黄肝颗粒一步制粒工艺优化及初步评价

Optimization and preliminary evaluation of Huanggan granules prepared by one-step granulation process

目的:优化黄肝颗粒成型工艺,并对颗粒剂的质量进行初步评价。方法:以成型率、含水量为评价指标,进液速率、风机频率、进风温度及物料温度为影响因素,通过正交试验优化一步制粒工艺,并对黄肝颗粒进行初步评价。结果:一步制粒最佳条件为雾化压力0.3~0.5 MPa,进液速率5 r/min,风机频率24 Hz,进风温度80℃,物料温度60℃;质量评价结果显示,所得颗粒成型率高、大小均匀、流动性好、水分较低、溶化性好、不易吸湿,易于保存。结论:黄肝颗粒一步制粒工艺合理可行、稳定性好,可为该制剂的开发及临床应用奠定基础。

Objective:To optimize the molding process of Huanggan granules and evaluate the quality of granules.Methods:The one-step granulation process was optimized by the orthogonal test with molding rate and water content as evaluation indexes,liquid feeding rate,fan frequency,air inlet temperature,and material temperature as influence factors.The preliminary evaluation of Huanggan granules was carried out.Results:The optimal conditions of one-step granulation were the spray of 5 r/min,atomization pressure of 0.3~0.5 MPa,spray frequency of 24 Hz,inlet temperature of 80℃,and material temperature of 60℃.The results of the quality evaluation showed that the obtained granules with high yields,uniform particle size,good fluidity,low moisture,good solubility,and easy to be preserved.Conclusion:The optimized one-step granulation process of Huanggan granules is reasonable,feasible,and stable,which can lay a foundation for the development and clinical application of the preparation.