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Protective agent in process for performing dry heat virus inactivation on high-purity prothrombin complex concentrate products

A dry heat virus inactivation and prothrombin technology, applied in the field of medicine and biology, can solve the problems of low protein content and strict requirements for protective agents.

Inactive Publication Date: 2013-12-25
BLOOD TRASFUSION INST CHINESE ACAD OF MEDICAL SCI +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] High-purity PCC has higher purity of coagulation factors, relatively less protein content, and more stringent requirements for protective agents. So far, there has been no research on protective agents for high-purity PCC dry heat virus inactivation process. In addition, no seaweed Sugar and / or histidine used as protective agent in PCC dry heat virus inactivation process

Method used

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  • Protective agent in process for performing dry heat virus inactivation on high-purity prothrombin complex concentrate products
  • Protective agent in process for performing dry heat virus inactivation on high-purity prothrombin complex concentrate products

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] After the blank control product without protective agent was inactivated by dry heat at 100°C for 30 minutes, the recovery rate of coagulation factor IX was lower than 58%, while the products with different concentrations (1.5%, 2.5%) of trehalose as protective agent, Blood coagulation factor IX activity recovery rate is more than 75%; Add different concentrations (1.5%, 2.5%) histidine as the goods of protective agent, blood coagulation factor IX activity recovery rate is more than 74% (see table 1), illustrates that the present invention protects The agent can effectively protect the coagulation factor IX, which is the main role of high-purity PCC, under the condition of single factor.

[0026] Table 1 Effect of trehalose and histidine on recovery rate of high-purity PCC coagulation factor IX activity treated by dry heat virus inactivation

[0027]

[0028] Example 2: Protective effect of trehalose and histidine on four coagulation factors of high-purity prothrombi...

Embodiment 2

[0029] After the blank control product without protective agent was inactivated by dry heat, the recovery rate of the four coagulation factors was not more than 59%, while the product added with 2.0% trehalose as the protective agent had the activity recovery rate of the four coagulation factors at 81%. More than %; add 2.0% histidine to make the goods of protecting agent, four kinds of blood coagulation factor activity recoveries are all more than 76% (see table 2), illustrate that protecting agent of the present invention can effectively protect high-purity PCC under single factor condition four coagulation factors.

[0030] Table 2 Effects of trehalose and histidine on the activity recovery rate of four coagulation factors of high-purity PCC treated with dry heat virus inactivation

[0031] coagulation factor type

[0032] Example 3: Protection test of trehalose or / and histidine+glycine on high-purity prothrombin complex mainly acting on blood coagulation factor I...

Embodiment 3

[0033] On the basis of 2.0% glycine, different concentrations (0.5%, 1.5%) of trehalose were added as protective agents, and the activity yield of blood coagulation factor IX was above 97% (see Table 3); on the basis of 2.0% glycine, different concentrations ( 0.5%, 1.5%) histidine was used as protective agent, and the yield of coagulation factor IX activity was above 76% (see Table 3), all higher than the 67.4% yield of 2.0% glycine control group. On the basis of 2.0% glycine, add 0.5% histidine+0.5% trehalose, 1.0% histidine+0.5% trehalose, 0.5% histidine+1.0% trehalose, 1.0% histidine+1.0% Trehalose is used as a protective agent, and the minimum active yield of blood coagulation factor IX is 92.8% (see Table 4), which is higher than the 2.0% glycine control group. During the heat inactivation process, the activity of coagulation factor IX, which is the main role of high-purity PCC, has a good protective effect.

[0034] Table 3 Effects of trehalose+glycine and histidine+gl...

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Abstract

The invention relates to the field of medicinal biotechnologies, and discloses a protective agent which can effectively prevent a mainly acting blood coagulation factor IX and other blood coagulation factors II, VII and X in high-purity prothrombin complex concentrate products (the specific activities of the blood coagulation factors II, VII, IX, and X are more than and equal to 3.5IU / mg protein) from being inactivated in the process of performing dry heat virus inactivation at the temperature of 100 DEG C for 30 minutes. The protective agent is trehalose or / and histidine and also contains two or three of common glycine, sodium citrate and NaCl. Experiments prove that if only high-purity prothrombin complex concentrate products contain 0.1 to 8 percent of trehalose or / and 0.1 to 8 percent of histidine, the activities of the blood coagulation factors IX, II, VII and X can be effectively protected in the process of performing dry heat virus inactivation at the temperature of 100 DEG C for 30 minutes. Therefore, the invention can be used as the protective agent in the process for performing dry heat virus inactivation on the high-purity prothrombin complex concentrate products.

Description

technical field [0001] The invention relates to the field of medical biotechnology, which is several or several groups of high-purity prothrombin complex products (four blood coagulation factors II, VII, IX, and X specific activities are all ≥ 3.5IU / mg) at 100°C, 30min dry heat The virus inactivation process can effectively prevent the protective agent that mainly acts on blood coagulation factor IX and blood coagulation factors II, VII, X inactivation in the product. Specifically, adding 0.1%-8% trehalose or / and 0.1%-8% histidine to the high-purity prothrombin complex can effectively protect coagulation factor IX, coagulation factor II, Activity of VII, X. Background technique [0002] Human prothrombin complex (Prothrombin Complex Concentrate, PCC), also known as coagulation factor IX complex, is a freeze-dried plasma protein product prepared from the mixed plasma of healthy people. In addition to coagulation factor IX, it also contains other vitamin K-dependent synthesis...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/48A61K47/26C12N9/74A61P7/04
Inventor 李长清曹海军黄亮邱家山赵红卫何琦喻洪跃狄姗姗
Owner BLOOD TRASFUSION INST CHINESE ACAD OF MEDICAL SCI
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