摘要
以高水溶性药物溴吡斯的明为模型,采用流化床底喷包衣技术在蔗糖丸芯上包覆载药层和缓释层。以释放度为指标,考察了进风流量、雾化压力、蠕动泵流速、喷头直径、烘干时间等流化床包衣工艺参数和缓释层中致孔剂、增塑剂用量及包衣增重等处方因素的影响。结果表明,优化的流化床包衣工艺参数为:进风流量21～24 m^3/h、雾化压力0.9MPa、蠕动泵流速1.7 ml/min、喷头直径0.5 mm和烘干时间10 min;优化的处方参数为:致孔剂用量5%、增塑剂用量20%和包衣增重20%。优化缓释微丸能在12 h内缓慢释药,释药行为符合一级释药模型,释药机制为被动扩散。
The title pellets were prepared by coating drug layer and sustained-release layer on the sucrose pellet cores successively with fluidized bed technology with water-soluble pyridostigmine bromide as a drug model. The effects of process parameters(such as inlet air flow rate, atomization pressure, peristaltic pump velocity, sprinkler head diameter, drying time, inlet temperature and material temperature) and formulation parameters of sustained-release layer(such as the amounts of plasticizer and pore-forming agent, the weight gain of coating layer) on the in vitro release were investigated. Based on the experimental results, the optimal process and formulation parameters were as follows: inlet air flow rate was 21-24 m^3/h, atomization pressure was 0.9 MPa, peristaltic pump flow rate was 1.7 ml/min, sprinkler head diameter was 0.5 mm, drying time was 10 min, inlet temperature was(50.0±2.0)℃, material temperature was(37.0±1.0)℃, the amount of pore-forming agent was 5% the amount of plasticizer was 20%, and the weight gain was 20%. The release of the prepared pellets conformed to the first order kinetic model. These results of the study indicated that the 12 h sustained-release pellets was successfully prepared with a model drug pyridostigmine bromide as poreforming agent, and the release mechanism was passive diffusion.
作者
汪少
杨恒博
袁婷
晏祺
高秀容
WANG Shao;YANG Hengbo;YUAN Ting;YAN Qi;GAO Xiurong(Dept.of Pharmacy,Chengdu Medical College,Chengdu 610083)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2019年第1期84-92,共9页
Chinese Journal of Pharmaceuticals
基金
四川省科技支撑计划项目(2016RZ0062)
四川省医学会医学科研青年创新课题计划(Q15035)
成都医学院国家级大学生创新创业训练计划项目(201513705008)
关键词
溴吡斯的明
缓释微丸
流化床包衣
致孔剂
pyridostigmine bromide
sustained-release pellet
fluidized bed coating
pore-forming agent
