Method for preparing freeze-dried human blood coagulation factor VIII
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A human blood coagulation factor and freeze-drying technology, which is applied in the field of preparation of freeze-dried human blood coagulation factor VIII, can solve the problems of low product yield and success rate, and achieve the effects of avoiding Al3+ residues, improving product quality, and ensuring stability
Active Publication Date: 2011-11-02
NANYUE BIOPHARMING
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Problems solved by technology
The specific activity, product yield and success rate of human coagulation factor VIII produced by the existing production process are low. Facing the shortage of human coagulation factor VIII in China, the current research and development and production of human coagulation factor VIII have high safety, high product purity and good specific activity. Factor VIII is positive
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Embodiment 1
[0035] A preparation method of freeze-dried human blood coagulation factor VIII, comprising the following process: using water for injection containing 3-10 IU / ml of heparin as heparin sodium solution to dissolve cryoprecipitate, taking the supernatant after PEG precipitation, and centrifugally filtering, 24-26 ℃ S / D inactivation, DEAE Sepharose Fast Flow chromatography column equilibration, adsorption, washing, elution, molecular membrane ultrafiltration, preparation, sterilization and packaging, freeze-drying, capping, 99.5-100.5 ℃ dry heat inactivation; The specific process is as follows:
[0036] 1. Take plasma cryoprecipitate that meets the requirements of the pharmacopoeia: melt at room temperature for 1-2 hours, process into small pieces of 1.5-2.5cm, and wet crush;
[0037] 2. Cryoprecipitate dissolution: place the cryoprecipitate in 5-6 times the volume of heparin sodium solution, stir for 1 hour, then adjust the pH to 6.5-7.5 with 1mol / L HCl, continue stirring for 20...
Embodiment 2
[0068] The basic requirements are the same as those in Embodiment 1.
[0069] A preparation method of freeze-dried human blood coagulation factor VIII, comprising the following process: using water for injection containing 3-10 IU / ml of heparin as heparin sodium solution to dissolve cryoprecipitate, taking the supernatant after PEG precipitation, and centrifugally filtering, 24-26 ℃ S / D inactivation, DEAE Sepharose Fast Flow chromatography column equilibration, adsorption, washing, elution, molecular membrane ultrafiltration, preparation, sterilization and packaging, freeze-drying, capping, 99.5-100.5 ℃ dry heat inactivation; The specific process is as follows:
[0070] 1. Take plasma cryoprecipitate that meets the requirements of the pharmacopoeia: melt at room temperature for 1-2 hours, process into small pieces of 1.5-2.5cm, and wet crush;
[0071] 2. Cryoprecipitate dissolution: place the cryoprecipitate in 5-6 times the volume of heparin sodium solution, stir for 1 hour,...
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Abstract
The invention discloses a method for preparing a freeze-dried human blood coagulation factor VIII. The method comprises the following process of: dissolving by taking water for injection, comprising 3-10 IU (International Unit)/ml of heparin, as a heparin sodium solution and cryoprecipitating; performing PEG (Polyethylene Glycol) precipitation and taking supernatant; performing centrifugal filtration; performing S/D (Solvent/Detergent) inactivation at the temperature of 24-26 DEG C; performing DEAE (Diethylaminoethyl) Sepharose Fast Flow chromatographic column balance, adsorption, washing andelution; performing molecular membrane ultrafiltration; preparing, removing bacteria, sub-packaging, freeze-drying and capping; and dry-heating at the temperature of 99.5-100.5 DEG C and inactivating. In the invention, the process method of combining the PEG precipitation and an ion exchange chromatography technology is adopted; the method is easy and convenient to operate; the F VIII active recovery rate is increased; miscellaneous proteins can be removed on a large scale; the product yield reaches over 60 percent; and the specific activity of the product reaches 5 IU/mg and is obviously greater than a value which is not less than 1 IU/mg stipulated in the pharmacopeia. Meanwhile, the PEG residue is 0.08g/L which is obviously less than the value which is less than or equal to 0.5 IU/mg stipulated in the pharmacopeia, so that Al<3+> residues in the final preparation of an Al(OH)3 gel method are avoided; the product has high purity and high safety; and the quality of the final product is obviously improved.
Description
technical field [0001] The invention belongs to the field of biopharmaceuticals, and in particular relates to a preparation method of freeze-dried human blood coagulation factor VIII. Background technique [0002] Blood coagulation factor Ⅷ (referred to as FⅧ) preparations, albumin preparations, and immunoglobulin preparations are the three pillar products of plasma protein preparations abroad. FⅧ preparations are clinically effective preparations for the substitute treatment of hemorrhagic diseases in patients with hemophilia A. Since there is no cure for this disease so far, the patient needs to infuse FⅧ preparations throughout his life, so there is a large demand in domestic and foreign markets. In order to avoid potential blood-derived virus infection and for safety reasons, my country currently prohibits the import of coagulation factor blood products. At present, there are only a few domestic manufacturers with human coagulation factor VIII, such as Shanghai Laishi and...
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