The invention relates to the technical field of pharmaceutical preparations, in particular to a freeze-
drying process of
mycophenolate mofetil for injection, which comprises the following steps: cooling a
mycophenolate mofetil injection to-35 DEG C to-45 DEG C, carrying out primary heat preservation,
tempering and heating to-10 DEG C to-5 DEG C, carrying out secondary heat preservation, cooling to-40 DEG C to-50 DEG C, carrying out third heat preservation, and carrying out freeze-
drying under the condition that the vacuum degree is 25-35Pa, so as to obtain the
mycophenolate mofetil for injection. And heating the pre-frozen
solid to-25 DEG C to-15 DEG C, preserving heat for four times, heating to 35-45 DEG C, and preserving heat for five times to obtain the freeze-dried mycophenolate mofetil for injection. Through the freeze-
drying process, the total
impurity content of a freeze-dried product is smaller than or equal to 0.15%, the medication safety and stability are remarkably improved, and the one-time sublimation
drying time is greatly shortened to 9 h from 16 h in a traditional process; meanwhile, the
residual moisture of the finished product is controlled to be about 0.1%, and the finished product can be stored at
room temperature and meets the requirements of industrial large-scale production.