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目的:建立测定前列欣胶囊中欧前胡素、水分、细菌含量的即时快速检测分析方法。方法:采用声光可调滤光器-近红外(AOTF-NIR)光谱技术。检测器为InGaAs,测样方式为漫反射,光谱范围为1100～2200nm,波长增量为2.0nm,平均次数为300次。采用偏最小二乘法分别建立校正集样本中5个检测指标的NIR定量分析模型,并对验证集样本进行预测。采用TheUnscram-bler软件分析。结果:欧前胡素和水分含量模型的预测结果较好,NIR预测值与化学值之间的相关系数r分别为0.9993和0.9950,平均RSD为2.44%和1.07%;所建细菌梯度模型则可对不同范围内的细菌个数进行较准确预测,预测结果的平均RSD为6.61%和4.59%。结论:AOTF-NIR为前列欣胶囊的全面质量快速分析提供了一种新方法,而且为中成药固体制剂中水分的快速测定提供了借鉴,为中成药生产过程中细菌等微生物的在线检测做了有益的探索。
Objective: To establish a rapid real-time assay for the determination of imperatorin, water and bacteria in Qianliexin capsules. Methods: AOTF-NIR spectroscopy was used. The detector is InGaAs, the sample measurement mode is diffuse reflection, the spectral range is 1100 ~ 2200nm, the wavelength increment is 2.0nm, the average number of times is 300 times. The partial least squares method was used to establish the NIR quantitative analysis model of the five detection indexes in the calibration set samples respectively, and the validation set samples were predicted. Using TheUnscram-bler software analysis. Results: The predictions of imperatorin and water content model were good, and the correlation coefficients r between predicted value of NIR and chemical value were 0.9993 and 0.9950 respectively, with the average RSDs of 2.44% and 1.07%. The bacterial gradient model was established The accurate prediction of the number of bacteria in different ranges showed that the average RSD of the predicted results was 6.61% and 4.59%. Conclusion: AOTF-NIR provides a new method for rapid quantitative analysis of Qianleixin capsules, and provides a reference for the rapid determination of moisture in solid preparations of traditional Chinese patent medicines. It has been applied to on-line detection of microbes and other microorganisms in the production of proprietary Chinese medicines Useful exploration.