基于近红外光谱法建模的替米沙坦片快速鉴别及含量预测  

Rapid Identification and Content Prediction of Telmisartan Tablets with Model Based on Near Infrared Spectroscopy

作　　者：庄莹 秦斌 梁雪 闫研 陈静丽 殷果 ZHUANG Ying;QIN Bin;LIANG Xue;YAN Yan;CHEN Jingli;YIN Guo(Shenzhen Institute for Drug Control,NMPA Key Laboratory for Bioequivalence Research of Generic Drug Evaluation,Guangdong Shenzhen 518057,China)

机构地区：[1]深圳市药品检验研究院,国家药品监督管理局仿制药评价生物等效性研究重点实验室,广东深圳518057

出　　处：《广州化工》2024年第19期85-88,114,共5页GuangZhou Chemical Industry

基　　金：2021年国家药品抽验(中央补助地方经费项目106号)。

摘　　要：使用光纤法采集替米沙坦片(40 mg)的近红外光谱,利用一致性指数(CI)值和一致性指数限度比较法,且结合偏最小二乘回归方法(PLS)建立一致性检验模型并进行定量分析。研究发现,所建立的一致性检验模型能迅速区分替米沙坦片(40 mg)与其他规格的同类产品,所建立的定量分析模型相关系数(r^(2))和外部验证均方根误差(RMSEP)分别为0.9659和0.18。结果表明该方法可用于替米沙坦片的快速定性和定量分析且方便快捷。The telmisartan tablets(40 mg)were determined by optic fiber method.The consistency index(CI)and consistency index limit comparison method were used to establish the conformity test model,and telmisartan tablets were quantitatively analyzed by partial least squares regression(PLS)algorithm.It was found that the conformity test model can quickly distinguish telmisartan tablets(40 mg)from similar products of other specifications.The correlation coefficient(r^(2))of quantitative model and the root mean square error of external validation(RMSEP)were 0.9659 and 0.18.The results indicated that the method can be used for the qualitative and quantitative analysis of telmisartan tablets,which was convenient and rapid.

关 键 词：近红外光谱 一致性检验模型 替米沙坦片 定性定量 

分 类 号：R972.4[医药卫生—药品] TQ460.7[医药卫生—药学]