摘要
目的 制备硫酸特布他林双层包衣脉冲片 ,考察处方及释放条件对体外释药行为的影响 ,解析其释放机理。方法 粉末直接压片法制备含渗透活性物质的片芯 ,滚转包衣锅法分别包溶胀层和控释衣层。通过测定释放度研究脉冲片的制剂学特征 ,并研究脉冲片的吸水动力学和膨胀行为。结果 双层包衣片以脉冲形式释放 ,释药时滞随控释衣层厚度增加而延长 ,释药速度减小 ;渗透活性物质和溶胀层可提高快速释放期的释药速率。溶出介质pH值和搅拌速度对释药行为无影响。释药机理包括扩散、溶胀和渗透泵原理。结论 调整控释衣膜厚度和组成可获得理想的脉冲释药行为 。
Aim To prepare terbutaline sulphate (TB) bi-layered pulsatile release tablets, evaluate the effects of the formulation and dissolution medium on drug release behavior, and to elucidate the mechanism of drug release based on obtained results. Methods Core tablets containing osmotic active agent were prepared by direct compression and spray coated with swelling layer and semipermeable membrane subsequently. Pharmaceutical properties of TB pulsatile tablets were investigated by dissolution test. The water up...
出处
《药学学报》
CAS
CSCD
北大核心
2003年第11期854-858,共5页
Acta Pharmaceutica Sinica
基金
国家杰出青年科学基金 (3 992 5 0 3 9)
关键词
硫酸特布他林
渗透泵
膨胀
扩散
terbutaline sulphate
osmotic pumping
swelling
diffusion