感冒清热颗粒HPLC特征图谱研究

目的: 建立感冒清热颗粒的HPLC特征图谱分析方法,为全面的质量评价提供依据。 方法: 对10批感冒清热颗粒进行分析。色谱柱:Agilent ZORBAX SB C₁₈(4.6 mm×250 mm,5 μm);流动相:甲醇(A)-水(B)系统,梯度洗脱,A相:0→15 min,5%→25%;15→55 min,25%→70%;55→75 min,70%→95%。检测波长:250 nm,柱温:30℃,流速:1.0 mL·min^-1,进样量:5 μL。 结果: 采用《中药色谱指纹图谱相似度评价系统 2.0版》进行分析,确定10个共有峰,精密度、稳定性和重复性试验中各共有峰相对保留时间的RSD均小于0.6%,相对峰面积的RSD均小于5.0%。建立了感冒清热颗粒的对照特征图谱,并进行相似度分析。 结论: 该方法简单、快速,重复性好,建立的对照特征图谱对感冒清热颗粒的整体质量提出了更高的要求,可以为提供质量控制和评价标准提供有益的借鉴。

Objective: To analyze the specific chromatograms of Ganmao Qingre granules by HPLC,and provide experimental basis for comprehensive quality evaluation. Methods: The samples were separated on Agilent ZORBAX SB C₁₈(4.6 mm× 250 mm,5 μm)column,with mobile phase consisting of methanol(A)and water(B)and at a flow rate of 1.0 mL·min^-1,the UV detection wavelength was set at 250 nm,column temperature was 30℃,the gradient elution program:A 0→15 min,5%→25%;15→55 min,25%→70%;55→75 min,70%→95%. Results: All results of the experiment were analyzed with Chromatographic Fingerprint Evaluation System Version 2.0,10 common peaks were identified;the RSD of the relative retention time in precision,stability and repeatability experiments were all less than 0.6%,and the RSD of relative peak area was less than 5.0%.The standard specific chromatogram was established,and similarity analysis was carried out. Conclusion: The method is simple,rapid and reproducible,the establishment of the control characteristic map will put forward higher requirements for product quality,and contribute to the quality evaluation of Ganmao Qingre granule.

1 ChP(中国药典).2010.Vol I(一部):1185
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