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Preparation method, product and application of a human von Willebrand factor/human coagulation factor ⅷ complex

A technology for hemophilia factor and human coagulation factor, which is applied in the field of preparation of human von Willebrand factor/human coagulation factor VIII complex, can solve problems such as complicated steps, reduce the risk of thromboembolism, achieve high quality, The effect of improving safety

Active Publication Date: 2021-12-14
华润博雅生物制药集团股份有限公司
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  • Application Information

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Problems solved by technology

[0008] Chinese patent (Application No. 201610077346.0) provides a process for preparing vWF from the waste of coagulation factor VIII extracted from cryoprecipitate. The cryoprecipitate is used as the starting material, and the steps are cumbersome through two-step anion exchange chromatography and one-step affinity chromatography.
At present, there is no product on the market in China. Therefore, it is necessary to develop a vWF preparation process with very little impurity content, vWF:Ag / vWF:Act≈1:1, and good safety.

Method used

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  • Preparation method, product and application of a human von Willebrand factor/human coagulation factor ⅷ complex

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preparation example Construction

[0052] The invention provides a preparation method of a human von Willebrand factor / human blood coagulation factor VIII complex, comprising the following steps:

[0053] (1) Take the frozen plasma, centrifuge after thawing the plasma, and collect the cryoprecipitate;

[0054] (2) Dissolving the cryoprecipitate described in step (1), adjusting the pH value to 6.35-6.55, centrifuging at 12-18°C, and collecting the supernatant;

[0055] (3) Mix the supernatant described in step (2) with the aluminum hydroxide gel, centrifuge after stirring and absorbing, and collect the supernatant;

[0056] (4) Adjust the protein concentration of the supernatant in step (3) to 5.0-15.0 g / L with an equilibrium buffer, then filter in series at 0.6-0.7um+0.4-0.5um, and collect the filtrate;

[0057] (5) Mix the filtrate described in step (4) with the S / D solution, stir at 24-26° C. for 5-7 hours, and then filter, the filter tool for the filtration has a pore size of 0.4-0.5 μm, and collect the fil...

Embodiment 1

[0085] Taking 6000 liters of plasma as an example, the specific preparation process is as follows:

[0086] (1) During the quarantine period, after receiving the plasma from qualified individuals, wipe the surface of the plasma bag with 75% ethanol, rinse it with water for injection below 35°C, break the bag and merge it into a slurry tank, and circulate it with circulating water at 30-35°C. The temperature of plasma should not be higher than 4°C; after melting, it should be centrifuged (centrifugal force should not be lower than 6000g), the temperature of the liquid should be controlled at 0-4°C, and 34.8kg of cryoprecipitate should be collected;

[0087] (2) Add the cryoprecipitate obtained in step (1) into 209kg of dissolving solution (dissolving solution preparation method: 2.94g sodium citrate, 3000IU heparin sodium, add water for injection to 1L, and control the temperature at 20-26°C) , stir until the cryoprecipitate is completely dissolved, and the temperature of the c...

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Abstract

The invention provides a preparation method of a human von Willebrand factor / human blood coagulation factor VIII complex as well as its product and application, and relates to the technical field of biomedicine. The preparation method provided by the invention is easy to operate, and the vWF / Ⅷ complex is prepared by cryoprecipitation. By making full use of the cryoprecipitate, scarce plasma resources can be indirectly saved, which is of great significance for improving market competitiveness. The product prepared by the present invention is of high quality, the specific activity of vWF in the stock solution can reach 50IU / mg, and the final product has very little impurities such as residual aluminum, fibrinogen, fibronectin, plasminogen, IgG, IgA, and IgM , can further ensure the safety of clinical use. The vWF / Ⅷ≈1:1 prepared by the present invention can better reflect normal human plasma and help to optimize the dose required for treatment.

Description

technical field [0001] The invention relates to the technical field of biomedicine, in particular to a preparation method of a human von Willebrand factor / human blood coagulation factor VIII complex as well as its product and application. Background technique [0002] Human von Willebrand factor (vWF) is a multimeric plasma glycoprotein that exists in the form of supramolecular mass multimers, with a molecular weight of 250-20,000 kDa (each mature subunit is 250 KDa). protein with the largest molecular weight. The average content in normal human plasma is 10mg / L (0.5-2IU / mL), the primary structure contains 2050 amino acid residues, and the half-life is 12-18 hours. vWF plays an important role in primary hemostasis: (1) It is responsible for combining with platelet membrane GPⅠb-IX complex and subendothelial collagen, mediating the adhesion of platelets at the site of vascular injury, and contributing to the formation of fibrin coagulation; (2) vWF can also bind GPⅡb-Ⅲa and...

Claims

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Application Information

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IPC IPC(8): C07K14/755C07K1/18C07K1/34C07K1/36C07K1/14A61K38/37A61P7/04
CPCC07K14/755A61K38/37A61P7/04A61K2300/00
Inventor 匡青芬罗二华陈新朋陈家啡张猛刘敏亮梁小明饶振
Owner 华润博雅生物制药集团股份有限公司
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