七叶皂苷钠冻干粉针的工艺优化研究

Optimization of Process of Sodium Aescinate Lyophilized Powder

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 optimal freeze-drying process of Sodium Aescinate lyophilized powder in order to shorten the lyophilization cycle.Methods： Using the single factor experiment and L9（ 34） orthogonal test to optimize parameters of the herbal liquid volume and concentration,pre-freezing time,pressure,drying time and analytical temperature.Results： The best lyophilization process parameters were as follows：1.0 mL herbal liquid with concentration of 10 mg /mL,phased cooling style,pre-freezing temperature at- 35 ℃,6.5 h; vacuum of 20 Pa; sublimation drying time of 7 h; and desorption-drying temperature of 35 ℃ for 5.5 h.Conclusion：Compared with the original process conditions,the product quality is more stable and the freezing-drying cycle time is shorten of 3 h,which can provide technical reference for production process of the freeze-dried powder of sodium aescinate.