Estimation of efficiency of solvent-detergent method for virus inactivation in the technology of immunoglobulin production on the model of duck hepatitis B virus.

The virucidal action of solvent tributyl phosphate and detergent sodium cholate used in the production of immunoglobulin for inactivation of viruses with lipid envelope was studied on the model of duck hepatitis B virus. PCR analysis revealed no significant decrease in duck hepatitis B virus DNA concentrations after treatment with solvent/detergent. At the same time, in vivo experiments showed that treatment of duck hepatitis B virus with tributyl phosphate (concentration >0.15%) and sodium cholate (concentration >0.1%) at 37°C for 6 h or longer completely inactivated this model virus added to immunoglobulin solution in concentration 5 log ID50. Duck hepatitis B virus appears to be one of the most acceptable model viruses for validation of virus inactivating technologies in manufacturing human plasma preparations.

[Neutralization of hepatitis B virus surface antigen with immunoglobulin preparations].

The in vitro experiments with immunoglobulin and blood plasma containing hepatitis B virus (HBV) markers, revealed that the control of immunoglobulin preparations for the presence of hepatitis B virus surface antigen (HBsAg), mandatory for Russia, was not sufficiently informative. The neutralization of HBsAg with specific antibodies to the level, not determined by the EIA method, reached not less than 24 ng/ ml in 2 hours of incubation and not less than 49 ng/ml in 24 hours of incubation, which, when evaluated in 1 lU of anti-HBs, was 34.6 +/- 0.9 ng and 70.7 +/- 1.8 ng of HBsAg respectively. The process of the formation of immune complexes depended mainly on the time of incubation of experimental samples and on the antibody--antigen proportion in the system. The neutralization of viruses by antibodies had no influence on the capacity of the polymerase chain reaction to detect HBV DNA.

[Dynamics of oxidase activity in blood plasma upon intravenous and intramuscular administration of ceruloplasmin]. / Dinamika izmeneniia oksidaznoi aktivnosti plazmy pri razlichnikh sposobakh vvedeniia preparata Tseruplazmin.

Oxidase activity dynamics in the blood plasma of test animals was studied upon intravenous and intramuscular injections of ceruloplasmin. It was found that the enzymatic activity does not reflect the content of drug in the blood plasma and is not always correlated with the amount of exogenously introduced drug. Intramuscular injections can also be used for the administration of ceruloplasmin.

[Antioxidant and antihypoxic effects of the ceruloplasmin preparation in the hypobaric hypoxia model]. / Izuchenie antioksidantnogo i antigipoksicheskogo deistviia preparata tseruloplazmin na modeli gipobaricheskoi gipoksii.

The antioxidant and antihypoxant effects of the drug ceruloplasmin were studied on an experimental model of hypobaric hypoxia in rats. Two forms of the drug characterized by low and high enzymatic activity were administered (intramuscularly or intraperitoneally) 20 min or 1 day before hypobaric hypoxia test. The drug effect was independent of the enzymatic activity level. The maximum activity of ceruloplasmin was observed when the drug was administered one day before test. Analyses showed that the drug activated superoxide dismutase, while not changing the catalase activity.

[Treatment of idiopathic thrombocytopenic purpura in adults: efficacy of domestic intravenous immunoglobulin in immune thrombocytopenia]. / Lechenie idiopaticheskoi trombotsitopenicheskoi purpury u vzroslykh: éffektivnost' otechestvennogo immunoglobulina dlia vnutrivennogo vvedeniia pri immunnykh trombotsitopeniiakh.

AIM: The study of effectiveness of intravenous immunoglobulin (IVIG) in therapy of idiopathic thrombocytopenic purpura (ITP) in adults. MATERIALS AND METHODS: High doses of IVIG (0.2-0.4 g/kg b.w. for 4-6 days) were given to 6 female patients aged 20 to 59 years (median--39 years) with immune thrombocytopenia. 4 patients had primary ITP resistant to glucocorticosteroids (GCS) and 1 female had chronic ITP treated by splenectomy without effect. 1 patient with rheumatoid arthritis developed severe thrombocytopenia combined with agranulocytosis when treated with nonsteroid antiinflammatory drugs. RESULTS: The response was observed in 5 of 6 patients (in 4 patients resistant to GCS and 1 RA patient). In 3 of them the effect was rated as excellent (platelets level > 150,000 per cubic millimeter), in 2 patients it was good (platelets count from 50,000 to 150,000 per cubic millimeter). Splenectomy was performed in 4 cases with ITP on day 8-14 after IVIG therapy. The 2- and 6-month follow-up evidenced for good results of the surgical treatment. The RA patient showed a stable rise of the blood count. Serious side effects of IVIG therapy were not registered. CONCLUSION: IVIG of Russian produce is effective in the treatment of drug-induced thrombocytopenia and ITP resistant to GCS.

[Removal of biologically active admixtures from immunoglobulin preparations]. / Udalenie biologicheski aktivnykh primesei iz preparatov immunoglobulinov.

Inclusion of an additional treatment of the products obtained at centrifugation stages b1 and b13 with activated bentonite and aluminium hydroxide into the alcohol method for the production of immunoglobulin from placental and abortion blood permits obtaining preparations with lowered content of proteolytic enzymes and thermostable acid phosphatase, free from chorionic gonadotropin and blood pigment. The treatment of the final preparation with DEAE cellulose removes blood group antigens from immunoglobulins. The preparations obtained by this method have been shown to meet the requirements for immunoglobulins imposed by technological specifications.