The invention relates to the technical field of new drugs, in particular to a
clevidipine butyrate concentrated solution and a preparation method thereof, and the composition contains
clevidipine butyrate, a solubilizer, a cosolvent, a pH
regulator and water for injection. Injection oil is abandoned, so that the requirements of
lipid metabolism defect patients are met; no
phospholipid is used in the prescription, safety risks such as
hemolysis, immunoreaction and long-term
toxicity and stability problems such as
oxidative degradation are avoided, after
phospholipid is removed, the
clevidipine butyrate preparation can tolerate excessive hot-press sterilization, the
sterility level guarantee degree is higher, the state of the clevidipine butyrate preparation is converted into a true
solution system from a
micelle system, and the stability of the clevidipine butyrate preparation is improved. The solubilizer and the cosolvent are combined, so that the
solubility of clevidipine butyrate is greatly improved,
dichloromethane,
chloroform and other organic solvents with large toxic and side effects are not needed, the
toxicity of the
medicine is reduced, the stimulation to blood vessels is small, and the adverse reaction of the
medicine is reduced; and the preparation method is simple and easy to amplify, and production amplification is facilitated by selecting a production process of a common injection.