PROBLEM TO BE SOLVED: To provide liquid aqueous pharmaceutical formulations comprising an effective amount of a recombinant hTNFα antibody suitable for inhibiting or antagonizing hTNFα activities with a shelf life of at least 18 months.SOLUTION: A buffer containing mannitol, citric acid monohydrate, sodium citrate, disodium phosphate monohydrate, disodium phosphate dihydrate, sodium dihydrogen phosphate dehydrate, sodium chloride, polysorbate and water as the ingredients of the buffer is prepared of which pH is adjusted with a solution of sodium hydroxide, where the addition order of the ingredients is not important and arbitrarily selected so as to provide a liquid aqueous pharmaceutical formulation whose pH is 4-8, having a shelf life of 18 month, and maintaining stability after at least 3 cycles of freeze and thawing.SELECTED DRAWING: None【課題】ｈＴＮＦα活性を阻外又は対抗する為に適した組換えｈＴＮＦα抗体であって、緩衝液中に治療有効量の抗体を含み、少なくとも１８か月間の保存期間をもつ液体水性医薬製剤。【解決手段】緩衝液の成分として、マンニトール、クエン酸１水和物、クエン酸ナトリウム、リン酸２ナトリウム２水和物、リン酸２水素ナトリウム２水和物、塩化ナトリウム、ポリソルベート、及び水を含む緩衝液を調製し、水酸化ナトリウム水溶液で溶液のｐＨを調整。緩衝液成分の添加順序は重要ではないため、任意に選択できる。ｐＨ４～８で、１８ヶ月間の保存期間を持ち、少なくとも３回の凍結／解答サイクル後も安定性を維持する液体水性医薬製剤。【選択図】なし
