Method for inactivating virus in source plasma of blood product

A blood product and virus inactivation technology, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and medical raw materials derived from mammals, etc., can solve the problems that the absolute safety of raw materials cannot be completely guaranteed, and achieve Quick and effective removal, easy to use, and the effect of reducing the chance of secondary pollution

Active Publication Date: 2015-02-25
TONROL BIOLOGICAL PHARM CO LTD
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  • Summary
  • Abstract
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  • Claims
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Problems solved by technology

However, human beings are unknown to many viruses and are the first in detection methods, coupled with the limitations of the virus detection method itself, so the absolute safety of raw materials cannot be fully guaranteed

Method used

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  • Method for inactivating virus in source plasma of blood product
  • Method for inactivating virus in source plasma of blood product
  • Method for inactivating virus in source plasma of blood product

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Multiple pooled human plasma was treated with virus using organic solvent and detergent mixture.

[0030] (1) plasma melting

[0031] Received 1,668 servings of plasma (net weight: 1,002.34 kg) from the cold storage that complied with the provisions of "human plasma for blood product production" in the third part of the "Chinese Pharmacopoeia" 2010 edition, and passed the re-inspection and met the quarantine period. The plasma was melted in a D-level clean area within. Use natural melting method or water bath melting method. The water temperature of the water bath melting method should be controlled below 37°C.

[0032] (2) Plasma pooling

[0033] The plasma is merged, and the plasma is merged in a D-level clean area. Before the merger, the plasma bag should be disinfected, that is, soaked in 75% alcohol for more than three minutes, and the outer alcohol of the plasma bag can be wiped with clean gauze before merging. When merging plasma, attention should be paid to ...

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Abstract

The invention discloses a method for inactivating virus in source plasma of a blood product. The method disclosed by the invention comprises the following steps: (1), mixing plasma; (2), stirring by adding a CaCl2 liquid, filtering and clarifying by using a filter element, thus obtaining a filtered liquid; (3), adding a mixed liquid of tween-80 and Tri-n-butyl phosphate (TNBP) so that the final volume percentages of tween-80 and TNBP are (1+/-0.3)% and (0.3+/-0.1)% respectively, keeping the temperature of reaction liquid at 24+/-2 DEG C, and keeping the constant temperature for 4-6 h; (4), adding vegetable oil so that the final volume percentage of vegetable oil is (5+/-2)%, and reducing the temperature of the reaction liquid to 16+/-2 DEG C; (5), stirring and standing; and (6), extracting, and eliminating an oil phase, thus obtaining a liquid phase. By means of the method disclosed by the invention, the safety of the source plasma is greatly increased; and the secondary pollution rate is reduced.

Description

technical field [0001] The invention relates to a method for virus inactivation treatment, in particular to a method for virus inactivation treatment of raw material plasma of blood products. Background technique [0002] Blood products are an emerging biopharmaceutical industry. Its starting material is single, and it is made by mixing the plasma of multiple healthy people. There are very strict management regulations in the country where the raw plasma is collected in our country, requiring that each collected Plasma must be screened and tested for various viruses, and only after passing the test can it be used as raw material for production. However, human beings are unknown to many viruses and are the first in detection methods, coupled with the limitations of virus detection methods themselves, so the absolute safety of raw materials cannot be fully guaranteed. In 2002, the State Food and Drug Administration promulgated the [Technical Methods and Validation Guidelines ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/16A61K47/34A61K47/24A61K38/38A61K39/395
CPCA61K35/16A61K38/38A61K39/395A61K47/24A61K47/34A61K47/44
Inventor 胡辉恒邓坤董海军
Owner TONROL BIOLOGICAL PHARM CO LTD
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