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Preparation method of water-soluble alginate for in-vivo implantation

A kind of alginate and water-soluble technology, which is applied in the field of preparation of water-soluble alginate implanted in the body, can solve the problems of difficult removal, limited application, and inability to meet the needs of mass production, so as to avoid adverse effects and have high purity Effect

Active Publication Date: 2020-02-18
QINGDAO BRIGHT MOON ALGINATE TISSUE ENG MATERIAL CO LTD
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Problems solved by technology

Ma Xiaojun etc. have reported a kind of preparation method of sodium alginate for tissue engineering, and the product of this treatment method can reach the high-purity sodium alginate quality standard for tissue engineering promulgated by my country's State Food and Drug Administration (YY / T 0606.8-2008 " Tissue Engineering Medical Products Part 8: Sodium Alginate "), but in the process, the gel microsphere preparation process has low efficiency and cannot meet the needs of mass production. The Ba 2+ or Ca 2+ Difficult to remove, residual ions affect product purity and performance
In addition, simple activated carbon adsorption has very limited effect on endotoxin removal, which severely limits its application in in vivo injection and implant and interventional products.

Method used

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  • Preparation method of water-soluble alginate for in-vivo implantation
  • Preparation method of water-soluble alginate for in-vivo implantation

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preparation example Construction

[0031] A preparation method for implanting water-soluble alginate in vivo, comprising the following steps:

[0032] (1) Dissolve commercially available food-grade or pharmaceutical excipient-grade water-soluble alginate (sodium alginate, potassium alginate and / or ammonium alginate) in purified water to obtain a water-soluble alginate solution with a concentration of 0.3% ~3% (w / v, g / ml);

[0033] (2) Pass the water-soluble alginate solution through a microporous folded membrane filter element (polypropylene filter element (PP), polyethersulfone filter element (PES) or polytetrafluoroethylene filter element (PTFE) with a pore size of 0.8 μm, 0.45 μm, and 0.22 μm. ) after filtering and adding activated carbon for adsorption, the mass ratio of water-soluble alginate to activated carbon is 5:1 to 0.1:1, and mechanically stirred at room temperature for 0.5 to 20 hours;

[0034] (3) decarburize the solution adsorbed by activated carbon in step (2) using a microporous folded membran...

Embodiment 1

[0041] 1. Add 10 g of commercially available pharmaceutical excipient grade sodium alginate into 2 L of distilled water, and dissolve it with mechanical stirring at a speed of 1500 rpm for 6 hours to obtain alginic acid with a content of 0.5% (g / ml) sodium solution.

[0042] 2. The solution obtained in step 1 was filtered through a microporous folded membrane filter element with a pore size of 0.8 μm, and then 50 g of activated carbon was added, and mechanically stirred for 6 hours at room temperature.

[0043] 3. The solution containing activated carbon is filtered through a microporous folded membrane filter element with a pore size of 0.8 μm to remove the activated carbon, and activated carbon is added to the obtained solution again, and the adsorption and decarbonization filtration process is repeated twice.

[0044] 4. Spray the alginate solution obtained in step 3 into a 0.5M hydrochloric acid solution to form alginate gel microspheres. After soaking for 8 hours, fully w...

Embodiment 2

[0053] 1. Add 10 g of commercially available food-grade potassium alginate into 1 L of distilled water, and dissolve it with mechanical stirring at a speed of 1500 rpm for 8 hours to obtain a potassium alginate solution with a content of 1.0% (g / ml) .

[0054] 2. The solution obtained in step 1 was filtered through a microporous folded membrane filter element with a pore size of 0.45 μm, then 30 g of activated carbon was added, and mechanically stirred for 4 hours at room temperature.

[0055] 3. Same as embodiment 1

[0056] 4. Drop the alginate solution obtained in step 3 into a 0.2M sulfuric acid solution to form alginate gel microspheres. After soaking for 12 hours, fully wash the gel microspheres with purified water.

[0057] 5. Soak the alginate gel microspheres in 2L, 100mM potassium carbonate solution for 20 hours, then take out the gel microspheres and wash them thoroughly with purified water.

[0058] 6. Add pH 12.0 potassium bicarbonate solution to the eluted algi...

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Abstract

The invention relates to the technical field of natural polysaccharides for in-vivo implantation, in particular to a preparation method of water-soluble alginate for in-vivo implantation. The preparation method comprises the following steps of: taking commercially available food-grade or pharmaceutical adjuvant-grade water-soluble alginate as a raw material, performing microporous filtration and multistage activated carbon adsorption, and then acidifying to form gel; eluting the gel with an alkaline solution for redissolving the gel, and adsorbing the gel with polymyxin B agarose; and separating out alginate with an organic solution in a sterile environment, and vacuum drying to obtain sodium alginate for in- vivo implantation. According to the invention, the synergistic effects of physical adsorption, affinity adsorption and chemical chelation are utilized to remove impurities such as foreign proteins, endotoxin and the like, impurity ions are not introduced in the preparation process, adverse effects of ion residues on product quality are avoided, and the obtained alginate has high purity and can be implanted in vivo; a folded membrane filter element and activated carbon adsorption are used to complete microporous filtration of high viscosity liquid; a two-fluid nozzle is adopted for dispersion granulation, and the method is suitable for industrial batch production.

Description

technical field [0001] The invention relates to the technical field of natural polysaccharides for implantation in vivo, in particular to a preparation method for water-soluble alginate for implantation in vivo. Background technique [0002] Alginic acid (ALG) is a natural polysaccharide formed by mixing and copolymerizing β-D-mannuronic acid and α-L-guluronic acid through 1-4 glycosidic bonds. Sodium, potassium, ammonium and other monovalent ion salts of alginic acid have good water solubility, among which sodium alginate (NaALG) is the most commonly used alginate. Aqueous alginate solution encounters Ca 2+ 、Ba 2+ When it waits for divalent ions, it forms an insoluble alginate gel, which has good network structure, biocompatibility and degradability. It has been widely used in medical and clinical research, and is one of the hot tissue engineering materials. The existing sodium alginate preparation methods include acid coagulation acidification method, calcium coagulatio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/04
CPCC08B37/0003C08B37/0084
Inventor 张德蒙张梦雪于炜婷谢威杨王发合来永强
Owner QINGDAO BRIGHT MOON ALGINATE TISSUE ENG MATERIAL CO LTD
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