Identification of Norvasc and counterfeit drugs based on Raman spectra of pharmaceutical excipients
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摘要: 目的 针对药物活性成分与原研药质量相同的一类仿冒药,以苯磺酸氨氯地平片原研药及仿冒药为工具药,建立基于两者所用药用辅料的差异,用于鉴别络活喜仿冒药的方法。 方法 收集络活喜片剂常用辅料的拉曼光谱,采用相似度算法及特征峰查找待检样品中辅料,若待检样品的辅料与原研药辅料不同则判为仿冒药;若待检品辅料与原研药辅料相同,则采用主成分分析法区分仿冒药与原研药。 结果与结论 该方法可快速、准确地鉴别络活喜仿冒药。Abstract: Objective To build an identification method for Norvascand its counterfeit drugs based on the differences of their pharmaceutical excipients with the original and generic Amlodipine besylatetablets as tools. Methods Raman spectra of pharmaceutical excipients which were usually used in tablets were collected.Similarity algorithm and characteristic Raman bands were used to search the excipients contained in the tablets. If the excipients was not the same as excipients contained in Norvasc, the tablet was judged as counterfeit drugs. Otherwise, principal component analysis was used to identify counterfeit and generic. Results and conclusion The method based on Raman spectra of pharmaceutical excipients could identify Norvasc and counterfeit drugs efficiently and accurately.
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