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A kind of preparation method of human prothrombin complex

A human prothrombin and complex technology, applied in the field of preparation of human prothrombin complex, can solve the problem of unbalanced improvement of the yield and specific activity of four factors, single increase of yield and specific activity, and coagulation factor ratio Low activity and other problems, to achieve the effect of reducing open operation pollution, good specific activity, and high purity

Active Publication Date: 2020-07-21
GUIZHOU TAIBANG BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] CN201710118663.7, the invention discloses a method for preparing human prothrombin complex from plasma, using DEAE A-50 gel to directly adsorb human prothrombin complex from plasma, and coagulating the adsorbed A-50 The gel is packed in a fixed bed chromatography column, and the packed chromatography column uses a peristaltic pump to pump the eluent into the online washing and elution, and the eluent is inactivated by S / D, and the fixed bed chromatography column is subjected to secondary chromatography Purification, so that the gel loss in the production process can be reduced by more than 20%, but the specific activity of the coagulation factor obtained is low, and the product quality is not good
[0008] The preparation of the human prothrombin complex mentioned above was improved from a single aspect, and the entire production process was not optimized, and the obtained human prothrombin complex only improved a certain factor of the human prothrombin complex. Yield and specific activity, there is no balanced improvement of the yield and specific activity of the four factors, yet human prothrombin complex (prothrombin complex concetrate, PCC) is prepared from the separation and preparation of mixed plasma of healthy people, and the raw material plasma for production is scarce, so It is necessary to improve each step of its production, hoping to obtain an efficient and safe preparation method

Method used

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  • A kind of preparation method of human prothrombin complex
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  • A kind of preparation method of human prothrombin complex

Examples

Experimental program
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Effect test

Embodiment 1

[0037] A preparation method of human prothrombin complex, comprising the following preparation steps:

[0038] 1) Centrifugation: Using fresh frozen human blood as raw material, the cryoprecipitate in the plasma is removed by melting, mixing, and centrifugation. After centrifugation, the plasma supernatant is clarified and filtered with a PALL filter equipped with a 0.45um filter element to obtain plasma. supernatant;

[0039] 2) Adsorption: adjust the pH of the plasma supernatant, add DEAE Sephadex A-50 gel, 1.0°C, stir and adsorb for 30 minutes, then filter;

[0040] 3) Washing and elution: DEAE Sephadex A-50 gel is installed in the chromatography column, and the impurity protein is washed on-line with the washing liquid, 50cm / h, flushing 5 column volumes, and the adsorption II in the gel is eluted with the eluent , VII, IX, X factors and a small amount of protein, the elution speed is 30cm / hn, stop elution when the detection value of the online detector is lower than 500Au...

Embodiment 2-8

[0058] Table 1 Example 2-8 adsorption conditions

[0059]

[0060]

[0061] Other preparation steps of Examples 2-8 are the same as Example 1.

Embodiment 9-15

[0063] Table 2 embodiment 9-15 washing conditions

[0064] Sodium citrate is mol / L Sodium chloride mol / L pH Example 9 0.012 0.04 6.6 Example 10 0.012 0.04 7.2 Example 11 0.012 0.02 6.9 Example 12 0.012 0.06 6.9 Example 13 0.005 0.04 6.9 Example 14 0.02 0.04 6.9 Example 15 0.025 0.1 7.0

[0065] Other preparation steps of Examples 9-15 are the same as Example 1.

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Abstract

The invention belongs to the technical fields of bio-pharmaceuticals and blood products, and particularly relates to a preparation method of a human thrombinogen compound. According to the human thrombinogen compound prepared by the method, an excellent production process is obtained by improving and researching adsorbing balance liquid, subsequent washing liquid and eluent and a freeze-drying process, four blood coagulation factors that the PCC product contain have high active ratio, the yield of each component is high, the IX specific activity is up to 3.13 IU / mg, the specific activity is higher than that of the pharmacopeia standard, the thrombosis probability is effectively reduced and activation of the blood coagulation factors is reduced.

Description

technical field [0001] The invention belongs to the technical field of biopharmaceuticals and blood products, and in particular relates to a preparation method of human prothrombin complex. Background technique [0002] Human prothrombin complex concentrates (PCC) is a plasma protein preparation containing four vitamin K-dependent coagulation factors, coagulation factors II, VII, IX, and X, which can promote blood coagulation. Clinically, PCC is mainly used to treat hemophilia B and liver disease, as well as bleeding symptoms caused by low coagulation factor levels caused by vitamin K deficiency. In addition, it has also been affirmed in the treatment of bleeding symptoms caused by FVIII inhibitors in hemophilia A patients who have been infused with FVIII for a long time. In foreign countries, PCC is also widely used to treat bleeding symptoms caused by overdose of vitamin K antagonists as anticoagulant drugs. In recent years, with the recognition of clinicians, the demand...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C12N9/74C12N9/64
CPCC12N9/6429C12N9/6432C12N9/6437C12N9/644C12Y304/21005C12Y304/21006C12Y304/21021C12Y304/21022
Inventor 陈云华陈艾军向宏王勇符平松赵学梅刘欣晏杨刚
Owner GUIZHOU TAIBANG BIOLOGICAL PROD
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