盐酸二甲双胍渗透泵控释片的制备及体外释放度考察

目的研究盐酸二甲双胍渗透泵控释片的制备工艺及体外释药的影响因素。方法通过单因素考察和正交试验,优化制备工艺。结果盐酸二甲双胍渗透泵控释片的体外释药符合零级释放规律,释药速率受PEG种类、PEG用量、包衣膜重量影响较大,在一定范围内,释药孔大小、片芯硬度、溶出介质pH值和桨转速对其影响较小。结论盐酸二甲双胍渗透泵控释片工艺稳定,能够达到9h明显的恒速释药。

Preparation and drug release in vitro of the metformin hydrochloride osmotic pump controlled release tablets

Objective To study the formulation and influence factors of drug release in vitro of the metformin hydrochloride osmotic pump controlled release tablets.MethodsThe preparation technology was optimized by using single-factor test and orthogonal test.ResultsThe drug release in vitro of the metformin hydrochloride osmotic pump controlled release tablets accords with zero order release.The drug release rate was affected more by the PEG species,PEG amount,coating weight,and the diameter of orifice,hardness of tablet core,dissolution medium pH and rotating rates had little effect on the drug release rate within a certain range.ConclusionThe process conditions of metformin hydrochloride osmotic pump controlled release tablets is stable,it can reach the obvious steady release speed in 9 hours.