Human coagulation factor VIII preparation method

Abstract

The invention discloses a human coagulation factor VIII preparation method. In the preparation process of a human coagulation factor VIII, a two-step filter press technique is adopted during treatment of human plasma initial materials, that is, a K700 filter plate is adopted for filter pressing after cryoprecipitate dissolution, the filter press liquor is collected, the pH value is adjusted, a 2% aluminium hydroxide gel is added for adsorption, and then an EK filter plate is adopted for filter pressing. The two-step filter press technique is adopted to improve the separation effect, meanwhile, the aluminium hydroxide gel adsorption method is used together to remove a coagulation factor on which vitamin K depends, the aluminium hydroxide gel does not adsorb the human coagulation factor VIII, and the product yield is high. In the preparation process, the two-step filter press technique replaces a traditional two-step high-speed centrifuging method, a CUNO DELP deep filter element is adopted for filtration, a two-step gradient dialysis method is adopted, a re-dissolution and re-freezing process is added to a freeze-drying process, and meanwhile, various virus removal / inactivation technologies are adopted in the production process, so that the product yield can be improved, the risk of virus spreading can be reduced, and the clinical medication security is improved.

Description

technical field [0001] The invention relates to a preparation method of human blood coagulation factor VIII, which belongs to the field of biopharmaceuticals. Background technique [0002] Hemophilia A (HA) is the most common hereditary bleeding disorder caused by the absence of coagulation factor VIII (FVIII) in plasma. The FⅧ gene is located on the X chromosome, so the vast majority of patients are male, female heterozygotes are carriers, and female patients are extremely rare. Severe patients have repeated spontaneous hemorrhage since childhood. If not treated, it often causes joint deformity and disability. In severe cases, it may die due to intracranial hemorrhage. At present, alternative therapies are still mainly used, such as whole blood, cryoprecipitate, human coagulation factor Ⅷ preparations, etc., due to the low purity of whole blood and cryoprecipitate, large transfusion volume, many side effects, and the risk of spreading blood viruses, etc. Replacement thera...

AI Technical Summary

Problems solved by technology

Due to the low content, easy activation, and easy hydrolysis of human blood coagulation factor VIII, there are the following problems in the preparation process: (1) The purity is not high, the product contains too many impurities, and clinical use is prone to rash, tachycardia, fever, etc. Adverse reactions; (2) low potency and specific activity, due to easy activation and hydrolysis in the preparation process, resulting in low potency and specific activity of the product, thereby affecting clinical efficacy; (3) low yield, due to human The content of blood coagulation factor VIII is low, and the extraction is difficult, resulting in low yield; (4) There may be a risk of spreading blood viruses

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