HPLC多指标成分定量与化学计量学相结合的搜风理肺丸质量评价

Quality evaluation of Soufeng Lifei pills based on high performance liquid chromatography quantitative analysis of multi-components and chemometrics

目的:建立高效液相色谱法(HPLC)对搜风理肺丸进行质量控制和综合评价。方法:采用乙腈-0.1%磷酸溶液为流动相,梯度洗脱,流速0.9 mL·min^(-1);Agilent ZORBAX SB-C18色谱柱,柱温30℃;检测波长分别为210 nm、280 nm和321 nm;采用SPSS 26.0对搜风理肺丸中8种成分含量测定结果进行聚类分析和主成分分析。结果:去芹糖桔梗皂苷E、桔梗皂苷E、桔梗皂苷D3、黄芩苷、汉黄芩苷、白花前胡甲素、白花前胡乙素和白花前胡E素在各自浓度范围内线性关系良好(0.9991≤r≤0.9999);平均加样回收率在96.95%~100.10%,RSD为0.83%~1.52%(n=9);10批搜风理肺丸聚类分析为2类,主成分1~4为影响搜风理肺丸质量评价的主要因子。结论:该方法准确简便、稳定可靠,可用于搜风理肺丸的质量控制和综合评价。

Objective:To establish a high performance liquid chromatography(HPLC)method for the quality control and comprehensive evaluation of Soufeng Lifei pills.Methods:The mobile phase was composed of acetonitrile-0.1%phosphoric acid solution in gradient elution manner at a flow rate of 0.9 mL·min^(-1).The chromatographic column was Agilent ZORBAX SB-C18 column and the column temperature was 30℃.The detection wavelength were set at 210 nm,280 nm and 321 nm.Cluster analysis and principal component analysis(PCA)were conducted by SPSS 26.0 statistical software.Results:The linear relationship of apigenin E,platycodin E,platycodin D3,baicalin,wogonin,imperatorin A,imperatorin B and imperatorin E was good respectively(0.9991≤r≤0.9999).The average recoveries of them were 96.95%-100.10%.The RSDs were 0.83%-1.52%(n=9).Results of cluster analysis showed that the samples of 10 batches of Soufeng Lifei pills could be divided into two categories.And results of PCA showed that the principal component 1-4 were the main factor for the quality evaluation of Soufeng Lifei pills.Conclusion:The method was simple,accurate,stable and reliable,which could be used for the quality control and comprehensive evaluation of Soufeng Lifei pills.