Dry heat processing stabilizer for prothrombin complex or factor v a IX preparation

A technology of prothrombin and coagulation factor, applied in the field of medicine, can solve the problems of unsatisfactory protective effect, difficulty in meeting large-scale production, and difficulty in achieving the recovery rate of coagulation factor activity.

Inactive Publication Date: 2009-04-29
SHANGHAI XINXING MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the protective effect in actual use is not ideal, and the recovery rate of coagulation factor activity before and after the actual dry heat treatment is difficult to reach or exceed 70%, which is difficult to meet the needs of large-scale production
So far, there is no report about using sucrose or / and arginine as a stabilizer for dry heat treatment of prothrombin complexes or coagulation factor IX preparations

Method used

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  • Dry heat processing stabilizer for prothrombin complex or factor v a IX preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0007] Example 1: The protective effect of the stabilizer of the present invention on the prothrombin complex.

[0008] 1. Preparation of Prothrombin Complex

[0009] According to conventional methods, the frozen plasma or plasma supernatant from which cryoprecipitation was removed was adsorbed with anion resin DEAE-Sepharose A50 to prothrombin complex, and eluted with an eluent containing 2M NaCl and 0.02M trisodium citrate, and the obtained eluted The solution was desalted and concentrated by ultrafiltration with an ultrafiltration buffer solution containing 0.02M trisodium citrate, 0.6% NaCl, and pH 6.6-7.8 to obtain a concentrated solution of prothrombin complex.

[0010] 2. Add stabilizer to prepare prothrombin complex freeze-dried preparation (until dry heat treatment)

[0011] A stabilizer composed of sucrose and arginine in a certain ratio (see Table 1) was added to the prothrombin complex prepared above, sterilized, sub-packaged, and freeze-dried, then subjected to 8...

Embodiment 2

[0017] Embodiment 2: Arginine is to the protection test of coagulation factor IX preparation

[0018] Conventionally, the blood coagulation factor IX eluted from the heparin affinity chromatography Sepharose CL-6B column is desalted by ultrafiltration, and the resulting solution contains 100 IU / ml blood coagulation factor IX, and 1% arginine is added. After freeze-drying, it was subjected to dry heat treatment at 80°C / 72 hours and 100°C / 30 minutes respectively, and the potency of blood coagulation factor IX was detected before and after dry heat treatment, and the recovery rate of activity was calculated. Compared with the blank control, the recovery rate of the blank control coagulation factor IX without adding arginine was 50.9% (80°C / 72 hours) and 57.8% (100°C / 30 minutes), while the recovery rate of adding 1% arginine 90.8% (80°C / 72 hours) and 92.0% (100°C / 30 minutes), respectively. The results showed that the products with arginine as a stabilizer could effectively protec...

Embodiment 3

[0019] Embodiment 3: the protective test of sucrose to coagulation factor IX

[0020] According to the conventional method, the blood coagulation factor IX obtained from the elution of the heparin affinity chromatography Sepharose CL-6B column was concentrated by ultrafiltration, and the obtained concentrated solution contained 80IU / ml blood coagulation factor IX, added 1% sucrose, sterilized and freeze-dried, respectively passed through Dry heat treatment at 80°C / 72 hours and 100°C / 30 minutes, detect the activity of coagulation factor IX before and after dry heat treatment, and calculate the activity recovery rate. The coagulation factor IX recovery rate of the blank control was 59.4% (80°C / 72 hours) and 63.9% (100°C / 30 minutes) respectively, and the recovery rate of adding 1% sucrose was 92.9% (80°C / 72 hours) and 94.7% % (100°C / 30 minutes). The results showed that the preparation with sucrose as a stabilizer could effectively protect coagulation factor IX during dry heat tr...

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Abstract

The invention relates to a stabilizing agent for preventing blood clotting factor reactive loss for prothrombin composite or blood clotting factor IX preparation during virus animatum eradication by dry heat, wherein the stabilizing agent is sucrose or / and arginine or its salt, it also can contain one or more of the conventional glycine, NaCl, citric acid trisodium and hamocura.

Description

technical field [0001] The invention relates to the technical field of medicine, and is a stabilizer capable of preventing loss of coagulation factor activity when prothrombin complex or coagulation factor IX is dry-heated to inactivate viruses. Specifically, the addition of sucrose or / and arginine or its salts to the prothrombin complex or coagulation factor IX can protect the coagulation factor and increase the coagulation factor when the virus is inactivated by dry heat (80°C or 100°C). recovery rate. Background technique [0002] Prothrombin complex (Prothrombin Complex Concentrate, PCC), that is, coagulation factor IX complex, including vitamin K-dependent coagulation factors II, VII, IX, X and protein C, protein S, etc., because it contains coagulation factor IX can be used It is used for the treatment of hemophilia B, and because it contains a variety of coagulation factors, it can also be used for the treatment of hemorrhage caused by low factors II, VII, IX, and X ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/43A61K38/36A61K47/26A61P7/04
Inventor 张美华王强彭柬潘文斌盛凤仙李玲
Owner SHANGHAI XINXING MEDICINE
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