香砂胃苓丸混合终点在线监测及质量评价近红外模型的建立  

On-line Monitoring of Mixed End Point and Establishment of Near Infrared Model for Quality Evaluation of Xiangsha Weiling Pills

作　　者：付立娟 邢成 边雨 姜春凤 郭敏 曲佳乐 高陆 王宝成 FU Li-juan;XING Cheng;BIAN Yu(Jilin Modern Chinese Medicine Engineering Research Center Co.,Ltd.,Changchun,Jilin 130102;Tongyao Pharmaceutical Group Co.,Ltd.,Baishan,Jilin 134300)

机构地区：[1]吉林省现代中药工程研究中心有限公司,吉林长春130102 [2]通药制药集团股份有限公司,吉林白山134300

出　　处：《安徽农业科学》2024年第4期153-156,共4页Journal of Anhui Agricultural Sciences

基　　金：吉林省科技发展计划项目(202007087031YY)。

摘　　要：[目的]利用近红外光谱技术,快速判断香砂胃苓丸中间体的混合终点。结合高效液相色谱分析方法,建立中间体的近红外光谱模型,实现香砂胃苓丸中间体质量的快速评价。[方法]采用声光可调-近红外光谱(AOTF-NIR)技术,通过主成分分析法和移动窗标准偏差法判断中间体的混合终点。采用高效液相色谱法,检测35批香砂胃苓丸中间体中橙皮苷的含量,即得化学值。利用SNAP光谱软件进行光谱采集,以一阶导数法和平滑滤波系数法进行光谱预处理。采用The Unscrambler分析软件,将近红外光谱图与含量化学值相关联,以偏最小二乘法(PLS)和交叉-验证法(cross-validation)建立香砂胃苓丸中间体中橙皮苷含量的定量校正模型。[结果]香砂胃苓丸中间体在40 min时基本达到混合终点,且近红外光谱预测值与化学值混合终点的结果一致。香砂胃苓丸中间体中橙皮苷定量模型内外部验证相关系数均大于0.90,校正均方根偏差(RMSEC)为0.1329,预测均方根偏差(RMSEP)为0.1553,定量模型的外部验证结果相对标准偏差(RSD)均小于5%,表明橙皮苷含量预测值准确性较高。[结论]声光可调-近红外光谱技术能够实现香砂胃苓丸中间体混合终点的快速判断和质量的快速评价,缩短生产周期,提高生产效率。[Objective]The mixed end point of intermediates in Xiangsha weiling pills were determined quickly by near-infrared spectroscopy.Based on the high-performance liquid chromatography analysis method,the near infrared spectroscopy model of the intermediates was established to realize the rapid quality evaluation of the intermediates of Xiangsha weiling pills.[Method]Acousto-optic tunable near infrared spectroscopy(AOTF-NIR)was used to determine the mixed endpoint of intermediates by principal component analysis and moving window standard deviation.The hesperidin content in 35 batches of Xiangsha weiling pill intermediates was determined by high-performance liquid chromatography method.The first derivative method and the smooth filtering coefficient method were used to preprocess the spectra.The Unscrambler software was used to correlate the NIR spectra with the chemical values of the contents,a quantitative calibration model for hesperidin content in the intermediates of Xiangsha weiling pills was established by using partial least squares test(PLS)and cross-validation.[Result]The intermediate of Xiangsha weiling pill basically reached the mixed end point at 40 min,and the predicted value of near infrared spectrum was consistent with the mixed end point of chemical value.The correlation coefficients between internal and external validation of hesperidin quantitative model in Xiangsha weiling pill intermediates were all greater than 0.90,the corrected root-mean-square deviation(RMSEC)was 0.1329,and the predicted root-mean-square deviation(RMSEP)was 0.1553,the relative standard deviation(RSD)of the quantitative model was less than 5%,which indicated that the prediction value of hesperidin content was accurate.[Conclusion]AOTF-NIR technology can be used to quickly judge the mixed end point and evaluate the quality of Xiangsha weiling pill intermediates,shorten the production cycle and improve the production efficiency.

关 键 词：香砂胃苓丸 声光可调-近红外光谱技术 混合终点 在线监测 质量评价 

分 类 号：R927[医药卫生—药学]