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目的:采用近红外(NIR)光谱技术建立天舒胶囊水提取工序中天麻素含量和含固量2个质量控制指标的快速定量分析方法,实时获得二者在该制剂2次水提过程中的动态变化情况,实现水提液浓缩过程关键指标的质量控制。方法:收集天麻、川芎2次水提取过程中样品,通过异常点去除、光谱预处理方法确定及最优波段选择,运用偏最小二乘法(PLS)分别建立NIR光谱与天麻素含量和含固量之间的定量校正模型,采用未知样品对定量校正模型进行验证,判断其准确性。结果:天麻素含量和含固量校正模型的相关系数分别为0.968 0,0.977 2,验证模型的相关系数分别为0.965 9,0.978 6,校正均方差(RMSEC)分别为4.686,0.053,预测均方差(RMSEP)分别为3.698,0.034,预测相对偏差(RSEP)分别为4.85%,3.07%。结论:近红外光谱分析技术操作简便、分析速度快且准确度高,可用于天舒胶囊水提取过程天麻素含量及含固量的快速监测。
OBJECTIVE: To establish a rapid and quantitative method for the determination of gastrodin content and solid content in Tianshu capsule by near infrared spectroscopy (NIR) Dynamic changes, to achieve the key indicators of the quality control of water extract concentration process. Methods: The samples of Gastrodia elata Blume and Rhizoma Chuanxiong were collected during the water extraction. Abnormal spots were removed, spectral pretreatment method was used to determine the optimal wavelength band, and partial least square method (PLS) was used to establish the NIR spectra and gastrodin content and solid content Between the quantitative correction model, the use of unknown samples to verify the quantitative calibration model to determine its accuracy. Results: The correlation coefficients of gastrodin content and solid content correction model were 0.968 0 and 0.977 2 respectively, the correlation coefficient of validation model were 0.965 9 and 0.978 6 respectively, and the RMSECs were 4.686 and 0.053 respectively. The mean square error of prediction (RMSEP) were 3.698 and 0.034 respectively, and the relative prediction deviations (RSEPs) were 4.85% and 3.07% respectively. Conclusion: The technique of near infrared spectroscopy is simple, rapid and accurate. It can be used for rapid monitoring of gastrodin content and solid content in Tianshu capsule water extraction process.