采用挤出-滚圆法制备了木瓜酶小丸,以评价该工艺用于制备蛋白质类药物固体制剂的可行性。采用N-苯甲酰基-DL-精氨酰-4-硝基苯胺为底物,测定木瓜酶的生物活性,以监测制备过程各阶段(干物料混合、湿物料、挤出、滚圆和干燥)及贮存条件对木瓜酶生物活性的影响,并考察了制品的粒度分布、表观密度和脆碎度。结果表明,所得制品均具有合适的物理和机械性能。生物活性监测结果表明,干燥过程和贮存条件 Papaya pellets were prepared by extrusion-spheronization to evaluate the feasibility of the process for the preparation of solid preparations of proteinaceous drugs. The biological activity of papain was measured using N-benzoyl-DL-arginyl-4-nitroaniline as a substrate to monitor the various stages of the preparation process (dry mix, wet mix, extrusion, spheronization and drying) And storage conditions on the biological activity of papain, and investigated the particle size distribution, apparent density and friability. The results show that the resulting products have suitable physical and mechanical properties. Biological activity monitoring results show that the drying process and storage conditions