离心造粒法制备复方丹参微丸

The Preparation of Compound Danshen Pellets by Using Centrifugal Granulator

摘要:

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200 r ·min-1、鼓风流量8 L ·min^-1、喷气流量18 L ·min^-1、喷气压力0.06 Mpa、喷浆泵转速12~17 r ·min^-1、供粉机转速15~20 r ·min^-1。复方丹参微丸在15 min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。

Abstract:

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.