A method of producing human immunoglobulin for intravenous antistaphylococcal introduction

 

(57) Abstract:

The invention relates to the production of specific immunoglobulins for intravenous administration. The method consists in the fact that the allocation of specific immunoglobulin fraction conduct alcohol method at low temperature fractionation lead to the stage of obtaining a dry powder of immunoglobulin. The dry residue of the drug dissolved in 2% glucose solution, spend the acid-enzyme hydrolysis, remove excess pepsin hydroxide of aluminum, the pH of the solution was adjusted to 6.5-7.0, hold the bleaching and sterilizing filtration and the product stand for the formation of a precipitate unstable proteins. Remove the precipitate by centrifugation and after bleaching and sterilizing filtration obtain the target product. Technical result: get antistaphylococcal immunoglobulin human intravenous low anticomplementary activity.

The invention relates to the production of specific immunoglobulins for intravenous administration.

Immune plasma containing antibodies to the staphylococcal exotoxin, prepare by the method of plasmapheresis donors with natural based on the absence of the surface antigen of hepatitis B virus (HB Ag) and antibodies to human immunodeficiency virus, as well as for hepatitis C. the Content of antialdosterone plasma donors must be at least a 4.5+0.5 IU/ml

The prototype of the invention is a method of obtaining antistaphylococcal immunoglobulin human liquid for intramuscular injection (FS 42-3158-95, the date of introduction is installed with 3.10.85 year, valid up to 31.12.2000,).

It is known that the antistaphylococcal immunoglobulin human liquid for intramuscular injection has a number of disadvantages, namely: in the muscle breaks down to 30% of the injected drug, you cannot reach therapeutic doses it has a high anticomplementary activity that prevents injected intravenously.

The aim of the present invention to provide immunoglobulin antistaphylococcal person for intravenous low anticomplementary activity.

Immune plasma donors fractionary ethanol at a temperature below 0oC (method Kona), raw sludge immunoglobulin lyophilizer, dry powder dissolved in 2% glucose solution, treated with pepsin in an acid environment within 18 hours, neutralize the calcium hydroxide of aluminum, bring the pH to 6.5 and 7.5, conduct sterilizaton, moreover, to accelerate the sedimentation of the drug is heated at a temperature of +37oC for 24 hours, remove the precipitate by centrifugation at 6000 rpm and after bleaching and sterilizing filtration obtain the target product.

Example. Immune plasma containing antibodies to the staphylococcal exotoxin, number 84 l obtained by the method of plasmapheresis donors who have natural antibodies and specifically vaccinated staphylococcal toxoid. In boiler load content antialfastafilolizina amounted to 4.5 IU/ml

The allocation of specific immunoglobulin fraction conduct alcohol by the method of Cohn at low temperatures. Fractionation lead to the stage of a dry powder.

426 g (21 vials) dissolved in 2% p-d-glucose, pH of the solution was adjusted to 3.9-4.1 and add pepsin activity is not less than 2000 units of quantity 25-50 ml per 100 g of protein in a 1 hour mix. After 18 hours of proteolysis at a temperature of +37oC neutralize excess pepsin hydroxide of aluminum, pH R-RA was adjusted to 6.5 and 7.5, conduct otetsudai and sterilizing filtration and maturation of the drug for 1-3 months at a temperature of +4 - +6oC for the formation of a precipitate unstable proteins. For the removed by centrifugation at 6000 rpm for 40 minutes Sterilize the solution by filtration, receive 3.5 l of the finished product with the title of antialdosterone 2 IU/ml, which is bottled in bottles of 50 ml and 25 ml of the target product.

Thus there was obtained 25 series immunoglobulin in the laboratory preparation of blood Kirov research Institute of Hematology and blood transfusion.

The antistaphylococcal immunoglobulin human for intravenous injection is a colorless liquid, transparent and slightly opalescense.

The immunoglobulin fraction is not less than 100% of the total protein.

The protein content of about 5%.

Fractional composition: immunoelectrophoresis should be identified intensive arc precipitation of IgG and not more than one additional arc.

Molecular parameters: monomers on average 80% of the dimers are not more than 4%, fragments not more than 16%.

Specific activity: the content of antialdosterone is 1 ml not less than 20 IU dose of less than 500 IU.

Compared with the prototype of the product has a low anticomplementary activity; in the presence of at least 10 mg of protein immunoglobulin 2 units CH50(complement) must retain the hemolytic activity.

The purpose of the drug - disease treatment of staphylococcal etiology, accompanied by bacteremia and septic condition.

State clinical trials, approved the Temporary pharmacopoeial article, written laboratory regulations, adopted the guidelines on the clinical use of antistaphylococcal immunoglobulin human for intravenous administration.

Thus, the resulting new drug for the treatment of diseases staphylococcal etiology, with significant differences from the prototype and found application in health care.

The method of producing antistaphylococcal immunoglobulin for intravenous administration, comprising an alcohol fractionation of plasma donors with content antialdosterone in boiler load is not less than 4 IU/ml and wherein the dry residue of the immunoglobulin dissolved in 2% glucose solution, spend the acid-enzyme hydrolysis of a solution of immune globulin for 18 h followed by removal of the enzyme by gel aluminium hydroxide to bring the pH to 6.5 and 7.5, stand for 1 - 3 months for sediment unstable components, centrifuged at which not less than 20 IU/ml

 

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FIELD: medicine, surgery, urology.

SUBSTANCE: one should apply bactisporin probiotic preparation introduced per os at 1-10 x 109 microbial cells twice or thrice for 10-20 d in combination with staphylo-proteic-pyocyanic adsorbed (SPPA) vaccine; moreover, the mentioned combination of preparation should be applied, also, for instillation of wounds, serous cavities, cavities of urinary and biliary ducts at the quantity of 1-5 x 109 microbial cells in isotonic sodium chloride solution. The present innovation provides better humoral and cellular immunity to already developed infectious process, moreover, combined application of SPPA vaccine and bactisporin leads to increased body immune response to antigens of associated vaccine at the background of secondary immunodeficient state induced by infectious process.

EFFECT: higher efficiency of therapy.

1 cl, 5 ex, 3 tbl

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