Aseptic processing preparation method for allogeneic corneal grafts

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...

AI Technical Summary

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, the impact on the transparency, mechanical strength and degradation performance is still inevitable

[0006] In summary, there is currently no ideal method for preparing xenogeneic corneas, which can achieve the purpose of decellularization, antigen removal and virus inactivation, while retaining the tissue structure and composition characteristics of natural corneas to the greatest extent.

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