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目的:确定七叶皂苷钠冻干粉针的最佳冻干工艺参数,缩短冻干周期。方法:采用单因素试验和L9(34)正交试验,对药液浓度和装量、预冻时间、工作压力、干燥时间、解析温度等参数进行优化。结果:最佳冻干工艺参数为:药液浓度10 mg/mL,装量为1.0 mL,预冻温度-35℃,6.5 h;工作压力为20 Pa;升华干燥时间7 h;解析干燥温度35℃,5.5 h。结论:本品采用优化后冻干生产工艺,与原工艺条件相比,产品质量更稳定,其冻干工艺周期缩短3 h,可为七叶皂苷钠冻干粉针的生产工艺优化提供技术参考。
Objective: To determine the best lyophilization process parameters of sodium aescinate lyophilized powder to shorten the lyophilization cycle. Methods: The single factor test and L9 (34) orthogonal test were used to optimize the parameters such as concentration and loading of liquid, pre-freezing time, working pressure, drying time and analytical temperature. Results: The optimal parameters of freeze-drying process were as follows: liquid concentration 10 mg / mL, volume 1.0 mL, pre-freezing temperature -35 ℃, 6.5 h, working pressure 20 Pa, sublimation drying time 7 h, analytical drying temperature 35 ℃, 5.5 h. Conclusion: This product is optimized by freeze-drying production process, compared with the original process conditions, the product quality is more stable, the freeze-drying process cycle shortened 3 h, for sodium aescinate sodium freeze-dried powder production technology to provide technical reference .