海峡药学
海峽藥學
해협약학
STRAIT PHARMACEUTICAL JOURNAL
2015年
1期
6-7
,共2页
埃索美拉唑钠%冻干%温度
埃索美拉唑鈉%凍榦%溫度
애색미랍서납%동간%온도
Esomeprazole sodium%freeze drying%temperature
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A3 B3 C2 D1，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。
目的：通過對埃索美拉唑鈉凍榦工藝的摸索，製定相應的凍榦工藝參數。方法通過預凍溫度、升溫時間、一次升華溫度、二次升華溫度的正交試驗，目測凍榦成型和測定產品水分，確定最佳凍榦工藝參數。結果優選凍榦工藝參數條件水平組閤為A3 B3 C2 D1，成品率達99％。確定預凍溫度為－40℃，預凍時間為2h，一次升華榦燥升溫時間為2h，榦燥溫度為0℃，以壓力升測試，以1min內壓力升不超過3pa，結束一次升華過程。二次升華榦燥升溫時間為2h，升華溫度為30℃，以壓力升測試，以1min內壓力升不超過1pa，結束二次升華過程。結論影響凍榦工藝的主要因素為預凍溫度和時間，一次升華溫度。
목적：통과대애색미랍서납동간공예적모색，제정상응적동간공예삼수。방법통과예동온도、승온시간、일차승화온도、이차승화온도적정교시험，목측동간성형화측정산품수분，학정최가동간공예삼수。결과우선동간공예삼수조건수평조합위A3 B3 C2 D1，성품솔체99％。학정예동온도위－40℃，예동시간위2h，일차승화간조승온시간위2h，간조온도위0℃，이압력승측시，이1min내압력승불초과3pa，결속일차승화과정。이차승화간조승온시간위2h，승화온도위30℃，이압력승측시，이1min내압력승불초과1pa，결속이차승화과정。결론영향동간공예적주요인소위예동온도화시간，일차승화온도。
ABSTRACT: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 2 hrs.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 tem-perature.
