CS249221B1 - Mixture of croculoplasmin, transferrin and IgG 7 S immunoglobulins for intravenous, intraperitoneal and intrathecal - Google Patents

Abstract

The mixture of ceruloplasmin, transferrin and IgG 7 S immunoglobulins contains ceruloplasmin in an amount of 0.2 to 2.0 g/l, transferrin in an amount of 1.0 to 4.0 g/l, IgG 7 S immunoglobulin in an amount of 0.2 to 0.6 g/l, the above components being dissolved in an albumin solution with a concentration of 45 to 55 g/l. The human albumin solution is prepared by ethanol fractionation, subsequent lyophilization and dissolution in a solution of 0.02 mol. acetyl d,l tryptophan and a solution of 0.02 mol. sodium caprylate. The solution thus obtained is pasteurized for 10 hours at 60 °C, the pH is adjusted to a value of 6.4 to 7.4 and the obtained protein solution is sterilized by filtration and filled into 20, 50, 100 milliliters.

Description

(54) Mixture of ccruloplasmin, transferrin and IgG 7 S immunoglobulins for intravenous, intraperitoneal and intrathecal administration

2

The mixture of ceruloplasmin, transferrin and IgG 7 S immunoglobulins contains ceruloplasmin in an amount of 0.2 to 2.0 g / l, transferrin in an amount of 1.0 to 4.0 g / l, immunoglobulin IgG 7 S in an amount of 0.2 to 0, 6 g / l, said components being dissolved in a 45-55 g / l albumin solution. The human albumin solution is prepared by ethanol fractionation followed by lyophilization and dissolution in a 0.02 mol solution. acetyl d, 1 tryptophan and a solution of 0.02 mol. sodium caprylate.

The solution thus obtained is pasteurized at 60 ° C for 10 hours, the pH is adjusted to 6.4 to 7.4 and the protein solution obtained is sterilized by filtration and filled with 20, 50, 100 ml.

The invention relates to a process for the preparation of a mixture of ceruloplasmin, transferrin and immunoglobulin IgG 7 S intended for intravenous, intraperitoneal and intrathecal administration, wherein human albumin is added to the mixture of said proteins in order to reduce anticomplemtar activity.

Geruloplasmin has an important catalytic function in the oxidation of plasma iron and thus allows its binding to transferrin and talk promotes the bacteriostatostatic and, moreover, immonostimulatory functions of transferrin. (Wald, I., Moravski, K., Szatbol, W .: Chemical and Enzymatic Properties of Transferrin, Ceruloplasmin. Post. Hig. I Med. Dosw '. 13, 697, 1959, Samuel, I .: Relationships between Ceruloplaamine and Viral Immunology, Virology, 33 (1): 63-72, 1982, Letendre ED: Ceruloplasmin and regulation of transferrin iren during Neisseria meningitidis infection in mice. Infect. Immun. 45 (1), 133-138, 1984.)

The average ceruloplasmin content in blood plasma is 0.03 g per 100 ml.

The mixture of ceruloplasmin, transferrin and IgG 7 S immunoglobulin consists of ceruloplasmin in an amount of 0.2 to 2.0 g / l, transferrin in an amount of 1.0 to 4.0 g / l, of immunoglobulin IgG 7 S in an amount of 0.2 to 0 6 g / l, a 45-55 g / l albumin solution stabilized with 0.02 molar acetyl-d, 1-tryptophan solution and 0.02 molar sodium caprylate solution. The preparation is pasteurized, sterilized by filtration and filled with 20, 50 and 100 ml.

Execution example

Dissolve 0.02 g of ceruloplasmin, 0.4 g of transferrin and 0.5 g of immunoglobulin IgG 7 S for intravenous administration in 100 ml of a 5% w / w solution of 1'-human albumin, after adjusting the pH to 6,5 + 0, 1, the solution is homogenized and filtered through sterilizing pads and filled in 20, 50 and 100 ml.

Component concentrations are expressed in units commonly used in the art.

Claims (1)

SUBSTANCE A mixture of ceruloplasmin, transferrin and IgG 7 S immunoglobulin for intravenous, intraperitoneal and intrathecal administration, characterized in that it consists of ceruloplasmin in an amount of 0.2 to 2.0 g / l, transferrin in an amount of 1.0 to 4.0 g / l. 1, immunoglobulin DISCHARGE IgG 7 S in an amount of 0.2-0.6 g / L, said ingredients being dissolved in an albumin solution of 45-55 g / L which is stabilized with 0.02 moles. acetyl-d, 1-tryptophan and 0.02 mol. sodium caprylate solution.