摘要
目的通过对埃索美拉唑钠冻干工艺的摸索,制定相应的冻干工艺参数。方法通过预冻温度、升温时间、一次升华温度、二次升华温度的正交试验,目测冻干成型和测定产品水分,确定最佳冻干工艺参数。结果优选冻干工艺参数条件水平组合为A3B3C2D1,成品率达99%。确定预冻温度为-40℃,预冻时间为2h,一次升华干燥升温时间为2h,干燥温度为0℃,以压力升测试,以1min内压力升不超过3pa,结束一次升华过程。二次升华干燥升温时间为2h,升华温度为30℃,以压力升测试,以1min内压力升不超过1pa,结束二次升华过程。结论影响冻干工艺的主要因素为预冻温度和时间,一次升华温度。
OBJECTIVE To formulate the parameters of freezing-dry processing techniques through the study on the process. METHODS The optimum parameters was confirmed through the crossover test with pre-freezing temperature,heating-up time,primary drying temperature and secondary drying temperature,measuring the freezing drying molding and residual moisture final（ RMF）. RESULTS The optimum selection was A3B3C2D1,the rate of finished products reached 99%. The temperature of pre-freezing was-40℃,the time was 2hrs. The primary drying time was 2hrs,the temperature was 0℃,using the dynamic pressure measurement to manage the pressure rised no more than 3pa in 1 minute and over this step. The secondary drying time was 2hrs,the temperature was 30℃,using the dynamic pressure measurement to manage the pressure rised no more than 1pa in 1 minute and over this step. CONCLUSION The major effected factors are the temperature and time of pre-freezing,primary drying temperature.
出处
《海峡药学》
2015年第1期6-7,共2页
Strait Pharmaceutical Journal
关键词
埃索美拉唑钠
冻干
温度
Esomeprazole sodium
freeze drying
temperature
