离心造粒法制备复方丹参微丸

The Preparation of Compound Danshen Pellets by Using Centrifugal Granulator

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. Method： The compound Danshen pellets were prepared by using a centrifugal granulator. The composition and process factors were optimized by adopting several indices such as sphericity of pellets,repose angle,bulk density and friability. Result： The optimal process parameters were as follows：the quality ratio of Borneol-β-Cyclodextrinclusion Complexes and MCC was 4∶ 3,binder solvent was 40% syrup,which including extractive. The rotating rate of plate was 200 r·min -1,the blower rate was 8L·min -1,the rate of air flow was 18 L·min -1,the spray air pressure was 0. 06 MPa,the rotating rate of spray solution pump was 12 ～ 17 r·min -1 and the rotating rate of powder feed machine was 15 ～ 20 r·min -1. The active components could release more than 85% in 15 minutes. Conclusion： Under the optimal conditions,the compound Danshen pellets prepared by using the centrifugal granulator have prefect shape and surface characteristics,the yield of target size pellets are more than 85% . The three index components could release fast and synchronically.