| 摘要 |
PROBLEM TO BE SOLVED: To provide a method for preparing a liquid pharmaceutical formulation allowing improved tolerability of a chelate complex with gadolinium in a pharmaceutical formulation of a contrast medium for magnetic resonance imaging.SOLUTION: A large ring chelate compound is suitably selected from DOTA, NOTA, DOTAGA, DO3A and the like and preferably DOTA. A method comprises: b) preparing a liquid pharmaceutical composition containing firstly a complex of the large ring chelate compound and a lanthanide and secondly a free large ring chelate compound and/or a free lanthanide; c) measuring the concentration Cof the free large ring chelate compound and/or the concentration Cof the free lanthanide in the pharmaceutical formulation obtained in b); and d) adjusting Cand/or Cso that C=Cand C=0 are obtained, where Cis the target concentration of the free large ring chelate compound in a final liquid pharmaceutical formulation. |
