注射用活血通络制剂的冷冻干燥工艺优选

Optimization of Freeze Drying Technology for Huoxue Tongluo Preparation for Injection

目的:优化注射用活血通络冷冻干燥制剂的成型工艺条件,并考察其稳定性。方法:以冻干成型效果、复溶性、澄明度、芍药苷及阿魏酸含量的综合评分为指标,在单因素试验基础上,通过正交试验考察甘露醇的用量、药液质量浓度、预冻速率对冻干工艺的影响,采用HPLC测定阿魏酸、芍药苷含量。结果:优选的成型工艺为以5%甘露醇为填充剂,药液中有效成分质量浓度30 g.L-1,预冻速率30℃.h-1,制成的冻干粉针剂质量稳定。结论:优选的处方和冻干工艺稳定可行,可推广于大生产应用。

Objective： To optimize molding technology with vacuum freeze drying of Huoxue Tongluo powder for injection,and investigate its stability.Method： With composite score of freeze-dried molding effect,solubility,clarity,the content of ferulic acid and paeoniflorin as index,based on single factor test,effect of dosage of mannitol,liquid concentration,pre-freezing rate on freeze drying technology was investigated by orthogonal design,the content of ferulic acid and paeoniflorin was determined by HPLC.Result： Optimized molding technology was as following： with 5% mannitol as filler,liquid concentration 30 g.L-1,prefreezing rate 30 ℃.h-1,these prepared freeze-dried powder injection had stable quality.Conclusion： Optimized prescription and freeze-drying process was reliable and feasible,it could be used in large-scale production.