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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。
Objective To establish the discriminant model of the brand of Nisinopril tablets by near-infrared spectroscopy to combat counterfeit and shoddy products [1]. Methods In the Opus Setup Conformity Test module, the first derivative (17-point smoothing) and vector normalization data pre-processing were used to establish the discriminant model in the range of 10000 ~ 4200cm-1. Results The 12 lots of lisinopril tablets of Jiangsu Yellow River Pharmaceutical Co., Ltd. were all within the CI limits set by the model, while the two batches of counterfeit products were outside the range of CI values set by the model. Conclusion The brand model established by this method can quickly identify the authenticity of the brand drugs and can be applied to the initial screening of drugs under routine supervision in order to improve the sampling hit rate.