国产核黄素片的溶出曲线研究

The Curve Exploratory Research of Domestic Riboflavin Tablets

目的:建立国产核黄素片的溶出曲线方法。方法:参照《日本橙皮书》中普通制剂溶出曲线考察方法、USP该药物项下的溶出介质配制方法及《中国药典》2015年版二部中维生素B_2片的溶出度测定方法,确定溶出曲线考察方法。采用五种溶出介质对10个厂家的该品种进行了溶出曲线考察,确定了溶出过程最接近人体环境的溶出介质,并进行了方法验证,通过f_2相似因子法对溶出曲线进行评价。结果:通过比较f值,发现同一厂家样品在5种溶出介质的溶出曲线有一定差异,不同企业间样品溶出曲线差异大,真实的反映了各厂家之间药物溶出的差异。结论:提示生产工艺不稳定,产品质量的均一性较差,建立了国产核黄素片的溶出曲线测定方法,并建议厂家优化生产工艺。

Objective： To establish stripping curve method of domestic riboflavin tablets. Method： According to ＂Japanese orange book＂ about the ordinary preparation stripping curve investigation method,USP the stripping method of the drug and Chinese ＂Pharmacopoeia＂ 2015 edition of the Vitamin B2 Tablets stripping method,determining the inspection method of solubility curve. 10 factories the varieties stripping curve were studied using five kinds of solution,to determine the solution medium of the closest to human body environment,and the stripping curve is verified by f2 similarity evaluation. Results： by comparing the f value,found the same manufacturer in 5 kinds of sample dissolution medium dissolution curve has a certain difference,reflect the difference between the manufacturers of the drug release. Conclusion： it is suggested that the production process is not stable,product quality consistency is poor,Establishing a domestic riboflavin dissolution curve measurement method and suggesting manufacturersoptimize the production process.