湖北医药学院学报2017,Vol.36Issue(1):53-55,封4,4.DOI:10.13819/j.issn.1006-9674.2017.01.012
硝苯地平缓释片Ⅱ及其伪品的鉴别研究
The Identification Study on Nifedipine Sustained-release Tablets Ⅱ and its Counterfeit
摘要
Abstract
Objective To establish identification method of Nifedipine Sustained-release Tablets Ⅱ].Methhods UV-Vis spectrophotometry,chemical reaction and water-dissolving experiment were conducted for inspection of nifedipine sustained -release tablets (Ⅱ),and the results were compared with results by the legal method.Results Six batches of samples were analyzed.All samples have a maximum absorption at a wavelength of 237 nm and a large broad absorption at 320 ~ 355 nm in UV-Vis.One batch was unqualified in chemical reaction and the rest 5 batches were positive.Two batches were unqualified in content determination and the rest batches were 90.0% ~ 110.0% of the labelled amount.Three batches had different appearance changes in water-dissolving experiment.Whilst three batches were unqualified in drug-release test.Conclusion This detection method is simple and fast,and the test results are consistent with the legal method results.Water-dissolving experim,ent can be used for the rapid detection of Nifedipine Sustained-release Tablets (Ⅱ).关键词
硝苯地平缓释片Ⅱ/水溶解试验/鉴别研究Key words
Nifedipine Sustained-release Tablets (Ⅱ)/Water-dissolving experiment/Identification引用本文复制引用
李志浩,陈银华..硝苯地平缓释片Ⅱ及其伪品的鉴别研究[J].湖北医药学院学报,2017,36(1):53-55,封4,4.基金项目
十堰市科技局项目(16y68) (16y68)