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Instant freeze-dried fibriogen preparation with anti dry heat treatment

A fibrinogen and preparation technology, applied in the field of medicine, can solve the problems of unsatisfactory, more than 30 minutes, biological activity decline, etc., and achieve the effect of convenient clinical use

Inactive Publication Date: 2004-04-14
SHANGHAI XINXING MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Adding glycine as a stabilizer can reduce the denaturation effect of dry heat on fibrinogen, but it is still unsatisfactory, especially when the high-concentration fibrinogen product is reconstituted at 37°C, the time is often more than 30 minutes, and the biological activity is greatly improved. decline
Therefore the prescription of existing fibrinogen preparation is not suitable for the processing of above-mentioned dry heat inactivated virus

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Embodiment 1: Preparation of fibrinogen preparation of the present invention (dry heat method)

[0016] According to routine, adjust the plasma pH to 6.8-7.2, add cold ethanol to 8% concentration, lower the temperature to about -2°C, centrifuge to obtain a precipitate rich in fibrinogen, and dissolve the precipitate in 4 times 10-37°C solution , stir to dissolve, the final solution contains 0.4% sodium chloride, 1.2% trisodium citrate, 2% L-arginine hydrochloride, 0.65% L-leucine, 2% sorbitol, 2% fibrinogen, Sterilize and subpackage, freeze-dry, and then heat in a water bath at 100°C for 30 minutes to inactivate the virus.

Embodiment 2

[0017] Embodiment 2: S / D method and dry heat method are combined inactivated virus treatment:

[0018] Adjust the plasma pH to 6.8-7.2, add ethanol to 8% concentration, lower the temperature to about -2°C, and centrifuge to obtain a precipitate rich in fibrinogen. Dissolve the precipitate in solution 1 (containing 0.85% sodium chloride, 1.2% trisodium citrate, 1% sucrose) at 10-37°C, filter to remove particles, then add Tween 80 (Tween80) and tributyl phosphate (TNBP ) to a final concentration of 1% Tween80 and 0.3% TNBP, stir evenly, adjust the temperature of the product to 24-30° C., and keep it warm for at least 6 hours to inactivate lipid-enveloped viruses.

[0019] After the above S / D inactivation treatment, cool the product to 0°C, add cold ethanol so that the ethanol in the final reaction solution is about 8%, gradually adjust the temperature to about -2°C, and centrifuge to obtain a precipitate.

[0020] Redissolve the precipitate in solution 2 (containing 0.85% sodiu...

Embodiment 3

[0021] Example 3: Comparative test of performance indicators of fibrinogen preparations prepared with different stabilizer ratios

[0022] According to the method of Example 2, the precipitate after secondary ethanol purification after S / D treatment was obtained, the precipitate was divided into several parts, and dissolved in the following solution of different stabilizer formulations in a ratio of 1:2 respectively, and the precipitation dissolution time was observed and compared. , Filtration speed, appearance, filtration loss and product liquid stability.

[0023] Group number Stabilizer solution formulation

[0024] 1 0.2% NaCl, 0.3% trisodium citrate, 2.5% glucose

[0025] 2 0.2% NaCl, 0.3% trisodium citrate, 1% glucose

[0026] 3 0.2% NaCl, 0.3% trisodium citrate, 1% L-arginine hydrochloride

[0027] 2.5% Sorbitol

[0028] 4 0.3% trisodium citrate, 2.5% L-arginine hydrochloride,

[0029] ...

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PUM

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Abstract

The invention is a dry-heat processing resistant instant freeze-dried fibrinogen preparation, composed of fibrinogen and stabilizer, the stabilizer including L-arginine or L-arginine salts, and sorbierite, and also including L-leucine, NaCl, Tris or trisodium citric acid. It can adopt dry-heat 80íµ-72hours or 100íµ-30minutes to inactivate virus and quickly dissolve under room temperature, which meets the requirement of clinical first-aid.

Description

technical field [0001] The invention relates to the technical field of medicine, and is a freeze-dried fibrinogen preparation that can withstand dry heat inactivation virus treatment and can be rapidly reconstituted at room temperature. Background technique [0002] Fibrinogen, coagulation factor I, is one of the main components of plasma protein, with a molecular weight of about 340,000. Fibrinogen can form fibrin under the action of thrombin, and then form a stable fibrin thrombus together with platelets, so Clinically, it is used together with thrombin for emergency hemostasis and wound adhesion, and it can also supplement fibrinogen through intravenous injection alone. [0003] Fibrinogen is easily inactivated in a liquid state, so the preparations used clinically are freeze-dried preparations, which are reconstituted with water for injection. Due to its special molecular properties, the existing freeze-dried fibrinogen is difficult to dissol...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/36A61P7/04
Inventor 王强程燕堵疾阎晨
Owner SHANGHAI XINXING MEDICINE