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。
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 consis- tency test model was established using near infrared diffuse reflectance spectroscopy and OPUS software to analyze with different pretreat- ment 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.
出处
《中国药物评价》
2017年第2期95-96,共2页
Chinese Journal of Drug Evaluation
关键词
近红外光谱
甲钴胺片
一致性模型
Near-infrared spectrum
Mecobalamin tablets
Consistency model
