国产与进口尼莫地平片溶出曲线相似性分析  

Similarity Analysis of Dissolution Curves Between Domestic and Imported Nimodipine Tables

作　　者：孔彬[1] 刘晓霞[1] KONG Bin;LIU Xiaoxia(Department of Pharmacy,the Xinjiang Production and Construction Corps Hospital,Urumqi 830002,China)

机构地区：[1]新疆生产建设兵团医院药学部,乌鲁木齐830002

出　　处：《医药导报》2021年第2期252-256,共5页Herald of Medicine

基　　金：新疆生产建设兵团卫生健康委卫生科技计划项目(兵卫发〔2014〕58号)。

摘　　要：目的采用光纤溶出度分析方法,评价国产与进口尼莫地平片溶出曲线的相似性。方法不同pH值条件下模拟胃肠道环境,采用光纤药物溶出度实时测定仪,在测定波长238 nm处,分别测定国产与进口尼莫地平片的溶出曲线,通过相似因子法比较溶出曲线的相似性。结果在不同pH值条件下测定溶出曲线,通过f2因子比较,7个厂家的尼莫地平片溶出曲线有显著差异。结论光纤药物溶出度仪能准确测定数据,真实地描绘溶出曲线,为改进药品制剂和检测药品质量方面提供真实参考数据。Objective To evaluate the similarity of dissolution curves between domestic-made and imported nimodipine tablets by optical fiber dissolution analysis.Methods The gastrointestinal environment was simulated at different pHs.The dissolution curves of domestic-made and imported nimodipine tablets were examined by a real-time optic fiber dissolution process monitoring system at the wavelength of 238 nm.The similarity of dissolution curves was compared by a similarity factor method.Results The dissolution curves of nimodipine tablets from 7 manufacturers determined at different pHs were significantly different by f2 factor comparison.Conclusion The optic fiber dissolution process monitoring system can accurately measure the data and truly describe the dissolution curve,which can provide reliable reference data for improving pharmaceutical preparations and drug quality testing.

关 键 词：尼莫地平 溶出曲线 光纤药物溶出度实时测定仪 F2因子 

分 类 号：R972[医药卫生—药品]