| 摘要 |
PURPOSE: Stable aqueous alpha-IFN solution formulations containing alpha-IFN, a stabilizer, an osmosis pressure controller, an antimicrobial preservative selected from phenol, m-cresol or mixtures thereof and a buffer system are provided, which have the advantages of maintaining the activity for a long period of time, exhibiting no latent dangerousness on a human body by reducing an amount of a preservative to be added and being stable in an aqueous solution. CONSTITUTION: This formulation comprises 1x10¬6 IU/ml to 1x10¬7 IU/ml of alpha-IFN, a stabilizer, an osmosis pressure controller, an antimicrobial preservative selected from 0.10 to 0.30 w/v of phenol, 0.1 to 0.2 w/v of m-cresol or mixtures thereof and a buffer system. The stabilizer is polysorbate 80 having a concentration of 0.01 to 0.05 w/v. The buffer system is a buffer solution of ammonium acetate and acetic acid or a buffer solution of sodium monohydrogen phosphate and sodium dihydrogen phosphate. The formulations have a pH of 4.5 to 6.0.
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