缓释控释制剂的释放度测定方法的研究进展

Development of dissolution testing study for sustained or controlled release oral dosage forms

目的 介绍缓、控释制剂的体外释放度测定方法 ,使其能更好地模拟体内状态。方法 综述最近的中外文献中有关缓释、控释制剂的体外释放度测定实验方法 ,实验条件的选择及影响因素。结果 体外释放度实验条件如释放介质的 pH值、离子强度、增溶剂、表面活性剂和释放仪器等可影响缓、控释制剂的体外释放度。

Objective Introduce the in vitro dissolution testing method for sustained or controlled release dosage forms,so that the in vivo state can be better simulated.Methods Summarize all current literatures about experimental methods,the choice and influence factors of experimental condition of in vitro dissolution testing.Results The experimental condition like the pH value and ion intensity of release medium,solubilizers,surfactants,release apparatus and so on can effect the in vitro dissolution testing of sustained or controlled release dosage forms.Conclusion Choose the methods are likely to in vivo state according to different drugs.