| abstract |
The present invention provides a kind of production technology of injection Calcium Levofolinate freeze-dried powder, include the following steps: that 40 DEG C~50 DEG C of water for injection is added in (1) in Agitation Tank；(2) by mass, 1 portion of mannitol is added to stir to dissolution, is kept for 40 DEG C~50 DEG C of fluid temperature；(3) 1 part of l-leucovorin calcium raw material drug is added to stir to dissolution, reduces fluid temperature to 20 DEG C~30 DEG C, adjusts pH to 7.8-8.2, water for injection is added and is settled to 1000 parts；(4) aseptic filtration, it is filling, after freeze-drying, obtain formulation products.The technique can effectively control the impurity level in finished product, it is made to grind medicine better than the commercially available original in the U.S.. |