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采用多指标指纹图谱结合定量分析与方剂分析全面评价天麻头痛片的质量。

A new method to comprehensively evaluate the quality of Tianma Toutong tablets by multiple fingerprints combined with quantitative analysis and prescription analysis.

机构信息

School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, Liaoning 110016, China.

School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, Liaoning 110016, China.

出版信息

J Pharm Biomed Anal. 2024 May 15;242:116008. doi: 10.1016/j.jpba.2024.116008. Epub 2024 Feb 3.

Abstract

Tianma Toutong Tablets (TMTTTs) are composed of six traditional Chinese medicines (TCMs), and there is currently no comprehensive method to evaluate the quality of TMTTT. To ensure its quality, it is necessary to propose methods for evaluation and control. To address the issue, we established an HPLC and electrochemical fingerprint of TMTTT and quantify eight components-Gastrodin, p-hydroxybenzyl alcohol, chlorogenic acid, parishin A, ferulic acid, hesperidin, imperatorin, and isoimperatorin. We used the Sub-quantified profiling method (SQPM) to calculate the actual contribution value of each individual herb and evaluated and predicted the quality of the compound medication. In addition, electrochemical fingerprinting (ECFP) was established using a Belousov-Zhabotinsky (B-Z) oscillation system in which six characteristic electrochemical parameters were recorded to compare the differences between batches. Finally, a compound synthesizing fingerprint (CSF) of TMTTT was developed by fitting the compounds of the six herbs, the contribution of individual herbs to the prescription was evaluated. Principal component analysis (PCA) was used to downscale the data of different fingerprint profiles to assist the analysis process. The rational combination of multidimensional fingerprinting and PCA provided a comprehensive and reliable method for the evaluation of TMTTT and other TCM compound preparations, SQPM could effectively link single herbs to compound preparations, avoiding the use of non-compliant TCMs at source and improving the quality of compound preparations.

摘要

天麻头痛片(TMTTTs)由六种中药组成,目前尚无综合方法来评估 TMTTT 的质量。为了确保其质量,有必要提出评估和控制方法。针对这一问题,我们建立了 TMTTT 的 HPLC 和电化学指纹图谱,并定量了天麻素、对羟基苯甲醇、绿原酸、白头翁素 A、阿魏酸、橙皮苷、欧前胡素和异欧前胡素八种成分。我们使用 Sub-quantified profiling method (SQPM) 计算每个草药的实际贡献值,并评估和预测复方药物的质量。此外,使用 Belousov-Zhabotinsky (B-Z) 振荡系统建立了电化学指纹图谱(ECFP),记录了六个特征电化学参数,以比较批次间的差异。最后,通过拟合六种草药的化合物,开发了 TMTTT 的复合合成指纹(CSF),评估了各草药对处方的贡献。主成分分析(PCA)用于将不同指纹图谱的数据降维,以辅助分析过程。多维指纹图谱和 PCA 的合理结合为 TMTTT 及其他中药复方制剂的评价提供了一种全面可靠的方法,SQPM 可以有效地将单味草药与复方制剂联系起来,避免在源头使用不合格的中药,提高复方制剂的质量。

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