硝苯地平口服渗透泵片的制备及其体外释药特性

Preparation and in vitro Release of Oral Osmotic Pump System with Single Room and Layer Nifedipine as the Model Drug

研制了单室单层硝苯地平口服渗透泵片 ,考察了片剂配方和主要制备参数、实验条件参数对药物释放速率的影响。在大量实验基础上 ,对硝苯地平口服渗透泵片的配方和制备参数进行优化 ,所确定的最优片芯配方为 (以片为基准 ) :硝苯地平 30mg ,β 环糊精 98 3mg ,聚环氧乙烷10mg ,聚乙烯吡咯烷酮 2 1 2 5mg ,渗透活性物质 14 0 4mg ;最佳孔径为 5 0 0 μm。依据最优方案制备的硝苯地平口服渗透泵片经体外释放度测定表明 ,在 2 1h内该渗透泵制剂形态稳定 。

The elementary osmotic pump tablet of nifedipine was successfully prepared and the drug release mechanism of this system was investigated.According to the experimental results the optimized ingredients of the osmotic pump tablet core was determined as follows (based on one tablet):nifedipine 30 mg, β cyclodextrin 98 3 mg,mannite 70 2 mg,sodium chloride 70 2 mg,PEO 10 mg,and PVP 21 25 mg,and the optimized orifice size was 500 μm.The measurements of in vitro release of this osmotic pump system indicated that this preparation possessed novel character of zero order release within 21 h.