| 主权项 |
1. A pharmaceutical formulation containing an insulin derivative having the general formula I: Acy-X—Yn-Ins, wherein “Ins” designates an insulin analogue to which a side chain (designated Acy-X—Yn-) has been attached to the ε amino group present in the B29 lysine amino acid in said insulin analogue, said insulin analogue is human insulin containing glutamic acid in the A14 position, histidine in the B25 position, optionally histidine in the B16 position and, optionally, the B27 and/or B30 amino acid(s) has/have been removed, Acy is a fatty diacid with 8-24 carbon atoms from which a hydroxyl group has been removed, X is γGlu wherein the amino residue has been connected to “Acy” and—if n is different from zero—the carbonyl group in γGlu has been connected to Y or—if n is zero—the carbonyl group in γGlu has been connected to the ε amino group in lysine in the B29 position in said insulin analogue, Y is —NH—(CH2)2—O—(CH2)2—O—CH2—CO— wherein the amino group is connected to X and the carbonyl group is connected to the ε amino group in lysine in the B29 position in said insulin analogue, and n is 0 (zero), 1, 2 or 3, not more than about 2% (weight/weight) of glycerol, from about 16 to about 35 mM of phenol, from about 16 to about 35 mM of m-cresol, from about 3.5 to about 8 mole of zinc ions per six mole of said insulin derivative and having an ionic strength in the range from about 0 to about 150. |
