School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, PR China.
Zhengzhou food and Drug Inspection Institute, Zhengzhou, PR China.
J Pharm Biomed Anal. 2021 Mar 20;196:113910. doi: 10.1016/j.jpba.2021.113910. Epub 2021 Jan 19.
Yankening Tablet (YKNT) is an anti-inflammatory Chinese medicine, which has the effect of heat-clearing and purging pathogenic fire. In this paper, a novel method for quality consistency evaluation of YKNT by multi-wavelength fusion profiling combined with multi-component quantification, overall components dissolution method and antioxidant activity analysis was established. The five-wavelength fusion fingerprint (FWFFP) of 19 batches of YKNT was established, which was evaluated qualitatively and quantitatively by systematic quantified fingerprint method (SQFM), and the quality of YKNTs was divided into different grades successfully. Three active components, Berberine (BBR), baicalin (BCL) and chrysophanol (CRP) in YKNT, were quantitatively determined by quantitative analysis of multi-components by single marker (QAMS). Principal component analysis divided the 19 batches of samples into two categories according to the content difference, which was consistent with the SQFM evaluation results. The combination of SQFM and QAMS successfully achieved the quantitative determination of YKNT from the whole to accurate. Partial least squares (PLS) model was developed to explore the relationship between the antioxidant ability and fingerprint of YKNT. Further overall dissolution UV fingerprints (ODUV-FP) were successfully established, in which the ultraviolet fingerprint (UV-FP) quantitative method was applied to determine the dissolution of the whole chemical substance of traditional Chinese medicine (TCM) preparation. HPLC fingerprints (HPLC-FP) and ODUV-FP were combined to realize the dual control of the quality and efficacy of YKNT, providing a new method for consistency evaluation of TCM.
咽康含片（YKNT）是一种具有清热泻火作用的抗炎中药。本文建立了一种新的方法，通过多波长融合谱图结合多成分定量、整体成分溶出度法和抗氧化活性分析，对 YKNT 的质量一致性进行评价。建立了 19 批 YKNT 的五波长融合指纹图谱（FWFFP），采用系统量化指纹法（SQFM）对其进行定性和定量评价，成功将 YKNTs 的质量分为不同等级。采用单标记定量分析多成分（QAMS）法定量测定 YKNT 中的三种活性成分：小檗碱（BBR）、黄芩苷（BCL）和大黄酚（CRP）。主成分分析（PCA）根据含量差异将 19 批样品分为两类，与 SQFM 评价结果一致。SQFM 和 QAMS 的结合成功地实现了从整体到准确的 YKNT 定量测定。偏最小二乘法（PLS）模型被用来探索 YKNT 的抗氧化能力与指纹图谱之间的关系。进一步成功建立了整体溶出度紫外指纹图谱（ODUV-FP），其中应用紫外指纹图谱（UV-FP）定量法来测定中药制剂的整体化学物质的溶出度。将 HPLC 指纹图谱（HPLC-FP）和 ODUV-FP 相结合，实现了 YKNT 质量和疗效的双重控制，为中药的一致性评价提供了一种新方法。
