汤蕊,高庆军,杨慧芳,罗雪,陈星宏,赵代伟
TANG Rui,GAO Qingjun,YANG Huifang,LUO Xue,CHEN Xinghong,ZHAO Daiwei

• 1:贵州医科大学临床医学院
• 2:贵州医科大学附属医院甲状腺外科
• 3:贵州省第二人民医院普外科

摘要(Abstract)：

目的 建立夏枯草口服液HPLC指纹图谱，并同时测定其中5种成分的含量。方法 采用ACE EXCEL 5 C18(250 mm×4.6 mm,5μm)色谱柱，流动相为乙腈-0.1%磷酸水溶液，梯度洗脱，流速为1.0 mL/min，柱温30℃，进样量10μL，检测波长280 nm；建立夏枯草口服液HPLC指纹图谱；通过相似度评价、主成分分析（PCA）和正交偏最小二乘法-判别分析（OPLS-DA）等化学模式识别，对不同批次夏枯草口服液的质量进行评价，同时测定迷迭香酸、咖啡酸、丹参素、原儿茶酸和原儿茶醛5种成分的含量。结果 建立了夏枯草口服液的HPLC指纹图谱，标定了50个共有峰，指认了其中5种成分；25批样品相似度均在0.90以上，通过化学模式识别揭示了25批夏枯草口服液的质量相似性与差异性；所测定5种成分在相应的浓度范围内线性关系良好，r≥0.999 0，平均加样回收率98.44%～103.6%,RSD≤2.67%。结论 HPLC指纹图谱结合多指标成分含量测定的方法简便可行、准确可靠，可为夏枯草口服液的质量控制与评价提供实验依据。
Objective To establish the HPLC fingerprints and determine the content of 5 chemical ingredients of xiakucao oral liquid.Methods The analysis was performed on ACE EXCEL 5 C18(250 mm ×4. 6 mm, 5 μm) chromatographic column with acetonitrile-0. 1% phosphoric acid solution for gradient elution. Working conditions were as follows: the flow rate was 1. 0 mL/min, the detection wavelength was 280 nm, the column temperature was 30 ℃, and the injection volume was10 μL. HPLC fingerprint of xiakucao oral liquid were established. Similarity analysis combined with principal component analysis(PCA), and orthogonal partial least squares discriminant analysis(OPLSDA) were adopted to assess the quality of various batches of liquid. Meanwhile, contents of rosmarinic acid, caffeic acid, tanshinol, protocatechuic acid, and protocatechuic aldehyde were determined.Results HPLC fingerprint xiakucao oral liquid was established, a total of 50 peaks were selected as the common peaks, of which 5 contents were identified. The similarities of 25 batches of samples were above 0. 90; the similarities and differences in the quality of 25 batches of xiakucao oral liquid were revealed by chemical pattern recognition. Five constituents showed good linear relationships in corresponding concentration ranges(r≥0. 999 0), whose average recoveries were 98. 44% to 103. 6%with theRSD≤2. 67%.Conclusion The method of HPLC fingerprints combined with multi-index component content determination is simple, accurate, and reliable, which can provide experimental basis for the quality control and evaluation of xiakucao oral liquid.

关键词(KeyWords)： 夏枯草口服液;HPLC;指纹图谱;化学模式识别;含量测定;质量控制
xiakucao oral liquid;HPLC;fingerprint;chemical pattern recognition;content determination;quality control

Abstract:

Keywords:

基金项目(Foundation): 贵州省卫生健康委科学技术基金项目（gzwjk2019-1-119）

作者(Author): 汤蕊,高庆军,杨慧芳,罗雪,陈星宏,赵代伟
TANG Rui,GAO Qingjun,YANG Huifang,LUO Xue,CHEN Xinghong,ZHAO Daiwei

DOI: 10.19367/j.cnki.2096-8388.2022.06.005

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