基于总量统计矩分析法的祛瘀清热颗粒剂HPLC指纹图谱研究

HPLC chemical fingerprint of Quyu Qingre Granule based on total quantity statistical moment analysis

目的:建立祛瘀清热颗粒剂的HPLC指纹图谱及其整体特征的质量评价方法。方法:采用HPLC法,建立了10批祛瘀清热颗粒剂的指纹图谱,并结合总量统计矩分析法,对其指纹图谱进行整体特征和相似度分析。结果:在所选择的色谱条件下,祛瘀清热颗粒剂各特征峰均得到了较好的分离,其标准指纹图谱由15个特征峰组成;经总量统计矩分析,该指纹图谱的整体特征参数总量零阶矩、总量一阶矩、总量二阶矩的平均值分别为3.175×106μv/s、19.35min、343.6min2,RSD分别为13.03%、2.89%、1.56%,10批制剂指纹图谱的总量统计矩平均相似度为0.9511。结论:HPLC指纹图谱结合总量统计矩分析法可对祛瘀清热颗粒剂进行准确、可靠的识别,为祛瘀清热颗粒剂的质量评价提供一定的科学依据。

Objective： To establish a combinative method for quality control of Quyu Qingre Granules by HPLC chemical fingerprint and total quantity statistical moment （TQMS） analysis. Methods： The preparation was analyzed by HPLC. Then the general characteristic of HPLC chemical fingerprint was evaluated by TQMS. Results： Fifteen common peaks were presented in 10 batches of Quyu Qingre Granules. By TQMS analysis, the averages of total area under the curves, the averages of chromatographic retention time and variance of mean chromatographic retention time were 3.175×106 μv/s, 19.35 min, 343.6 min2 with RSD 13.03%, 2.89%, 1.56%, respectively. The similarities of 10 batches of Quyu Qingre Granules were all over 0.9511. Conclusion： The combinative method using HPLC chemical fingerprint and TQMS analysis was steady and accurate with a good repeatability and convenient operation, and can be used as a quality control method for Quyu Qingre Granules.