CAJ | 학술논문

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。
목적：건립뢰낙보리편품패근홍외광보기술적판별모형，이타격가모위렬품[1]。방법재Opus Setup Conformity Test모괴중，취10000～4200cm-1보단범위대원시광보진행일계도수화（17점평활）가시량귀일법수거전처리후건립판별모형。결과강소황하약업고빈유한공사적12비뢰낙보리편균재모형설정적CI한도범위내，이2비가모품균재모형설정적 CI치범위지외。결론차방법건립적품패모형，능쾌속감별해품패약품적진위，병가응용우일상감독중적약품적초사，이제고추양명중솔。
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.