基于指纹图谱和多指标成分多元统计分析的石芪外肝颗粒质量定量评价

IF 1.7 4区 医学 Q4 BIOCHEMICAL RESEARCH METHODS
Feng Lin, An Yaling, Mei Fang, Xia Tiyu, Jiang Huiling, Peng Lihua, Qiao Weilin, Guo De-an
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引用次数: 0

摘要

石气外肝颗粒是一种广泛用于治疗普通感冒的中药,但缺乏快速、全面的质量控制方案。采用Agilent ZORBAX SB-C18色谱柱(4.6 × 250 mm, 5µm),乙腈-0.1%磷酸梯度洗脱,检测波长330 nm,柱温40℃,流速0.6 mL/min,建立HPLC指纹图谱。对11个商业批次进行了分析,得到9个一致的共同峰(相似度> 0.9)。其中8个峰被明确地识别和量化,都显示出良好的线性(r > 0.9999)。采用SIMCA软件和投影变量重要度(VIP)评分的正交偏最小二乘判别分析(OPLS-DA)突出了四种不同批次之间含量差异最大的化合物,从而影响了产品质量。将指纹图谱、定量分析和多元统计相结合,为石芪外肝颗粒的常规质量控制提供了可靠、有效的方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Quantitative Evaluation of the Quality of Shiqi Waigan Granules Based on Fingerprinting and Multi-Indicator Components With Multivariate Statistical Analysis

Quantitative Evaluation of the Quality of Shiqi Waigan Granules Based on Fingerprinting and Multi-Indicator Components With Multivariate Statistical Analysis

Shiqi Waigan Granules (SWG) are a widely used traditional Chinese medicine for treating common colds, yet a rapid and holistic quality-control protocol has been lacking. In this work, an HPLC fingerprint was built on an Agilent ZORBAX SB-C18 column (4.6 × 250 mm, 5 µm) with acetonitrile–0.1% phosphoric acid gradient elution, 330 nm detection, 40°C column temperature, and 0.6 mL/min flow. Eleven commercial batches were profiled, yielding nine consistent common peaks (similarity > 0.9). Eight of these peaks were unequivocally identified and quantified, all showing excellent linearity (r > 0.9999). Orthogonal partial least-squares discriminant analysis (OPLS-DA) with SIMCA software and variable-importance-in-projection (VIP) scoring highlighted four compounds whose levels differ most among batches and therefore drive product quality. Integrating fingerprinting, quantification, and multivariate statistics thus furnishes a reliable, efficient strategy for routine quality control of Shiqi Waigan Granules.

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来源期刊
Biomedical Chromatography
Biomedical Chromatography 生物-分析化学
CiteScore
3.60
自引率
5.60%
发文量
268
审稿时长
2.3 months
期刊介绍: Biomedical Chromatography is devoted to the publication of original papers on the applications of chromatography and allied techniques in the biological and medical sciences. Research papers and review articles cover the methods and techniques relevant to the separation, identification and determination of substances in biochemistry, biotechnology, molecular biology, cell biology, clinical chemistry, pharmacology and related disciplines. These include the analysis of body fluids, cells and tissues, purification of biologically important compounds, pharmaco-kinetics and sequencing methods using HPLC, GC, HPLC-MS, TLC, paper chromatography, affinity chromatography, gel filtration, electrophoresis and related techniques.
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