Aseptic processing preparation method for allogeneic corneal grafts

A corneal graft and xenogeneic technology, applied in the field of tissue engineering biomedical materials, can solve the problems of corneal stroma transparency, mechanical strength and degradation performance, physical virus inactivation method does not meet, denaturation and other problems, so as to avoid terminal sterilization process, inhibit the growth of bacteria, and reduce production costs

Active Publication Date: 2015-10-14
SHAANXI BOYU REGENERATIVE MEDICINE CO LTD
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  • Claims
  • Application Information

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Problems solved by technology

A single physical virus inactivation method does not meet the requirements of my country's animal-derived implantable medical devices, and such a high radiation dose will inevitably cause the destruction of the collagen fiber structure in the corneal stroma and the destruction of biological macromolecules such as collagen and glycosaminoglycans. The degeneration of the corneal stroma, t

Method used

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  • Aseptic processing preparation method for allogeneic corneal grafts
  • Aseptic processing preparation method for allogeneic corneal grafts
  • Aseptic processing preparation method for allogeneic corneal grafts

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0044] Example 1: Preparation of porcine corneal xenograft

[0045] 1) UV irradiation

[0046] Place 100 sterile pig eyeballs obtained in a clean workbench with the eye surface facing up on a 316L sterile steel pan. The distance between the steel pan and a 254nm ultraviolet lamp (50w) is 30cm. Turn on the ultraviolet lamp and irradiate for 2 hours.

[0047] 2) Soak in sodium hypochlorite solution

[0048] Move the eyeballs irradiated by ultraviolet light into 10 times the sodium hypochlorite solution with a concentration of 0.1g / l, and soak at room temperature for 1 hour. Then use 20 times the amount of purified water to shake and wash at 100 rpm for 10 times, each time for 10 minutes, to obtain completely virus-inactivated eyeballs.

[0049] 3) Remove the epithelial layer

[0050] The eyeball has been fully swollen after vibratory cleaning with purified water in the previous step. Move the swollen eyeball into a sterile clean steel plate in the ultra-clean workbench, and w...

Example Embodiment

[0058] Example 2: Preparation of Donkey Corneal Xenografts

[0059] 1) UV irradiation

[0060] Put 100 sterile donkey eyeballs obtained in a clean bench with the eye surface facing up and place them on a 316L sterile steel pan. The distance between the steel pan and a 254nm ultraviolet lamp (50w) was 30cm. Turn on the ultraviolet lamp and irradiate for 4 hours.

[0061] 2) Soak in sodium hypochlorite solution

[0062] Move the eyeballs irradiated by ultraviolet rays into 15 times the sodium hypochlorite solution with a concentration of 1g / l, and soak them at room temperature for 20 minutes. Then use 30 times the amount of purified water to shake and wash 10 times at a speed of 120 rpm, each time for 10 minutes, to obtain completely virus-inactivated eyeballs.

[0063] 3) Remove the epithelial layer

[0064] The eyeball has been fully swollen after vibratory cleaning with purified water in the previous step. Move the swollen eyeball into a sterile clean steel plate in the ul...

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Abstract

The invention discloses an aseptic processing preparation method for allogeneic corneal grafts. By virtue of whole treatment on eyeballs, the method comprises the following steps: two-step virus inactivation, namely ultraviolet irradiation and sodium hypochlorite solution soaking, epithelial layer removal, two-step decellularization, namely serum soaking and an osmotic pressure method, cutting and dewatering, and glycerine solution storage. According to the preparation method disclosed by the invention, drying and terminal sterilizing steps are not needed, so that the preparation method is simple in process, short in production cycle and low in production cost; through soft decellularization treatment, the structure and components of the natural corneal stroma are kept to the maximal extent; no significant difference is formed among the transparency, the mechanical strength and the natural corneal stroma; the degradation speed is matched with the regeneration speed of newborn cornea tissues; antigen removal and virus inactivation are thorough; the biocompatibility and the biosecurity are high; the structure and performance of glycerine storage can be kept stable for a long period of time; clinical application is convenient; and corneal transplantation can be carried out instead of the allogeneic cornea.

Description

technical field [0001] The invention belongs to the technical field of tissue engineering biomedical materials, and in particular relates to a method for aseptic processing and preparation of a xenogeneic corneal graft. The xenograft can replace the allogeneic cornea for corneal transplantation. Background technique [0002] The cornea (Cornea) is the transparent part of the front of the eye, covering the iris, pupil and anterior chamber, and provides most of the refractive power of the eye. Coupled with the refractive power of the crystal, the light can be accurately focused on the retina to form an image. According to the WHO report, corneal disease caused by trauma, chemical burn, tumor, severe dry eye, infection and other reasons has become the second most common blind eye disease, with 1.5 million to 2 million new corneal blind patients worldwide every year. Currently, the only effective treatment is allogeneic corneal transplantation. However, the source of donors i...

Claims

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Application Information

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IPC IPC(8): A61L27/36
Inventor 刘雪梅
Owner SHAANXI BOYU REGENERATIVE MEDICINE CO LTD
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