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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 prepare ambroxol hydrochloride (Amb) coated pellets and evaluate their in vitro release characteristics and drug release mechanism. Methods: The drug-loaded pellets were prepared by suspension method in Glatt fluidized bed bottom spray apparatus. The coated pellets were prepared with different eudragitRS10 0 / eudragit RL10 0 coating materials respectively. The release test and scanning electron microscopy Drug release characteristics and drug release mechanism. Results: The surface of the coated pellets was smooth and round under the scanning electron microscope. The longitudinal section of the coated pellets was clear and distinct. The release curves of the four kinds of pellets were not different from those of the imported sustained release capsules, pH and rotating speed of baskets. The drug release mechanism of coated pellets may be that Amb is diffused from the molecular pores of the complete eudragit polymer chain by Fick’s law under the concentration gradient. Conclusion: Amb coated pellets have an ideal sustained-release effect.