目的 制备麝香保心微丸。方法 采用离心造粒法制备麝香保心微丸 ,考察处方和工艺因素对微丸收率的影响 ,并采用均匀设计法对影响微丸收率的主要因素进行筛选优化。结果 在微丸起模过程中 ,主机转速、粘合剂的加入速度和加量、喷枪喷雾条件对起模微丸的收率具有较为显著的影响。在成丸的工艺过程中 ,对微丸收率影响的主要因素为喷浆速度与供粉速度 ,经均匀设计试验优化得微丸成丸的最佳处方和工艺参数为:精制中间品与微晶纤维素 (MCC)比例为 1∶ 1,粘合剂为 3%羟丙基甲基纤维素 (HPMC,5 m Pa· s) ,主机转速为 2 0 0 r/ m in,鼓风流量为 10× 2 0 L/ min,喷气流量为 15 L/ min,喷气压力为 0 .5 MPa,喷浆泵转速为 14 r/ min,供粉机转速为 18r/ m in。结论 在优化条件下采用离心造粒法可制得表面较为光滑、圆整度较高的麝香保心微丸 ,10 0 0～ 70 0μm微丸的收率达 90 .4 %。

Object To prepare Heart protecting Musk Pellet (HPMP). Methods The HPMP was prepared by using a centrifugal granulator. The effect of formulation and technology on the yield of pellets was investigated. The optimal conditions of technology were selected by the uniform design. Methods The yields of core pellets were affected significantly by the rotating rate of plate, amount of adhesive agent, the added speed of adhesive agent and the conditions of nebulization. The spraying rate of binder solution and feeding rate of powder were found to have significant influences on pelletizing. The process parameters established by the uniform design were as follows: the ratio of fine intermediate product and MCC was 1∶1, the adhesive agent was 3% HPMC solution. The rotating rate of plate was 200 r/min, the blower rate was 10×20 L/min, the rate of air flow was 15 L/min, the spray air pressure was 0 5 MPa, the rotating rate of spray solution pump was 14 r/min and the rotating rate of powder feed machine was 18 r/min. Conclusion Under the optimal conditions, the pellets prepared by using centrifugal granulator have perfect shape and surface characteristics and the yield of 1 000 700 μm pellets could reach to 90 4%.

国家自然科学基金资助课题(30200363);辽宁省博士启动基金资助课题(2001102042)