Method for effectively inactivating parvovirus in prothrombin complex and preparation obtained by method

A technology of prothrombin and parvovirus, applied in medical preparations containing active ingredients, blood diseases, extracellular fluid diseases, etc., can solve the problem of not being able to guarantee the safety of heat-resistant non-lipid enveloped viruses and the difficulty of ensuring product potency Recovery rate and other issues to achieve the effects of reduced production costs, high safety, and shortened time

Active Publication Date: 2015-05-20
SICHUAN YUANDASHUYANG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, it is difficult to guarantee the titer recovery rate of the product of the present invention by adopting 80 DEG C to process 72h in the open literature, and adopting 100 DEG C to process 30 min can not guarantee the safety of heat-resistant non-lipid enveloped virus (such as PPV) (Santagostino E.et al ., "Transmission of Parvovirus B19 by Coagulation Factor Concentrates Exposed to 100 Degrees C Heat After Lyophilization," Transfusion 37(5), 517–522 (May 1997)

Method used

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  • Method for effectively inactivating parvovirus in prothrombin complex and preparation obtained by method
  • Method for effectively inactivating parvovirus in prothrombin complex and preparation obtained by method
  • Method for effectively inactivating parvovirus in prothrombin complex and preparation obtained by method

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Comparison scheme
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Embodiment 1

[0028] Embodiment 1 Preparation of prothrombin complex preparation of the present invention

[0029] like figure 1 Shown schematic diagram, preparation of thrombin complex preparation of the present invention:

[0030] 1. Preparation of thrombin complex solution

[0031] Ⅰ. Separation and purification

[0032] Collect the A50 gel after absorbing plasma, wash the gel with 3-10 times the amount of gel washing solution (solution composition: 0.1-0.3M NaCl, 0.01-0.03M sodium citrate, pH: 6.5-7.5), and then Use 3-10 times the amount of gel eluent (recipe: 0.01-0.03M sodium citrate + 1M-2M sodium chloride, pH 6.5-7.5) to elute the product, collect the eluted protein solution for ultrasonography filter.

[0033] II. S / D inactivation

[0034] Slowly add 11% S / D concentrated solution (formula: 11% Tween-80 + 3.3% tributyl phosphate) into the protein concentrated solution, and add while stirring, so that the final concentration of Tween 80 is 0.8-1.2%, and the final concentration o...

Embodiment 2

[0044] Embodiment 2 Preparation of prothrombin complex preparation of the present invention

[0045] like figure 1 Shown schematic diagram, preparation of thrombin complex preparation of the present invention:

[0046] 1. Preparation of thrombin complex solution

[0047] With embodiment 1.

[0048] 2. Dry heat inactivation

[0049] (1) Take the prothrombin complex prepared in step I, add 3% (w / v) arginine, sterilize, subpackage, and freeze-dry;

[0050] (2) Dry heat treatment: treat at 80°C for 10 hours, and then at 100°C for 30 minutes to obtain the prothrombin complex preparation of the present invention.

Embodiment 3

[0051] Embodiment 3 Preparation of prothrombin complex preparation of the present invention

[0052] 1. Preparation method

[0053] 1. Preparation of thrombin complex solution

[0054] With embodiment 1.

[0055] 2. Dry heat inactivation

[0056] (1) Take the prothrombin complex prepared in step I, add 4% (w / v) arginine hydrochloride, sterilize, subpackage, and freeze-dry;

[0057] (2) Dry heat treatment: treat at 80°C for 2 hours, and then at 100°C for 60 minutes to obtain the prothrombin complex preparation of the present invention.

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Abstract

The invention discloses a method for effectively inactivating parvovirus (PPV) in a prothrombin complex. The method comprises the following steps: lyophilizing an S/D inactivated parvovirus in prothrombin complex preparation, carrying out dry-heat treatment for 2-10 hours at 80 DEG C and for 30-120 hours at 100 DEG C. The invention further discloses a prothrombin complex preparation prepared by the method. The inactivating method can be used for effectively inactivating PPV over 4log; the prothrombin complex preparation prepared by the method has high virus safety and good long-time stability, is qualified in full-inspections after being placed for 3 years at 2-8 DEG C, and has an FIX recovery rate of over 90 percent; and the II, VII, IX and X blood coagulation factors are not remarkably lost, and an excellent proportion is maintained. Furthermore, the preparation method has low cost which is lower than that of traditional 80-DEG C 72-hour dry-heat inactivation.

Description

technical field [0001] The invention relates to the field of plasma products, in particular to a method for effectively inactivating parvoviruses in prothrombin complexes and the obtained preparations. Background technique [0002] Prothrombin Complex Concentrate (PCC), which contains coagulation factors IX, II, X, and a small amount of other plasma proteins. It is mainly used to prevent and treat bleeding caused by the deficiency of coagulation factors Ⅱ, Ⅶ, Ⅸ and Ⅹ, such as hemophilia B, severe liver disease and disseminated intravascular coagulation (DIC), etc. It can also be used to reverse anticoagulants (such as Coumarins, indandione, etc.)-induced bleeding also has an effect on hemophilia A patients who have produced inhibitory antibodies to coagulation factor VIII. [0003] Prothrombin complex is a complex composed of various coagulation factors and is a special blood product. Since blood products are derived from human plasma, they are usually prepared by mixing m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/04A61K35/16A61K38/36A61P7/04
Inventor 陈海王强蒋德席冉曙光杨德军何海兵
Owner SICHUAN YUANDASHUYANG PHARM CO LTD
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