摘要
目的建立中美天津史克制药有限公司的复方盐酸伪麻黄碱缓释胶囊（新康泰克）品牌的近红外定性模型。方法在OPUS的Setup Conformity Test模块中,取9 122.4~5 947.9 cm-1谱段范围的漫反射光谱,进行一阶导数加矢量归一化对数据前处理后,建立定性模型。结果15批复方盐酸伪麻黄碱缓释胶囊均在模型设定CI限度范围内,而1批假冒品和4种药物化学成分类似的制剂均在模型设定CI限度范围外。结论建立该药品牌的定性模型可在打击假冒品中应用。
Objective To develop a qualitative near-infrared model for Compound Pseudoephedrine Hydrochloride Sustained Release Capsules（ContacNT） from Glaxo Smith Kline（China）.Method The diffuse reflectance spectra in the 9 122.4～5 947.9 cm-1 spectral coverage range in the OPUS Setup conformity test module was refined and performed with first derivative＋vector normalization to set up quantitative model.Result 15 batches of authentic samples were all within CI limit of the qualitative model,and one counterfeit sample and 4 similar preparations exceeded the CI limit.Conclusion The qualitative model can be used to detect counterfeit smaples.
出处
《今日药学》
CAS
2010年第9期34-36,39,共4页
Pharmacy Today
关键词
近红外定性模型
假冒品
复方盐酸伪麻黄碱缓释胶囊(新康泰克)
qualitative model of near-Infrared
counterfeit products
compound pseudoephedrine hydrochloride sustained release capsules（ContacNT）
