目的：确定FKⅣ颗粒剂制粒的最佳工艺条件。方法：比较湿法制粒与干法制粒制得颗粒剂的含量差异，选择干法制粒并考察该法中辅料种类、轧轮压力、轧轮转速和浸膏粉含水量对颗粒成型率、吸湿性和溶化性等影响，采用L9（34）正交试验优化干法制粒工艺参数。结果:添加50%浸膏粉量的微晶纤维素为稀释剂，1.0%的阿司帕坦为矫味剂，控制轧轮压力5.0 MPa，转速400 rpm，浸膏粉含水量约3.0%，所得颗粒具有成型率高、溶化性好、吸湿率低、口感好等优点。结论:FKⅣ颗粒剂干法制粒工艺合理可行，可满足生产需要。

This article was aimed to study the optimum technological conditions of roller compaction of FKⅣgranules. This experimentation compared content of two granule preparation techniques which were the dry process granulation and the wet process granulation, and adopted L9(34) orthogonal experiment to study the technological parameters of FKⅣgranules. The dry process granulation was selected. And factors such as roller pressure, roller speed and moisture content of power, which influence the result of granule yield were also studied in the dry process granulation. The results showed that the optimum technological conditions were roller pressure at 5.0 Mpa, roller speed at 400 rpm, and moisture content of power at 3.0%. It was concluded that the roller compaction process of FKⅣgranules was feasible in production which was able to meet the requirement of production.

科学技术部国家重大新药创制项目（2013ZX09402203）：现仪中药创新集群与数字制药技术平台，负责人：王振中。