| 摘要 |
In the present invention, there is described a process for preparing a liquid pharmaceutical composition comprising polypeptide or a biologically active variant thereof, wherein the preparation process is characterized by combining the said polypeptide or a variant thereof with at least one amino acid base and a buffer preparation being in the form of an acid being perfectly freed of its salt, whereby said amino-acid base contains at least one amino acid being selected from the group consisting of arginine, lysine, aspartic acid and glutamic acid, wherein any amino acid is in the form of a free base or in the form of a salt, wherein the composition pH value is in the range of 4.0 to 9.0, the polypeptide is represented by interleukin 2 (IL-2), and the said variant has a sequence identity of at least 70 percent with the polypeptide, wherein the pH value is adjusted prior addition of the polypeptide. The pharmaceutical composition is nearly isotonic and exhibits enhanced storage stability. |
