赖诺普利片近红外光谱法定性模型的建立

目的：建立赖诺普利片品牌近红外光谱技术的判别模型，以打击假冒伪劣品[1]。方法在Opus Setup Conformity Test模块中，取10000～4200cm-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。结果江苏黄河药业股份有限公司的12批赖诺普利片均在模型设定的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 Lisinopril Tablets

Objective To establish Near Infrared Qualitative Model for Lisinopril Tablets, attack counterfeit product.Methods The diffuse spectra in the 10000~4200cm-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 12 batches of authentic samples form Jiangsu Huanghe Mountain Pharmaceutical Co,Ltd were all within CI linit of the qualitative modle, and 2 counterferit producr exceeded the CI limit .Conclusion The qualitative model can be used to detect counterfeit samples fast. Applies the drugs initially sieves in the daily surveillance, raises the sampling hit probability.