盐酸阿夫唑嗪微孔渗透泵控释片的研制及释药影响因素考察

Preparation of alfuzosin hydrochloride porosity osmotic pump tablets and study on factors influencing drug release

目的制备盐酸阿夫唑嗪微孔渗透泵型控释片,并考察其体外释药的影响因素。方法以醋酸纤维素为膜材,聚乙二醇-400为致孔剂,邻苯二甲酸二丁酯为增塑剂,制备微孔渗透泵片,通过单因素考察影响释药的处方因素,并采用相似因子为指标通过正交设计筛选处方。结果促渗剂的种类、包衣膜厚度、致孔剂和增塑剂的量是影响释药的主要因素。结论制备了盐酸阿夫唑嗪微孔渗透泵控释片,12 h内呈现明显的恒速释药。

Objectives To prepare alfuzosin hydrochloride porosity osmotic pump tablets and investigate factors influencing the drug release.Methods Cellulose acetate(CA) was used as the semipermeable membrane and PEG-400 was chosen as channeling agents.The factor influencing the drug investigated was selected by the single factor study and the optimal formulation of alfuzosin hydrochloride porosity osmotic pump tablets was screened by an orthogonal design.Results Coating level,channeling agents and plasticizer were all found to have great effect on the in vitro release of porosity osmotic pump tablets.Conclusions The tablets with optimized formulation could achieve the desired zero- order release profile in 12 hours.