近红外光谱技术用于氯芬黄敏片中3种成分含量的快速测定  

Rapid Determination of Three Components in Compound Diclofenac Sodium and Chlorphenamine Maleate Tablets by Near-Infrared Spectroscopy

作　　者：黄江剑 吴斌 肖利颖 刘顺国 陈红英 HUANG Jiang-jian;WU Bin;XIAO Li-ying;LIU Shun-guo;CHEN Hong-ying(Guangzhou Baiyunshan Ming xing Pharmaceutical Co.,Ltd.,GuangZhou 510250,China)

机构地区：[1]广州白云山明兴制药有限公司,广东广州510250

出　　处：《海峡药学》2020年第9期61-64,共4页Strait Pharmaceutical Journal

基　　金：广州市科技创新委员会科技创新人才专项(201710010116):清开灵颗粒剂近红外在线质量控制关键技术研究(201710010116)。

摘　　要：目的采用近红外光谱技术建立氯芬黄敏片中3种成分的快速定量分析方法。方法采用HPLC和UV法分别测定氯芬黄敏片中双氯芬酸钠、马来酸氯苯那敏、人工牛黄的含量,近红外光谱仪采集氯芬黄敏片的近红外光谱数据,以偏最小二乘法结合多种预处理方法及波长选择方法建立氯芬黄敏片中3种成分含量与近红外光谱之间的校正模型,通过不同的参数和模型对未知样品进行的预测分析来评价模型的预测性能。结果氯芬黄敏片中双氯芬酸钠、马来酸氯苯那敏和人工牛黄的近红外光谱模型预测集的相关系数分别为0.9993、0.9998、0.9968;交叉检验的校正标准偏差分别为0.7416、2.0559、0.0022;校正标准偏差分别为0.0619、0.0298、0.0003。11批片剂双氯芬酸钠、马来酸氯苯那敏及人工牛黄验证集的参考值与预测值的含量接近。结论建立的近红外光谱技术模型性能较好,能够快速准确的测定氯芬黄敏片中3种成分的含量,方法可控,可应用于生产。OBJECTIVE To construct a quantitative method quickly analyzing the three components(Diclofenac Sodium,Chlorphenamine Maleate and Bovis Calculus Artifactus)of Compound Diclofenac Sodium and Chlorphenamine Maleate Tablets by near in-frared(NIR).METHODS The contents of Diclofenac Sodium,Chlorphenamine Maleate and Bovis Calculus Artifactus in Compound Diclofenac Sodium and Chlorphenamine Maleate Tablets were determined by HPLC and the near-infrared spectrum data.To establish the calibration model,the THUNIR software was used to combine the data of NIR and HPLC with different pretreatment,methods,band selection methods and partial least square method.The calibration model was evaluated through different parameters and the unknown samples.RESULTS The established models of Diclofenac Sodium,Chlorphenamine Maleate and Bovis Calculus Artifactus showed that the determination coefficient was 0.9993,0.9998 and 0.9968.The standard error of cross-validation was 0.7416,2.0559 and 0.0022,respectively and standard error of calibration was 0.0619,0.0298 and 0.0003,respectively.Tests of the optimal models with prediction samples were made,which showed that the relative deviation of Compound Diclofenac Sodium and Chlorphenamine Maleate Tablets of these three components were closed.CONCLUSION The model established by the near infrared spectroscopy technology has good performance and can quickly and accurately determine the content of the three components in Compound Diclofenac Sodium and Chlorphenamine Maleate Tablets,The method is reliable,and can be used as a method of quality control.

关 键 词：氯芬黄敏片 双氯芬酸钠 马来酸氯苯那敏 人工牛黄 近红外光谱技术 

分 类 号：R927[医药卫生—药学]