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A kind of preparation method of human coagulation factor VIII

A technology of human blood coagulation factor and blood coagulation factor, which is applied in the field of medicine, can solve the problems of human albumin spreading other viruses or pathogens, decrease of coagulation factor VIII titer, and high cost of human blood albumin, so as to avoid flocculation and precipitation and improve stability Sex, the effect of maintaining protein activity

Active Publication Date: 2017-01-25
广东双林生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the protective agent added in the preparation process of conventional human blood coagulation factor VIII mainly utilizes albumin or sugar alcohol, and cooperates with amino acids, inorganic salts, etc. to play a role. For example, human blood white protein, but the introduction of human albumin is not only costly, but the use of human albumin is likely to have the potential risk of spreading other viruses or pathogens; Chinese invention patent 201210060299.0 uses a combination of sugar alcohol and amino acid as a protective agent, but the prepared human Blood coagulation factor VIII products contain sugar or sugar alcohols, which are not suitable for diabetic patients, which limits the scope of application of the product. At the same time, after the heat treatment of the patented product inactivates the virus, the titer of blood coagulation factor VIII drops seriously, and the blood coagulation activity decreases after heat treatment. The rate is only about 33%, and the practical application value is not great

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] 1. Preparation of human coagulation factor VIII solution

[0046] (1) Making cryoprecipitate and dissolving cryoprecipitate

[0047] Use fresh frozen human plasma as raw material, melt the plasma, and centrifuge to prepare cryoprecipitate. Dissolve the cryoprecipitate with normal saline containing 8 IU / ml heparin pre-cooled at 15~20℃. The amount of saline is 7~9% of the weight of the precipitate. times, stirred and dissolved and then stood still for 60 min.

[0048] (2) Aluminum glue adsorption

[0049] Heat up the dissolved solution after standing to 25~28°C, add aluminum hydroxide gel with a mass concentration of 3% at the same temperature, the amount added is 40% of the weight of the cryoprecipitate, and add in the way of infiltration under stirring, that is, at 80~ At a stirring speed of 100 rpm, use a latex tube to pump the aluminum hydroxide gel below the liquid level of the solution at a rate of 80-100 ml / min. After the addition, cool down to 15-20°C and remove...

Embodiment 2

[0061] 1. Preparation of human coagulation factor VIII solution

[0062] Refer to step 1 of Example 1.

[0063] 2. Preparation of human coagulation factor VIII freeze-drying and dry heat treatment protective agent

[0064] Weigh various inorganic salts, amino acids and surfactants in proportion, use common medical injection water to prepare human blood coagulation factor VIII freeze-drying and dry heat treatment protective agents, and prepare human blood coagulation factor VIII freeze-drying and dry heat treatment protective agents. The original concentrations were as follows: sodium citrate 10 mmol / L, sodium chloride 100 mmol / L, calcium chloride 4 mmol / L, glycine 50 mmol / L, arginine 50 mmol / L, histidine 100 mmol / L, Lysine 100 mmol / L, Tween 80 0.1 mmol / L.

[0065] 3. The use of human coagulation factor VIII freeze-drying and dry heat treatment protective agent

[0066] Refer to step 3 of Example 1.

Embodiment 3

[0068] 1. Preparation of human coagulation factor VIII solution

[0069] Refer to step 1 of Example 1.

[0070] 2. Preparation of human coagulation factor VIII freeze-drying and dry heat treatment protective agent

[0071] Weigh various inorganic salts, amino acids and surfactants in proportion, use common medical injection water to prepare human blood coagulation factor VIII freeze-drying and dry heat treatment protective agents, and prepare human blood coagulation factor VIII freeze-drying and dry heat treatment protective agents. The original concentrations were as follows: sodium citrate 15 mmol / L, sodium chloride 50 mmol / L, calcium chloride 7 mmol / L, glycine 100 mmol / L, arginine 100 mmol / L, histidine 80 mmol / L, Lysine 80 mmol / L, Tween 80 0.2 mmol / L.

[0072] 3. The use of human coagulation factor VIII freeze-drying and dry heat treatment protective agent

[0073] Refer to step 3 of Example 1.

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Abstract

The invention discloses a preparation method of a human coagulation factor VIII. The human coagulation factor VIII prepared by the method does not contain human serum albumin or other animal-derived protein, does not contain sugar or sugar alcohol, does not have the risk for transmitting other viruses or pathogene, and is wide in applicable crowd scope, and can be used by diabetic patients; the human coagulation factor VIII prepared by the method is fast to redissolve and good in redissolving effect, and still keeps high titer and high specific activity which are respectively larger than 80 percent and 40 IU / mg; in addition, the preparation method is simple, the cost is low, the human coagulation factor VIII is safe and effective, and has a good industrial application prospect.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of human blood coagulation factor VIII. Background technique [0002] Hemophilia is a genetic bleeding disorder in which the level of clotting factors in the human body is reduced or lacked due to mutations in the clotting factor genes, leading to bleeding. Deficiency or insufficiency of clotting factor FVIII leads to hemophilia A, and deficiency or insufficiency of clotting factor IX leads to hemophilia B. Clotting factor replacement therapy is the mainstay of treatment for hemophilia. [0003] With the development of modern chromatography technology, foreign blood product companies have developed high-purity human coagulation factor products to meet the needs of hemophiliacs. Considering the safety of viruses in my country, the National Drug Administration has not yet approved the import of coagulation factors derived from human blood. Domes...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07K14/755C07K1/36C07K1/34C07K1/30C07K1/16A61K38/37A61P7/04
CPCC07K14/755
Inventor 朱光祖蒋桂香
Owner 广东双林生物制药有限公司
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