CAJ | 학술논문

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。
위건립합괄적정이광산선감단안산동간공예,채용진공냉동간조법,대정이광산선감단안산동간조건여공정점、장량、예동정서、승화온도、승화진공도급해흡간조온도등진행연구。결과현시：동간공예：장량위액면고도소우10 mm,예동정서위예동지-40℃,연후회온지-10℃,재강지-50℃,재진공도10～30 Pa,-25℃하승화,35℃해흡간조。차공예제비적정이광산선감단안산외관호,산품질량부합국가표준。
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.