基于制剂原料物理特性的止颤颗粒干法制粒处方与工艺优选

Optimization of Dry Granulation Prescription and Technology of Zhichan Granules Based on Physical Characteristics of Raw Materials in Preparations

目的:考察止颤颗粒制剂原料的物理特性,优选止颤颗粒的处方及成型工艺。方法:用粉体综合测试仪、激光粒度分布仪等测定止颤颗粒制剂原料的休止角、压缩度、含水量及黏聚力等;以颗粒成型率、脆碎度和外观评分为指标,采用单因素与正交试验筛选止颤颗粒最佳辅料与最佳制粒工艺参数。结果:制剂原料的休止角31°,黏聚力1.36 kpa,压缩度33.96%,含水量4.84%,粒径分布37.96μm;最佳处方组成为84.0%浸膏粉,1.0%硬脂酸镁,0.7%三氯蔗糖,0.5%红茶香精,13.8%糊精;干法制粒最优工艺参数为水平转速30 r.min-1,辊轮转速5 r.min-1,辊轮压力5 MPa。结论:制剂原料的物理特性研究可指导干法制粒制剂处方的筛选;所制得的颗粒载药量高、成型率较高、外观好、口感好,优选的干法制粒工艺稳定可行。

Objective： To investigate physical characteristics of raw materials in Zhichan granules, and optimize prescription and molding technology of Zhichan granules. Method： Physical characteristics of raw materials in Zhichan granules were determined by powder comprehensive test instrument, laser particle size distribution instrument and so on including water content compression degree, angle of repose, et al; With , . , , forming rate, friability and appearance score as indexes, single factor and orthogonal test were used to select optimum ace：essory and granulation technology parameters of Zhiehan granules. Result： Angle of repose of preparation materials was 31~, cohesion 1.36 kpa, compression degree 33.96% , water content 4. 84% , particle size ：distribution 37.96 p^m; Optimum prescription consisted of 84.0% extract powder, 1.0% magnesium stearate, 0.7% sucralose, 0.5% black tea flavor, 13.8% dextrin; Optimal dry granulation technology parameters were as follows： horizontal speed 30 r ~ min-~, roll wheel speed 5 r rain-1 , roll wheel pressure 5 MPa. Conclusion： Study of physical property of preparation materials could guide screening prescription of dry granulation preparations; These prepared Zhichan grunules had high drug-loading and forming rate with good taste and appearance, this optimized dry granulation technology was stable and reasonable.