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Production method of human fibrinogen

A technology of human fibrinogen and production method, which is applied in the fields of peptide/protein components, pharmaceutical formulations, and medical preparations containing active ingredients, etc. Guaranteed effect of inactivating DNA and RNA non-lipid-enveloped viruses, less clinical side effects, and stable temperature changes

Active Publication Date: 2012-07-11
GREEN CROSS CHINA BIOLOGICAL PRODS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the complex amino acid composition can easily lead to problems such as yellowing of the product after heating, difficulty in reconstitution, and a large amount of denatured protein after reconstitution, which directly affects the quality of the products of these manufacturers; the third is: as a simulation of DNA non-lipid enveloped virus Virus --- PPV virus, due to its super heat resistance and acid and alkali resistance, it is very difficult for general manufacturers to inactivate the products extracted from the manufacturing process of component I

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] 1. Plasma collection: 100L of frozen raw plasma that has passed the virus test and complies with the national quarantine period regulations, melts naturally at room temperature, disinfects the surface of the plasma bag with 75% alcohol, and then rinses the surface of the plasma bag with 25°C water for injection Use alcohol, 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. Pour into the centrifuge for continuous centrifugation at a speed of 5000rmp, the centrifuged supernatant is used for the manufacture of human serum albumin, human immunoglobulin, etc., and the centrifuged solid component---2.0kg of cryoprecipitate is used for the production of human fibrinogen Production.

[0029] 2. Cryoprecipitate dissolution and centrifugation:

[0030] Take out 2.0 kg of cryoprecipitate ...

Embodiment 2

[0046] 1. Plasma collection: 100L of frozen raw plasma that has passed the virus test and complies with the national quarantine period regulations, melted naturally at room temperature, sterilized the surface of the plasma bag with 75% alcohol, and then rinsed the surface of the plasma bag with 20°C water for injection Use alcohol, 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 to the special centrifuge tank in time, and control the temperature of the plasma at 0°C, Pour into the centrifuge for continuous centrifugal separation at a speed of 20000rmp. The centrifuged supernatant is used for the manufacture of human serum albumin, human immunoglobulin, etc., and the centrifuged solid component---2.0kg of cryoprecipitate is used for the production of human fibrinogen Production.

[0047] 2. Cryoprecipitate dissolution and centrifugation:

[0048] Take out 2.0kg of cryop...

Embodiment 3

[0064] 1. Plasma collection: 100L of frozen raw plasma that has passed the virus test and complies with the national quarantine period regulations, melts naturally at room temperature, disinfects the surface of the plasma bag with 75% alcohol, and then rinses the surface of the plasma bag with 22°C water for injection Use alcohol, 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 to a special centrifuge tank in time, and control the temperature of the plasma at 2°C. Pour into the centrifuge for continuous centrifugation at a speed of 12000rmp. The centrifuged supernatant is used for the manufacture of human serum albumin, human immunoglobulin, etc., and the centrifuged solid component---2.0kg of cryoprecipitate is used for the production of human fibrinogen Production.

[0065] 2. Cryoprecipitate dissolution and centrifugation:

[0066] Take out 2.0kg of cryoprecipitate ...

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Abstract

The invention provides a production method of human fibrinogen, which is against the method that domestic conventional manufacturers extract and separate human fibrinogen from component I, and the method for extracting fibrinogen from cryoprecipitate is adopted; an S / D method and a water-bath heat treating method are adopted to carry out double-virus inactivation, thereby effectively inactivatingfat enveloped virus and non-fat enveloped virus, and ensuring the security of products; the purity of extracted products reaches as high as more than 90%, the protein content of impurities is low, and the clinical side reaction of the product is small. In the production process of the human fibrinogen of the invention, glycine is utilized as a stabilizer, the freeze-drying time is prolonged about6-8 days to ensure the temperature variation of the product to be stable in freeze-dying process, but the freeze-drying time of general manufacturers is about 3 days; after being freeze-dried for 6-8days, the product has uniform structure, then water bath heat treatment is carried out on the product, thus the product can be evenly heated in the shortest time, thereby achieving the purposes of effectively inactivating DNA and RNA non-fat enveloped virus and simultaneously ensuring the stability of human fibrinogen.

Description

technical field [0001] The invention relates to the field of blood products, in particular to a production method of human fibrinogen. Background technique [0002] Background information: Human fibrinogen is mainly synthesized by the liver, and the human body content is about 2.5-4.0g / L. Most exist in human plasma, and less than 20% exist outside blood vessels. It is mainly used in the treatment of congenital and acquired fibrinogenemia, severe liver injury, liver cirrhosis, DIC, surgery or postpartum hemorrhage, etc. It is one of the necessary emergency medicines for hemostasis in clinical practice. Although there are currently several blood product manufacturers in China that have the qualifications to produce human fibrinogen, these manufacturers use the centrifuged supernatant of plasma after fractionation with low-temperature ethanol to produce Component I as raw material in the production process. , to produce a finished product. However, the main problems of this ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/36A61K9/19A61P19/08
Inventor 金昌燮鱼湖权王冰峰陈向东石政桓王玉兵杨雪瑶
Owner GREEN CROSS CHINA BIOLOGICAL PRODS
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