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

作　　者：徐桂红[1,2] 林夏[2,3] 曹苗苗[2,3] 黄道省[2,3] 王正宽[2,3] 吴建雄[1,2,3] 萧伟[2,3] 

机构地区：[1]南京中医药大学,南京210046 [2]江苏康缘药业股份有限公司,江苏连云港222001 [3]中药制药过程新技术国家重点实验室,江苏连云港222001

出　　处：《中国实验方剂学杂志》2013年第13期25-28,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家科技部重大新药创制项目(2009ZX09313-032)

摘　　要：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.

关 键 词：注射用活血通络 冷冻干燥 共晶点温度 冻干曲线 

分 类 号：R283.6[医药卫生—中药学]