基于近红外光谱的甲苯磺酸索拉菲尼片抗癌有效成分的无损鉴别与含量预测  

Nondestructive Identification and Content Prediction of Anticancer Active Ingredient in Sorafenib Tosylate Tablets Based on Near Infrared Spectroscopy

作　　者：闫研 梁雪 秦斌 庄莹 陈静丽 殷果 YAN Yan;LIANG Xue;QIN Bin;ZHUANG Ying;CHEN Jing-li;YIN Guo(Shenzhen Institute for Drug Control,NMPA Key Laboratory for Bioequivalence Research of Generic Drug Evaluation,Key Laboratory of Drug Quality Standard Research,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,深圳药品质量标准研究重点实验室,广东深圳518057

出　　处：《广州化工》2024年第13期101-103,106,共4页GuangZhou Chemical Industry

摘　　要：采用近红外光谱技术对抗癌药物甲苯磺酸索拉非尼片建立定性定量模型以便快速无损分析。以甲苯磺酸索拉非尼片为研究对象,用光纤探头测定样品的近红外光谱,通过一致性指数(CI)值和CI值限度比较法,对甲苯磺酸索拉非尼片建立一致性检验模型;运用最小偏二乘法(PLS)通过内部交叉验证的方法建立甲苯磺酸索拉非尼片的定量分析模型。建立的一致性检验模型能有效进行甲苯磺酸索拉非尼片的定性鉴别,迅速区分不同类产品,建立的甲苯磺酸索拉非尼片的定量模型相关系数(r^(2))为98.34%,交叉验证均方根差(RMSECV)为0.178。该方法简便快速、绿色无损,可用于甲苯磺酸索拉非尼片的快速定性定量分析。A qualitative and quantitative model for the rapid and non-destructive analysis of the anticancer drug sorafenib tosylate tablets was established using near infrared spectroscopy.Taking sorafenib tosylate tablets as the research object,the near infrared spectroscopy of the samples was measured using a fiber optic probe.A consistency test model was established for sorafenib tosylate tablets by comparing the consistency index(CI)value and the CI value limit.A quantitative analysis model for sorafenib tosylate tablets was established using the least partial multiplication method(PLS)and internal cross validation.The established consistency test model can effectively identify sorafenib tosylate tablets,and clearly distinguish different types of products,and the quantitative model correlation coefficient(r^(2))of the established sorafenib tosylate tablets was 98.34%,and the root mean square difference(RMSECV)of cross-verified was 0.178.This method is simple,rapid,green and non-destructive,and can be used for rapid qualitative and quantitative analysis of sorafenib tosylate tablets.

关 键 词：近红外光谱 甲苯磺酸索拉非尼片 无损鉴别 含量预测 

分 类 号：O657.3[理学—分析化学]