Preparation method of human VIII blood coagulation factor

Abstract

The invention discloses a preparation method of a human VIII blood coagulation factor. The preparation method comprises the following steps: (1) separating cryoprecipitates from human plasma, and adding a Tris-HCl dissolving solution to dissolve; (2) primary PEG (Polyethylene Glycol) precipitation: adding a PEG 1 solution into the dissolving solution, stirring, standing, and then, centrifuging; (3) collecting a centrifuged suspension liquid, and adding an S / D solution to inactivate; (4) secondary PEG precipitation: clarifying the inactivated suspension liquid, filtering to obtain a filtrate, transferring the filtrate into a low-temperature reaction tank, adding a PEG 2 solution under the condition of stirring, stirring, standing, and then, centrifuging; and (5) cleaning a precipitate, dissolving the sediment by using the dissolving solution, centrifuging after complete dissolution, collecting the suspension liquid, filtering, preparing, degerming, split charging, freeze-drying, capping, and carrying out dry heat inactivation to obtain the human VIII blood coagulation factor. A two-step PEG precipitation method is adopted in the method disclosed by the invention, so that the production process is simplified, and the requirement for large equipment is reduced; the preparation method is small in floor area, simple in operation, low in cost and capable of increasing the labor efficiency and economic benefit.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a preparation method of human coagulation factor VIII. Background technique [0002] Blood coagulation factor VIII preparations, albumin preparations and immunoglobulin preparations are the three pillar products of plasma protein preparations abroad. In hemophilia, 80% of patients belong to hemophilia A, which mainly lacks normal people Possessed human coagulation factor VIII, therefore, human coagulation factor VIII is a life-saving drug for the treatment of hemophilia. At present, there are only a few companies in China that have approved the production of human blood coagulation factor VIII, mainly because the process is cumbersome and the quality is not easy to control. The existing production process has a low yield of human coagulation factor VIII. Facing the shortage of human coagulation factor VIII in China, it is of positive significance to develop and produce human co...

AI Technical Summary

Problems solved by technology

At present, there are only a few domestic production approval documents for human blood coagulation factor VIII, mainly because the process is cumbersome and the quality is not easy to control

The current production process has a low yield of human coagulation factor VIII. Facing the shortage of human coagulation factor VIII in China, it is of positive significance to develop and produce human coagulation factor VIII with high safety and high specific activity at this stage.

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