基于流化床顶喷技术的巴戟天寡糖胶囊成型工艺研究

Granulating process of Morindea officinalis oligosaccharides capsule based on top spray technique by fluidized bed coater

目的采用流化床顶喷制粒技术优化和建立中药巴戟天寡糖颗粒一次成型的工艺路线和工艺参数。方法采用单因素考察法,设定流化床顶喷包衣锅的主要工艺参数范围,将巴戟天水提取物喷至一定量的微晶纤维素粉末上,制备巴戟天寡糖颗粒,并分别测定其休止角、抹角、松密度、轻敲密度、压缩度和均一度等,计算流动性指数和平均粒径。结果当进风温度设定为40～45℃;进风压力设定为0.35～0.45bar;雾化压力设定为1.5～2.0bar;喷液速率设定为15～25r.min-1范围时,制备的巴戟天寡糖颗粒可顺利灌装装量均一的胶囊。结论该工艺使制剂一次成型,具有生产周期短、生产效率高、辅料用量小和产品成本低等优点,在中药制剂的成型工艺中值得推广应用。

Objective To establish the one-step granulating process and investigate the operational parameters of Morindea officinalis oligosaccharides granulation. Methods The top spray technique was used in coating process. The liquid （water） extract of M officinalis was sprayed onto microcrystalline cellulose powders under adequate operational parameters of fluidized bed coater. Consequently, the uniform granules of M officinalis oligosaccharides were achieved. The characteristic parameters of the granules such as angle of repose, angle of spatula, bulk density, tapped density, compressibility and uniformity were determined and then the flowability index was calculated. The distribution of particle size of the granules was also measured by the sieving method. Results The process parameters were optimized as follows： spraying rate （ 15 - 25 r · min^-1 ）, inlet air temperature （40 - 45℃ ）, inlet air pressure （0. 35 -0. 45 bar）, and atomizing air pressure （ 1.5 -2. 0 bar）. It could meet the requirement of the capsule filling process. Conclusion Fluidized bed top spray technique could reduce the amount of excipients applied in the granulation process significantly and is worthy of popularization in the granulation process of Traditional Chinese Medicine.