高速搅拌湿法制备穿心莲颗粒过程中润湿剂的动态分布规律

目的研究穿心莲粉体高速搅拌湿法制粒过程润湿剂在颗粒中的动态分布规律。方法以模型药物穿心莲-微晶纤维素(MCC)质量比为1∶1.5制备混合粉体,60%乙醇为润湿剂,高速搅拌湿法制粒。以荧光素钠为示踪剂加入润湿剂中,检测荧光素钠在制粒过程不同时间点颗粒中的量。结果在制粒初期润湿剂分布不均匀,局部过度润湿,部分未被润湿,制粒结果出现两极分化,制粒时间增加,润湿剂分布逐步均匀化,颗粒粒径呈近单峰分布。结论高速搅拌湿法制备穿心莲颗粒过程中,润湿剂随时间分布符合一级动力学模型。

Dynamic distribution of moistening agent in preparation of Andrographis paniculata granule by high shear wet granulation

Objective To explore the dynamic distribution of moistening agent in Andrographis paniculata granule (APG) during the high shear wet granulation (HSG). Methods A. paniculata extract was utilized as a model drug and mixed with microcrystalline cellulose (MCC) with the ratio of 1:1.5 by weight. The granules were prepared using HSG with 60% ethanol as the moistening agent. Sodium fluorescein was incorporated as a tracer in the moistening agent in order to detect its distribution in the granules during the process. Results The moistening agent was heterogeneously distributed at the beginning of the process, fractional powder was over wetted, meanwhile partial powder was not wetted, and granule size distribution was polarization. The moistening agent tended to be evenly distributed and the granule size distribution presented nearly unimodal distribution with the increase of granulation time. Conclusion The distribution of moistening agent obeys the first-order kinetics model during HSG of APG.