感冒清热颗粒HPLC特征图谱研究

HPLC specific chromatograms of Ganmao Qingre granules

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,5μm);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:5μL。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 ex- perimental basis for comprehensive quality evaluation. Methods：The samples were separated on Agilent ZORBAX SB C js （4.6 mm×250 mm, 5 ixm）column, with mobile phase consisting of methanol （A）and water （B）and at a flow rate of 1.0 mL · rain^- 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 rain ,25% →70% ;55→75 rain ,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 experi- ments were all less than O. 6% , and the RSD of relative peak area was less than 5.0%. The standard specific ehro- matogram was established, and similarity analysis was carried out. Conclusion：The method is simple, rapid and re- producible, the establishment of the control characteristic map will put forward higher requirements for product qual- ity, and contribute to the quality evaluation of Ganmao Qingre granule.