头孢呋辛酯片近红外光谱法定性模型的建立

目的:建立头孢呋辛酯片品牌近红外光谱技术的判别模型,以打击假冒伪劣品。方法:在OpusSetup Conformity Test模块中,取10 000～4 200cm-1谱段范围对原始光谱进行一阶导数化(17点平滑)加矢量归一法数据前处理后建立判别模型。结果:广州白云山天心制药股份有限公司的13批头孢呋辛酯片均在模型设定的CI限度范围内,而2批假冒品均在模型设定的CI值范围之外。结论:此方法建立的品牌模型,能快速鉴别该品牌药品的真伪,并可应用于日常监督中的药品的初筛,以提高抽样命中率。

Near Infrared Qualitative Model Establishment for Cefuroxime Axetil Tablets

Objective：To establish Near infrared Qualitative model for Cefuroxime Axetil Tablets,attack counterfeit product.Methods：The diffuse reflectance spectra in the 10 000～4 200cm-1 spectral coverage range in the opus setup Conformity test module was refined and performed with first derivative ＋ vector normalization to set up qualitative model.Results：13 batches of authentic samples form Guangzhou Baiyun Mountain Tianxin Pharmaceutical Co,Ltd were all within CI limit of the qualitative model,and 2 counterfeit product exceeded the CI limit.Conclusion：The qualitative model can be used to detect counterfeit smaples fast.Applies the drugs initially sieves in the daily surveillance,raises the sampling hit probability.