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目的:制备复方丹参微丸。方法:采用离心造粒法,以微丸粒径分布、休止角、堆密度、脆碎度等为指标考察影响微丸成型过程的处方因素和工艺因素。结果:复方丹参微丸成型的优化处方为:冰片-β环糊精包合物与稀释剂MCC重量比为4∶3(g∶g),以40%糖浆(含丹参三七混合物)作为黏合剂。采用离心造粒法,工艺参数如下:主机转速200r·min-1、鼓风流量8L·min-1、喷气流量18L·min-1、喷气压力0.06Mpa、喷浆泵转速12～17r·min-1、供粉机转速15～20r·min-1。复方丹参微丸在15min内的体外溶出度达到85%以上。结论:采用离心造粒法在优化条件下可制得表面较光滑、圆整度高的复方丹参微丸,20～24目微丸的得率达85%以上,3种指标成分体外溶出迅速且同步性良好。
Objective: To prepare compound Danshen pellets. Methods: The pellet size distribution, angle of repose, bulk density and friability of pellets were used as indexes to study the prescription factors and process factors that influence pellet forming process by centrifugal granulation method. Results: The optimum formulation of Compound Salvia Miltiorrhiza Pellets was as follows: the weight ratio of borneol-βcyclodextrin inclusion compound to diluent MCC was 4: 3 (g: g), 40% syrup (containing Salvia miltiorrhiza mixture) Agent. Centrifugal granulation method, the process parameters are as follows: the host speed 200r · min-1, blast flow 8L · min-1, jet flow 18L · min-1, jet pressure 0.06Mpa, spray pump speed 12 ~ 17r · min- 1, powder speed 15 ~ 20r · min-1. Compound Danshen Pellets in vitro dissolution within 15min reached 85%. Conclusion: The centrifugal granulation method can be made under the optimized conditions, the surface is smooth, high roundness of the compound Danshen pellets, 20 ~ 24 mesh pellets yield was 85%, three indicators of rapid dissolution in vitro and Synchronization is good.