生脉汤HPLC指纹图谱的建立及质量控制

Establishment and Quality Control of HPLC Fingerprint of Shengmai Decoction

目的:建立传统方剂生脉汤的HPLC指纹图谱,为生脉汤质量控制提供参考依据。方法:采用Diamonsil C_(18)(L)(4.6 mm×250.0 mm)色谱柱,以乙腈(A)-水(B)为流动相,梯度洗脱,流速为1.0 mL·min^(-1),柱温为30℃,进样量为5μL,检测波长为203 nm,以五味子醇甲色谱峰为参照峰,绘制10批生脉汤样品的HPLC指纹图谱,采用中药色谱指纹图谱相似度评价系统(2004 A版)进行相似度评价,确定共有峰,采用SPSS 26.0和SIMCA-P 14.1软件进行聚类分析、主成分分析和正交偏最小二乘判别分析。结果:建立了生脉汤的指纹图谱,共标定了13个共有峰,并指认出五味子醇甲、五味子甲素和五味子乙素3个成分。聚类分析结果显示,S1、S3、S8、S10聚为一类,其他批次聚为一类,且主成分分析得分图和正交偏最小二乘判别分析的得分矩阵结果与聚类分析结果一致,主成分分析结果显示两个主成分因子的累计方差贡献率达到94.126%。正交偏最小二乘判别分析结果显示,2(五味子醇甲)、10、7号色谱峰对生脉汤成分含量上的差异影响较大。结论:该方法简便、稳定、可靠,可为生脉汤的质量评价提供依据。

Objective:To establish the HPLC fingerprint of traditional prescription Shengmai Decoction,and to provide reference for the quality control of Shengmai Decoction.Method:Diamonsil C_(18)(L)(4.6 mm×250.0 mm)column was used,acetonitrile(A)-water(B)was used as mobile phase,gradient elution was carried out,the flow rate was 1.0 mL·min^(-1),and the column temperature was 30℃,the injection volume was 5μL,the detection wavelength was 203 nm,and the chromatographic peak of Schisandrin A was used as the reference peak to draw the HPLC fingerprints of 10 batches of Shengmai Decoction samples.Similarity evaluation was carried out to determine common peaks,and SPSS 26.0 and SIMCA-P 14.1 software were used for cluster analysis,principal component analysis and orthogonal partial least squares discriminant analysis.Result:The fingerprint of Shengmai Decoction was established,13 common peaks were demarcated,and 3 components of schisandrin A,schisandrin A and schisandrin B were identified.The cluster analysis results showed that S1,S3,S8,S10 Clustered into one category,other batches clustered into one category,and the score matrix results of the principal component analysis score map and the orthogonal partial least squares discriminant analysis were consistent with the cluster analysis results,and the principal component analysis results showed two principal component factors.The cumulative variance contribution rate of two is up to 94.126%.The results of orthogonal partial least squares discriminant analysis showed that the chromatographic peaks No.2(schisandrin methyl),No.10 and No.7 had a great influence on the difference of the components of Shengmai Decoction.Conclusion:The method is simple,stable and reliable,which can provide a basis for the quality evaluation of Shengmai Decoction.