhena asphodeloides,Taraxacum mongolicum and Lonicera japonica Thunb.And the HPLC determination of chlorogenic acid were established.The results were accurate,reliable,reproducible and easy to operate.It was suitable for the quality control of Ganmao Reduqing mixture.