离心造粒法制备盐酸二甲双胍微丸的研究

Preparation of metformin hydrochloride pellets by using a centrifugal granulator

目的：制备盐酸二甲双胍微丸。方法：采用离心造粒法制备盐酸二甲双胍微丸，分别对影响微丸粒径分布及收率的处方和工艺因素进行考察，并采用均匀设计法对成丸过程中影响收率的主要工艺因素进行优化。结果：主药与辅料的比例、黏合剂的浓度、主机转速和滚圆时间对微丸的粒径分布和收率有较显著的影响。喷浆和供粉速度是成丸过程中影响微丸收率的主要因素。结论：按优化后的处方及工艺采用离心造粒法制得18～24目微丸的收率为89．7％，且表面光滑，圆整度高。

OBJECTIVE To prepare rnetformin hydrochloride pellet. METHODS The metformin hydrochloride pellet was prepared by using a acentrifugal granulator. The influences of formulation and processing variables on the size distribution and yield of pellets were investigated. The optimal conditions of processing were selected by the uniform design. RESULTS The ratio of metformin hydrochloride to excipient, the concentration of the adhesive agent anti rotor rotation speed were found to have an significant influence on the size distribution and yield of pellets. The growth of pellets was affected significantly by the spraying rate of binder solution and feeding rate of powder. CONCLUSION Under the optimal formulation and processing variables, the pellets prepared by using the centrifugal granulator have perfect shape and surface characteristics and the yields of 1824 mesh pellets were 89.7%.