阿托伐他汀钙片近红外光谱一致性检验模型的建立  

Establishment of a Model for the Near Infrared Spectral Consistency Test of Atorv Astatin Calcium Tablets

作　　者：李刘炜 曾文珊[1] 韩莹[1] LI Liuwei;ZENG Wenshan;HAN Ying(Guangzhou Institute for Drug Control,Guangzhou 510160,China)

机构地区：[1]广州市药品检验所,广州510160

出　　处：《药品评价》2020年第14期59-60,64,共3页Drug Evaluation

摘　　要：目的:采用近红外光谱法建立快速筛查进口化学药品阿托伐他汀钙片的一致性检验模型。方法:随机选取50批A公司生产的阿托伐他汀钙片,在12 000~4 200 cm^(-1)范围内进行直接接触扫描,每批样品扫描6次,收集光谱图,光谱预处理方法为二阶导数加矢量归一化,平滑点17,采用一致性检验方法建立一致性模型。结果:模型在判定谱段为9 000~7 500 cm^(-1)、6 900~5 600 cm^(-1)及5 000~4 200 cm^(-1)的一致性指数(CI)均<6,预测10批同厂家样品能通过模型,验证用两个国产仿制样品的CI均>6,结果为不通过,所建立的近红外一致性模型能快速定性不同厂家生产的阿托伐他汀钙片。结论:近红外光谱法建立的阿托伐他汀钙片一致性模型适用于假劣药的现场快速筛查鉴定。Objective:To establish a consistency test model for rapid screening of atorvastatin calcium tablets.Methods:50 batches of atorvastatin calcium tablets produced by A company were randomly selected for direct contact scanning in the range of 12000-4200 cm-1.Each batch of samples was scanned six times,and spectrograms were collected.The spectral pretreatment method was second derivative plus vector normalization,smooth point 17,and the consistency model was established by consistency test.Results:In the model,the CI of 9000-7500 cm-1,6900-5600 cm-1 and 5000-4200 cm-1 were all less than 6.It was predicted that 10 batches of samples from the same manufacturer could pass the model,and the CI of two domestic imitated samples were all more than 6.The results were not passed.The near-infrared consistency model established could quickly determine the quality of atorvastatin calcium tablets produced by different manufacturers.Conclusion:The consistency model of atorvastatin calcium tablets established by NIRS is suitable for rapid screening and identification of fake and inferior drugs.

关 键 词：阿托伐他汀钙片 近红外光谱 一致性模型 快速筛查 

分 类 号：R917[医药卫生—药物分析学]