Liquid immunoglobulin formulations
    5.
    发明授权
    Liquid immunoglobulin formulations 失效
    液体免疫球蛋白制剂

    公开(公告)号:US5871736A

    公开(公告)日:1999-02-16

    申请号:US813219

    申请日:1997-03-07

    摘要: Immunoglobulin preparations, particularly liquid preparations of immunogllin G for intravenous infusion, are stabilized against dimer formation by the addition of one or more amphiphilic stabilizers. Preferred amphiphilic stabilizers are nicotinic acid derivatives, particularly nicotinamide, and naturally-occurring .alpha.-amino acids having a lipophilic side chain, for example phenylalanine, proline, leucine and isoleucine.

    摘要翻译: 免疫球蛋白制剂,特别是用于静脉内输注的免疫球蛋白G的液体制剂,通过加入一种或多种两亲稳定剂来稳定,防止二聚体形成。 优选的两亲稳定剂是烟酸衍生物,特别是烟酰胺,以及具有亲脂侧链的天然存在的α-氨基酸,例如苯丙氨酸,脯氨酸,亮氨酸和异亮氨酸。

    Method of producing reconstituted lipoproteins
    6.
    发明授权
    Method of producing reconstituted lipoproteins 失效
    生产重构脂蛋白的方法

    公开(公告)号:US5652339A

    公开(公告)日:1997-07-29

    申请号:US361132

    申请日:1994-12-21

    CPC分类号: C07K14/775 A61K9/1275

    摘要: Reconstituted high density lipoproteins (rHDL) are produced from apolipoproteins and lipids in that an aqueous apolipoprotein solution with a concentration of 1-40 g protein/l is mixed with an aqueous lipid-detergent solution without mandatory addition of organic solvents, the molar ratio of lipid to detergent being 1:0.5 to 1:4 and the weight ratio of lipid to detergent being 1:1.5 to 1:5, the resultant apolipoprotein-lipid-detergent mixture then being incubated at a temperature in the range of the phase change temperature of the lipid in water .+-.10.degree. C., and the detergent being at least partially removed.The rHDL are useful for various prophylactic and therapeutic treatments of diseases that have a connection with lipids and lipidoidal substances. This method is especially suitable for technical and industrial production.

    摘要翻译: 重组的高密度脂蛋白(rHDL)由载脂蛋白和脂质产生,因为浓度为1-40g蛋白/ l的载脂蛋白溶液溶液与水性脂质 - 洗涤剂溶液混合,而不必强制加入有机溶剂,摩尔比 脂类与洗涤剂的比例为1:0.5至1:4,脂质与洗涤剂的重量比为1:1.5至1:5,然后将所得载脂蛋白脂质洗涤剂混合物在相变温度范围内的温度 的脂质在水中+/- 10℃,并且洗涤剂被至少部分去除。 rHDL可用于与脂质和脂质物质有关联的疾病的各种预防和治疗性治疗。 这种方法特别适用于技术和工业生产。

    Method of producing an anti-D immunoglobulin concentrate and a
pharmaceutical preparation
    7.
    发明授权
    Method of producing an anti-D immunoglobulin concentrate and a pharmaceutical preparation 失效
    制备抗D免疫球蛋白浓缩物和药物制剂的方法

    公开(公告)号:US5593675A

    公开(公告)日:1997-01-14

    申请号:US360334

    申请日:1994-12-21

    CPC分类号: C07K16/065 C07K16/34

    摘要: An anti-D immunoglobulin G-preparation is produced in high-yield from human plasma containing anti-D IgG, or a plasma fraction containing an anti-D IgG, in which (A) the plasma, or the plasma fraction, with a pH in the range of pH 3.5 to 6.5 and a conductivity value in the range of 2 to 4 mS/cm, is subjected to ion exchange chromatography with an adsorbent which has carboxymethyl groups as functional groups, the anti-D IgG being bound to the adsorbent, (B) the adsorbent with the bound anti-D IgG is first rinsed with a wash solution at a pH in the range of 5 to 8 and a conductivity value in the range of 2 to 4 mS/cm, and the anti-D IgG is subsequently eluted, and further (C) the eluted anti-D IgG at a pH in the range of 6 to 8 and a conductivity value in the range of 2 to 4 mS/cm is treated with an alkaline adsorbent with ion-exchange characteristics in order to bind undesired components, and finally, the anti-D IgG is concentrated. The non-infectious anti-D concentrate thus obtained possesses a high specific activity of more than 1% anti-D IgG per gram of total IgG.

    摘要翻译: 抗-D免疫球蛋白G制剂以含有抗-D IgG的人血浆的高产率或含有抗-DIgG的血浆级分产生,其中(A)血浆或血浆级分具有pH 在pH 3.5〜6.5的范围内,电导率值在2〜4mS / cm的范围内,用具有羧甲基作为官能团的吸附剂进行离子交换层析,抗D IgG与吸附剂结合 ,(B)具有结合的抗-D IgG的吸附剂首先用pH为5〜8,电导率值为2〜4mS / cm的洗涤溶液冲洗,反-D 随后洗脱IgG,并且进一步(C)在6至8范围内的pH值和2至4mS / cm 2范围内的电导率值下洗脱的抗-D IgG用离子交换的碱性吸附剂处理 特性以便结合不合需要的组分,最后浓缩抗D IgG。 由此获得的非感染性抗-D浓缩物具有高于每克总IgG超过1%抗-D IgG的比活性。