| 摘要 |
<p>A stable, pharmaceutically acceptable, aqueous solution of insulin having an adjusted pH of between 7 and 8 comprises beef insulin which has: 1) a protaminase content causing less than 15% w/w loss at 37 DEG C in 30 days when the insulin is converted into a protamine-containing isophane insulin suspension; 2) an optical density (absorbance) corrected (as defined) to a manifold diluted sample of less than 0.5 as a 1% acid solution in a 4 cm. cell at 396 mm and, 3) an optical density of less than 0.03 at 400mm when measured as a 40 I.U./ml. solution in a 1 cm. cell at a pH of 7.4 after standing at 5 DEG C. for 8 days with an instrument adapted to exclude scattered light. Conventional purification methods may be used to obtain insulin of the desired purity.</p> |
