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Preparation method for fibrinogen

A fibrinogen and sediment technology, applied in the field of pharmaceutical bioengineering, can solve problems such as inconvenience of use, increase the content of toxins such as pyrogen, and prolong the production cycle, so as to achieve the protection of biological activity, shorten the reconstitution time, and reduce the possibility of sexual effect

Active Publication Date: 2013-08-21
DATIAN HUACAN BIO TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] 1. The time of primary dissolution and secondary dissolution in the production process is as long as several hours. This process will easily lead to the reproduction of bacteria and other microorganisms, thereby increasing the content of pyrogens and other toxins in the product; if the dissolution time is too long, it will easily cause other harmful substances. pollution, while prolonging the production cycle and increasing costs;
[0006] 2. The product made by the above-mentioned process takes too long to redissolve, which is inconvenient to use, especially when every second counts in first aid, which is very unfavorable;
[0014] Although the solubility rate has increased after the above improvements, it still cannot achieve satisfactory purity and reconstitution speed

Method used

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  • Preparation method for fibrinogen
  • Preparation method for fibrinogen
  • Preparation method for fibrinogen

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] All operations in the process of Example 1 are carried out in a sterile 10,000-level purification area, wherein subpackaging and freeze-drying operations are all carried out in a local 100-level purification area, and the operations performed all meet the operating requirements of the clean area. The production specification is 2.5ml.

[0061] (1) Get 10000ml of aseptically collected pig blood;

[0062] (2) Centrifuge, take supernatant anticoagulant plasma 5500ml;

[0063] (3) Add 2.5% w / v glucose and 0.38% w / v trisodium citrate to the supernatant anticoagulated plasma obtained in step (2) as auxiliary agents, then add 0.3% w / v tributyl phosphate and 1% w / v Tween-80 was used as a virus inactivating agent, and the virus was inactivated at 25°C for 6 hours;

[0064] Centrifuge the inactivated plasma, discard the precipitate, and take the supernatant;

[0065] (4) Primary sedimentation: Pre-cool the clear liquid obtained through step (3) to 0-4°C, carry out centrifugati...

Embodiment 2

[0077] All operations in the process of Example 2 are carried out in a sterile ten thousand-level purification area, wherein subpackaging and freeze-drying operations are all carried out in a local one-hundred-level purification area, and the operations performed all meet the operating requirements of the clean area. The production specification is 2.5ml.

[0078] (1) Get 150000ml of aseptically collected pig blood;

[0079] (2) Centrifuge and take 82000ml of supernatant anticoagulated plasma;

[0080] (3) Add 2% w / v glycine to the supernatant anticoagulated plasma obtained in step (2) as an auxiliary agent, then add 0.3% w / v tributyl phosphate and 1% w / v Tween-80 as a virus Inactivator, carry out virus inactivation at 25°C for 6 hours;

[0081] Centrifuge the inactivated plasma, discard the precipitate, and take the supernatant;

[0082] (4) Primary sedimentation: pre-cooling the clear liquid obtained through step (3) to 0-4°C, centrifuging, discarding the precipitate, tak...

Embodiment 3

[0094] All operations of the process in Example 3 are carried out in a ten thousand-level purification area, wherein subpackaging and freeze-drying operations are all carried out in a local one-hundred-level purification area, and the operations performed all meet the operating requirements of the clean area. The production specification is 2.5ml.

[0095] (1) Get 50000ml of aseptically collected pig blood;

[0096] (2) Centrifuge and get supernatant anticoagulated plasma 26000ml;

[0097] (3) Add 0.3% w / v tributyl phosphate and 1% w / v Tween-80 to the supernatant anticoagulated plasma obtained in step (2) as a virus inactivator, and carry out virus inactivation at 25° C. Hour;

[0098] Centrifuge the inactivated plasma, discard the precipitate, and take the supernatant;

[0099] (4) Primary sedimentation: Pre-cooling the clear liquid obtained through step (3) to 0~4° C., centrifuging, discarding the precipitate, getting the clear liquid and adding cold ethanol (95% v / v) 2340m...

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Abstract

The invention provides a preparation method for fibrinogen with the advantages of high dissolution rate in the production process, short production period, fast solubility in clinical use, good biological activity, high safety in clinical use and high yield. An aid is added into supernate anticoagulant plasma. Compared with the prior art, the preparation method has the advantages that: 1, the preparation method provided by the invention is high in extraction efficiency; 2, the aid adopted in the method can improve the quality of the fibrinogen product, and plays a role in protecting the biological activities of the fibrinogen and blood coagulation factors XIII in virus inactivation and cold ethanol settlement processes; 3, in the process, the process solubility time of the fibrinogen is shortened to about 10 minutes; and 4, the solubility time of the freeze dried product of the fibrinogen is within 30 seconds, so precious time is won for rescuing patients in time in clinic.

Description

technical field [0001] The invention relates to the field of medical bioengineering, in particular to a method for preparing fibrinogen in a binary component of medical biological glue by using human blood or mammalian blood as a raw material. Background technique [0002] At present, fibrinogen at home and abroad is mainly extracted and prepared from human plasma and animal plasma. When it is used clinically, it is catalyzed by thrombin to break the fibrinogen peptides A and B into fibrin gel. The fibrin gel is further covalently cross-linked into an insoluble fibrin clot by cross-linking of activated coagulation factor XIII in the gel. [0003] The medical bioglue (fibrin glue) referred to in the present invention is a kind of biological hemostatic adhesive, which is prepared by mixing purified human or animal blood fibrinogen, human or animal blood thrombin and calcium ions. Medical bioglue with fibrinogen and thrombin as binary components is widely used clinically, and ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07K14/75C07K1/30
Inventor 黄发灿
Owner DATIAN HUACAN BIO TECH
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