张亚非;左翔云;毕宇安;吴建雄;王振中;李萍;萧伟;
ZHANG Ya-fei;ZUO Xiang-yun;BI Yu-an;WU Jian-xiong;WANG Zhen-zhong;LI Ping;XIAO Wei;School of Traditional Chinese Medicine,China Pharmaceutical University;Jiangsu Kanion Pharmaceutical Co. ,Ltd.;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process;

• 1:中国药科大学中药学院
• 2:江苏康缘药业股份有限公司
• 3:中药制药过程新技术国家重点实验室

摘要(Abstract)：

目的:应用近红外(NIR)光谱分析技术,建立热毒宁注射液产业化生产中萃取液浓缩过程绿原酸含量及固含量质量控制指标的快速定量分析方法,实时反映浓缩过程的状态,真正实现萃取液浓缩过程质量控制。方法:收集金青萃取液浓缩过程中样品,经过异常点剔除、光谱预处理和波段选择,运用偏最小二乘法(PLS)分别建立NIR光谱与绿原酸HPLC分析值和固含量之间的定量校正模型,并对未知样品进行预测。结果:绿原酸含量和固含量校正模型的相关系数分别为0.992 1,0.994 0,验证模型的相关系数分别为0.994 4,0.998 4,RMSEC分别为0.814 6,2.656 1,RMSEP分别为0.704 6,1.876 7,RSEP分别为6.01%,2.93%。结论:该方法操作简便、快速无损且准确可靠,可用于热毒宁注射液萃取液浓缩过程中绿原酸含量及固含量的快速监测。
Objective: To establish a rapid quantitative analysis method for the content of chlorogenic acid and solid content in the extraction liquid concentration process during the production of Reduning injection by using the near-infrared( NIR) spectroscopy,in order to reflect the concentration state in a real-time manner and really realize the quality control of concentrating process of the extraction and concentration process. Method: The samples during the Jinqing extraction liquid concentration process were collected. After the removal of abnormal samples,the spectra pretreatment and the wave band selection,the quantitative calibration model between NIR spectra and chlorogenic acid HPLC analytical value and solid content was established by using PLS algorithm,and unknown samples were predicted. Result: The correlation coefficients between the chlorogenic acid content and the solid content were respectively0. 992 1 and 0. 994 0,and the correlation coefficients of the verification model were respectively 0. 994 4 and 0. 998 4,with the root mean square error of calibration( RMSEC) of 0. 814 6 and 2. 656 1 and the root mean square error of prediction( RMSEP) of 0. 704 6and 1. 876 7 respectively,and the relative standard errors of predictions( RSEP) were 6. 01% and 2. 93% respectively. Conclusion:The method is simple,rapid,nondestructive,accurate and reliable,thus could be adopted for the fast monitoring of the chlorogenic acid content and the solid content during the concentration process of Reduning injection extraction liquid.

关键词(KeyWords)： NIR光谱;热毒宁注射液;萃取;绿原酸;固含量
near-infrared spectroscopy;Reduning injection;extraction;chlorogenic acid;solid content

Abstract:

Keywords:

基金项目(Foundation): 国家“重大新药创制”科技重大专项(2013ZX09402203)

作者(Author): 张亚非;左翔云;毕宇安;吴建雄;王振中;李萍;萧伟;
ZHANG Ya-fei;ZUO Xiang-yun;BI Yu-an;WU Jian-xiong;WANG Zhen-zhong;LI Ping;XIAO Wei;School of Traditional Chinese Medicine,China Pharmaceutical University;Jiangsu Kanion Pharmaceutical Co. ,Ltd.;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process;

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DOI:

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