A method of producing human immunoglobulin against tick-borne encephalitis intravenous

 

(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 temperatures. Fractionation of plasma donors lead to the stage of obtaining a dry Deposit of immunoglobulin, which is dissolved in 2% glucose solution, add pepsin. After proteolysis removes the enzyme aluminum hydroxide, the pH of the solution was adjusted to 6.5 and 7.5, conduct sterilizing filtration and maturation of the drug for the formation of a precipitate unstable proteins. The precipitate is removed by centrifugation at 6000 rpm and after sterilizing filtration obtain the target product. Effect: receiving intravenous immunoglobulin against tick-borne encephalitis with low anticomplementary activity.

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

Raw material for producing the drug is selected according to the response inhibition of haemagglutination (rtga) plasma donors with a title encephalitis antibodies of at least 1:20. Plasma Calendarist human (HIV) and hepatitis C virus

The prototype of the invention is a method of producing human immunoglobulin against tick-borne encephalitis for intramuscular (FS 42-3155-95, the date of introduction is installed with 3.10.95 , the validity of 3.10.2000).

It is known that intramuscular human immune globulin has a number of disadvantages: in the muscle breaks down to 30% of the administered drug; in the treatment of severe forms of infection, it is impossible in the short term to achieve a high concentration of antibodies in the serum of the patient; the drug has a high anticomplementary activity that prevents injected intravenously.

The aim of the present invention is to obtain a human immunoglobulin against tick-borne encephalitis with low anticomplementary activity.

Combined pool of immune plasma fractionary ethanol by cold; crude residue of the immunoglobulin lyophilizer; dry powder dissolved in 2% glucose solution and treated with pepsin in an acid environment within 18 hours; remove the calcium hydroxide of aluminum; bring the pH to neutral values; conduct sterilizing filtration, the maturation of the drug for the formation of a precipitate unstable proteins that remove centrifuging plasma in the amount of 360 l obtained by the method of plasmapheresis donors having natural titer of antibodies to tick-borne encephalitis virus and detected by screening. In boiler load, the title encephalitis antibody was 1:20 according to RTG.

The allocation of specific immunoglobulin fraction was performed with the alcohol method at low temperatures. Received 6650 g wet sediment fraction II. The weight after drying was 2300, To receive intravenous drug 500 g of dry cake mix immunoglobulin dissolved in 2% glucose solution, bring the pH to 3.9 - 4.1 and add pepsin activity of at least 2000 IU of 25 - 50 mg per 100 g of protein. After 18 hours of proteolysis at a temperature of +37oC remove the calcium hydroxide of aluminum, bring the pH to 6.5 and 7.5, spend bleaching and sterilizing filtration and maturation of the drug for 1 - 3 months at a temperature of (6 4)oC for the formation of a precipitate colloidal-volatile components. In order to accelerate sedimentation drug thermostatic within 24 hours. The precipitate is removed by centrifugation at 6000 rpm for 40 min, hold sterilizing filter, get a 3.5 l of the finished product with a title encephalitis antibody 1:40 and above in rtga. Intravenous immunoglobulin spill the AI Hematology and blood transfusion received 8 episodes of the drug.

The human immunoglobulin against tick-borne encephalitis for intravenous injection is a colorless, transparent or slightly opalescense liquid.

Fraction of immunoglobulins is not less than 100% of the total protein.

The protein content is about 5%.

Fractional composition: immunoelectrophoresis reveals intense arc precipitation of IgG and not more than one additional arc.

Molecular parameters: monomers on average 77% of the dimers is not more than 7%, fragments not more than 16%.

Specific activity: the titer of antibodies to tick-borne encephalitis virus was 1:40 and above according to RTG.

Compared with the prototype of the product has a low anticomplementary activity: two 50% hemolytic unit of complement (2CH50retain activity in the presence of at least 10 mg of protein.

The human immunoglobulin against tick-borne encephalitis intravenous sterile, apyrogenic, non-toxic, tested in the absence of HBsAg and antibodies to HIV.

The purpose of the drug treatment of patients with viral encephalitis.

Currently, the human immunoglobulin against tick encephal is, , Yekaterinburg, Kirov.

Thus, the resulting new drug for the treatment of patients with viral encephalitis, with significant differences from the prototype and found application in health care.

A method of producing human immunoglobulin against tick-borne encephalitis for intravenous injection, comprising low-temperature ethanol fractionation of plasma donors containing antibodies to tick-borne encephalitis virus titer of at least 1 : 10 according to RTCA, characterized in that the dry residue of the immunoglobulin dissolved in 2% glucose solution, treated with pepsin in acid medium for 18 h, remove excess pepsin hydroxide of aluminum, bring the pH to 6.5 and 7.5, sterile filtration, hold the maturation of the drug at the temperature of (6 4)oC for 1 - 3 months for the formation of a precipitate unstable proteins, and to accelerate sedimentation immunoglobulin thermostatic within 24 h, remove the precipitate by centrifugation at 6000 rpm and after sterilizing filtration obtain the target product with the titer of antibodies to tick-borne encephalitis virus not less than 1 : 40.

 

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