伏格列波糖胶囊近红外一致性检验模型的建立

Establishment of Near-infrared Consistency Model of the Mecobalamin Tablets

目的:运用近红外漫反射光谱(NIR)技术建立药品的"一厂一品一规"一致性检验模型。方法:在12000~4200 cm^(-1)范围内对伏格列波糖胶囊进行直接接触扫描,采用近红外漫反射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。

Objective：Using near-infrared spectrum（NIR） 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 12000 -d200cm-~. The consistency test model was established using near-infrared diffuse reflectance spectroscopy and OPUS software to analyze with different pretreatment meth- ods. Results： The consistency test model can well distinguish the different plant producte of voglibose capsules. Conclusion： The estab- lished consistency model can accurately and quickly be used to distinguish different manufactures voglibose capsules, and have a certain reference value in the first test.