背景:益心舒胶囊(YXSC),最初来自名为“生麦三”的经典中医配方,临床上广泛用于心血管疾病的治疗。然而,国内外关于YXSC质量评估的报道很少。
目的:目的是开发一个包含系统定量指纹图谱分析和抗氧化活性测定的多策略平台,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。
方法:s:首先,根据《中国药典》(2020年版),通过HPLC方法对7种草药的12种关键指标成分进行了定量。然后,包括五波长融合指纹(FWF-FP)的三维指纹,采用系统定量指纹法(SQFM)和主成分分析(PCA)建立了YXSCs的电化学指纹图谱(EC-FP)和差示扫描量热法指纹图谱(DSC-FP)。此外,通过整合三维指纹分析,对不同批次的YXSCs进行了质量有效的筛选。最后,通过DPPH和ABTS方法评估该中药的抗氧化活性,并对L-抗坏血酸等效抗氧化能力(AEAC)值进行比较,评价两种方法的抗氧化活性。采用偏最小二乘(PLS)模型建立了FWF-FP与AEAC之间的光谱-活性关系,采用双变量相关分析(BCA)评估FWF-FP与EC-FP的相关性。
结果:关键指标包括丹参酮I,tol,脚趾,Atp,第一个放热峰,和第二放热峰可以根据YXSC的三维指纹图谱区分不同批次的YXSC。将42批YXSC的整合评价结果分为2-5级,表明不同批次的质量一致性良好。体外研究表明YXSC具有显著的抗氧化活性。PLS模型显示41个指纹峰中的37个具有抗氧化活性。BCA总体趋势与PLS模型结果一致。
结论:这项研究为YXSC的质量一致性评价提供了科学和整体的策略,从而为彻底评估中药提供了一种有效的方法。
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: The key indexes including tanshinone I, tol, toe, Atp, 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.
CONCLUSIONS: 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.