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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 the molding process conditions of Huoxuetongluo injection for injection and study its stability. Methods: Based on the single factor test, the content of mannitol, the mass concentration of drug solution, the concentration of drug solution Freezing-drying rate of freeze-drying process, the determination of ferulic acid, paeoniflorin content by HPLC. Results: The preferred molding process was that the lyophilized powder was stable with 5% mannitol as filler, active ingredient concentration 30 g · L-1 and pre-freeze rate 30 ℃ .h-1. Conclusion: The preferred prescription and freeze-drying process is stable and feasible, which can be extended to large-scale production applications.