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Method for preparing heterogeneous biological amniotic membrane product

A kind of amniotic membrane and biological technology, applied in medical science, prosthesis, etc., can solve the problems affecting the clinical use effect, and achieve the effect of simple preparation method and wide source

Inactive Publication Date: 2019-06-28
广州锐澄医疗技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At the same time, what kind of amniotic membrane processing technology is used will directly affect the biological function and mechanical strength of amniotic membrane products, thus directly affecting the clinical use effect

Method used

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  • Method for preparing heterogeneous biological amniotic membrane product
  • Method for preparing heterogeneous biological amniotic membrane product
  • Method for preparing heterogeneous biological amniotic membrane product

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preparation example Construction

[0029] The invention provides a preparation method of a heterogeneous biological amniotic membrane product, which mainly includes placenta acquisition and stripping; cleaning, sterilization and fixing; irradiation inactivation and packaging.

[0030] In the stage of placenta acquisition and stripping, after the animal (the source of the animal is a farm that meets the regulatory requirements for the source of animal-derived medical device materials, and the species is one of pigs, cattle, sheep, horses, and rabbits) after production (natural delivery or caesarean section), , collect the placenta at the first time, wash the residual blood of the placenta with water or sterile water containing double antibodies, and then transfer the washed animal placenta to the treatment room. Within 12 hours under refrigerated conditions (6°C-0°C), and within 10 days under frozen conditions (below 0°C). The processing room strives to be clean, and the standardized production requirements are ...

Embodiment 1

[0038] Strictly follow the relevant national standards, and screen the Boer goats whose species and sources are clear in the farms where the livestock and poultry feeding and slaughtering meet the health and quarantine standards.

[0039] In the stage of placenta acquisition and stripping, select healthy expectant ewes that meet veterinary testing standards and traceable sources to produce in the animal delivery room. The fresh placenta obtained is rinsed with sterile PBS at room temperature for blood, tissue fluid, etc., and transferred within 1 hour at 4°C In the 10,000-level GMP factory building, post-processing is carried out. In the clean operating table of the GMP workshop, the placenta was flatly spread on a Teflon plate, and the tissue rich in blood vessels / vascular nodes, the fibroblast layer and sponge layer of the chorion and amnion were bluntly peeled off to retain certain mechanical properties. Intense epithelial cell layer, basement membrane layer and part of the...

Embodiment 2

[0043] Strictly follow the relevant national standards, and screen the Boer goats whose species and sources are clear in the farms where the livestock and poultry feeding and slaughtering meet the health and quarantine standards. Healthy expectant ewes that meet veterinary testing standards and traceable sources are selected for production in the animal delivery room, and the fresh placenta obtained is washed with sterile PBS at room temperature for blood, tissue fluid, etc. Store at -20°C, and transfer a batch of placenta raw materials to a 10,000-level GMP factory every 2 days for post-processing. In the clean operating table of the GMP workshop, the placenta is laid flat on a glass plane with a certain curvature, and the tissue rich in blood vessels / vascular nodes, the fibroblast layer and sponge layer of the chorion and amnion are bluntly peeled off to retain the The epithelial cell layer, basement membrane layer and compact layer with certain mechanical strength form the ...

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Abstract

The invention provides a method for preparing a heterogeneous biological amniotic membrane product. The method comprises the following main steps of 1, placenta acquisition and peeling; 2, cleaning sterilization and fixation; 3, irradiation inactivation; 4, packaging and program freezing. Compared with the prior art, the method has the following advantages that the product related derives from heterogeneous mammals (including pigs, cattle, sheep and the like), and raw materials are controllable and scalable; animal-derived materials are subjected to non-destructive treatment, and a natural amniotic membrane structure and active ingredients are maintained as much as possible; under the protection of preservation liquid with specific functions, the sterilization and inactivation of the product are achieved by irradiation, and the safety and effectiveness of the product are both achieved. The method brings a novel solution to the raw material source and standardization problem of the biological amniotic membrane product, and also provides a reference method and technical way for the high value reuse of the traditional animal husbandry biological waste.

Description

technical field [0001] This project involves the technical field of animal-derived medical device materials, specifically a method for preparing a heterogeneous biological amniotic membrane product. Background technique [0002] Amniotic membrane is used as an immune-privileged biological graft. Natural amniotic membrane has a large number of different components such as collagen, fibronectin, laminin and proteoglycan. In addition, natural amniotic membrane contains a variety of nutritional factors, such as transforming growth factor-β (TGF-β), transforming growth factor-α (TGF-α), basic growth factor (bFGF), epidermal growth factor (EGF), nerve growth factor Hepatocyte growth factor (NGF), brain-derived neurotrophic factor (BDNF), hepatocyte growth factor (HGF) and keratinocyte growth factor (KGF), etc., can promote cell growth, proliferation and differentiation. Amniotic membrane can act as a "basement membrane" to facilitate cell adhesion and growth to promote epithelial...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/36
Inventor 王晓然王柏文王涛杨习锋曾晨光
Owner 广州锐澄医疗技术有限公司
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