Preparation method of human blood coagulation factor VIII and human blood coagulation factor VIII product
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A technology of human blood coagulation factor and cryoprecipitation, which is applied to the preparation method of factor VII, peptide, coagulation/fibrinolysis factor, etc. It can solve the problems of low specific activity, low yield, and failure to meet the basic medication needs of patients.
Active Publication Date: 2018-04-06
HUALAN BIOLOGICAL ENG INC +2
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Problems solved by technology
At present, there are only a few companies in China that have the production approval of AHF, and the supply is seriously in short supply, unable to meet the basic drug needs of patients
The existing AHF is mainly prepared by methods such as polyethylene glycol precipitation and aluminu...
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Embodiment 1
[0069] The method for preparing human coagulation factor VIII provided in this embodiment includes the following steps:
[0070] 1. Steps for collecting raw plasma:
[0071] 1.1 The collection and quality of plasma should comply with the provisions of "Human Plasma for the Production of Blood Products" in the current edition of the Pharmacopoeia of the People's Republic of China. It should be frozen within 4 hours after collection and stored at -30°C for no more than 1 year.
[0072] 1.2 The plasma should have no clots, no fibrin precipitation, no lipemia, and no hemolysis.
[0074] Weigh 2097kg of frozen plasma (total 3495 human plasma), soak or wipe the surface with 70% ethanol solution (the ethanol solution is required to control 70%-75%), then break the bag and combine it into the tank. Melt in a water bath, and control the melting temperature at 4°C (control the melting temperature at 0-4°C).
[0075] Use a low-temperature high...
Embodiment 2
[0107] The method for preparing human coagulation factor VIII provided in this embodiment is basically the same as that in Embodiment 1, except that in this embodiment:
[0108] The balance solution contains: tromethamine 18mmol / L, sodium chloride 90mmol / L, glycine 110mmol / L and calcium chloride 38μmol / L.
[0109] The dialysate contains: sodium nitrate 11mmol / L, histidine 28mmol / L, glycine 130mmol / L and calcium chloride 1.1mmol / L.
Embodiment 3
[0111] The method for preparing human coagulation factor VIII provided in this embodiment is basically the same as that in Embodiment 1, except that in this embodiment:
[0112] The balance solution contains: tromethamine 22mmol / L, sodium chloride 110mmol / L, glycine 130mmol / L, and calcium chloride 42μmol / L.
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Abstract
The invention discloses a preparation method of a human blood coagulation factor VIII and a human blood coagulation factor VIII product and relates to the field of blood products. The preparation method of the human blood coagulation factor VIII comprises the following steps: dissolving a cryoprecipitate with a 0.015-0.025mol/L tromethamine solution in a mass ratio of (3-5): 1 by reasonably processing the cryoprecipitate; and carrying out separation and purification by means of a polyethylene glycol precipitating method combined with ion exchange chromatography, wherein the recovery ratio of the human blood coagulation factor VIII and the specific activity of a final product can be improved effectively, the yield reaches 180-240IU/L plasma, and the specific activity is not lower than 100IU/mg proteins. The prepared human blood coagulation factor VIII product is rich in vWF factors and the proportion of the vWF factors and the human blood coagulation factor VIII is close to 1: 1. Besides treating hemophiliac A, the human blood coagulation factor VIII can be also used for treating patients with angiohemophilia, and the human blood coagulation factor VIII has good stability and heat resistance.
Description
Technical field [0001] The present invention relates to the field of blood products, in particular to a method for preparing human coagulation factor VIII and a human coagulation factor VIII product. Background technique [0002] Human Cogulation Factor VIII (Human Cogulation Factor VIII, AHF) has a corrective effect on the coagulation dysfunction caused by the lack of human coagulation factor VIII. It is a lifelong medication for patients with hemophilia A and a rescue medication for emergency patients. Among the nearly 400,000 hemophilia A patients in the world, there are about 60,000 to 100,000 patients in my country, but only about 8,000 people are receiving treatment. From increasing the treatment rate of hemophilia A patients and guaranteeing emergency medication, The domestic human coagulation factor VIII gap is about 20 times the current output. At present, there are only a few domestic companies with AHF production approval, and the supply is severely in short supply, un...
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