甲钴胺片近红外一致性检验模型的建立

甲钴胺片近红外一致性检验模型的建立

戴震,胡小崧

南京市食品药品监督检验院,南京市食品药品监督检验院

收稿日期:2016-08-19 修回日期:2017-04-24 出版日期:2017-04-25 发布日期:2017-04-25

Establishment of Near-infrared Consistency Model of the Mecobalamin Tablets

Nanjing Food and Drug Supervision and Inspection Institute,

Received:2016-08-19 Revised:2017-04-24 Online:2017-04-25 Published:2017-04-25

摘要/Abstract

摘要： 目的：采用近红外漫反射光谱（NIR）法建立药品的“一厂一品一规”一致性检验模型。方法：在12000～4200 cm-1范围内对甲钴胺片进行直接接触扫描，采用近红外漫反射光谱法，运用 OPUS 软件通过不同的预处理方法对图谱进行分析，建立一致性检验模型。结果：建立的一致性检验模型可以很好地区分不同厂家生产的甲钴胺片。结论：所建立的一致性检验模型能准确快速地对特定厂家的甲钴胺片进行初筛检验。

Abstract: Objective： Using near-infrared spectrum（NIR） method to establish consistency model“Plant a product of a regulation”. Methods：The mecobalamin tablets were respectively scanned with direct contact scanning in the range of 12000-4200 cm-1.The consistency test model was established using near infrared diffuse reflectance spectroscopy and OPUS software to analyze with different pretreatment methods.Results： The consistency test model can well distinguish the different plant producte of mecobalamin tablets.Conclusion： The established consistency model of mecobalamin tablets can accurately and quickly be used in the first test.

戴震,胡小崧. 甲钴胺片近红外一致性检验模型的建立[J]. .