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糖鎖を有する顆粒球コロニー刺激因子と、顆粒球コロニー刺激因子１重量部に対して１重量部以下の少なくとも１種の製薬上許容される非イオン界面活性剤を含み、ｐＨ５〜７である、安定な顆粒球コロニー刺激因子含有製剤。
A granulocyte colony stimulating factor having a sugar chain and at least one pharmaceutically acceptable nonionic surfactant in an amount of 1 part by weight or less per 1 part by weight of the granulocyte colony stimulating factor, and having a pH of 5 to 7. A stable granulocyte colony-stimulating factor-containing preparation.
界面活性剤を顆粒球コロニー刺激因子１重量部に対して０．２〜１重量部の範囲内の量で含む請求項１記載の顆粒球コロニー刺激因子含有製剤。
The granulocyte colony stimulating factor-containing preparation according to claim 1, comprising a surfactant in an amount within the range of 0.2 to 1 part by weight with respect to 1 part by weight of the granulocyte colony stimulating factor.
界面活性剤を顆粒球コロニー刺激因子１重量部に対して０．２〜０．８重量部の範囲内の量で含む請求項２記載の顆粒球コロニー刺激因子含有製剤。
The granulocyte colony stimulating factor-containing preparation according to claim 2, comprising a surfactant in an amount in the range of 0.2 to 0.8 parts by weight with respect to 1 part by weight of the granulocyte colony stimulating factor.
界面活性剤を顆粒球コロニー刺激因子１重量部に対して０．４〜０．８重量部の範囲内の量で含む請求項２記載の顆粒球コロニー刺激因子含有製剤。
The granulocyte colony stimulating factor-containing preparation according to claim 2, comprising a surfactant in an amount within the range of 0.4 to 0.8 parts by weight with respect to 1 part by weight of the granulocyte colony stimulating factor.
界面活性剤を顆粒球コロニー刺激因子１重量部に対して０．４又は０．８重量部含む請求項２記載の顆粒球コロニー刺激因子含有製剤。
The granulocyte colony stimulating factor-containing preparation according to claim 2, comprising 0.4 or 0.8 part by weight of a surfactant per 1 part by weight of granulocyte colony stimulating factor.
安定化剤として実質的にタンパク質を含まない請求項１記載の顆粒球コロニー刺激因子含有製剤。
The granulocyte colony-stimulating factor-containing preparation according to claim 1, which contains substantially no protein as a stabilizer.
非イオン界面活性剤がソルビタン脂肪酸エステル、グリセリン脂肪酸エステル、ポリグリセリン脂肪酸エステル、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレンソルビット脂肪酸エステル、ポリオキシエチレングリセリン脂肪酸エステル、ポリエチレングリコール脂肪酸エステル、ポリオキシエチレンアルキルエーテル、ポリオキシエチレンポリオキシプロピレンアルキルエーテル、ポリオキシエチレンアルキルフェニルエーテル、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンミツロウ誘導体、ポリオキシエチレンラノリン誘導体、ポリオキシエチレン脂肪酸アミドからなる群から選択される少なくとも１種である請求項１記載の顆粒球コロニー刺激因子含有製剤。
Nonionic surfactants pixel Rubitan fatty acid esters, glycerin fatty acid esters, polyglycerol fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene sorbitol fatty acid esters, polyoxyethylene glycerin fatty acid esters, polyethylene glycol fatty acid esters, polyoxyethylene alkyl ethers, polyoxyethylene polyoxypropylene alkyl ethers, polyoxyethylene alkyl phenyl ethers, polyoxyethylene hardened castor oil, polyoxyethylene beeswax derivatives, polyoxyethylene lanolin derivatives, are selected from polyoxyethylene fatty acid ami de or Ranaru group The granulocyte colony-stimulating factor-containing preparation according to claim 1, which is at least one kind.ポリオキシエチレンソルビタン脂肪酸エステルがポリソルベート２０又はポリソルベート８０である請求項７記載の顆粒球コロニー刺激因子含有製剤。
The granulocyte colony-stimulating factor-containing preparation according to claim 7, wherein the polyoxyethylene sorbitan fatty acid ester is polysorbate 20 or polysorbate 80 .
ｐＨが６〜６．８である請求項１記載の顆粒球コロニー刺激因子含有製剤。
The granulocyte colony-stimulating factor-containing preparation according to claim 1, having a pH of 6 to 6.8.
ｐＨが６．２〜６．８である請求項１記載の顆粒球コロニー刺激因子含有製剤。
2. The granulocyte colony stimulating factor-containing preparation according to claim 1, which has a pH of 6.2 to 6.8.
バイアル、注射器用アンプル又はプレフィルドシリンジに充填された請求項１記載の顆粒球コロニー刺激因子含有製剤。
2. The granulocyte colony stimulating factor-containing preparation according to claim 1, which is filled in a vial, an ampule for a syringe, or a prefilled syringe.
長期保存後におけるＧ−ＣＳＦの残存率が高く、かつ糖鎖分解体の生成が少ない、請求項１記載の顆粒球コロニー刺激因子含有製剤。
2. The granulocyte colony-stimulating factor-containing preparation according to claim 1, wherein the residual rate of G-CSF after long-term storage is high and the production of sugar chain degradation products is small.
Ｇ−ＣＳＦ含有溶液製剤を２５℃の保存条件下で６ヶ月保存した後のＧ−ＣＳＦ残存率が９５％以上、あるいは４０℃の保存条件下で２週間保存した後のＧ−ＣＳＦ残存率が７５％以上保たれる、請求項１２記載の顆粒球コロニー刺激因子含有製剤。
G-CSF residual ratio after storage of G-CSF containing solution preparation at 25 ° C. for 6 months is 95% or more, or G-CSF residual ratio after storage at 40 ° C. for 2 weeks. The granulocyte colony stimulating factor-containing preparation according to claim 12, which is maintained at 75% or more.
糖鎖を有する顆粒球コロニー刺激因子が、ＣＨＯ細胞によって遺伝子組換え法を用いて生産されるものである、請求項１記載の顆粒球コロニー刺激因子含有製剤。
2. The granulocyte colony stimulating factor-containing preparation according to claim 1, wherein the granulocyte colony stimulating factor having a sugar chain is produced by a CHO cell using a gene recombination method.