目的:探讨影响注射用奥扎格雷钠(80mg)萎缩的因素,优化注射用奥扎格雷钠冻干工艺曲线。方法:以空洞(熔化)萎缩比例为指标,采用正交试验法优选冻干参数。结果:所优化冻干工艺曲线和未作优化的工艺比较,出箱的合格品率提高了64.06%。结论:提高了合格品率,减少空洞(熔化)萎缩的数量,同时又保证了产品质量;影响制品萎缩的冻干参数为升华通道中预冻第四步温度不合适和预冻第二步温度不合适。 Objective: To explore the factors affecting the shrinkage of sodium ozagrel (80mg) for injection and optimize the freeze-drying process of ozagrel sodium for injection. Methods: Taking the percentage of empty (melting) atrophy as an index, the parameters of freeze-drying were optimized by orthogonal test. Results: Compared with the non-optimized process, the yield of the optimized freeze-drying process increased by 64.06%. Conclusions: The quality of products is improved and the number of cavities (melts) atrophy is reduced, while the product quality is guaranteed. The freeze-drying parameters affecting the shrinkage of products are the fourth step of pre-freezing in the sublimation channel, and the second step of pre-freezing temperature Not suitable.