药品冷冻干燥过程的退火机理分析  

Research on annealing mechanism in freeze-drying process of pharmaceuticals

作　　者：周新丽[1] 翁宇[1] 陈光明[1] 

机构地区：[1]浙江大学制冷与低温研究所,浙江杭洲310027

出　　处：《化学工程》2005年第6期4-7,共4页Chemical Engineering(China)

基　　金：国家自然科学基金资助项目生物材料超声波玻璃化低温保存机理研究(50076039)

摘　　要：运用热力学和动力学理论分析了药品冷冻干燥过程中的退火操作改变冻结药品结构的机理。通过对化学势随晶粒曲率半径变化、重结晶过程中冰晶半径随时间变化、非晶态基质的粘度随温度变化几个关系式的分析,得出退火温度必须要高于冻结药品的玻璃化转变温度;最佳退火持续时间与重结晶的速率紧密相关,且是退火温度的函数;退火后再冷却过程的冷却速率不影响升华干燥速率等结论。By using thermodynamic and kinetic theories, the mechanism that annealing in freeze-drying process of pharmaceuticals can change the structure of frozen pharmaceuticals was explained. The relationships of chemical potential changes with radius of curvature of ice crystal, ice crystal radius changes with time during recrystallization and the viscosity of amorphous matrix changes with temperature were analyzed. Several guides to practice are concluded： （1） Annealing temperature must be above the glass transition temperature of frozen pharmaceuticals; （2） The optimal annealing duration is related to the velocity of recrystallization and is the function of annealing temperature; （3） Post-annealing re-solidification cooling rates do not affect the primary drying rate.

关 键 词：冷冻干燥 退火 冰晶 非品态 

分 类 号：TQ460.1[化学工程—制药化工]