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注射用阿莫西林钠舒巴坦钠近红外通用型模型的建立

于畅游,刘云飞,张肖宁   

  1. 黑龙江省食品药品检验检测所,黑龙江省食品药品检验检测所,黑龙江省食品药品检验检测所
  • 收稿日期:2016-08-30 修回日期:2016-08-30 出版日期:2017-02-25 发布日期:2017-01-25

Establishment of General Near-infrared Spectroscopy Models of Amoxicillin Sodium and Sulbactam Sodium for Injection

  1. heilongjiang institue for food and drug control,,
  • Received:2016-08-30 Revised:2016-08-30 Online:2017-02-25 Published:2017-01-25

摘要: 目的:建立注射用阿莫西林钠舒巴坦钠近红外模型,快速鉴别其真伪。方法:首先运用OPUS光谱分析软件采集图谱,以全谱为研究对象,对所抽样品进行聚类分析;然后选择哈药集团制药总厂样品的图谱为校正集,以其他生产企业样品图谱为验证集,建立一致性和相关系数定性模型。结果:建立的近红外一致性和相关系数模型,稳健性好,判别结果与检验结果相同。结论:该方法简便快速、准确,可用于快速鉴别该品种。

Abstract: Objective: To establish a near-infrared spectroscopy (NIR) model for the rapid identification of amoxicillin sodium and sulbactam sodium for injection.Methods:First NIR spectra were collected by OPUS software, and the clustering analysis was used with the full spectrum of the research object.Then spectra of samples of harbin pharmaceutical group were selected as calibration set, the spectra of samples of the other companies were as test set to set up conformity and correlation coefficient of qualitative model.Results:Conformity and correlation coefficient of qualitative model were established with good robustness. The results of discrimination agreed well with the reality.Conclusion:The method is simple, rapid and accurate, and can be used for rapid identification of the varieties.