近红外光谱对热毒宁注射液栀子萃取过程中的可行性分析

目的:对近红外光谱(NIR)分析技术在热毒宁注射液栀子萃取过程中可行性进行分析研究。方法:收集7批共147个栀子萃取液样品,扫描NIR离线光谱,测定栀子苷含量和固含量,应用偏最小二乘法建立定量校正模型,并用此模型进行预测。结果:建立的栀子苷和固含量模型校正集R2分别为0.987 2,0.994 7,RMSEC分别为1.460 9,2.367 7,说明所建模型性能良好。该模型对20个栀子萃取液样品进行预测,栀子苷和固含量的R2分别为0.980 7和0.986 1,RMSEP分别为1.827 5和7.307 7,RSEP分别为3.08%和5.29%均小于6%,能够满足中药生产过程中质量控制要求。结论:建立的近红外离线定量模型可以准确预测栀子苷含量和固含量,证实了NIR技术在热毒宁注射液栀子萃取过程应用的可行性。

Feasibility Study on Use of Near-infrared Spectroscopy for Monitoring Extraction Procedure of Gardeniae Fructus in Preparation of Reduning Injection

Objective: To analyze the feasibility of using Near-infrared (NIR) spectroscopy for quality control of liquid-liquid extraction procedure of Cardeniae Fructus in the preparation of reduning injection. Method: 147 extraction stream samples from seven batches were collected and NIR off-line spectra were acquired by Luminar 5030 spectrometer. The contents of geniposide (GS) and soluble solid content (SSC) were determined by the reference method. The partial least square(PLS) algorithm was used to build GS and SSC NIR models and predict the contents in prediction set. Result: The R² of the established GS and SSC models were 0.987 2 and 0.994 7 as well as the RMSEC was 1.460 9 and 2.367 7, which indicated the models had good performance. Besides, the predictive results of 20 samples were satisfactory. The R² was 0.980 7 and 0.986 1, the RMSEP was 1.827 5 and 7.307 7 and the RSEP was 3.08% and 5.29% for GS and SSC, respectively. Both of the RSEP values were lower than 6%, which can satisfy the quality control standard in the traditional Chinese medicine production process. Conclusion: The established models could precisely predict the content of GS and SSC. The results demonstrated that the NIR spectroscopy might be a suitable and alternative technology for monitoring the liquid-liquid extraction procedure of Gardeniae Fructus.