摘要
目的 :研制盐酸氨溴索 (Amb)包衣小丸 ,评价其体外释药特性及释药机制。方法 :Glatt流化床底喷装置中混悬液法上药制备载药小丸 ,分别以不同eudragitRS10 0 /eudragitRL10 0配比为包衣材料制备包衣小丸 ,释放度试验及扫描电镜考察小丸的体外释药特性及释药机制。结果 :包衣小丸在扫描电镜下表面光滑圆整 ,纵切面层次分明 ;4种小丸配比而成的缓释胶囊释药曲线与进口缓释胶囊兰勃素差异无显著性 ,且不受介质pH和转篮转速等因素影响 ;包衣小丸的释药机制可能为浓度梯度作用下Amb按Fick’s定律从完整eudragit膜聚合物链间的分子孔隙扩散。 结论 :Amb包衣小丸具有理想的缓释效果。
OBJECTIVE To develop an ambroxol hydrochloride coated pellets and evaluate its release characteristics and mechanism in vitro.METHODS Drug-containing beads were prepared by drug layering onto nupareils using the fluid-bed and then coated by the pan coating process.The coated pellets were coated by different ratios of eudragit RS100 and eudragit RL100,respectively.The release characteristics and mechanism were studied by the dissolution test and scanning electron microscopy.RESULTS The surface of the coated pellets was smooth and glossy and round, the stratification of cross section was distinct under scanning electron microscopy.The release profile from the capsule consists of four kind of pellets was similar to improted sustained-release capsule lanbroxol and less influenced by pH of the dissolution medium and not influenced by rotation speed. The possible mechanism of ambroxol hydrochloride is solution diffusion through a continuous polymer phase.CONCLUSIONS The pellets ambroxol hydrochloride exhibited ideal sustained-release characteristics.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2002年第1期11-13,共3页
Chinese Journal of Hospital Pharmacy
关键词
盐酸氨溴索
包衣小丸
制备
释药机制
ambroxol hydrochlorid
coated
pellets
preparation
release mechanism
