| abstract |
PROBLEM TO BE SOLVED: To provide a pharmaceutically acceptable preparation containing a pharmaceutical protein buffered by the protein itself without requiring an additional buffer for maintaining a desired pH. SOLUTION: The composition contains a pharmaceutical protein, and at pH, 21 ° C., 1 atm, and equilibrium with the atmosphere of the composition, the protein has a pH of 5.0 to 4.0 or pH under the same conditions. It has a buffering capacity per unit volume equal to or higher than the buffering capacity of about 4.0 mM sodium acetate buffer in pure water in a pH range of 5.0 to 5.5, and further, the buffering capacity of the protein is excluded, and the buffering capacity is the same. The buffering capacity per unit volume of the composition is less than or equal to the buffering capacity per unit volume of 2.0 mM sodium acetate buffer in pure water in the pH range 5.0-4.0 or 5.0-5.5 under the same conditions. The composition is said to have been approved for pharmaceutical use by an authority having legal authority to grant approval for pharmaceutical use. [Selection diagram] None |