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伏格列波糖胶囊近红外一致性检验模型的建立

张燕芬   

  1. 南京市食品药品监督检验院
  • 收稿日期:2017-02-22 修回日期:2017-06-18 出版日期:2017-06-25 发布日期:2017-06-26

Establishment of near-infrared consistency model of the Mecobalamin tablets

  1. Nanjing Food and Drug Supervision and Inspection Institute
  • Received:2017-02-22 Revised:2017-06-18 Online:2017-06-25 Published:2017-06-26

摘要: 目的 运用近红外技术建立药品的“一厂一品一规”一致性检验模型。方法 在 4200~12000 cm -1 范围内对伏格列波糖胶囊进行直接接触扫描 ,采用近红外光谱仪采集样品光谱,通过 OPUS 软件运用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的区分不同厂家生产的伏格列波糖胶囊。 结论 建立的一致性检验模型的方法能准确快速地区分不同厂家生产的伏格列波糖胶囊,对特定厂家的伏格列波糖胶囊进行初筛检验具有一定的参考价值。

Abstract: Objective Using near-infrared consistency to establish model “Plant a product of a regulation.” Methods The Voglibose capsules were respectively scanned with direct contact scanning in the range of 4200-12000cm-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 Voglibose capsules. Conclusion The established consistency model can accurately and quickly be used to distinguish different manufactures Voglibose capsules, and have a certain reference value in the first test.