ISSN 0234-5730

9 "770 23 4"573007

Hematology and Transfusiology

2'2010
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[13].

1. 3. . . .: . .
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18.04.08

. . , 2010
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THROMBIN GENERATION TEST AS AN INTEGRAL INDICATOR OF THE BLOOD CLOTTING SYSTEM
STATUS
Yu. A. Namestnikov
Russian Institute of Hematology and Transfusiology, St. Petersburg

Summary. This review presents data on the diagnostic value of thrombin generation test. The
test values characterize the velocity and intensity of formation of thrombin, the key hemostasis enzyme.
These data can be used for objective evaluation of hypo- or hypercoagulation status.
Key w o r d s : thrombin generation, endogenous thrombin potential, calibrated automated thrombogram

in vitro .
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thrombin, 12%. , , , .

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thrombin Lag time [16].
.

Peak thrombin.


, , in vivo
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in vitro
[1820].
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150%. [2325]
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35

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-
[26]. S. Tchaikovski . [21]
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[2830].
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. , L. Rugeri . [35] Peak thrombin Lag time
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,

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[47]. Lag time Peak thrombin .

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.

.

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57. . ., . ., . . .
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2009: 258-259.
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2008; 5(1): 314.
22.09.09

. . , 2010
615.45:547.962.4].012.6

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SOLVENT/DETERGENT METHOD FOR VIRUS INACTIVATION IN THE IMMUNOGLOBULIN PRODUCTION
TECHNOLOGY
N. V. Zubkova
"ImBio" Affiliated Department of Nizhny Novgorod Firm for Bacterial Preparation Manufacture, Microgen Firm for
Medical Immunobiological Preparations, Nizhny Novgorod

Summary. This review of literature presents the characteristics of various solvent/detergent (SD)
methods for the treatment of immunoglobulin preparations, including the use of tri-N-butylphosphate in
combination with a detergent - for example, sodium cholate, Twin-80 (polysorbate), Triton X-100 or X-45
(octoxynol). Technology of the removing of the mixtures is described. Permissible residual levels of the
reagents in ready dosage forms are substantiated. Stages of validation of the SD processing and methods for evaluating the virus reduction are presented. It is shown that the safety of SD processed preparations is provided by inactivation of enveloped viruses and by sparing the biological characteristics of
the preparations and activities of specific antibodies.
Key w o r d s : immunoglobulin preparations, solvent/detergent processing, chromatographic purification, virus reduction

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