Preparation method of acellular dried active amnion

Abstract

The invention discloses a preparation method of the acellular dried active amnion, comprising the following steps: (1) material processing: taking a human placenta which passes the detection of pathogen and obtained from a full term cesarean section, washing the human placenta with aseptic normal saline, removing blood components from the human placenta, blunt dissecting the amnion from the human placenta perfectly, striking off matrix components from the amnion substrate with a cell curet; (2) repeatly freezing and thawing; (3) washing; (4) freeze drying; and (5) disinfecting and sterilizing with gamma-ray. The method adopts the combination of repeat freeze-thaw method and using decontaminating agent to remove amnion cells, overcomes the defects of bad effects of removing cells by using freeze-thaw method alone, removes amnion cells effectively, keeps the integrity of collagen structure and basement membrane in tissue well, and keeps good mechanical property and no cytotoxicity.

Description

technical field [0001] The invention relates to the field of medical materials, in particular to a decellularized and dried active amniotic membrane capable of long-term preservation and a preparation method thereof. Background technique [0002] The amniotic membrane is derived from the embryo. It is a transparent tissue with no nerves, blood vessels, and lymphatic vessels. It is the thickest basement membrane in the human body. At the beginning of the 20th century, amniotic membrane was first used clinically to repair burns and ulcers. 20 In the 1940s, DeRoth used amniotic membrane for the treatment of conjunctival defects, which opened the history of amniotic membrane application in ophthalmology. It was not until 1995 that Kim and Tseng successfully used the preserved amniotic membrane to reconstruct the corneal surface that the application of amniotic membrane in ophthalmology accelerated. [0003] At present, the amniotic membranes used clinically are mainly fresh amn...

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Problems solved by technology

[0004] However, there are problems in the pretreatment process of several freeze-dried biological amniotic membranes disclosed at present. The biological amniotic membrane products with the patent publication number of CN 1644047A have not undergone decellularization treatment before freeze-drying, and the immunogens that may occur during clinical application cannot be guaranteed. sexual reaction, and the patent publication number is CN 1757717A "preparation method of dry active amniotic membrane: described amniotic membrane preparation, although decellularization has been taken, but the chemical method of mixed solution of trypsin and EDTA is used to decellularize, according to the literature and The experimental data of our company shows that trypsin has a strong destructive effect on the matrix, which will cause damage to the fibers, resulting in loose and disordered arrangement of the fibers, as well as breakage. The mechanical properties of the amnion matrix are greatly reduced, which affects the clinical use of the amnion.

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