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Sterilization method of dry collagen-based biological material

A technology of biological materials and sterilization methods, applied in the directions of botanical equipment and methods, chemicals for biological control, biocides, etc., can solve the problems affecting structural stability and performance, incomplete sterilization, and low production costs and other problems to achieve the effect of reducing endotoxin content, improving sterilization effect and complete sterilization

Active Publication Date: 2020-05-29
JILIN VENUS HAOYUE MEDICAL LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Aiming at the above-mentioned problems existing in the prior art, the present invention provides a sterilization method for dry collagen-based biomaterials, which is simple and quick to operate and does not require professional sterilization equipment, effectively solving the problem that the sterilization process affects structural stability and performance, Problems of incomplete sterilization, difficult operation and low production cost

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  • Sterilization method of dry collagen-based biological material
  • Sterilization method of dry collagen-based biological material

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Embodiment 1

[0027] A method for sterilizing dry collagen-based biomaterials, comprising the following steps:

[0028] (1) Initial sterilization: Soak tissue engineered blood vessels in an antibiotic solution, the antibiotic solution is 40mg / L vancomycin hydrochloride solution, the antibiotic solution is added in an amount of 0.2mL / mg, incubate at 20°C for 12h, Then wash with sterile water, the first wash for 30 minutes, and the second wash for 12 hours to obtain the collagen-based biomaterial after the first sterilization;

[0029] (2) Secondary sterilization: soak the collagen-based biomaterial after the initial sterilization in step (1) in a peracetic acid solution with a concentration of 0.02 wt%, and adjust the pH to 7.3±0.5 before adding the peracetic acid solution. Then filter through a 0.22 μm filter, add peracetic acid solution at an amount of 0.4 mg / mg, shake at a rate of 120 rpm for 2 hours at room temperature, and then wash with sterile water. The first 2 washes are 30 minutes,...

Embodiment 2

[0032] A method for sterilizing dry collagen-based biomaterials, comprising the following steps:

[0033] (1) Initial sterilization: Soak tissue engineered blood vessels in antibiotic solution, antibiotic solution is 40mg / L vancomycin hydrochloride solution, 10mg / L gentamicin solution and 23mg / L penicillin solution by volume ratio 1: The mixture formed by mixing 1:1, the amount of antibiotic solution added is 1mL / mg, incubated at 30°C for 30h, and then washed with sterile water, the first wash is 30min, the second wash is 12h, and the initial sterilization is obtained. post-collagen-based biomaterials;

[0034] (2) Secondary sterilization: soak the collagen-based biomaterial after the initial sterilization in step (1) in a peracetic acid solution with a concentration of 0.3 wt%, and adjust the pH to 7.3±0.5 before adding the peracetic acid solution. After filtering through a 0.22 μm filter, the amount of peracetic acid solution added is 0.7 mg / mg, then shaken at a rate of 120...

Embodiment 3

[0037] A method for sterilizing dry collagen-based biomaterials, comprising the following steps:

[0038] (1) Initial sterilization: Soak tissue engineered blood vessels in antibiotic solution, antibiotic solution is 40mg / L vancomycin hydrochloride solution, 10mg / L gentamicin solution, 23mg / L penicillin solution, 250mg / L cephalosporin A mixture of cidin solution, 23mg / L streptomycin solution, 23mg / L chloramphenicol solution and 30mg / L amphotericin B solution at a volume ratio of 1:1:1:1:1:1:1 , the amount of antibiotic solution added is 1mL / mg, incubated at 30°C for 30h, and then washed with sterile water, the first wash is 30min, the second wash is 12h, and the collagen-based biomaterial after the initial sterilization is obtained;

[0039] (2) Secondary sterilization: soak the collagen-based biomaterial after the initial sterilization in step (1) in a peracetic acid solution with a concentration of 0.3 wt%, and adjust the pH to 7.3±0.5 before adding the peracetic acid soluti...

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Abstract

The invention provides a sterilization method of a dry collagen-based biological material, wherein the sterilization method comprises the following steps: soaking a collagen-based biological materialin an antibiotic solution, and cleaning to obtain a collagen-based biological material subjected to primary sterilization; soaking the sterilized collagen-based biological material in a peroxyacetic acid solution, then oscillating at room temperature, and cleaning to obtain a secondarily sterilized collagen-based biological material; and soaking the secondarily sterilized collagen-based biologicalmaterial in an organic solvent, and dehydrating and drying after soaking to obtain the dried collagen-based biological material. The method is simple and quick to operate, does not need professionalsterilization equipment, and effectively solves the problems of influence on structural stability and use performance in the sterilization process, incomplete sterilization, high operation difficultyand low production cost.

Description

technical field [0001] The invention belongs to the technical field of sterilization methods, and in particular relates to a sterilization method for dry collagen-based biological materials. Background technique [0002] For exogenous implantable biomaterials, sterilization is a critical process prior to implantation. If the sterilization is not complete, the residual bacteria will be brought into the human body by implantable biomaterials, which will cause reactions such as fever, infection and inflammation. If the biological material comes into contact with blood, the bacteria will spread rapidly, causing widespread infection and even life-threatening; meanwhile, the side effects caused by the bacteria will also lead to damage to the performance of the biological material. However, the sterilization of dry collagen-based implantable biomaterials is more difficult. Due to the stability of its own structure, dry collagen-based biomaterials cannot be sterilized by convention...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A01N43/90A01N37/16A01N43/16A01N47/44A01N37/18A01P1/00
CPCA01N37/16A01N37/18A01N43/16A01N43/90A01N47/44
Inventor 王云兵郭高阳金林赫雷洋
Owner JILIN VENUS HAOYUE MEDICAL LTD