基于HPLC-QAMS多指标成分含量测定联合化学计量学的恒古骨伤愈合剂质量控制

Comprehensive Quality Evaluation of Henggu Gushangyu Mixture Based on HPLC-QAMS and Chemometrics

目的:建立高效液相色谱-一测多评法(HPLC-QAMS)多指标成分含量测定联合化学计量学的恒古骨伤愈合剂质量控制研究的方法。方法:采用HPLC-QAMS检测15批恒古骨伤愈合剂中11个成分的含量,并与外标法结果进行对比,采用聚类分析、主成分分析与偏最小二乘法-判别分析对HPLC-QAMS结果进行分析评价。结果:11个成分分别在各自质量浓度范围内线性关系良好(r>0.9993);平均加样回收率为96.81%~100.21%(RSD<2.0%);HPLC-QAMS所测结果与ESM差异无统计学意义;通过化学计量学分析,羟基红花黄色素A[变量重要性投影(VIP)值=1.446]、三七皂苷R_(1)(VIP值=1.351)、橙皮苷(VIP值=1.258)、京尼平苷(VIP值=1.138)、人参皂苷Rg_(1)(VIP值=1.067)可能是影响恒古骨伤愈合剂产品质量的差异性标志物。结论:建立的方法操作便捷、可靠稳定,可为深入研究恒古骨伤愈合剂质量控制提供参考。

Objective:To establish a high-performance liquid chromatography-quantitative analysis of multicomponents by single marker(HPLC-QAMS)method,combined with chemometrics,and study the quality control of Henggu Gushangyu Mixture.Methods:Eleven components in 15 batches of Henggu Gushangyu Mixture were determined by HPLC-QAMS.The results were compared with those of external standard method(ESM),and were analyzed and evaluated by cluster analysis(CA),principal component analysis(PCA)and partial least squares discriminant analysis(PLSDA).Results:The 11 components had good linear relationship within their respective ranges(r>0.9993).The average recoveries were 96.81%-100.21%(RSD<2.0%).There was no significant difference between HPLC-QAMS and ESM.Chemometrics revealed hydroxysafflor yellow A[variable importance in projection(VIP)=1.446],notoginsenoside R_(1)(VIP=1.351),hesperidin(VIP=1.258),geniposide(VIP=1.138)and ginsenoside Rg_(1)(VIP=1.067)might be the differential markers affecting the quality of Henggu Gushangyu Mixture.Conclusion:The established method was convenient,reliable and stable,and provided reference for further study on the quality of Henggu Gushangyu Mixture.