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Preparation process of human prothrombin compound

A human prothrombin and preparation technology, applied in the field of biopharmaceuticals, can solve problems such as coagulation disorders, achieve the effects of reducing pollution, improving safety, and simplifying production steps

Active Publication Date: 2011-02-16
华润博雅生物制药集团股份有限公司
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Problems solved by technology

Deficiencies in any of these factors can lead to coagulation disorders

Method used

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Embodiment

[0047] 1. Basic requirements:

[0048] 1. The collection and quality of raw plasma should comply with the regulations on human plasma used in the production of blood products;

[0049] 2. Plasma should have no clots, no fibrin precipitation, no hemolysis, etc.;

[0050] 3. Plasma removal of cryoprecipitate, blood coagulation factor VIII, etc.;

[0051] 4. Production equipment, pipelines and utensils should be cleaned and disinfected.

[0052] Second, the main reagent preparation:

[0053] Prepare a balance solution containing 0.08mol / L NaCl and 0.02mol / L trisodium citrate, the balance is water, and the pH is 6.8-7.2;

[0054] The prepared washing solution contains 0.14 mol / L NaCl and 0.02 mol / L trisodium citrate, the balance is water, and the pH is 6.8-7.2;

[0055] Prepare S / D washing solution containing 0.05 mol / L NaCl and 0.02 mol / L trisodium citrate, the balance is water, and the pH is 6.8-7.2;

[0056] The prepared eluent contains 2mol / L NaCl and 0.02mol / L trisodium ...

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Abstract

The invention relates to a preparation process of a human prothrombin compound, belonging to the field of biological pharmacy. The preparation process comprises the following steps of: absorbing blood plasma, washing, eluting and clarifying by filtration; inactivating viruses by using the S / D (Solvent / Detergent) method; purifying by absorption; subpackaging; freeze-drying; and inactivating viruses by the dry heat method. The human prothrombin compound is directly absorbed from blood plasma by using gel, only the gel chromatography technology is used in the entire extraction process, so that the production steps are simplified, the pollution of various factors on the production process of the product is reduced, meanwhile, the yield of the product is increased by 25-30%. In addition, the S / D method is used for removing lipid-enveloped viruses and the dry heat method is used for removing non lipid-enveloped viruses in the production process, and the safety of clinic medication is obviously increased through the two virus inactivation steps.

Description

technical field [0001] The invention relates to a preparation process of a human prothrombin complex, which belongs to the field of biopharmaceuticals. Background technique [0002] The human prothrombin complex contains four coagulation factors II, VII, IX, and X that vitamin K depends on for its synthesis in the liver. Both vitamin K deficiency and severe liver disease can cause deficiency of these four factors. The lack of any of the above factors can lead to coagulation disorders. Infusion of human prothrombin complex can increase blood coagulation factor II, VII, IX, and X concentrations. Therefore, it is mainly used for the treatment of congenital and acquired coagulation factor II, VII, IX, and X deficiency. The standard preparation method is: take freshly separated liquid plasma and frozen plasma from healthy blood donors, use direct gel adsorption method or low-temperature ethanol and polyethylene glycol method to separate protein from plasma, and use nationally ...

Claims

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Application Information

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IPC IPC(8): C07K1/16C07K1/36C07K1/34
Inventor 廖昕晰邓志华徐建新梁小明何淑琴
Owner 华润博雅生物制药集团股份有限公司
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