| 摘要 |
PROBLEM TO BE SOLVED: To provide an improved method for stabilizing a protein, capable of substantially preventing the formation of aggregates and granules on the reconstitution of the lyophilization product of the pharmaceutical composition of the protein. SOLUTION: This improved method for preventing the formation of protein aggregates on the reconstituted lyophilization product of a pharmaceutical protein composition comprises freezing an aqueous buffer solution of the protein, thawing the frozen solution, dividing the thawed solution into injectable divisions and subsequently again lyophilizing the divisions. Therein, the aqueous buffer solution of the protein contains potassium phosphate as a buffering substance, and the ratio of potassium ion: sodium ion in the solution is at least 10:1.
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