麝香保心渗透泵控释片体外释放的影响因素研究

摘要

Objective: To survey the factors affecting SheXiang BaoXin osmotic pump controlled release tablets release in vitro and drug-release mechanism after preparing the preparation.Methods: By investigating the releasing conditions of osmotic pump controlled release tablets under different conditions,the drug-release factors affecting the preparations were studied.Results: by taking osmotic pressure difference inside and outside the membrane as main drug-release power,drug-release in vitro of SheXiang BaoXin osmotic pump controlled release tablets conformed to zero level release rule,drug-release speed was affected by film coating weight gain,the hardness of tablets core,the contents of pore-forming agent in the film coating,was foreign to the sorts of osmotic active substance,dissolution method,pH value of the medium and speed.Conclusion: SheXiang BaoXin osmotic pump controlled release tablets possess the characteristics of excellent controlled release preparation,which shows drug release stability and notable zero level drug release.%目的:制备麝香保心渗透泵控释片,考察该制剂的释药影响因素及释药机理.方法:通过考察渗透泵控释片在不同条件的释放情况,研究影响该制剂的释药因素.结果:麝香保心渗透泵控释片以膜内外的渗透压差为主要释药动力,体外释药符合零级释放规律,释药速率受衣膜增重、片芯硬度、衣膜中致孔剂含量影响较大,与渗透压活性物质的种类、溶出方法、介质pH值、转速无关.结论:麝香保心渗透泵控释片释药稳定,零级释药明显,具备优良控释制剂的特征.