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目的:建立银翘解毒颗粒高效液相特征图谱的测定方法,整体评价银翘解毒颗粒质量。方法:采用色谱柱Kromasil100-5 C18(4.6 mm×250 mm);检测器为DAD检测器;检测波长279 nm;柱温30℃;甲醇-0.2%磷酸为流动相,1 mL·min-1的流速梯度洗脱。结果:模拟银翘解毒颗粒剂特征图谱有13个共有峰,其精密度、重复性、稳定性试验中各共有峰的相对保留时间的RSD均小于0.1%,相对峰面积的RSD均小于6%。模拟颗粒相似度较好,银翘解毒颗粒样品图谱存在较大差异。在已建立特征图谱基础上,归属了3个特征色谱峰及1个组峰作为金银花、牛蒡子、连翘、甘草4味药材的样品特征峰。结论:建立的银翘解毒颗粒HPLC特征图谱分析法,为进一步控制银翘解毒颗粒样品质量提供研究基础。
OBJECTIVE: To establish a method for the determination of HPLC profile of Yinqiao Jiedu granules, and evaluate the quality of Yinqiao Jiedu granules as a whole. Methods: Kromasil 100-5 C18 column (4.6 mm × 250 mm) was used as the detector. The detector was DAD detector. The detection wavelength was 279 nm. The column temperature was 30 ℃. The mobile phase consisted of methanol-0.2% Flow gradient elution. RESULTS: There were 13 common peaks in the simulated Yin Qijie Jiedu granule. The RSDs of the relative retention time of each common peak in the precision, repeatability and stability tests were all less than 0.1%, and the RSDs of the relative peak area were less than 6% . The similarity of simulated particles is good, there is a big difference between the samples of Yinqiao Jiedu granules. Based on the established characteristic maps, three characteristic chromatographic peaks and one group peak were assigned as the characteristic peaks of samples of four medicinal materials, namely honeysuckle, burdock, forsythia, licorice. Conclusion: The established HPLC method of Yinqiao detoxification particles provides the basis for further control of the quality of Yinqiao detoxification granules.