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

目的摸索并建立洛索洛芬钠胶囊溶出曲线研究方法。方法分别采用方法a.篮法,以水900 ml为溶出介质,转速为100转/min,方法b.篮法,以水900ml为溶出介质,转速为50转/min,以及方法c.桨法,以水900ml为溶出介质,转速为50转/min,经5、10、15、20、30、45、60 min时,取溶出液滤过,取续滤液作为供试品溶液进行预实验,采用高效液相色谱法进行溶出量分析。结果选择方法c为溶出条件,3家企业的洛索洛芬钠胶囊在4种介质中的溶出速率均较快,但达到平台期前各取样时间点溶出量批内差异较大。3家企业的洛索洛芬钠胶囊在介质pH1.0盐酸溶液中溶出量均受限。结论建议上述各生产企业进一步优化处方与工艺,缩小达到平台期前各取样时间点溶出量批内差异。

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.