Pharmaceutical composition

摘要

The present invention relates to a parenteral pharmaceutical composition comprising therapeutically effective amounts of N-(2-pyrazine)carbonyl-L-phenylalanine-L-leucine boronic acid or its salts or its derivatives and tromethamine wherein the composition is stable.

主权项

1. A method of preparing a lyophilised composition of N-(2-pyrazine) carbonyl-L-phenylalanine-L-leucine boronic acid, said method consisting of:
(a) dissolving N-(2-pyrazine)carbonyl-L-phenylalanine-L-leucine boronic acid having a total impurity of less than 0.51%, tromethamine and a bulking agent in water, wherein the N-(2-pyrazine) carbonyl-L-phenylalanine-L-leucine boronic acid and tromethamine are present in a molar ratio of at least about 1:3; (b) adjusting the pH of the solution obtained in step (a) to about 6.8 to 7.2; (c) subjecting the solution obtained in step (b) to sterilization; (d) filling the solution obtained in step (c) into vials and lyophilizing the solution.