超声微球与机械剪切微球的质量指标比较

Comparison of quality indexes of microspheres prepared by ultrasonication process and mechanical shearing process

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—4．2μm和5．5～6．4μm。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 a replacement process of uhrasonication 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 micro- spheres prepared by two 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 com- pared with those prepared by ultrasonication process. Conclusion Mechanical shearing process can replace uhrasonication process to manufacture microspheres on a large scale.