Gadolinium contrast agents are currently the most widely used magnetic resonance imaging contrast agents in clinical practice. Gadobutrol, as a second-generation gadolinium contrast agent, is an extracellularly distributed, non-tissue-specific, non-ionic, macrocyclic paramagnetic gadolinium chelator. Due to its high relaxivity, high concentration, and high stability (macrocyclic structure), it has become a leader among contrast agents in combining excellent imaging and high stability.

Based on safety reports on the use of gadolinium contrast agents, foreign drug regulatory authorities such as the United States and the European Union have successively released safety information on gadolinium contrast agents, warning of the risk of gadolinium deposition in the brain after multiple enhanced MRI scans. In particular, the European EMA announced in 2017 the suspension of the marketing authorization and use of three linear gadolinium contrast agents for intravenous injection: gadopentetate dimeglumine injection, gadodiamide injection, and gadoflutamide injection.

Gadobutrol is composed of a gadolinium ion and a macrocyclic ligand. Gd³⁺ has nine coordination bonds, eight of which bind to the macrocyclic butrol, forming a chelation compound. Gd³⁺ is tightly embedded in the center of this complete cage-like structure. Under physiological conditions, gadobutrol releases virtually no free Gd³⁺, whereas linear gadolinium contrast agents can release 10% to 20% free Gd³⁺. Free Gd³⁺ is highly toxic and can displace Ca ions from many peptides and enzymes in the body, thereby inhibiting their function. Therefore, compared to linear gadolinium contrast agents, macrocyclic gadolinium contrast agents are more stable and safer.

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