中国药物经济学2024，Vol.19Issue(3)：101-104,4.DOI:10.12010/j.issn.1673-5846.2024.03.021
洛索洛芬钠胶囊溶出曲线研究方法的建立及实践
Establishment and Practice of a Study Method for the Dissolution Curve of Losoprofen Sodium Capsules
摘要
Abstract
Objective Explore and establish a research method for the dissolution curve of losoprofen sodium capsules.Methods Using method a.basket method,with 900ml of water as the dissolution medium and a speed of 100 revolutions per minute,method b Basket method,using 900ml of water as the dissolution medium at a speed of 50 revolutions per minute,and method c.Paddle method,using 900ml of water as the dissolution medium at a speed of 50 revolutions per minute,after 5,10,15,20,30,45,and 60 minutes,the dissolution solution is filtered,and the subsequent filtrate is taken as the test solution for pre validation.The dissolution amount is analyzed using high-performance liquid chromatography.Results Method C was chosen as the dissolution condition,and the dissolution rates of losoprofen sodium capsules from three companies were relatively fast in all four media.However,there were significant differences in the dissolution amount within batches at each sampling time point before reaching the platform period.The dissolution amount of losoprofen sodium capsules from three companies is limited in the medium pH 1.0 hydrochloric acid solution.Conclusion It is recommended that the above-mentioned production enterprises further optimize their prescriptions and processes,and reduce the intra batch differences at each dissolution sampling time point before reaching the platform period.关键词
洛索洛芬钠胶囊/体外溶出曲线/溶出方法/4 种溶出介质Key words
Losoprofen sodium capsules/In vitro dissolution curve/Dissolution method/4 dissolution media分类
医药卫生引用本文复制引用
陈雨蕉,付金凤,许直,刘晓强..洛索洛芬钠胶囊溶出曲线研究方法的建立及实践[J].中国药物经济学,2024,19(3):101-104,4.基金项目
国家药品监督管理局2023年国家药品抽检计划(序号7) （序号7）
