基于化学模式识别技术的苍耳子鼻炎胶囊(滴丸)中3个活性成分含量测定及质量评价研究  

Quantitative and Quality Evaluation Research of Three Active Components in Xanthium Rhinitis Capsule(Dripping Pills) Combined with Chemical Pattern Recognition Technologies

作　　者：郑利 冯亮 昝毅 江雪 李平 赵阳 ZHENG Li;FENG Liang;ZAN Yi;JIANG Xue;LI Ping;ZHAO Yang(Suining Inspection and Testing Center,Suining 629000,China)

机构地区：[1]遂宁市检验检测中心,四川遂宁629000

出　　处：《中央民族大学学报（自然科学版）》2023年第3期81-89,共9页Journal of Minzu University of China(Natural Sciences Edition)

摘　　要：本文采用同时测定苍耳子鼻炎胶囊(滴丸)中3个活性成分含量的高效液相色谱法(HPLC)的方法,并用化学模式识别技术综合评价该药物质量。采用HPLC-PDA分析检测,Agilent poroshell 120 EC-C18(4.6 mm×50 mm, 2.7μm)为色谱柱,流动相为乙腈-0.2%磷酸水溶液,梯度洗脱;流速为1.0 mL/min;柱温为35℃;进样量为10μL;检测波长为327 nm(绿原酸),230 nm(黄芩苷、木兰脂素)。采用统计软件SPSS 22.0及SIMCA14.1对21批苍耳子鼻炎胶囊(滴丸)样品含量测定结果进行聚类分析与主成分分析。结果显示,在一定浓度范围内,苍耳子鼻炎胶囊(滴丸)中绿原酸、黄芩苷、木兰脂素线性关系良好(r≥0.9994);精密度、稳定性(24 h)、重复性试验的RSD<2.0%(n=6);平均加样回收率分别98.66%,99.84%,100.21%(n=9),RSD均<2.0%;21批样品中绿原酸、黄芩苷、木兰脂素含量分别为0.170 2~1.415 5 mg/g, 13.160 5~46.831 4 mg/g, 1.833 8~4.012 4 mg/g;聚类分析与主成分分析均将21批样品分为四类,两种分类结果一致。结合化学模式识别技术,所建立的3个活性成分含量测定方法可为苍耳子鼻炎胶囊(滴丸)的质量控制提供依据。This study was aimed to develop a HPLC method for the simultaneous determination of three active components in Xanthium Rhinitis capsules(dripping pills),and to give a comprehensive evaluation of the quality of the drug by the chemical pattern recognition technologies. The HPLC-PDA was used and the chromatographic conditions were as follows: Agilent poroshell 120 EC-C18(4.6 mm×50 mm, 2.7 μm) column with the mobile phase of acetonitrile-0.2% phosphoric acid flowing at 1.0 mL/min with gradient elution. The column temperature and the injection volume was respectively 35℃ and 10 μL. The detection wavelengths were 327 nm(chlorogenic acid),230 nm(baicalin and magnolin). The cluster anlysis(CA) and principal componet analysis(PCA) were conducted for the results of content determination in 21 batches of Xanthium Rhinitis capsules(dripping pills) by statistical software SPSS 22.0 and SIMCA14.1. The results showed that within a certain concentration range, the chlorogenic acid, baicalin and magnolin in Xanthium Rhinitis capsules(dripping pills) all showed good linear relationship(r≥0.9994). RSDs of precision, stability(24 h) and reproducibility tests were all lower than 2.0%(n=6). The average recoveries were 98.66%,99.84%,100.21%(n=9),respectively with the RSDs lower than 2.0%. The contents of chlorogenic acid, baicalin and magnolipin in 21 batches of samples were respectively 0.170 2~1.415 5 mg/g, 13.160 5~46.831 4 mg/g, 1.833 8~4.012 4 mg/g. The samples could be classified into four categories by using CA and PCA,and the results of classification were consistent. The established method for the determination of three active components can provide a foundation for the quality control of Xanthium Rhinitis capsules(dripping pills) combined with the chemical pattern recognition technologies.

关 键 词：苍耳子鼻炎胶囊(滴丸) 高效液相色谱法 质量评价 化学模式识别技术 绿原酸 黄芩苷 木兰脂素 

分 类 号：R284[医药卫生—中药学]