离心造粒法制备微晶纤维素空白丸核的工艺研究

Studies on the effects of the process variables on the characteristics of the MCC core pellets prepared in a centrifugal granulator

目的研制一种无糖型空白丸核为药物粉末层积提供便捷、优质的母核。方法用国产实验室规模的离心包衣造粒机研究了制备微晶纤维素空白丸核的工艺。以产率、粒径分布、堆密度、粒密度、表面形态和圆整度及脆碎度为评价指标 ,用完全析因设计实验讨论了重要工艺参数主机转速、鼓风流量对空白丸核物理性质的影响。结果和结论主机转数对丸核产率、粒径分布有显著影响 ;鼓风流量则影响丸核的表面形态、圆整度和堆密度 ;

Objective To develop a sugar free substitute for the traditionally used sugar starch core pellets as a substrate for durg layering.Methods To prepare microcrystalline cellose(MCC using a laboratory scale centrifugal coating & granulating equipment).A complete factorial design was used to study the two important process parameters,including the rotor rotation speed and slit air rate.The responses evaluated were expected yield,size and size distribution,bulk density,real density,surface shape,roundness and friability. Results and Conclusions The effect of the rotor rotation speed was found to be critical on the expected yield of the core pellects and size distribution while the slit air flow rate had influence on the surface shape,roundness and bulk density.The two process variables were not related to friasbility.