近红外光谱法在琥乙红霉素片定量分析中的应用  

Application of near infrared spectroscopy in quantitative analysis of erythromycin ethylsuccinate tablets with different manufactures

作　　者：肖莹[1] 彭凤[1] 杨洪芹[1] 熊歆诺 李晖[1] XIAO Ying;PENG Feng;YANG Hong-qin;XIONG Xin-nuo,;LI Hui

机构地区：[1]四川大学化学工程学院,四川成都610065

出　　处：《化学研究与应用》2016年第7期954-959,共6页Chemical Research and Application

基　　金：四川省科技厅应用基础研究项目(2014JY0042)资助

摘　　要：运用近红外光谱法对14个厂家22个批次的琥乙红霉素片进行定量分析,包括琥乙红霉素片含量及溶出度的测定。通过偏最小二乘回归方法建立的含量均匀度和溶出度模型相关系数分别达0.99601和0.98189,校正均方根误差分别为0.670和0.575,预测均方根误差为0.646和0.514,与交叉验证均方根误差相近(分别为0.822和0.683)。基于准确性轮廓外部验证的95%的公差区间,样品相对误差低于5%,含量均匀度和溶出度模型的可预测性得到进一步的验证。本研究表明,近红外光谱法能用于琥乙红霉素片含量的测定,同时也能实现对不同厂家琥乙红霉素片溶出度的预测。A set of quantitative methods based on near infrared(NIR)spectroscopy was established for quantitative determination ofactive content and the drug dissolution percentage of 22 batches erythromycin ethylsuccinate tablets from 14 manufacturers. The contentand dissolution models were developed by partial least square regression method with good correlation coefficient(R)0. 99601and 0. 98189 respectively,the root mean square error of calibration values are 0. 670 and 0. 575 respectively,the root mean squareerror of prediction are 0. 646 and 0. 514 respectively,which are all close to the root mean square error of cross validation(0. 822 and0. 683 respectively). Based on the 95%tolerance intervals and the relative error below ±5%,the accuracy profile obtained from theexternal validations further demonstrated good predictability for both the content and dissolution model. This research shows thatNIR spectroscopy is able to be used for the determination of the active content,which was successfully applied to predict dissolutionrate of tablets from different manufactures of erythromycin ethylsuccinate tablets

关 键 词：近红外光谱 琥乙红霉素片 含量和溶出度定量模型 准确度轮廓 

分 类 号：O657.33[理学—分析化学]