The invention provides butanedisulfonic acid adenosyl
methionine for injection and a preparation method thereof, and relates to the technical field of
medicine preparation. The preparation method comprises the following steps: filtering a butanedisulfonic acid
ademetionine liquid
medicine, sub-packaging and semi-plugging to obtain a sample, freeze-
drying the sample, and carrying out
nitrogen charging and plug pressing and re-pressing and capping to obtain butanedisulfonic acid
ademetionine for injection; the
freeze drying sequentially comprises pretreatment, pre-freezing, sublimation
drying and
desorption drying; the pretreatment comprises the steps that the temperature is set to be-5 DEG C to 0 DEG C, the
holding time is set to be 1-2 h, then the vacuum degree is set to be 80-150 pa, and the
holding time is 0.5-2 min; the sublimation drying is one-time sublimation. According to the invention, the sample can be rapidly nucleated and uniformly form large
ice crystals at a relatively high
supercooling temperature, so that the uniformity in batches is ensured, the one-time sublimation
drying time can be shortened, the
moisture of the obtained freeze-dried preparation is lower, meanwhile, the
shelf life of the product can be effectively ensured to meet the
quality standard, and the
clinical safety effectiveness is improved.