采用叔丁醇-水共溶剂体系冷冻干燥法制备了紫杉醇白蛋白亚微粒。以冻干溶液外观,复溶后平均粒径及分布、放置稳定性等为指标,优化了处方和制备工艺。结果表明,以乳糖为冻干保护剂为最佳,所得亚微粒平均粒径在300～400 nm,复溶后室温放置8 h内稳定。 Paclitaxel albumin submicron particles were prepared by freeze-drying using tert-butanol-water cosolvent system. The freeze-dried solution appearance, average particle size and distribution after re-dissolution, placement stability and other indicators as an optimization of the prescription and preparation process. The results showed that lactose as lyoprotectant was the best, the average diameter of the obtained submicron particles was 300-400 nm, and was stable within 8 h after reconstitution.