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A dry heat treatment stabilizer for preparing human prothrombin complex and its application

A technology of human prothrombin and dry heat treatment, which is applied in the field of dry heat treatment stabilizer for the preparation of human prothrombin complex, which can solve the problem of poor protection effect of coagulation factors, only 78% FIX activity yield, and low practical application value, etc. problems, to achieve good industrial application prospects, quality, safety and effectiveness, and to maintain the effect of activity

Active Publication Date: 2020-03-27
CHENGDU RONGSHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Under this protective agent, although dry heat treatment can inactivate the non-lipid envelope virus in the product, the applicant found that the FIX activity yield of the product obtained by using this formula is only 78% during the test.
The above-mentioned protective agents have poor protective effects on blood coagulation factors, and their practical application value is not high.

Method used

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  • A dry heat treatment stabilizer for preparing human prothrombin complex and its application
  • A dry heat treatment stabilizer for preparing human prothrombin complex and its application
  • A dry heat treatment stabilizer for preparing human prothrombin complex and its application

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Effect test

Embodiment 1

[0026] Embodiment 1 Preparation of human prothrombin complex of the present invention

[0027] The preparation process of human prothrombin complex of the present invention is shown in figure 1 .

[0028] The preparation method is as follows:

[0029] Ⅰ. Separation and purification

[0030] (1) Using DEAE Sephadex A50 ion exchange chromatography for the first time, using DEAE Sephadex A50 as the starting material, collecting the eluate to obtain the first purified product;

[0031] (2) After ultrafiltration and dialysis for the first purified product, Tween-80 and tributyl phosphate were added to make the final concentrations 1% and 0.3% respectively, and treated at 25°C for 6 hours to complete the first virus inactivation (i.e. S / D virus inactivation);

[0032] (3) Take the product after the first virus inactivation and use DEAE Sephadex A50 for the second ion exchange chromatography, collect the eluate, and obtain the second purified product (that is, the eluate containi...

Embodiment 2

[0036] Embodiment 2 Preparation of human prothrombin complex of the present invention

[0037] The preparation method is as follows:

[0038] Ⅰ. Separation and purification

[0039] (1) Using DEAE Sephadex A50 ion exchange chromatography for the first time, using DEAE Sephadex A50 as the starting material, collecting the eluate to obtain the first purified product;

[0040] (2) After ultrafiltration and dialysis for the first purified product, Tween-80 and tributyl phosphate were added to make the final concentrations 1% and 0.3% respectively, and treated at 25°C for 6 hours to complete the first virus inactivation (i.e. S / D virus inactivation);

[0041] (3) Take the product after the first virus inactivation and use DEAE Sephadex A50 for the second ion exchange chromatography, collect the eluate, and obtain the second purified product (that is, the eluate containing the human prothrombin complex);

[0042] Ⅱ. Preparation

[0043] (1) Carry out ultrafiltration dialysis to ...

Embodiment 3

[0045]Embodiment 3 Preparation of human prothrombin complex of the present invention

[0046] The preparation method is as follows:

[0047] Ⅰ. Separation and purification

[0048] (1) Using DEAE Sephadex A50 ion exchange chromatography for the first time, using DEAE Sephadex A50 as the starting material, collecting the eluate to obtain the first purified product;

[0049] (2) After ultrafiltration and dialysis for the first purified product, Tween-80 and tributyl phosphate were added to make the final concentrations 1% and 0.3% respectively, and treated at 25°C for 6 hours to complete the first virus inactivation (i.e. S / D virus inactivation);

[0050] (3) Take the product after the first virus inactivation and use DEAE Sephadex A50 for the second ion exchange chromatography, collect the eluate, and obtain the second purified product (that is, the eluate containing the human prothrombin complex);

[0051] Ⅱ. Preparation

[0052] (1) Carry out ultrafiltration dialysis to t...

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Abstract

The invention discloses a dry-heat treatment stabilizer for a human prothrombin complex, and further provides application of the dry-heat treatment stabilizer and the human prothrombin complex prepared through the dry-heat treatment stabilizer. The dry-heat treatment stabilizer can not only effectively keep the activity of the human prothrombin complex but also ensure the virus inactivation effect of dry-heat treatment, is simple in formula and low in preparation cost and has the good industrial application prospect.

Description

technical field [0001] The invention belongs to the field of blood products, and in particular relates to a dry heat treatment stabilizer for preparing human prothrombin complex and its application. Background technique [0002] Human prothrombin complex (Human prothrombin complex, referred to as PCC) is a blood product, and the raw material is healthy human plasma. Some blood-borne viruses may be transmitted during transfusion, and human thrombin appeared abroad around the 1990s Protocomplex transmission of HIV and HBV reported. For this reason, the governments of various countries have required all blood product companies to establish a complete set of virus inactivation / removal process to improve the virus safety of blood products. [0003] At present, internationally recognized virus inactivation / removal methods include pasteurization, organic solvent / surfactant (S / D) method, terminal dry heat treatment and nano-membrane filtration. Among them, the S / D method is widely...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/36A61K47/18A61K47/12A61K47/02A61K38/36
CPCA61K38/36A61K47/02A61K47/12A61K47/183A61K47/36
Inventor 余伟李伟鲁涛牟蕾王黔川
Owner CHENGDU RONGSHENG PHARMA
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