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Method for producing human prothrombin complex

A technology of human prothrombin and production method, which is applied in the fields of biochemical equipment and methods, enzymes, blood diseases, etc. The effect of stability, increasing yield, and ensuring virus safety

Active Publication Date: 2011-08-17
哈尔滨派斯菲科生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The traditional process mostly uses the intermediate in the production of blood products-fraction III to extract. Due to the destructive effect of the early operation of the production of component III on the coagulation factor, there is a large difference between batches of products, the activity of the coagulation factor is unstable, and the product yield is low. And some blood coagulation factors are easy to be activated, and it is easy to cause adverse reactions such as thrombosis in use

Method used

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  • Method for producing human prothrombin complex
  • Method for producing human prothrombin complex
  • Method for producing human prothrombin complex

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] A. Separation and extraction

[0023] Melt the raw plasma, keep the plasma temperature at 0°C, and centrifuge at 0°C to remove the cryoprecipitate, heat the supernatant from the cryoprecipitate to 12°C, add 1% swollen diethylaminoethyl cross-linked agarose gel and stir , adsorbed for 45 minutes, collected the gel, quickly rinsed the gel 3 times with the washing solution, then soaked in the eluent for 10 minutes / time, washed 3 times in total, eluted the product, collected the eluted protein solution for ultrafiltration, Pre-concentrate, then use dialysate ultrafiltration to make the residual sodium chloride concentration less than 0.85% (g / ml), concentrate the product until the titer of factor IX is about 10IU / ml, and measure the weight of the concentrate;

[0024] B. Virus inactivation

[0025] While stirring the concentrated solution, slowly add 11% S / D solution in a ratio of 10:1, so that the final concentration of polysorbate-80 is 1% (g / ml), and the final concentra...

Embodiment 2

[0040] A. Separation and extraction

[0041] Melt the raw plasma, keep the plasma temperature at 2°C, and centrifuge at 2°C to remove the cryoprecipitate, heat the supernatant from the cryoprecipitate to 13°C, add 1% swollen diethylaminoethyl cross-linked agarose gel and stir , adsorbed for 45 minutes, collected the gel, quickly rinsed the gel 3 times with the washing solution, then soaked in the eluent for 10 minutes / time, washed 3 times in total, eluted the product, collected the eluted protein solution for ultrafiltration, Pre-concentrate, then use dialysate ultrafiltration to make the residual sodium chloride concentration less than 0.85% (g / ml), concentrate the product until the titer of factor IX is about 10IU / ml, and measure the weight of the concentrate;

[0042] B. Virus inactivation

[0043] While stirring the concentrated solution, slowly add 11% S / D solution in a ratio of 10:1, so that the final concentration of polysorbate-80 is 1% (g / ml), and the final concentra...

Embodiment 3

[0057] A. Separation and extraction

[0058] Thaw the raw plasma, keep the plasma temperature at 4°C, and centrifuge at 4°C to remove cryoprecipitate, remove the cryoprecipitate supernatant and raise the temperature to 14°C, add 1% swollen diethylaminoethyl cross-linked dextran gel Stir, absorb for 45 minutes, collect the gel, quickly rinse the gel with washing solution for 3 times, then soak in the eluent for 10 minutes / time, wash 3 times in total, elute the product, collect the eluted protein solution for ultrafiltration , pre-concentration, and then use dialysate ultrafiltration to make the residual sodium chloride concentration less than 0.85% (g / ml), and the product is concentrated to about 10IU / ml in factor IX titer, and the weight of the concentrated solution is measured;

[0059] B. Virus inactivation

[0060] While stirring the concentrated solution, slowly add 11% S / D solution in a ratio of 10:1, so that the final concentration of polysorbate-80 is 1% (g / ml), and th...

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Abstract

The invention relates to a method for producing a human prothrombin complex. The method is characterized in that the following steps of direct separation and extraction from blood plasma, virus inactivation, refining and secondary virus inactivation are adopted to obtain finished human prothrombin complex. As the method adopts the step of direct separation and extraction from the blood plasma, the separation condition is mild, the batch-to-batch difference of the products is small, the blood coagulation factor activity is stable, the yield rate is high, and the activation phenomenon basicallydoes not exist. The virus inactivation process adopts a method of combining an S / D (organic solvent / detergent) method and a dry and thermal activation method and fully ensures that the virus safety of the human prothrombin complex.

Description

technical field [0001] The invention relates to a production method of human prothrombin complex. Background technique [0002] Human prothrombin complex (PCC), a preparation containing vitamin K-dependent coagulation factors II, VII, IX, and X, is mainly used to treat hemophilia B and coagulation dysfunction caused by abnormal liver function . The traditional process mostly uses the intermediate in the production of blood products-fraction III to extract. Due to the destructive effect of the early operation of the production of component III on the coagulation factor, the product batch difference is large, the activity of the coagulation factor is unstable, and the product yield is low. And some blood coagulation factors are easy to be activated, and it is easy to cause adverse reactions such as thrombosis in use. The invention adopts direct separation and extraction from blood plasma, the separation condition is mild, the difference between batches of products is small, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/16A61K38/48C12N9/74A61P7/04
Inventor 杨金平魏舒李常禄孙晓东陈凤珠于洋郭晶
Owner 哈尔滨派斯菲科生物制药有限公司
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