UA45557U - Method for producing specific human immunoglobulin against hepatitis c virus (hcv) - Google Patents

Abstract

A method for producing the specific human immunoglobulin against hepatitis C virus relates to medicine and can be used for producing the specific human immunoglobulin from donor blood plasma or the precipitate of fraction II-III representing the waste product after protein isolation. Such a procedure can be integrated into the whole cycle of processing donor blood plasma.

Description

( (51) IPC (2009)

S AbIK 39/395

Mo

MINISTRY OF EDUCATION issued by

AND SCIENCES OF UKRAINE (F) P I S responsibility

REGIONAL DEPARTMENT of patent ownership and INTELLECTUAL to PATENT

UTILITY MODEL PROPERTIES

Y. nn (54) METHOD OF OBTAINING SPECIFIC HUMAN IMMUNOGLOBULIN AGAINST THE HEPATITIS C VIRUS (HCV) 1 2 (21) и200907110 hepatitis C, by the modified alcohol method (22) 07/08/2009 Horses with sufficient titers of specific antibodies to (24) 11/10/2009 hepatitis C virus, followed by concentration, (46) 10.11.2009, Byul.Mo 21, 2009 filtration and illumination, which differs (72) TIMCHENKO ANATOLIY SERGIYOVYCH, KOR- that the final solution of immunoglobulin containing

NIENKO VASYL IVANOVYCH, BABAK KOSTYANTYN titer 8.0-12.0 95 protein and titers of specific antibodies

ANATOLYYOVYCH from 1:128 to 1:562, refined on deep (73) TYMCHENKO ANATOLYY SERGHYYOVYCH, correlating filters and additionally carried out

NIENKO VASIL IVANOVYCH, BABAK KOSTYANTYN synactivation of immunoglobulin solvent

ANATOLIYOVYCH by the detergent method with subsequent removal (57) The method of obtaining specific immunoglobulin in the free volume of solvent and detergent solutions against the hepatitis C virus (HCV) by means of ethanoate, in the presence of glycine (1-2 9o) as a stabilizer of fish fractionation donor plasma of specific immunoglobulin molecules. or sediment fraction of IP from donors who were ill with

A useful model belongs to the field of meditite C (NS). tsin and can be used to obtain The closest to the declared technical solution - specific immunoglobulin from the blood plasma of the donor is the method of obtaining allogeneic immunoglobulins from pits or sediment of fractions 1I-II, i.e. production waste - against several viral infections (cytomegalovirus of proteins in a single cycles of industrial pertussis, rubella, hepatitis A and B, herpes) by reprocessing donor blood plasma. Obtained by ethanol fractionation of donor blood plasma - specific immunoglobulin can be used according to Kohn's method, followed by lyophilic drying for the prevention and treatment of viral disease and obtaining standard protein solutions caused by the hepatitis C virus in children and preparations for intramuscular injections (De- and adults. declaration patent of Ukraine Mob7984 A from the East)

Known methods of obtaining specific immuno- 15.07.2004... IF) globulins against tetanus, Rhesus factor, which are based on by heteroantigens, followed by blood-specific human immunoglobulin from plasma 2 boron of blood plasma and its alcohol fractionation of blood from non-immunized donors who were ill by the Kohn method to obtain virus-specific hepatitis C (HCV), with titers of non-immunoglobulin antibodies. less than 1:128 - 1:562 (50-100 IU/ml), in the final

The disadvantages of these methods are that the solutions should not contain antibiotics. "long-term immunization of animals or Specific immunoglobulin obtained from plasma donors, which often affects the immune status of the blood of donors or the precipitate of the alcohol fraction of the body of blood plasma donors, sensitizes them, by the Kohn method, which is enriched with antibodies in leads to allergic diseases and significantly against hepatitis C virus (INSU) with antibody titers that increases the cost of specific immunoglobulins against hepatitis C virus in 1 ml of the drug does not change 100 IU/ml).

Mo11155A1. cific immunoglobulin is filtered, clarified,

Known methods of obtaining immunoglobulins are concentrated, virus inactivation is carried out with salt-directed action against hepatitis A (authenticated by the vent-detergent method with the subsequent release of

Me1128913, USSR), antidiphtheria (solvent and detergent patent, and then the final

of Ukraine Mo22426b A), against viral infections (Pa solution of immunoglobulins with a protein concentration of 8-12 tent of Ukraine Mob7984А), with the exception of the hepatitis virus, is further purified on deep sterilizing filters

Claims (1)

from dimers and polymers. are used for antivirus processing with each Stage 1. Plasma or sediment of fraction III immediately at the chromatography stage, come out in free volume and are discarded after collection in order to reduce the risk of transmission, with subsequent washing of the colon AIDS, hepatitis and other viral infections with the same buffer with pH 7, 5, it is possible to obtain Antiviral treatment by adding tributyl A. phosphate and detergent - Triton X-100, or Tween - Stage 4. The final solution of immunoglobulin 80 is brought to a concentration of 0.3595 and 0.295, respectively, and extracted to a protein concentration of 8 -1295, cleaned and kept for 30 min. with a constant change of deep sterilizing filters from dimers by washing at a temperature of 4 "С. For accumulation and polymers, which makes the drug more qualitative and in the material, the plasma is frozen in refrigerators under the conditions of a sterile box and poured into ampoules. and matured for 3-6 months at a temperature - Information sources 2076. 1. Nikitin I.K. Quarantine - add- Stage 2. To obtain protein components, the ultimate guarantee of viral safety of plasma and plasma is thawed at Е 4 "C, centrifuged ee preparations / I.K. Nikitin, T.V. Golosova at a speed of 3000 rpm. at the same temperature and /Bulletin of services! blood of Russia - 2002. - Mo1. - S. is applied to a column with DEAE-sepharose EE. At 10. this, immunoglobulins are obtained in the free volume 2. Vydyborets S.V. New trends in the industry and detergents. blood plasma preparations in Ukraine and the "world Stage 3. Obtaining immunoglobulins of class 0. / Vydyborets S.V. //New in hematology and transfusion The fraction that appeared on the column from DEAE-siology. - 2007. - Issue 6. - C 69-84. with RE sepharose in free volume, rich in immunoglo- 3. Patent of the USSR dated 09.01.87. The method is obtained by bulins, adjusted to pH 7.0 with a solution of IM MoOH, and the antirabies immunoglobulin Me153 is applied to a column with CM-sepharose EE. At 6978 A1. by pumping a solution of sodium chloride and glycine with 4. Patent of Ukraine Moe311/07-300200000 from pH 9.0, a class 0 immunoglobulin fraction is obtained, 21.08.2007. Human immunoglobulin against the virus, i.e. specific human immunoglobulin against Epstein-Barr, liquid. hepatitis C virus (HCV). Detergents that use Computer layout L. Lytvynenko Signed Circulation 28 approx. Ministry of Education and Science of Ukraine State Department of Intellectual Property, str. Urytskogo, 45, m. Kyiv, MSP, 03680, Ukraine SE "Ukrainian Institute of Industrial Property", str. Glazunova, 1, m. Kyiv - 42, 01601