摘要
目的建立西安杨森制药有限公司的伊曲康唑胶囊(斯皮仁诺)品牌的近红外光谱技术判别模型,打击假冒品。方法在OPUS的Setup Conformity Test模块中,取8559.2～5897.7cm-1谱段范围的漫反射光谱进行矢量归一化数据前处理后建立判别模型。结果 13批伊曲康唑胶囊均在模型设定CI限度范围内,而1批假冒品和5种化学结构相近的药品均在模型设定CI限度范围外。结论本文建立的品牌模型,可在日常打假工作中快速应用。
Objective To develop a conformity test method for ietraconazole capsules （Sporanox） from Xian-Janssen Pharmaceutical Ltd.company by near-infrared spectroscopy （NIR）.Methods The conformity test method was established by vector normalization on the diffuse reflectance spectra in the 8 559.2～5 897.7 cm-1 spectral range.Results 13 batches of authentic itraconazole capsules samples were all within CI limit of the conformity test method,and the 1 batch of counterfeit medicine and 5 pharmaceutical preparations of similar chemical structure with itraconazole capsules all exceed the CI limitl.Conclusion The established conformity test method has good performance according the validation results,and can be implemented to detect counterfeit medicines for branded itraconazole capsules.
出处
《今日药学》
CAS
2010年第10期34-36,共3页
Pharmacy Today
关键词
近红外光谱法
打假
伊曲康唑胶囊
near infrared spectroscopy
crack down on counterfeit products
itraconazole capsules
