Department of Laboratory Medicine, The First Hospital of Jilin University, 1 Xinmin Street, Changchun, Jilin Province, 130021, PR China.
School of Pharmacy, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenyang, Liaoning Province, 110016, PR China.
J Ethnopharmacol. 2024 Dec 5;335:118630. doi: 10.1016/j.jep.2024.118630. Epub 2024 Jul 23.
YiXinShu capsule (YXSC), originally from the classical TCM formula named "Sheng-Mai-San", has been extensively utilized in clinic for the treatment of cardiovascular diseases. However, there were few reports about the quality assessment of YXSCs both internationally and domestically.
The objective was to develop a multi-strategy platform incorporating systematic quantitative fingerprint analysis and antioxidant activity determination, with chemometric analysis and bivariate correlation analysis as the auxiliary approaches, to assess and monitor the quality of YXSCs.
Firstly, according to the Chinese Pharmacopoeia (2020 edition), 12 key indicator components from seven herb medicines were quantified by HPLC method. Then, three-dimensional fingerprints comprising five-wavelength fusion fingerprint (FWF-FP), electrochemical fingerprint (EC-FP) and Differential Scanning Calorimetry fingerprint (DSC-FP) were established to assess and monitor YXSCs using systematically quantified fingerprint method (SQFM) and principal component analysis (PCA). Moreover, by integrating the analysis of the three-dimensional fingerprints, the quality of YXSCs from different batches was effectively screened. Finally, the antioxidant activity of this TCM was assessed through DPPH and ABTS methods, and the L-ascorbic acid equivalent antioxidant capacity (AEAC) values were compared to evaluate the antioxidant activities of the two methods. A Partial Least Squares (PLS) model was used to develop the spectrum-activity relationship between FWF-FP and AEAC, and a bivariate correlation analysis (BCA) was used to assess the correlation between FWF-FP and EC-FP.
The key indexes including tanshinone I, t, t, A, first exothermic peak, and second exothermic peak can differentiate between various batches of YXSCs based on their three-dimensional fingerprint profiles. The integration evaluation results from 42 batches of YXSCs were categorized into 2-5 grades, indicating good quality consistency across different batches. In vitro studies have indicated a significant antioxidant activity capacity of YXSCs. The PLS model revealed that 37 out of the 41 fingerprint peaks exhibited antioxidant activity. The overall trend of BCA was consistent with PLS model results.
This research presents a scientific and holistic strategy for the quality consistency evaluation of YXSCs, thereby offering an effective approach for the thorough evaluation of TCMs.
益心舒胶囊（YXSC）源自经典的中药方剂“生脉散”，已广泛应用于心血管疾病的临床治疗。然而，国内外关于 YXSC 的质量评估报告都很少。
本研究旨在建立一个多策略平台，结合系统的定量指纹分析和抗氧化活性测定，以化学计量学分析和双变量相关分析为辅助方法，评估和监测 YXSC 的质量。
首先，根据《中国药典》（2020 年版），采用高效液相色谱法对七种草药中的 12 种关键指标成分进行定量。然后，采用系统定量指纹法（SQFM）和主成分分析（PCA）建立包含五波长融合指纹（FWF-FP）、电化学指纹（EC-FP）和差示扫描量热法指纹（DSC-FP）的三维指纹，对 YXSC 进行评估和监测。此外，通过整合三维指纹分析，有效筛选出不同批次的 YXSC 质量。最后，通过 DPPH 和 ABTS 法评估该中药的抗氧化活性，并比较 L-抗坏血酸当量抗氧化能力（AEAC）值，以评估两种方法的抗氧化活性。采用偏最小二乘（PLS）模型建立 FWF-FP 与 AEAC 的光谱-活性关系，并采用双变量相关分析（BCA）评估 FWF-FP 与 EC-FP 的相关性。
根据三维指纹图谱，包括丹参酮 I、丹参酮 IIA、丹酚酸 B、迷迭香酸、第一次放热峰和第二次放热峰在内的关键指标可以区分不同批次的 YXSC。对 42 批 YXSC 的综合评价结果分为 2-5 级，表明不同批次之间的质量一致性较好。体外研究表明，YXSC 具有显著的抗氧化活性。PLS 模型显示，41 个指纹峰中有 37 个具有抗氧化活性。BCA 的总体趋势与 PLS 模型结果一致。
本研究为 YXSC 的质量一致性评价提供了一种科学全面的策略，为中药的全面评价提供了有效途径。
