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High-purity prothrombin complex product freeze-drying stabilizer

A prothrombin and complex technology, applied in the field of medicine and biology, can solve the problems of no research report, low content of high-purity PCC protein, and high stabilizer

Inactive Publication Date: 2012-05-09
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] The protein content of high-purity PCC is relatively small, and the requirements for stabilizers are higher. So far, there have been no reports about PCC freeze-drying stabilizers, let alone arginine or / and trehalose or / and histidine or / and Research Report on Glycine Used as Freeze-drying Stabilizer of High Purity PCC

Method used

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  • High-purity prothrombin complex product freeze-drying stabilizer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1: Protective effect of arginine, trehalose, and histidine on the main role of high-purity PCC coagulation factor IX

[0028] After freeze-drying the blank control product without adding any stabilizer, the recovery rate of coagulation factor IX was 59.5%, while adding different concentrations (0.5%, 1.5%) trehalose as a stabilizer product, the recovery rate of coagulation factor IX activity was 70%. % or more; add different concentrations (0.5%, 1.5%) of arginine as a stabilizer, and the recovery rate of coagulation factor IX activity is more than 76%; add different concentrations (0.5%, 1.5%) of histidine as a stabilizer Products, the recovery rate of coagulation factor IX activity is more than 77% (see Table 1), indicating that the protective agent of the present invention can protect the activity of coagulation factor IX, which is the main role of high-purity PCC, under a single factor.

[0029] Table 1 Effects of arginine, trehalose, and histidine on the re...

Embodiment 2

[0031] Example 2: The protective effect of glycine and glycine+trehalose or arginine or histidine on four coagulation factors of high-purity PCC

[0032] The product with only 2% glycine stabilizer added, after freeze-drying, the highest activity yield of the four coagulation factors is 75.4%; on the basis of 2% glycine, adding 0.5% trehalose stabilizer, the activity yield of the four coagulation factors is the lowest 81.2%; on the basis of 2% glycine, add 0.5% arginine stabilizer, the lowest active yield of four coagulation factors is 84.6%; on the basis of 2% glycine, add 0.5% histidine stabilizer, The lowest activity yield of the four coagulation factors was 83.5% (see Table 2); in addition, compared with 2% glycine, the products with trehalose, arginine, and histidine existed in freeze-dried form and reconstituted clarification. Better (see Table 3), it can be seen that on the basis of the presence of glycine, any of trehalose, arginine, and histidine can further effective...

Embodiment 3

[0037] Example 3: Protective effects of glycine and glycine+trehalose or / and arginine or / and histidine on four coagulation factors of high-purity PCC

[0038] Add 1.0% glycine + 0.5% arginine + 0.5% trehalose stabilizer, after freeze-drying, the activity yield of the four coagulation factors is the lowest 79.6%; add 1.0% glycine + 0.5% histidine + 0.5% trehalose to stabilize After freeze-drying, the activity yield of the four coagulation factors was the lowest at 77.9%; only adding 1.0% glycine protectant as a contrast, the activity yield of the four coagulation factors was the highest at 69.2% (see Table 4); in addition, with arginine acid and trehalose or histidine and trehalose stabilizers exist, the product freeze-dried appearance and reconstitution clarity are better than the glycine control group (see Table 5), it can be seen that on the basis of the presence of glycine, there is The presence of amino acid or histidine and trehalose can improve the stability of the four ...

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Abstract

The invention relates to the field of medicinal biotechnology, and in particular to a high-purity prothrombin complex product stabilizer capable of effectively preventing the inactivation of a blood coagulation factor IX with a main effect and blood coagulation factors II, VII and X in a product in a freeze-drying process, wherein the specific activity of each of four blood coagulation factors II, VII, IX and X is greater than or equal to 3.5IU / mg protein. The stabilizer provided by the invention contains arginine or / and trehalose or / and histidine or / and glycine. The tests show that so long as the high-purity prothrombin complex contains 0.1-10% of arginine or / and 0.1-10% of trehalose or / and 0.1-10% of histidine, the activity of the blood coagulation factor IX and the activity of the blood coagulation factors II, VII and X can be effectively protected in the freeze-drying process. Thus, the stabilizer provided by the invention can be applied to the freeze-drying process of the high-purity prothrombin complex.

Description

technical field [0001] The invention relates to the field of medical biotechnology, which is several and several groups of high-purity prothrombin complex products (four blood coagulation factors II, VII, IX, and X specific activities are all ≥ 3.5IU / mg) in the freeze-drying process, which can be effectively A stabilizer that prevents the inactivation of coagulation factor IX and coagulation factors II, VII, and X, which are mainly used in products. In more detail, 0.1%-10% arginine or / and 0.1%-10% trehalose or / and 0.1%-10% histidine or / and 0.1%- 10% glycine can effectively protect the activity of blood coagulation factor IX and blood coagulation factors II, VII, and X in the freeze-drying process. Background technique [0002] Human prothrombin complex (Prothrombin Complex Concentrate, PCC) is a blood product that is isolated from the mixed plasma of healthy people and can promote blood coagulation. It mainly contains coagulation factors II, VII, IX, and X that rely on vit...

Claims

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Application Information

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IPC IPC(8): A61K47/36A61K47/22A61K47/18A61K38/36A61P7/04
Inventor 曹海军黄亮李长清何琦赵红卫邱家山林方昭李志雄
Owner BLOOD TRASFUSION INST CHINESE ACAD OF MEDICAL SCI
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