High-strength biological scaffold material and preparation method thereof

A method for preparing a high-strength biological scaffold material, characterized in that, the method comprises the following steps:

• boiled-off silk obtained by degumming silk is woven into a woven material by a textile machine to form a framework according to the desired shape, and then the framework is placed into a mold;
• a solution containing silk fibroin is injected into the mold having the framework placed therein, and subjected to freezing and vacuum treatment;
• thereby a coating layer having a thickness of 100 microns to 5 cm is formed on the surface of the framework, and the high-strength biological scaffold material is prepared, wherein said solution containing silk fibroin is one selected from the group consisting of:
• an aqueous silk fibroin solution, a mixed solution of silk fibroin and gelatin, and a mixed solution of silk fibroin and collagen;
• the weave density of the woven material is such that the distance between adjacent boiled-off silks is between 0.5 mm and 3 mm, and the material of the coating layer is selected from the group consisting of:
• silk protein scaffold material, silk fibroin/gelatin biological scaffold material or silk fibroin/collagen biological scaffold material.

A method for preparing a high-strength anal fistula repair plug, characterized in that, the method comprises the following steps:

• 1) preparing a solution containing silk fibroin, the solution containing silk fibroin being one selected from the group consisting of:
• an aqueous silk fibroin solution, a mixed solution of silk fibroin and gelatin, and a mixed solution of silk fibroin and collagen;
• 2) weaving degummed boiled-off silk into a tubular material to provide a framework and placing the tubular material into a mold for preparing anal fistula repair plug, the weave density of the tubular material being such that the distance between adjacent boiled-off silks is between 0.5 mm and 3 mm;
• 3) injecting the solution containing silk fibroin into the mold having the tubular material placed therein, and subjecting it to freezing under a low temperature of −10 to −30° C. for 20 to 24 hours to obtain a frozen body;
• freeze-drying the frozen body to obtain a soluble composite anal fistula repair plug, the soluble composite anal fistula repair plug having the tubular material woven from boiled-off silk as a framework and a layer of soluble silk fibroin layer/silk fibroin and gelatin composite layer/silk fibroin and collagen composite layer coated on the framework;
• 4) placing the soluble composite anal fistula repair plug into a vacuum dryer and performing a vacuum treatment for 4 hours or more to obtain a water-insoluble composite anal fistula repair plug, the water-insoluble composite anal fistula repair plug having the tubular material woven from boiled-off silk as a framework and a biological scaffold material as a coating layer, the biological scaffold material being selected from the group consisting of:
• silk protein biological scaffold material, silk fibroin/gelatin biological scaffold material or silk fibroin/collagen biological scaffold material, the framework being embedded inside the coating layer;
• and the vacuum dryer containing water, aqueous methanol or aqueous ethanol at the bottom thereof;
• wherein in step 1), the aqueous silk fibroin solution is prepared by:
• preparing an aqueous silk fibroin solution having a mass concentration of 0.5% to 5% by a conventional method, and leaving the aqueous silk fibroin solution at 0 to 10° C. for 30 minutes or more;
• the mixed solution of silk fibroin and gelatin is prepared by:
• preparing an aqueous gelatin solution having a mass concentration of 0.05% to 1%, and leaving the solution at 0 to 10° C. for 30 minutes to 2 hours;
• mixing an aqueous silk fibroin solution with the aqueous gelatin solution uniformly such that the mass concentration of silk fibroin is 0.2% to 3% and the mass concentration of gelatin is 0.02% to 0.2% upon mixing;
• and leaving the mixture stand for 4 to 10 hours to obtain the mixed solution of silk fibroin and gelatin;
• the mixed solution of silk fibroin and collagen is prepared by:
• preparing a solution of collagen in acetic acid at a concentration of 0.05% to 1%, and leaving the solution at 0 to 10° C. for 30 minutes to 2 hours;
• mixing an aqueous silk fibroin solution with the solution of collagen in acetic acid uniformly at 0 to 10° C. such that the mass concentration of silk fibroin is 0.2% to 3% and the mass concentration of collagen is 0.02% to 0.2% upon mixing;
• and leaving the mixture stand for 4 to 10 hours to obtain the mixed solution of silk fibroin and collagen.