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目的:建立应用近红外光纤光谱法对清热解毒口服液进行现场快速定量分析的方法。方法:收集100批清热解毒口服液为样本,利用HPLC测定样品中黄芩苷的含量,采集光谱,用偏最小二乘法(PLS)对清热解毒口服液中黄芩苷成分建立了定量分析模型,并对模型的处理方法、波长范围进行了研究。结果:建立的黄芩苷校正模型相关系数(R2)、估计误差均方根(RMSEE)、相对分析误差(RPD)分别为0.915 4,0.040 3,3.44。经外部验证,校正模型的预测均方差(RMSEP)、平均回收率分别为0.039 9,100.299%。结论:本研究使用近红外光纤光谱法所建立的对清热解毒口服液中黄芩苷的分析方法快速、准确,为清热解毒口服液的现场、即时快速定量分析提供了一种新方法,同时也为生产过程中的在线质量监控奠定了基础。
Objective: To establish a method for rapid quantitative analysis of Qingrejiedu oral liquid by near infrared spectroscopy. Methods: 100 samples of Qingrejiedu Oral Liquid were collected. The contents of baicalin in the samples were determined by HPLC. The spectra were collected. The quantitative analysis model of baicalin in Qingrejiedu Oral Liquid was established by partial least squares (PLS) The model processing method and wavelength range are studied. Results: The correlation coefficient (R2), root mean square error of estimation (RMSEE) and relative analytical error (RPD) of baicalin calibration model were 0.915 4,0.040 and 3.44 respectively. After external validation, the predicted mean square error (RMSEP) of the calibration model, the average recovery rates were 0.039 9,100.299%. Conclusion: The method for the determination of baicalin in Qingrejiedu Oral Liquid by using near-infrared optical fiber spectroscopy is rapid and accurate in this study, providing a new method for real-time and rapid quantitative analysis of Qingrejiedu Oral Liquid. The online quality control in the production process laid the foundation.