Freeze-dry and dry heat treatment protecting agent for human blood coagulation factor VIII

A technology of human coagulation factor and dry heat treatment, which is applied in the field of medicine, can solve the problems of coagulation factor VIII titer drop, little practical application value, and limited application range, and achieve high specific activity, high titer, and avoid flocculation and precipitation.

Active Publication Date: 2014-12-24
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

However, the introduction of human serum albumin is not only costly, but also the use of human serum albumin may have the potential risk of spreading other viruses or pathogens, and products made from sugar or sugar alcohol are not suitable for diabetics, which limits the The scope of application of this product, at the same time, after the patented product is heat-treated to inactivate the virus, the potency of blood coagulation factor VIII drops seriously, and the yield of blood coagulation activity after heat treatment is only about 33%, and the actual application value is not great

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] 1. Preparation of human coagulation factor VIII solution

[0027] (1) Making cryoprecipitate and dissolving cryoprecipitate

[0028] 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.

[0029] (2) Aluminum glue adsorption

[0030] 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

[0042] 1. Preparation of human coagulation factor VIII solution

[0043] Refer to step 1 of Example 1.

[0044] 2. Preparation of human coagulation factor VIII freeze-drying and dry heat treatment protective agent

[0045] 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.

[0046] 3. The use of human coagulation factor VIII freeze-drying and dry heat treatment protective agent

[0047] Refer to step 3 of Example 1.

Embodiment 3

[0049] 1. Preparation of human coagulation factor VIII solution

[0050] Refer to step 1 of Example 1.

[0051] 2. Preparation of human coagulation factor VIII freeze-drying and dry heat treatment protective agent

[0052] 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.

[0053] 3. The use of human coagulation factor VIII freeze-drying and dry heat treatment protective agent

[0054] Refer to step 3 of Example 1.

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PUM

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Abstract

The invention discloses a freeze-drying and dry heat treatment protecting agent for human coagulation factor VIII. The freeze-drying and dry heat treatment protecting agent for human coagulation factor VIII does not contain human serum albumin or other animal-source proteins, sugar or sugar alcohol, is composed of soluble salt, amino acid and a surface active agent, is free from the risk of spreading other viruses or causative agents, and is applicable to a wide crowd range, including diabetics; after being freeze-dried, a product of the human coagulation factor VIII using the protecting agent is quick in redissolving and has a good redissolving effect, still keeps high potency and high specific activity, and has the potency higher than 80 percent and the specific activity higher than 40 IU / mg; in addition, the freeze-drying and dry heat treatment protecting agent for human coagulation factor VIII is low in cost, simple to prepare, has an obvious protecting effect, is safe and effective, and has an excellent industrial application prospect.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a human coagulation factor VIII freeze-drying and dry heat treatment protective agent. 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 deriv...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/18A61K47/10A61K47/26
Inventor 朱光祖蒋桂香
Owner 广东双林生物制药有限公司
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