A method for effectively inactivating parvovirus in prothrombin complex and the obtained preparation

A technology of prothrombin and complexes, which is applied in medical preparations containing active ingredients, blood diseases, extracellular fluid diseases, etc., can solve the problem of difficult to guarantee the recovery rate of potency and the safety of heat-resistant non-lipid enveloped viruses Sex and other issues, to achieve the effects of reduced production costs, high safety, and shortened time

Active Publication Date: 2017-12-29
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 ensure the titer recovery rate of the product of the present invention by adopting 80°C for 72h in the open literature, and it is difficult to guarantee the safety of heat-resistant non-lipid enveloped virus (such as PPV) by using 100°C for 30min (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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  • A method for effectively inactivating parvovirus in prothrombin complex and the obtained preparation
  • A method for effectively inactivating parvovirus in prothrombin complex and the obtained preparation
  • A method for effectively inactivating parvovirus in prothrombin complex and the obtained preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

[0029] like figure 1 As shown in the schematic diagram, the thrombin complex preparation of the present invention is prepared:

[0030] 1. Preparation of thrombin complex solution

[0031] Ⅰ. Separation and purification

[0032] Collect the A50 gel after adsorption of plasma, wash the gel with 3-10 times the amount of 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 gel volume of the eluent (recipe: 0.01-0.03M sodium citrate + 1M-2M sodium chloride, pH 6.5-7.5) to elute the product, and collect the eluted protein solution for ultrafiltration .

[0033] II, S / D inactivation

[0034] Slowly add 11% S / D concentrate (recipe: 11% Tween-80+3.3% tributyl phosphate) to the protein concentrate, add while stirring, so that the final concentration of Tween 80 is 0.8-1.2%, and the final concentration of TNBP is 0.8-1...

Embodiment 2

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

[0045] like figure 1 As shown in the schematic diagram, the thrombin complex preparation of the present invention is prepared:

[0046] 1. Preparation of thrombin complex solution

[0047] Same as Example 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: treatment 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] Example 3 Preparation of prothrombin complex preparation of the present invention

[0052] 1. Preparation method

[0053] 1. Preparation of thrombin complex solution

[0054] Same as Example 1.

[0055] 2. Dry heat inactivation

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

[0057] (2) Dry heat treatment: treatment 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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PUM

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Abstract

The invention discloses a method for efficiently inactivating parvovirus PPV in a prothrombin complex. The prothrombin complex preparation inactivated by S / D is lyophilized and then subjected to dry heat treatment. The dry heat treatment method is 80°C. 2 to 10 hours, and then treated at 100°C for 30 to 120 minutes. The invention also discloses the blood zymogen complex preparation prepared by the method. The inactivation method of the present invention can effectively inactivate porcine parvovirus (PPV) greater than 4 log, and the prothrombin complex preparation prepared by the method of the present invention has higher virus safety and better long-term stability, and can be placed at 2-8°C The 3-year full inspection was qualified, the recovery rate of FIX was over 90%, and the coagulation factors II, VII, IX, and X had no significant loss and maintained a good ratio. At the same time, the preparation method has low cost, which is lower than the cost of traditional dry heat inactivation at 80° C. for 72 hours.

Description

technical field [0001] The invention relates to the field of plasma products, in particular to a method for effectively inactivating parvovirus in a prothrombin complex and a preparation obtained therefrom. 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 for the prevention and treatment of bleeding caused by 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 Bleeding induced by coumarins, indandione, etc.) also has an effect on hemophilia A patients who have produced inhibitory antibodies to coagulation factor VIII. [0003] Prothrombin complex is a complex of various coagulation factors, and is a special blood product. Since blood products are derived from human plasma, they are usually prepa...

Claims

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Application Information

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Patent Type & Authority Patents(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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