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    • 2. 发明授权
    • Method of producing a virus safe, storage-stable, and intravenously
tolerable immunoglobulin-G preparation
    • 产生病毒安全,储存稳定和静脉内可耐受的免疫球蛋白-G制剂的方法
    • US4877866A
    • 1989-10-31
    • US122092
    • 1987-11-18
    • Dieter RudnickNorbert KotheHerbert DichtelmullerDetlef PiechaczekWolfgang StephanHans Schleussner
    • Dieter RudnickNorbert KotheHerbert DichtelmullerDetlef PiechaczekWolfgang StephanHans Schleussner
    • A61K39/395A61K38/00A61L2/00C07K16/06
    • A61L2/0088C07K16/065A61K38/00
    • A method of producing a virus-safe, storage-stable, and intravenously tolerable immunoglobulin-G preparation. The object is to make the method appropriate for industrial-scale production and economical by means of the enrichment and multistage purification of a plasma that has had the coagulation factors removed from it or of a plasma fraction or serum fraction that contains immunoglobulin G accompanied by treatment with ion exchangers and by ultrafiltration. The precipitant is eliminated, by means of diafiltration or gelfiltration, either from the plasma that has had the coagulation factors removed from it or from the plasma fraction that contains the immunoglobulin G, and the desired ion composition is established. The resulting protein solution is subjected to fractionation over an ion exchanger to separate the immunoglobulin G. The proteolytic enzymes in the resulting immunoglobulin-G solution are removed by means of affinity chromatography over a dye linked sorbent and/or are ihibited by the addition of antithrombin III. The accordingly stabilized immunoglobulin-G solution is treated, at a protein concentration of 20 to 60 g/l and a pH 6.0 to 8.0, with 0.03 to 0.07% of .beta.-propiolactone, diluted to a protein concentration of 5 to 20 g/l and subjected to ultraviolet radiation. The accordingly sterilized dilute immunoglobulin-G solution is again diafiltered or gelfiltered to remove lower molecular-weight substances. The accordingly stabilized and sterilized solution is adjusted to the desired protein content of 2 to 16% and filtered sterile.
    • 一种产生病毒安全,储存稳定和静脉内可耐受的免疫球蛋白-G制剂的方法。 目的是使该方法适用于工业规模生产和经济性,这是通过从其中除去凝血因子的血浆的浓缩和多级纯化或含有伴随治疗的免疫球蛋白G的血浆级分或血清级分 用离子交换剂和超滤。 通过渗滤或凝胶过滤,从已经从其中除去凝血因子的血浆或来自含有免疫球蛋白G的血浆级分除去沉淀剂,并建立所需的离子组成。 将得到的蛋白质溶液通过离子交换剂进行分离,以分离免疫球蛋白G.通过在染料连接的吸附剂上的亲和层析除去得到的免疫球蛋白-G溶液中的蛋白水解酶和/或通过加入抗凝血酶 三, 将相应稳定的免疫球蛋白-G溶液以20至60g / l的蛋白质浓度和6.0至8.0的pH 6.0至8.0处理,稀释至5至20g / l的蛋白质浓度 并进行紫外线照射。 将相应灭菌的稀释的免疫球蛋白-G溶液再次进行渗滤或净化,以除去较低分子量的物质。 将相应稳定的和灭菌的溶液调节至2至16%的所需蛋白质含量并过滤灭菌。
    • 7. 发明授权
    • Microfiltration device for the filtration of coagula and microaggregates
from blood
    • 用于从血液过滤凝血酶和微团聚体的微过滤装置
    • US4450078A
    • 1984-05-22
    • US427234
    • 1982-09-29
    • Wolfram H. WalkerKarl H. GanshirtHans Schleussner
    • Wolfram H. WalkerKarl H. GanshirtHans Schleussner
    • A61K35/14A61M1/22A61M5/165B01D25/04B01D39/16
    • A61M5/165
    • A microfiltration device for the filtration of coagula and microaggregates from blood and blood components. The device contains a filter chamber with attaching nozzle, a filter cone containing truncoconical filter elements arranged in cascade with diminishing pore size and diminishing surface area, a drip chamber and a tailpiece. The filter chamber and filter cones have different tapers and are at a specific distance apart, the taper of the filter cone from inlet to outlet being greater than the taper of the filter chamber. The filter cone has up to four filter elements, and a spacer which extends into the filter element of smallest pore size and surface area and supports same. Each of the filter elements has at least two opposed ribs running from the base to the apex of the truncated cone. The spacer is constructed such that it serves simultaneously for the support of the ribs and for the support of the filter fabric of the smallest filter element. The device has a capacity of less than 100 ml. It is intended for use in transfusions of preserved blood or blood components, especially massive transfusions.
    • 用于从血液和血液成分过滤凝结物和微团聚体的微量过滤装置。 该装置包括具有连接喷嘴的过滤室,包含与孔径减小和表面积减小成一列排列的截面过滤元件的过滤器锥体,滴注室和尾件。 过滤室和过滤器锥体具有不同的锥度并且在特定的距离处,过滤器锥体从入口到出口的锥度大于过滤室的锥度。 过滤锥体具有多达四个过滤元件,以及间隔物,其延伸到具有最小孔径和表面积的过滤元件中并且支撑相同的。 每个过滤元件具有至少两个相对的肋,从基部到截锥的顶点延伸。 间隔件被构造成使得其同时用于肋的支撑和用于支撑最小过滤元件的过滤织物。 该装置的容量小于100毫升。 它用于输血保存的血液或血液成分,特别是大量输血。
    • 8. 发明授权
    • Nutrient medium carrier system
    • 营养培养基载体系统
    • US4396717A
    • 1983-08-02
    • US285647
    • 1981-07-21
    • Reinhard FiebigHans Schleussner
    • Reinhard FiebigHans Schleussner
    • C12M1/22C12M1/20C12M1/32C12M3/00C12M1/18
    • C12M23/04C12M23/20C12M23/34C12M23/38C12M23/46C12M37/04
    • A nutrient medium carrier system comprising a sterilizable plastic nutrient medium carrier, a sterilizable plastic cover, and a sealing foil, the nutrient medium carrier having a depression to receive the nutrient medium, a surrounding beaded edge above the surface of the nutrient medium, a handle on one end, and a flat edge running around both sides and the other end, the depression being subdivided into compartments by means of ridges; the cover having a depression and a surrounding flat edge to receive the sealing foil, the cover depression gradually widening on two sides and one end to a flat edge up to the dimensions of the nutrient medium carrier, the narrow part being of such size that both side walls and one end touch the beaded edge on two sides and on the end opposite the handle, the cover having a steplike offset with locking flanges on its upper edge to hold the nutrient medium carrier, the flat edge of the carrier contacting the steplike offset of the cover, the cover on the side on which the handle of the nutrient medium carrier comes to lie being rounded off or slanted and provided with a hollow for gripping and pulling out the nutrient medium carrier from the cover.
    • 一种营养培养基载体系统,包括可灭菌的塑料营养培养基载体,可灭菌塑料盖和密封箔,所述营养培养基载体具有接收营养培养基的凹陷,营养培养基表面上方的周围串珠边缘,手柄 在一端和平坦的边缘两边和另一端延伸,凹陷通过脊细分成隔间; 所述盖具有凹陷和围绕的平坦边缘以接收所述密封箔,所述盖凹陷在两侧逐渐变宽,并且一端到达平直边缘直至所述营养介质载体的尺寸,所述窄部具有如下尺寸: 侧壁和一端接触两侧的珠状边缘和与手柄相对的端部,盖具有阶梯状偏移,在其上边缘具有锁定凸缘以保持营养介质载体,载体的平坦边缘接触步进偏移 盖的营养介质载体的手柄侧面上的盖被倒圆或倾斜,并且设置有用于从盖上夹持和拉出营养介质载体的中空部。