4种辅料空白丸芯制备工艺的优选及差异性分析

Optimization and Difference Analysis of Preparation Technology for Blank Pellets Core with Four Kinds of Pharmaceutical Excipients by Centrifugal Granulation Method

目的:优选不同辅料空白丸芯的制备工艺,探索微丸母核制备工艺和制剂原料之间的适宜性。方法:采用离心造粒法分别制备微晶纤维素、淀粉、糊精和乳糖4种辅料空白丸芯,以粒径分布在0.25～0.355 mm的丸芯得率为主要评价指标,采用单因素试验、均匀设计试验和多元线性回归统计法优化4种辅料空白丸芯的制备工艺,并分析其差异性。结果:适宜4种辅料丸芯制备的工艺参数为微晶纤维素以水为黏合剂,其他3种辅料均以50%～60%蔗糖溶液为黏合剂,喷浆速度12～16 r.min-1,微晶纤维素、糊精和乳糖起母的主机转速225 r.min-1,淀粉起母的主机转速275 r.min-1,喷气压力0.025～0.05MPa,温度25℃,鼓风流量选小或中。结论:制备的4种不同辅料空白丸芯存在普遍适宜的工艺参数范围,研究为离心造粒法制备含药微丸的处方筛选和工艺参数优化提供参考。

Objective： To optimize preparation technology of blank pellets core with different pharmaceutical excipients,and explore the suitability between process conditions of pellets core and raw materials of preparation. Method： Blank pellets core of microcrystalline cellulose,starch,dextrin and lactose were prepared by centrifugal granulation,with yield of pellets core between 0.25-0.355 nm of particle size as main index,single factor test,uniform design test and multiple linear regression analysis method were used to optimize preparation process conditions of blank pellets core of this four kinds of pharmaceutical excipients,and comparison and difference analysis were made after optimization. Result： The appropriate process parameters of these four pharmaceutical excipients blank pellets core were as follows：water as adhesive of microcrystalline cellulose blank pellets core,and 50%-60% sucrose solution as that of other blank pellets core of three excipients,the jet velocity between 12-16 rmin-1,the bost rotating speed of blank pellets core with microcrystalline cellulose,dextrin and lactose 225 rmin-1,and that of blank pellets core with starch 275 rmin-1,the jet pressure between 0.025-0.05 MPa, the temperature at 25 ℃,the slit air flow chose minimum or medium. Conclusion： There was generally appropriate ranges of process parameters of these four different excipients blank pellets core prepared by centrifugal granulation,it could provide references in screening prescription and optimizing process parameters of drug pellets prepared by centrifugal granulation method.