Fibrous protein hemostatic patch and making method thereof

A fibrin and production method technology, applied in the direction of fibrinogen, animal/human protein, biochemical equipment and methods, etc., can solve the problems of denaturation, loss of hemostatic effect, heat intolerance, etc., and achieve the effect of expanding the scope of application

Active Publication Date: 2011-09-14
FUJIAN NANSHENG TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Fibrinogen, thrombin, and collagen are all protein products of biological origin, so they have the disadvantage of heat resistance. Storage at room temperature will easily cause protein inactivation and denaturation, thus losing the hemostatic effect
Usually, fibrin glue or fibrin hemostatic patch needs to be stored at a low temperature of about 4°C,...

Method used

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  • Fibrous protein hemostatic patch and making method thereof
  • Fibrous protein hemostatic patch and making method thereof
  • Fibrous protein hemostatic patch and making method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] The protecting agent that the present invention selects is sugar (sucrose, trehalose), sugar alcohol (mannitol, sorbitol, xylitol), amino acid (glycine, arginine, arginine hydrochloride, histidine), salts (Sodium Chloride, Sodium Citrate, Calcium Chloride, Sodium Acetate). The fibrinogen protective agent is a distilled water solution of sugar, sugar alcohol, amino acid, and salt. The thrombin protective agent is a distilled water solution of both amino acids and salts. Prepare several groups of protective agents with different components and concentrations. Dosage spare.

Embodiment 2

[0036] Pig plasma was inactivated by S / D method with 1% polysorbate 80 and 0.3% tributyl phosphate to remove virus. Fibrinogen was separated from pig plasma by low-temperature ethanol method, and fibrinogen was dissolved and then precipitated by low-temperature ethanol method to remove polysorbate 80 and tributyl phosphate. Utilize barium sulfate adsorption method (Li Zhongmin, Song Jian, separation and purification of bovine prothrombin and activity identification-Journal of China Medical University, 1994, 5 (23): 436-437) obtain prothrombin from blood plasma, use chlorination Thrombin is obtained after activation by calcium. Collagen extracted from porcine tendon was dissolved into a 20 mg / ml solution.

[0037] After dissolving the fibrinogen in distilled water, add the pre-dissolved fibrinogen protective agent solution and mix, so that the final mass concentration is 70mg / ml of fibrinogen, 30mg / ml of sucrose, 20mg / ml of mannitol, and 35mg / ml of arginine hydrochloride. ml,...

Embodiment 3

[0044] Fibrinogen, thrombin and collagen were prepared according to Example 1.

[0045] After dissolving the fibrinogen, add the pre-dissolved fibrinogen protective agent to make the final concentration of fibrinogen 30mg / ml, trehalose 25mg / ml, sorbitol 20mg / ml, arginine hydrochloride 35mg / ml, glycine 10mg / ml ml, sodium chloride 4mg / ml, trisodium citrate 7mg / ml, vitamin B 2 (For color indication) Appropriate amount.

[0046] After dissolving the thrombin, add the pre-dissolved thrombin protective agent solution, so that the final concentration is 100 IU / ml of thrombin, 20 mg / ml of glycine, and 4 mg / ml of calcium chloride.

[0047] The fibrinogen solution and the thrombin solution were freeze-dried and the virus was inactivated by dry heat method.

[0048] Dissolve the collagen extracted from pig tendon into a 10mg / ml solution, pour the collagen solution into a flat container, and add 0.5ml / cm 2 , become a loose collagen sponge after freeze-drying, and cut into certain speci...

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PUM

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Abstract

The invention relates to a fibrous protein hemostatic patch capable of being stored at room temperature. The fibrous protein hemostatic patch mainly comprises fibrinogen and thrombin derived from blood of human or mammal, and collagen derived from skin or tendon of the mammal; the fibrous protein hemostatic patch consists of the fibrinogen, the thrombin and the collagen. The fibrinogen and the thrombin are added with a protective agent, so that the fibrous protein hemostatic patch can be stored at room temperature, and has the quality guarantee period of more than 6 months and the longest quality guarantee period of 2 years. The fibrous protein hemostatic patch is suitable for locally stopping bleeding in surgeries and quickly stopping bleeding on occasions such as battlefields and disasters.

Description

technical field [0001] The invention relates to the technical field of biopharmaceuticals, in particular to a fibrin hemostatic patch that can be stored at room temperature and maintain its function and efficacy and a manufacturing method thereof. Background technique [0002] Fibrin-based hemostatic products are biological products that can quickly and effectively stop bleeding from wounds. They have the advantages of rapid hemostasis, good adhesion, good tissue compatibility, promotion of wound healing, and promotion of tissue regeneration. At present, fibrin-based hemostatic products have been widely used at home and abroad. According to different sources of fibrinogen, fibrin-based hemostatic products can be divided into two categories: human-derived fibrin preparations and porcine-derived fibrin preparations; according to different product formulations, they can be divided into two types: fibrin glue and fibrin hemostatic patches . [0003] Fibrin glue is composed of ...

Claims

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Application Information

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IPC IPC(8): A61L15/32C07K14/75C12N9/74
Inventor 黄发灿
Owner FUJIAN NANSHENG TECH
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