School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, Liaoning, 110016, China.
School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, Liaoning, 110016, China.
Anal Chim Acta. 2023 Apr 22;1251:341015. doi: 10.1016/j.aca.2023.341015. Epub 2023 Feb 27.
Improving the quality standard system of herbal preparations (HPs) is an arduous task for the development of traditional Chinese medicine (TCM). At present, an urgent task is to establish a comprehensive, scientific and effective evaluation method for improving the safety, effectiveness and quality consistency of HPs. In this study, Hu Gan capsules (HGCs) were used as an example. Firstly, the three quality markers (Q-markers) in 21 batches of HGCs from 4 manufacturers were determined by HPLC and great difference in content of each sample was found. Furthermore, four-wavelength fusion profiling (FWFP) was established and evaluated by systematically quantified fingerprint method (SQFM). Principal component analysis (PCA) was employed to make a preliminary analysis of the FWFP and distinguish the fluctuation of differences in chemical composition and content. Then, 9 characteristic parameters were recorded through the B-Z oscillating system, and the electrochemical fingerprint (ECFP) was constructed for jointing evaluation with the FWFP, using the equal weight of SQFM results to comprehensively evaluate the sample quality. The 21 batches of samples were divided into four groups and six grades, which indicated that there were significant differences in the content of indicator components and electrochemical active substances in samples. Finally, taking vitamin C as a positive control, 2, 2'-azino-bis (3 - ethyl -benzthiazoline - 6 - sulfonic acid) (ABTS) scavenging assay was applied to study the antioxidant activity of samples. Partial Least Squares (PLS) and bivariate correlation analysis (BCA) were used to analyze the fingerprint-efficacy relationships of FWFP-ABTS and FWFP-ECFP. Consequently, it was found that there were similar antioxidant capacities in electrochemistry and ABTS tests, and 31 of the 40 HPLC fingerprint peaks of HGCs were discovered to have antioxidant activity. The two methods supported each other, to effectively and corporately reflect the antioxidant components in HGCs. In this research, the FWFP and ECFP established could realize the quality detection of HGCs, and provide a novel direction for the improvement of the quality standard of HPs and the research of the quality standard method of TCM.
提高草药制剂（HP）的质量标准体系是中医药发展的一项艰巨任务。目前，当务之急是建立一种全面、科学、有效的评价方法，以提高 HP 的安全性、有效性和质量一致性。本研究以护肝胶囊（HGCs）为例，首先采用 HPLC 法测定了 4 家厂家 21 批 HGCs 的 3 个质量标志物（Q-标志物），发现各样本含量差异较大。然后，建立并通过系统量化指纹法（SQFM）对四波长融合图谱（FWFP）进行评价。采用主成分分析（PCA）对 FWFP 进行初步分析，区分化学成分和含量差异的波动。然后，通过 B-Z 振荡系统记录 9 个特征参数，构建电化学指纹（ECFP），并与 FWFP 进行联合评价，采用 SQFM 结果的等权重综合评价样品质量。将 21 批样品分为 4 组 6 级，表明样品中指标成分和电化学活性物质的含量存在显著差异。最后，以维生素 C 为阳性对照，采用 2,2'-偶氮-双（3-乙基-苯并噻唑啉-6-磺酸）（ABTS）清除试验研究样品的抗氧化活性。采用偏最小二乘法（PLS）和双变量相关分析（BCA）对 FWFP-ABTS 和 FWFP-ECFP 的指纹-功效关系进行分析。结果表明，电化学和 ABTS 试验的抗氧化能力相似，40 个 HGCs 的 HPLC 指纹峰中有 31 个具有抗氧化活性。两种方法相互支持，有效地、整体地反映了 HGCs 中的抗氧化成分。本研究建立的 FWFP 和 ECFP 可实现 HGCs 的质量检测，为 HP 质量标准的提高和 TCM 质量标准方法的研究提供了新的方向。
