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Sterilization solution and sterilization method suitable for allogeneic and heterogeneic tissue and tissue engineering medical instrument

A tissue engineering, allogeneic technology, applied in the fields of botanical equipment and methods, chemicals for biological control, applications, etc., can solve the problems of high storage requirements, inability to use aseptic manipulation, and damage to the cell microenvironment. , to achieve the effect of not easy to destroy, inhibit and destroy

Inactive Publication Date: 2020-01-17
江苏科瑞百奥生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The allogeneic or heterogeneous tissues that usually exist as raw materials are large in size and have high storage requirements, so they cannot be sterilized directly and effectively before use
In this way, aseptic manipulation cannot be used to achieve the final sterility of the product
If the first terminal sterilization method (such as: irradiation, ethylene oxide, dry heat, damp heat, ethanol, etc.) is simply used to sterilize the product, the structure of the tissue engineering product will be seriously damaged , and more importantly, it destroys the microenvironment on which cells grow

Method used

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  • Sterilization solution and sterilization method suitable for allogeneic and heterogeneic tissue and tissue engineering medical instrument
  • Sterilization solution and sterilization method suitable for allogeneic and heterogeneic tissue and tissue engineering medical instrument

Examples

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Effect test

example 1

[0060] Example 1 Sterilization of Allodermal Matrix

[0061] Step 1: Prepare 500ml of mixed sterilizing solution in a sterile environment, in which the concentration of N-acetylmuramoglycan hydrolase is 0.3mg / ml, and the concentration of penicillin is 0.25mg / ml, and dilute the sterilizing solution with dilute hydrochloric acid pH adjusted to 5.0;

[0062] Step 2: Take out the dermal matrix to be sterilized (the thickness of the material should be less than 0.5mm, and the total weight should be less than 25g), rinse the surface of the material with physiological saline, and lay it flat in the sterilization solution;

[0063] Step 3: The temperature of the sterilizing solution is kept constant to 35° C., and the sterilizing solution is titrated by a titrator with a sodium hydroxide solution having a concentration of 50 mg / ml. When titrating, the solution should be mixed evenly. The titration time is 2.5h, and the pH value of the final sterilization solution is 7.5;

[0064] S...

Embodiment 2

[0073] Example 2 Allograft tendon

[0074] 1. Prepare 500ml of mixed sterilizing solution in a sterile environment, in which the concentration of β-lactamase is 0.5mg / ml and the concentration of penicillin is 0.25mg / ml, and the value of the sterilizing solution is adjusted to 5.0 with dilute hydrochloric acid;

[0075] 2. Take out the allogeneic tendon to be sterilized (the width of the material should be less than 2cm, and the thickness should be less than 0.3cm), rinse the surface of the material with physiological saline, and spread it in the sterilization solution;

[0076]3. Keep the temperature of the sterilizing solution constant at 35°C, and use a sodium hydroxide solution with a concentration of 50 mg / ml to titrate the sterilizing solution with a titrator. When titrating, the solution should be mixed evenly. The titration time is 2.5h, and the pH value of the final sterilization solution is 7.5;

[0077] 4. After taking out the allogeneic tendon, wash it with steril...

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Abstract

The invention discloses a sterilization solution and sterilization method suitable for allogeneic and heterogeneic tissue and a tissue engineering medical instrument. The sterilization solution contains lysozymes and antibiotics. Through the sterilization solution and method, products can be effectively sterilized finally under the situation of not damaging active cells, relevant factor protein and matrix structures inside the tissue engineering medical instrument; and last, in cooperation with aseptic packaging, the tissue engineering medical instrument finally reaches an aseptic state.

Description

technical field [0001] The invention relates to the technical field of sterilization of medical products, in particular to a sterilizing solution and a sterilizing method suitable for allogeneic and heterogeneous tissues and tissue engineering medical devices. Background technique [0002] Non-Denature liquid sterilization method is mainly used in the terminal sterilization of some allogeneic and heterogeneous tissue engineering medical devices. As a single-use medical device, it should be sterile when it is finally used clinically. At present, there are usually two preparation methods for this kind of disposable sterile medical device products. The first type: terminal sterilization, which means that the product is sterilized after the preparation is completed, and then aseptically packaged, or sterilized after the packaging is completed (such as: irradiation sterilization). The second method: aseptic operation method: refers to sterilizing the raw and auxiliary materials...

Claims

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Application Information

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IPC IPC(8): A01N43/90A01N63/10A01P3/00A01P1/00
CPCA01N43/90A01N63/00
Inventor 宋云庆姜来
Owner 江苏科瑞百奥生物技术有限公司
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