清金益气方物质基准HPLC指纹图谱的建立

Establishment of HPLC fingerprint of Qingjin Yiqi Formula substance standard

关键词:  清金益气方  物质基准  指纹图谱  主成分分析  正交偏最小二乘法判别分析

Key words:  Qingjin Yiqi Formula  substance standard  fingerprint  principal component analysis  orthogonal partial least squares-discriminant analysis

摘要:

[目的] 建立清金益气方物质基准的高效液相色谱法（HPLC）指纹图谱，为清金益气方物质基准质量标准的建立及清金益气方现代制剂的研究提供相关依据。[方法] 文章采用HPLC建立清金益气方物质基准指纹图谱，并对10批清金益气方物质基准指纹图谱进行了峰归属和相似度评价。采用主成分分析（PCA）、正交偏最小二乘法判别分析（OPLS-DA）进行分析，进一步评价多批次物质基准间的质量差异。[结果] 根据10批样品的指纹图谱，确定了13个共有峰，共有峰之间的分离程度较好。此外，10批清金益气方指纹图谱的相似度均大于0.90，满足指纹相似度评价的基本要求，能够为整体评价清金益气方物质基准质量提供参考根据；对比对照品，指认出7个成分；通过化学模式识别将10批样品分为两类，并找出导致分类差异的4个主成分。分析发现导致10批差异分析的成分主要归属于黄芩和马鞭草，因此要严格控制黄芩和马鞭草的质量以保证物质基准质量稳定性[结论] 建立了稳定可行的清金益气方物质基准指纹图谱方法，全面地反映清金益气方物质基准的化学成分信息；结合化学模式识别进行评价，使研究更加全面科学，为后续研究提供参考。

Abstract:

[Objective] To establish HPLC fingerprint of Qingjin Yiqi Formula substance standard,and to provide relevant basis for the establishment of Qingjin Yiqi Formula substance standard quality standard and the study of modern Qingjin Yiqi Formula preparation. [Methods] The reference fingerprint of Qingjin Yiqi Formula substance standard was established by high performance liquid chromatography,and the peak attribution and similarity of 10 batches of Qingjin Yiqi Formula substance standard fingerprints were evaluated. Principal component analysis (PCA) and Orthogonal Partial Least Squares-Discriminant Analysis(OPLS-DA)were performed to further evaluate the quality differences between the multi-batch material benchmarks. [Results] According to the fingerprint of 10 batches of samples,13 common peaks were identified,and the degree of separation among common peaks was good. In addition,the similarity of 10 batches of Qingjin Yiqi Formula substance standard fingerprints is greater than 0.90,which meets the basic requirements of fingerprint similarity evaluation,and can provide a reference for the overall evaluation of Qingjin Yiqi Formula substance standard quality. Compared with the control product, 7 components were identified. The 10 batches of samples were divided into 2 classes by chemical pattern recognition,and the 4 principal components that caused the classification differences were identified. It was found that the ingredients leading to the 10 batches of difference analysis were mainly attributed to Radix Scutellariae and Verbena officinalis,so the quality of Radix Scutellariae and Verbena officinalis should be strictly controlled to ensure the stability of the material reference quality. [Conclusion] A stable and feasible fingerprint method was established to reflect the chemical composition information of Qingjin Yiqi Formula substance standard. The evaluation combined with chemical pattern recognition makes the research more comprehensive and scientific,and provides reference for subsequent research.