进口药品阿卡波糖片近红外一致性模型建立与验证  

Construction and Validation of Conformity Test Model Imported Drugs Acarbose Tablets by Near Infrared Reflectance Spectroscopy

作　　者：赵艳秋[1] 周子钰 尹燕杰[1] 张昊天[1] Zhao Yanqiu(Harbin Food and Drug Inspection Center,Harbin 450001)

机构地区：[1]哈尔滨市食品药品检验检测中心,哈尔滨150001 [2]哈尔滨医科大学,哈尔滨150001

出　　处：《黑龙江医药》2020年第4期793-796,共4页Heilongjiang Medicine journal

摘　　要：目的:建立进口药品阿卡波糖片的近红外一致性检验模型并验证。方法:采集光谱,并分别采用一阶导数化+矢量归一化和二阶导数化+矢量归一化对光谱进行预处理,建立并验证阿卡波糖片的近红外一致性检验模型。结果:进口药品阿卡波糖片不同批次验证CI限度值小于7,不同仪器验证CI限度值小于7,不同人员验证CI限度值小于7,不同厂家同规格验证CI限度值远大于7。结论:本实验建立的近红外一致性模型可有效地区分进口药品阿卡波糖片与同规格其他厂家生产的药品,可在我省进口药品检查中提供快速便捷的检验方法。Objective:To establish and verify the consistency inspection model of imported drugs acarbose tablets.Method:Spectrum acquisition and with first order derivative+vector normalization and second derivation+vector normalization.Construction and validation of conformity test model acarbose tablets by near infrared reflectance spectroscopy.Results:The CI limit value of different batches of the same manufacturer is verified less than 7;the CI limit value verified with the different persons is less than 7;the CI limit value verified with the different instruments is less than 7;the CI limit value of the same specification from different manufacturers is verified more than 7.Conclusion:The models established in this experiment have passed the verification with.the imported drugs acarbose tablets,to provide the fast and convenient test method in the inspection of imported drugs in our province.

关 键 词：近红外光谱 阿卡波糖片 一致性检验 快速检验 

分 类 号：R927.1[医药卫生—药学]