Lou Hongyin, Li Xuan, Yang Sha, Bao Mengfan, Li Gang, Cai Ming, Sun Guoxiang
College of Pharmacy, Shenyang Pharmaceutical University, Shenyang, Liaoning, 110016, China.
College of Life Science and Biopharmaceutics, Shenyang Pharmaceutical University, Shenyang, Liaoning, 110016, China.
Talanta. 2025 Dec 1;295:128349. doi: 10.1016/j.talanta.2025.128349. Epub 2025 May 22.
Qingfei Shibawei Pill (QFSBWP) is a traditional Tibetan medicine consisting of 18 herbs, which has the effects of clearing heat and removing toxins, relieving cough and resolving phlegm. In this study, the quality evaluation system of 22 batches of QFSBWP samples was established by using multidimensional analytical techniques, such as HPLC, UV, and FT-IR. The HPLC was based on dual-wavelength fusion fingerprinting (DWFFP) and dual-wavelength absorption coefficient ratio fingerprint (DWAR) as the core. DWFFP was constructed at 250 nm and 265 nm, and 24 common peaks were fused to generate the control fingerprint profile (RFP), and the similarity (S, P, α)) was calculated by systematically quantified fingerprint method (SQFM). DWAR identified the peak purity by the primary/secondary absorbance coefficient ratio, and found that the peaks such as G3, G6, and G19 fluctuated a lot. The PCA and HCA revealed that the quality of the samples from different manufacturers was different. In addition, the four target components, Gallic acid (GA), Agarotetrol (AT), Licorice glycoside (LG) and Ellagic acid (EA), were quantitatively analyzed by standard curve method (SCM). Meanwhile, UV and FT-IR quantitative fingerprints (QFP) were introduced to convert continuous spectra into discrete quantum peaks, which preserved the original information and enhanced the data visualization. Finally, the weighting analysis of the above four methods (2/5 UV+1/5 other methods) is combined to establish a multi-technology fusion method. It was shown that the method can characterize the overall quality of traditional Chinese medicine (TCM), overcome the single-technique limitations, and provide a new solution for the quality control of compound preparations.
清肺十八味丸是一种由18味药材组成的传统藏药，具有清热解毒、止咳化痰的功效。本研究采用高效液相色谱法（HPLC）、紫外可见分光光度法（UV）和傅里叶变换红外光谱法（FT-IR）等多维分析技术，建立了22批次清肺十八味丸样品的质量评价体系。HPLC以双波长融合指纹图谱（DWFFP）和双波长吸收系数比指纹图谱（DWAR）为核心。DWFFP在250nm和265nm波长下构建，融合24个共有峰生成对照指纹图谱（RFP），采用系统量化指纹图谱法（SQFM）计算相似度（S、P、α）。DWAR通过主次吸收系数比鉴定峰纯度，发现G3、G6和G19等峰波动较大。主成分分析（PCA）和聚类分析（HCA）表明，不同厂家的样品质量存在差异。此外，采用标准曲线法（SCM）对没食子酸（GA）、沉香四醇（AT）、甘草苷（LG）和鞣花酸（EA）4种目标成分进行定量分析。同时，引入UV和FT-IR定量指纹图谱（QFP）将连续光谱转换为离散量子峰，保留了原始信息，增强了数据可视化。最后，将上述4种方法（2/5 UV+1/5其他方法）进行加权分析，建立了多技术融合方法。结果表明，该方法能够表征中药的整体质量，克服单一技术的局限性，为复方制剂的质量控制提供了新的解决方案。
