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    • 9. 发明授权
    • Implants containing bioactive peptides
    • 植入物含有生物活性肽
    • US6159490A
    • 2000-12-12
    • US543707
    • 2000-04-05
    • Romano Deghenghi
    • Romano Deghenghi
    • A61K9/00A61K9/20A61K38/00A61K47/34A61F2/02B01J13/02B01J13/04A61F9/50
    • A61K9/0024A61K9/204A61K9/2095
    • A pharmaceutical implant for the delivery of an effective amount of a bioactive peptide or peptide analog over a period of 1 to 12 months. This implant has a diameter of about 1 to 2 mm, a length of between about 10 and 25 mm and is obtainable from a process which includes the steps of grinding a copolymer of lactic acid and glycolic acid having a ratio of glycolide to lactide units of from about 0 to 5:1 to a particle size of between about 50 and 150 .mu.m; sterilizing the ground copolymer with a dose of between about 1 and 2.5 Mrads of ionizing .gamma.-radiation; wetting the ground and sterilized copolymer with a sterile aqueous slurry of a bioactive peptide or peptide analog; aseptically blending the copolymer and the slurry to obtain a homogeneous mixture of the copolymer and between about 10 and 50% of the bioactive peptide or peptide analog; drying the mixture at reduced pressure and at temperature not exceeding 25.degree. C.; aseptically extruding the dried mixture at a temperature between about 70 and 110.degree. C.; and aseptically cutting a cylindrical rod from the extruded mixture to form the pharmaceutical implant.
    • 用于在1至12个月的时间内递送有效量的生物活性肽或肽类似物的药物植入物。 该植入物的直径为约1-2mm,长度在约10-25mm之间,可通过以下步骤获得,该方法包括以下步骤:将具有乙交酯与丙交酯单元的比例的乳酸和乙醇酸的共聚物 约0至5:1至约50至150μm的粒度; 以约1至2.5Mrad的电离γ辐射剂量灭菌研磨共聚物; 用生物活性肽或肽类似物的无菌水性浆液润湿研磨和灭菌的共聚物; 无菌混合共聚物和浆料以获得共聚物的均匀混合物和约10至50%的生物活性肽或肽类似物; 在减压和不超过25℃的温度下干燥混合物。 在约70至110℃的温度下无菌挤出干燥的混合物; 并从挤出的混合物无菌切割圆柱形杆以形成药物植入物。
    • 10. 发明授权
    • Process to manufacture implants containing bioactive peptides
    • 制造含有生物活性肽的植入物的方法
    • US6077523A
    • 2000-06-20
    • US311744
    • 1999-05-14
    • Romano Deghenghi
    • Romano Deghenghi
    • A61K9/00A61K9/20A61K38/00A61K47/34A61F2/02A61K9/50B01J13/02
    • A61K9/0024A61K9/204A61K9/2095
    • A pharmaceutical implant for the delivery of an effective amount of a bioactive peptide or peptide analog over a period of 1 to 12 months. This implant has a diameter of about 1 to 2 mm, a length of between about 10 and 25 mm and is obtainable from a process which includes the steps of grinding a copolymer of lactic acid and glycolic acid having a ratio of glycolide to lactide units of from about 0 to 5:1 to a particle size of between about 50 and 150 .mu.m; sterilizing the ground copolymer with a dose of between about 1 and 2.5 Mrads of ionizing .gamma.-radiation; wetting the ground and sterilized copolymer with a sterile aqueous slurry of a bioactive peptide or peptide analog; aseptically blending the copolymer and the slurry to obtain a homogeneous mixture of the copolymer and between about 10 and 50% of the bioactive peptide or peptide analog; drying the mixture at reduced pressure and at temperature not exceeding 25.degree. C.; aseptically extruding the dried mixture at a temperature between about 70 and 110.degree. C.; and aseptically cutting a cylindrical rod from the extruded mixture to form the pharmaceutical implant.
    • 用于在1至12个月的时间内递送有效量的生物活性肽或肽类似物的药物植入物。 该植入物的直径为约1-2mm,长度在约10-25mm之间,可通过以下步骤获得,该方法包括以下步骤:将具有乙交酯与丙交酯单元的比例的乳酸和乙醇酸的共聚物 约0至5:1至约50至150μm的粒度; 以约1至2.5Mrad的电离γ辐射剂量灭菌研磨共聚物; 用生物活性肽或肽类似物的无菌水性浆液润湿研磨和灭菌的共聚物; 无菌混合共聚物和浆料以获得共聚物的均匀混合物和约10至50%的生物活性肽或肽类似物; 在减压和不超过25℃的温度下干燥混合物。 在约70至110℃的温度下无菌挤出干燥的混合物; 并从挤出的混合物无菌切割圆柱形杆以形成药物植入物。