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Solubilization technology for producing human fibrinogen

A human fibrinogen, process technology, applied in the direction of fibrinogen, animal/human protein, coagulation/fibrinolytic factor, etc., can solve the problem of low solubility of human fibrinogen precipitation, prone to adverse reactions, and high content of impurities in the product and other problems, to achieve the effect of stable temperature change, rapid dissolution, and increased solubility

Active Publication Date: 2013-11-27
WUHAN ZHONGYUAN RUIDE BIOLOGICAL PROD CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there are mainly two methods for producing human fibrinogen: one is to separate the centrifuged supernatant of blood plasma through low-temperature ethanol, and the produced component I is used as a raw material to make a finished product, but the process mainly has the problem of low purity. The purity of the produced products is below 80%, and the product contains too many impurities. Patients are prone to adverse reactions when they are used for injection; Obtained, using cryoprecipitate as raw material, the human fibrinogen precipitate obtained through extraction, adsorption, centrifugation, chromatography and other manufacturing processes has low solubility (the solubility of the finished product obtained by this method is low), and it is difficult to dissolve

Method used

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  • Solubilization technology for producing human fibrinogen
  • Solubilization technology for producing human fibrinogen
  • Solubilization technology for producing human fibrinogen

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] 1. Plasma selection:

[0030] According to the production plan, the frozen plasma was weighed in the -20°C freezer and shipped out. Screen the frozen plasma out of the warehouse to remove damaged plasma. Qualified plasma is washed and placed in a clean stainless steel barrel, and the turnover box is built to 4-5 layers, and placed in a 2-15°C freezer overnight.

[0031] 2. Plasma collection: first wash with water for injection below 37°C to make the plasma reach the state of shelling; then sterilize with 75-80% ethanol, and replace with new alcohol after every 4 to 5 boxes of plasma are sterilized. Then remove the plasma bag to the washing table, and fully rinse the surface of the plasma bag with water for injection below 37°C. Break the bag, collect the plasma in a special plasma collection tank with an interlayer, heat it with circulating water at 35°C, transfer the melted plasma to a special centrifuge tank in time, and control the temperature of the plasma at 4°C,...

Embodiment 2

[0041] 1. Plasma selection:

[0042] According to the production plan, the frozen plasma was weighed from the -20°C freezer and shipped out. Screen the frozen plasma out of the warehouse, and pick out the damaged plasma. The damaged plasma should be picked out in time, washed and placed in a clean stainless steel bucket. Damaged plasma cannot produce cryoprecipitate; build the turnover box to 4-5 layers, and put the plasma in a 2-8 degree freezer overnight.

[0043] 2. Plasma collection: first wash with water for injection below 37°C to make the plasma reach the shell state; then sterilize with 75-80% ethanol. After every 4 to 5 boxes of plasma are sterilized, replace with new alcohol, and then remove the plasma bag to the washing table. Then fully rinse the surface of the plasma bag with water for injection below 37°C. Break the bag, collect the plasma in a special plasma collection tank with an interlayer, heat it with circulating water at 30°C, transfer the melted plasma...

Embodiment 3

[0052] 1. Plasma selection:

[0053] According to the production plan, the frozen plasma was weighed from the -20°C freezer and shipped out. Screen the frozen plasma out of the warehouse, and pick out the damaged plasma. The damaged plasma should be picked out in time, washed and placed in a clean stainless steel bucket. Damaged plasma cannot produce cryoprecipitate; build the turnover box to 4-5 layers, and put the plasma in a 2-8 degree freezer overnight.

[0054] 2. Plasma collection: first wash with water for injection below 37°C to make the plasma reach the shell state; then sterilize with 75-80% ethanol. After every 4 to 5 boxes of plasma are sterilized, replace with new alcohol, and then remove the plasma bag to the washing table. Then fully rinse the surface of the plasma bag with water for injection below 37°C. Break the bag, collect the plasma in a special plasma collection tank with an interlayer, heat it with circulating water at 25°C, transfer the melted plasma...

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Abstract

The invention relates to a solubilization technology for producing human fibrinogen. The solubilization technology comprises following main steps: (1) source plasma treatment; (2) dissolving and centrifuging of cryoprecipitate; (3) inactivation of viruses; (4) chromatography purification; (5) centrifugal separation; (6) dissolving of sediments; (7) degerming and filtering; (8) split charging and freeze drying. The solubilization technology has the advantages that the purity of the extracted product can be up to over 95%; the content of foreign protein is low; a lipid envelope virus and a non-lipid envelope virus can be effectively activated; the safety of the product is ensured; arginine hydrochloride and glycine are adopted as stabilizers; the product can be fully protected in a freeze-drying process; the temperature change of the product in the freeze-drying process is stable by prolonging the freeze-drying time (about 4-8 days, and about 3 days for general factories); a freeze-dried product with a uniform structure can be obtained; the solubility of the human fibrinogen is increased; the product is quick to dissolve after being re-dissolved; no highly visible denatured protein is generated.

Description

technical field [0001] The invention relates to the field of blood products, in particular to a solubilization process for producing human fibrinogen. Background technique [0002] Human fibrinogen is mainly synthesized by the liver, and the human body content is about 2.5-4.0g / L. Most of it exists in human plasma, and less than 20% exists outside blood vessels. It is mainly used for the treatment of congenital and acquired fibrinogenopenia, severe liver injury, liver cirrhosis, DIC, surgery or postpartum hemorrhage, etc. At present, there are mainly two methods for producing human fibrinogen: one is to separate the centrifuged supernatant of blood plasma through low-temperature ethanol, and the produced component I is used as a raw material to make a finished product, but the process mainly has the problem of low purity. The purity of the produced products is below 80%, and the product contains too many impurities. Patients are prone to adverse reactions when they are used...

Claims

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Application Information

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IPC IPC(8): A61K38/36A61K9/19A61K47/18A61K47/26C07K14/75C07K1/36C07K1/30C07K1/16A61P7/04A61P1/16
Inventor 徐建生王玉兵田健生梁华肖雷
Owner WUHAN ZHONGYUAN RUIDE BIOLOGICAL PROD CO LTD
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