丁二磺酸腺苷蛋氨酸冻干工艺研究

摘要

为建立合适的丁二磺酸腺苷蛋氨酸冻干工艺,采用真空冷冻干燥法,对丁二磺酸腺苷蛋氨酸冻干条件如共晶点、装量、预冻程序、升华温度、升华真空度及解吸干燥温度等进行研究。结果显示：冻干工艺：装量为液面高度小于10 mm,预冻程序为预冻至-40℃,然后回温至-10℃,再降至-50℃,在真空度10～30 Pa,-25℃下升华,35℃解吸干燥。此工艺制备的丁二磺酸腺苷蛋氨酸外观好,产品质量符合国家标准。%A suitable freeze-drying process of ademetionine butanedisulfonate was established.Methods：The vacuum freeze-drying method was modified by the process such as liquid altitude in bottle,the eutectic point,pre-freeing process,sublimating temperature,sublimating vacuum,and temperature of desorption.The acceptable freeze-drying process was that liquid altitude was NMT 10 mm in bottle,pre-freeing process was that fell the temperature to-40 ℃,then back to-10 ℃,then fell to-50 ℃,sublimating temperature was-25 ℃,sublimating vacuum was 10～30 Pa,and temperature of desorption was 35 ℃.The lyophilized agent of ademetionine butanedisulfonate prepared by this process had look good and met the requirement of the SFDA.