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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 the physical properties of the raw material of Zhifu Granules, and to optimize the formulation and molding process of Zhifu Granules. Methods: The angle of repose, compressibility, water content and cohesion of the raw materials of defibrillators were measured by powder tester, laser particle size distribution analyzer and so on. Based on the particle forming rate, friability and appearance score, Selection of Optimal Excipients and Optimal Granulation Process Parameters of Defibrillator Granules by Single and Orthogonal Experiments. Results: The angle of repose of the preparation raw material was 31 °, the cohesion was 1.36 kpa, the degree of compression was 33.96%, the water content was 4.84%, the particle size distribution was 37.96μm. The best formulation consisted of 84.0% extract powder, 1.0% magnesium stearate, 0.7% sucralose, 0.5% black tea flavor and 13.8% dextrin. The optimum technological parameters of dry granulation were horizontal rotation speed 30 r.min-1, rotation speed 5 r.min-1 and pressure 5 MPa. Conclusion: The study of the physical properties of preparation raw materials can guide the prescription of dry granulation preparations. The prepared granules have high drug loading, high molding rate, good appearance and good taste. The preferred dry granulation process is stable and feasible.