目的  建立超声制备微球的替代方法。方法  分别采用超声法和机械剪切法制备微球，并对两种方法制备的微球进行粒径、稳定性及其他质量指标比较。结果  超声微球和机械剪切微球的平均粒径分别为3.5～4.2 μm和5.5～6.4  μm。与超声微球相比，机械剪切微球的质量指标更优、稳定性更好、产量更高。结论  可用机械剪切法替代超声法来规模化生产微球。

Objective  To  estabilish the replacement process for  ultrasonication process for preparing microspheres. Methods  Microspheres were prepared  with ultrasonication process and mechanical shearing process, respectively.The comparisons of size,stability and other quality indexes were made between the two microspheres prepared by different processes. Results  Mean sizes of microspheres prepared by ultrasonication proess and mechanical shearing process were 3.5-4.2 μm and 5.5-6.4 μm, respectively. Microspheres prepared by  mechanical shearing process had better quality indexes, stronger stability and higher yield as compared with those prepared by ultrasonication process. Conclusion  Mechanical shearing process can replace ultrasonication process to manufacture microspheres on a large scale.