CN114344549A - Composite amnion dressing and preparation method thereof - Google Patents
Composite amnion dressing and preparation method thereof Download PDFInfo
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Abstract
The invention provides a composite amnion dressing and a preparation method thereof. The composite amniotic dressing comprises a recombinant amniotic membrane layer and a non-woven fabric layer. The recombined amniotic membrane layer is composed of carboxyl-containing polysaccharide and amniotic powder loaded on the carboxyl-containing polysaccharide, the non-woven fabric layer is composed of calcium-containing hydrophilic fibers, the carboxyl-containing polysaccharide can be effectively crosslinked with the non-woven fabric layer through calcium ions, so that the recombined amniotic membrane layer and the non-woven fabric layer are both in a three-dimensional network structure, and the recombined amniotic membrane layer and part of the non-woven fabric layer are crosslinked to form an interpenetrating network layer, which is favorable for absorbing and discharging seepage in time in the repair process so as to avoid the phenomenon of effusion; the carboxyl-containing polysaccharide is in a gel state after imbibing, so that the recombinant amniotic membrane layer can provide a wet healing environment for the wound surface, and the wound surface healing is promoted by combining the repair function of the amniotic membrane.
Description
Technical Field
The invention relates to the technical field of medical dressings, in particular to a composite amnion dressing and a preparation method thereof.
Background
When the wound surface, especially the chronic wound surface, can not rapidly reach the complete state of anatomy and function through the normal, ordered and timely repair process, the problem of delayed healing or even non-healing is easily caused. If the above problems cannot be effectively solved, the damage range of the wound surface can be further expanded to cause serious loss of the skin on the body surface, and even damage to muscles, bones or tissues in the body can be caused.
The amnion contains growth factors capable of inducing tissue repair, and shows application potential in the aspect of chronic wound treatment. The invention patent with the publication number of CN108853593B discloses a preparation method of a composite amnion patch. The method combines the amniotic membrane with the surface of the PET cloth to obtain the composite amniotic membrane patch. However, since the amniotic membrane is a compact thin film structure, although the released growth factors can induce wound repair, the exudate generated in the repair process cannot be discharged in time, and thus effusion is easily formed. When the accumulated liquid is too much, infection is easily caused, the wound periphery skin is soaked, and healing is delayed.
Therefore, there is a need to develop a novel composite amniotic dressing to solve the above-mentioned problems in the prior art.
Disclosure of Invention
The invention aims to provide a composite amnion dressing and a preparation method thereof, which are used for promoting the wet healing of a wound surface and avoiding hydrops.
In order to achieve the above object, the composite amniotic dressing of the present invention comprises:
the recombined amniotic membrane layer consists of carboxyl-containing polysaccharide and amniotic membrane powder loaded on the carboxyl-containing polysaccharide, the average diameter of the amniotic membrane powder is 5-500 micrometers, the recombined amniotic membrane layer accounts for 5-83% by mass, the molecular weight of the carboxyl-containing polysaccharide is 10-200 ten thousand, and the recombined amniotic membrane layer accounts for 17-95% by mass;
the non-woven fabric layer is 0.02-0.2 g/cubic centimeter in density, and consists of calcium-containing hydrophilic fibers, the diameter of the calcium-containing hydrophilic fibers is 5-60 microns, and the content of calcium in the calcium-containing hydrophilic fibers is 4-9 wt%;
the recombined amniotic membrane layer and the non-woven fabric layer are both in a three-dimensional network structure, and the recombined amniotic membrane layer and part of the non-woven fabric layer are crosslinked to form an interpenetrating network layer.
The composite amnion dressing has the beneficial effects that: the recombined amniotic membrane layer consists of carboxyl-containing polysaccharide and amniotic powder loaded on the carboxyl-containing polysaccharide, the non-woven fabric layer consists of calcium-containing hydrophilic fibers, the average diameter of the amniotic powder is controlled to be 5-500 micrometers in a combined manner, the molecular weight of the carboxyl-containing polysaccharide is 10-200 ten thousand, the contents of the amniotic powder and the carboxyl-containing polysaccharide are 5-83% and 17-95% respectively, the density of the non-woven fabric layer is 0.02-0.2 g/cc, the diameter of the calcium-containing hydrophilic fibers is 5-60 micrometers, the content of calcium in the calcium-containing hydrophilic fibers is 4-9 wt%, so that the carboxyl-containing polysaccharide can be effectively crosslinked with the non-woven fabric layer through calcium ions, the recombined amniotic membrane layer and the non-woven fabric layer are both in a three-dimensional network structure, and the recombined amniotic membrane layer and part of the non-woven fabric layer are crosslinked to form an interpenetrating network layer, the seepage can be absorbed and discharged in time in the repairing process, so that the phenomenon of liquid accumulation is avoided; the carboxyl-containing polysaccharide is in a gel state after imbibing, so that the recombinant amniotic membrane layer can provide a wet healing environment for the wound surface, and the wound surface healing is promoted by combining the repair function of the amniotic membrane.
Preferably, the gram weight of the amnion powder is 1-20 g/m, and the gram weight of the carboxyl-containing polysaccharide is 2-50 g/m.
Preferably, the height of the interpenetrating network layer is 0.1 to 1 mm. The beneficial effects are that: the recombined amniotic membrane layer is favorable for exerting a good healing promoting function, and the absorption efficiency of the exudate is improved.
Preferably, the calcium-containing hydrophilic fiber is a swellable fiber so as to be in a gel state after imbibing liquid. The beneficial effects are that: improving the wet healing effect.
Further preferably, the swellable fibers are calcium alginate fibers.
Further preferably, the carboxyl group-containing polysaccharide is at least one of sodium alginate, sodium carboxymethylcellulose and sodium hyaluronate.
The preparation method of the composite amnion dressing comprises the following steps:
s1: providing a mixed dispersion and a nonwoven material;
s2: coating the mixed dispersion liquid on the surface of the non-woven fabric material to finish coating treatment;
s3: performing freeze-drying treatment on the non-woven fabric material obtained by the coating treatment to obtain the composite amnion dressing;
in the step S1:
the mixed dispersion comprises 1-10% by mass of the carboxyl-containing polysaccharide and 0.5-5% by mass of the amniotic membrane powder, and the viscosity of the mixed dispersion is 0.4-18 Pa.s;
the non-woven fabric material is in a sheet shape, has the density of 0.02-0.2 g/cubic centimeter and consists of the calcium-containing hydrophilic fiber.
The preparation method of the composite amnion dressing has the beneficial effects that: in the step S1, the mixed dispersion is controlled to contain 1-10% by mass of the carboxyl-containing polysaccharide and 1-5% by mass of the amniotic membrane powder, the viscosity of the mixed dispersion is 0.4-18 pa.s, the nonwoven fabric material is in a sheet shape, the density is 0.02-0.2 g/cc, and the nonwoven fabric material is composed of the calcium-containing hydrophilic fiber, which is beneficial to the carboxyl-containing polysaccharide to realize effective crosslinking with the nonwoven fabric layer through calcium ions, so that the recombinant amniotic membrane layer and the nonwoven fabric layer both have a three-dimensional network structure, and the recombinant amniotic membrane layer and a part of the nonwoven fabric layer are crosslinked to form an interpenetrating network layer, which is beneficial to timely absorbing and discharging seepage liquid in the repairing process so as to avoid hydropsy; the carboxyl-containing polysaccharide is in a gel state after imbibing, so that the recombinant amniotic membrane layer can provide a wet healing environment for the wound surface, and the wound surface healing is promoted by combining the repair function of the amniotic membrane.
Preferably, in the step S2, the step of applying the mixed dispersion to the surface of the nonwoven fabric material includes: the coating weight of the mixed dispersion liquid is controlled to be 100-800 g/square meter. The beneficial effects are that: the carboxyl-containing polysaccharide can effectively crosslink with the non-woven fabric layer through calcium ions, and an interpenetrating network layer with proper height is obtained, so that the effects of absorbing seepage and repairing wound surfaces are exerted to the maximum extent.
Preferably, in the step S2, the step of applying the mixed dispersion to the surface of the nonwoven fabric material includes: control is performed to perform the step S3 within 60 minutes after the coating process is completed. The beneficial effects are that: because the crosslinking degrees of different acidic polysaccharides and different calcium content calcium alginate fibers are different, the diffusion of the coating solution to the whole non-woven fabric layer under the condition of low crosslinking degree is reduced, the amnion is concentrated on one surface of the non-woven fabric as much as possible, and the amnion can act on a wound more directly. .
Preferably, in step S3, the step of performing lyophilization on the nonwoven fabric material obtained by the coating process includes: and controlling the temperature of the freeze-drying treatment to be-40-25 ℃, and controlling the vacuum degree to be not lower than 50 pascal. The beneficial effects are that: the freeze-drying effect is ensured.
Drawings
FIG. 1 is a scanning electron micrograph of a composite amniotic dressing according to an embodiment of the present invention;
FIG. 2 is a scanning electron micrograph of the internal structure of the reconstituted amniotic membrane layer shown in FIG. 1;
fig. 3 is a scanning electron micrograph of the internal structure of the nonwoven fabric layer shown in fig. 1.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below, and it is obvious that the described embodiments are a part of the embodiments of the present invention, but not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention. Unless defined otherwise, technical or scientific terms used herein shall have the ordinary meaning as understood by one of ordinary skill in the art to which this invention belongs. As used herein, the word "comprising" and similar words are intended to mean that the element or item listed before the word covers the element or item listed after the word and its equivalents, but does not exclude other elements or items.
The current research shows that the proper moisture of the wound is kept under the aseptic condition, which is beneficial to the formation of wound epithelial cells and promotes the growth of granulation tissues and the healing of the wound. The embodiment of the invention provides a composite amnion dressing, which is used for promoting the wet healing of a wound surface and avoiding hydrops.
The composite amniotic membrane dressing provided by the embodiment of the invention comprises a recombinant amniotic membrane layer and a non-woven fabric layer.
FIG. 1 is a scanning electron micrograph of the composite amniotic dressing according to example 1 of the present invention; FIG. 2 is a scanning electron micrograph of the internal structure of the reconstituted amniotic membrane layer shown in FIG. 1; fig. 3 is a scanning electron micrograph of the internal structure of the nonwoven fabric layer shown in fig. 1. Specifically, observation was performed using a japanese FlexSEM 1000II scanning electron microscope. The sample preparation method is a conventional technical means of those skilled in the art, and is not described herein in detail.
Referring to fig. 1 to 3, the composite amniotic dressing shown in fig. 1 includes a reconstituted amniotic membrane layer 1 and a non-woven fabric layer 2. The recombined amniotic membrane layer 1 and the non-woven fabric layer 2 are both in a three-dimensional network structure, and the recombined amniotic membrane layer 1 and part of the non-woven fabric layer 2 are crosslinked to form an interpenetrating network layer.
In some embodiments, the recombinant amniotic membrane layer is a three-dimensional network structure and is composed of carboxyl-containing polysaccharide and amniotic membrane powder loaded on the carboxyl-containing polysaccharide. The carboxyl-containing polysaccharide can swell into a gel state after imbibing liquid, when the recombined amniotic membrane layer directly contacts with a wound surface, exudate can be absorbed by the recombined amniotic membrane layer in a three-dimensional network structure in time to avoid hydrops near the wound surface, and the carboxyl-containing polysaccharide is loaded with the amniotic membrane, so that an environment favorable for wet healing can be provided after swelling, and growth factors inducing tissue repair in the amniotic membrane can be released.
Furthermore, the carboxyl-containing polysaccharide loads the amniotic membrane powder, so that a slow release effect can be achieved, and a regeneration and repair effect can be continuously provided for the wound surface.
Moreover, the carboxyl-containing polysaccharide is used for loading the amniotic membrane powder instead of using the sheet-shaped amniotic membrane, so that on one hand, a network structure beneficial to absorption of seepage is constructed, on the other hand, the preparation process of the sheet-shaped amniotic membrane is complex, the effective utilization rate of the amniotic membrane is not high, and the waste condition is serious.
Specifically, the non-woven fabric layer is composed of calcium-containing hydrophilic fibers, is in a three-dimensional network structure, and can further absorb and conduct seepage outwards.
Furthermore, the recombined amniotic membrane layer and part of the non-woven fabric layer are crosslinked to form an interpenetrating network layer, on one hand, the non-woven fabric layer provides mechanical support for the recombined amniotic membrane layer, and the recombined amniotic membrane layer does not undergo structural disintegration after swelling in the using process; on the other hand, the formation of the interpenetrating network layer increases the porosity of the recombinant amniotic membrane layer, and is more favorable for timely absorption and outward conduction of seepage.
In some embodiments, the height of the interpenetrating network layer is 0.1 to 1 millimeter. The height of the interpenetrating network layer is controlled, which is helpful to ensure the wet healing effect. The height is too low, the swelling degree of the interpenetrating network layer is low, and proper humidity can not be continuously provided for the wound surface. Too high a height increases material costs.
In some embodiments, the amniotic membrane powder is 5-83% by weight of the recombinant amniotic membrane layer, and the carboxyl-containing polysaccharide is 17-95% by weight of the recombinant amniotic membrane layer.
In some embodiments, the amniotic membrane powder has a grammage of 1-20 grams per square meter and the carboxyl-containing polysaccharide has a grammage of 2-50 grams per square meter.
In some embodiments, the non-woven fabric layer is composed of calcium-containing hydrophilic fibers having a diameter of 5 to 60 micrometers, and the calcium content of the calcium-containing hydrophilic fibers is 4 to 9 wt%.
Specifically, calcium ions in the calcium-containing hydrophilic fiber can be crosslinked with the carboxyl-containing polysaccharide, so that the mechanical property of an interpenetrating network layer is enhanced, and the structure disintegration cannot be generated even if the recombinant amniotic membrane layer is saturated and imbibed.
In some embodiments, the calcium-containing hydrophilic fibers are swellable fibers to be in a gel state upon imbibing liquid, further contributing to the wet healing effect.
In some specific embodiments, the carboxyl-containing polysaccharide is at least one of sodium alginate, sodium carboxymethylcellulose, and sodium hyaluronate. The swellable fibers are calcium alginate fibers.
In some embodiments, the amniotic membrane powder has an average diameter of 5-500 microns.
In some embodiments, the carboxyl-containing polysaccharide has a weight average molecular weight of 10 to 200 ten thousand.
In some embodiments, the nonwoven layer has a density of 0.02 to 0.2 grams per cubic centimeter.
In some embodiments, the diameter of the calcium-containing hydrophilic fibers is 5-60 microns.
In some embodiments, the recombinant amniotic membrane layer comprises epidermal growth factor, fibroblast growth factor, and hepatocyte growth factor, per gram of amniotic membrane powder: the content of the epidermal growth factor is 8-15 ng, the content of the fibroblast growth factor is 20-30 ng, and the content of the hepatocyte growth factor is 100-230 ng, so as to promote the wound healing effect.
The embodiment of the invention also provides a preparation method of the composite amnion dressing, which comprises the following steps:
s1: providing a mixed dispersion and a nonwoven material;
s2: coating the mixed dispersion liquid on the surface of the non-woven fabric material to finish coating treatment;
s3: performing freeze-drying treatment on the non-woven fabric material obtained by the coating treatment to obtain the composite amnion dressing;
in said step S1 of some embodiments: the mixed dispersion comprises 1-10% by mass of the carboxyl-containing polysaccharide and 0.5-5% by mass of the amniotic membrane powder, and the viscosity of the mixed dispersion is 0.4-18 Pa.s.
Specifically, the viscosity of the mixed dispersion was measured by a rotational viscometer of model number NDJ-1 manufactured by bonsai instruments (shanghai) ltd.
Specifically, the mixed dispersion liquid with a certain viscosity is permeated into the non-woven fabric layer with a certain density through the coating treatment, so that an interpenetrating network structure, namely the recombinant amniotic membrane layer 1, is formed. The recombinant amniotic membrane layer 1 directly contacts with a wound, and collagen in the amniotic membrane can play a role of a scaffold on the surface of the wound to promote migration of cells. If the viscosity of the mixed dispersion is too low, or the density of the non-woven fabric layer is too low, so that the pore space is large, most of the mixed dispersion flows through the non-woven fabric layer, and cannot form an interpenetrating network structure as shown in fig. 1, the amnion can be dispersed in the whole non-woven fabric, and cannot directly contact with a wound. If the viscosity of the mixed dispersion is too high or the density of the non-woven fabric layer is too high, the pore gap is too small, the mixed dispersion cannot uniformly permeate into the non-woven fabric, the amnion is concentrated on the surface of the non-woven fabric, and the amnion is easy to fall off after freeze-drying, so that the waste of raw materials is caused.
In step S1 of some embodiments, the nonwoven material is in the form of a sheet having a density of 0.02 to 0.2 g/cc and is composed of the calcium-containing hydrophilic fibers.
In step S2 of some embodiments, the step of applying the mixed dispersion to the surface of the nonwoven material includes: the coating weight of the mixed dispersion liquid is controlled to be 100-800 g/square meter, so that the carboxyl-containing polysaccharide can realize effective crosslinking with the non-woven fabric layer through calcium ions and obtain an interpenetrating network layer with proper height, and the functions of absorbing seepage and repairing wound surfaces are exerted to the maximum extent.
In step S2 of some embodiments, the step of applying the mixed dispersion to the surface of the nonwoven material includes: control is performed to perform the step S3 within 60 minutes after the coating process is completed.
Specifically, after the coating treatment is completed, if the standing time is too long, the mixed dispersion liquid in the non-woven fabric material loses water seriously, and the carboxyl-containing polysaccharide is easily damaged through effective crosslinking formed by calcium ions and the non-woven fabric layer.
In the step S3 of some embodiments, the step of performing a lyophilization process on the non-woven fabric material obtained by the coating process includes: and controlling the temperature of the freeze-drying treatment to be-40-25 ℃, and controlling the vacuum degree to be not lower than 50 pascal so as to ensure the freeze-drying effect.
In the step S3 of some embodiments, the step of performing a lyophilization process on the non-woven fabric material obtained by the coating process includes: freezing the non-woven fabric material obtained by coating treatment at-40 ℃ for 2 hours under normal pressure, and then heating to 25 ℃ for drying under the condition that the vacuum degree is not lower than 50 pascal until the water content of the obtained composite amnion dressing reaches a preset standard.
The technical solution is explained in detail by examples 1 to 5 below.
In examples 1 to 5:
the sheep membrane powder is prepared by using placenta as a raw material. The placenta is derived from placenta donated by healthy parturient women in the traditional Chinese medicine institute of Haian city. The lying-in woman and his family members know the usage of the placenta and sign informed consent.
The preparation process of the amniotic membrane powder is a conventional technical means of a person skilled in the art. Specifically, the amniotic membrane is removed after the amniotic membrane is blunt-stripped from the placenta, and then the amniotic membrane is freeze-dried and pulverized by a pulverizer to obtain the amniotic membrane powder.
Specifically, the step of freeze-drying comprises: freezing the processed amnion at-40 deg.C for 2 hr under normal pressure, and heating to 25 deg.C under the condition of vacuum degree not lower than 50 Pa for drying until the water content of the obtained amnion powder reaches the predetermined standard.
The preparation method of the mixed dispersion comprises the following steps: dissolving carboxyl polysaccharide with water, adding amnion powder, and mixing.
The non-woven material is composed of calcium alginate fibers. The mixed dispersion was applied to a nonwoven fabric material using a calcium alginate nonwoven fabric produced by Qingdao Mingyue biomedical materials Co., Ltd, and the amount of the applied mixed dispersion was controlled by adjusting the extrusion amount per unit time and unit width. The freeze-drying treatment is carried out immediately after the coating treatment is completed.
The step of the lyophilization process comprises: freezing the non-woven fabric material obtained by coating treatment at-40 ℃ for 2 hours under normal pressure, and then heating to 25 ℃ for drying under the condition that the vacuum degree is not lower than 50 pascal until the water content of the obtained composite amnion dressing reaches a preset standard.
In examples 1 to 5, the carboxyl group-containing polysaccharide species, molecular weight M, and mass percentage W1 in the mixed dispersion, the average diameter D1 of the amniotic membrane powder used, and mass percentage W2 in the mixed dispersion, the density ρ of the nonwoven fabric layer used, the diameter D2 of the calcium alginate fiber, and the calcium ion content W3, the viscosity η of the mixed dispersion, and the coating amount are shown in table 1.
TABLE 1
In table 1, the molecular weights of sodium carboxymethylcellulose and sodium alginate of example 5 are 25 ten thousand and 100 ten thousand, respectively, and the mass ratio is 1: 1.
in examples 1 to 5, in the composite amniotic dressing obtained in step S3, the content W4 and the content W5 of carboxyl polysaccharide in the recombinant amniotic membrane layer, and the height h of the interpenetrating network layer are shown in table 2.
TABLE 2
| Examples | 1 | 2 | 3 | 4 | 5 |
| |
11％ | 23％ | 40％ | 71％ | 71％ |
| W5 | 89％ | 76％ | 60％ | 29％ | 29％ |
| h | 0.65mm | 0.85mm | 0.10mm | 0.43mm | 0.44mm |
In the embodiment of the invention, the composite amniotic dressings in the embodiments 1 to 5 are subjected to a gel property test by referring to a YY/T0471.1-2004 contact wound dressing test method, and the result shows that the five composite amniotic dressings can form gel after interaction with liquid and have gel property.
In the embodiment of the invention, the contents of the epidermal growth factor EGF, the fibroblast growth factor FGF and the hepatocyte growth factor HGF in the pure amnion powder and the composite amnion dressings in the embodiments 1 to 5 are measured after being extracted.
Specifically, the PBS buffer solution is adopted for leaching, the solution and a leached sample are mixed and then are fully homogenized by a freezing grinder, the mixture is placed for 24 hours at 4 ℃, the obtained sample is centrifuged, and supernatant is taken to test the content of each factor in the obtained solution.
More specifically, each of the composite amniotic dressings used in examples 1 to 5 had an area of 50 square centimeters, weights of 0.79g, 0.76g, 0.51g, 0.64g, and a volume of 5 ml of PBS buffer solution.
The amniotic membrane content (in grams) in each extracted sample and the factor content (in picograms) in each ml of supernatant are shown in table 3.
TABLE 3
| Examples | 1 | 2 | 3 | 4 | 5 |
| Amnion content | 0.031 | 0.06 | 0.005 | 0.1 | 0.1 |
| EGF | 82.6 | 132.1 | 23 | 171.5 | 182.6 |
| FGF | 161.6 | 244.9 | 577.4 | 577.4 | 572.4 |
| HGF | 1153.8 | 1955.2 | 106.6 | 4428.3 | 4506.9 |
In the examples of the present invention, growth factor release tests were performed on pure amniotic membrane powder and each of the composite amniotic membrane dressings of examples 2, 4 and 5. The specific test method comprises the following steps: 0.2 g of amnion and 50 cm square of the sample to be tested of examples 2, 4 and 5 were placed in different petri dishes, 10 ml of PBS buffer solution was added to the different petri dishes, and the mixture was allowed to stand at 4 ℃ and the leaching solution was extracted every 24 hours to test the content of each factor. See table 4 for the factor content.
TABLE 4
As can be seen from table 4, each of the composite amniotic dressings of the present application has a significant sustained release effect compared to the amniotic powder.
In the embodiment of the invention, different dressings are externally applied to ICR mice with full skin injury, and the healing promoting effect of various dressings on open wounds is examined.
The various dressings were the composite amniotic membrane dressing, the pure amniotic membrane dressing, and the calcium alginate fiber dressing of examples 2, 4, and 5, respectively. Wherein the amnion source of the pure amniotic membrane dressing is the same as that of the amnion source of the embodiment 1-5, and the amnion dressing is prepared by removing bloodstain and immunogenic substances from the amnion stripped by placenta and then freezing and drying the amnion; the calcium alginate fiber dressing is a non-woven fabric material without coating treatment of the embodiment of the invention and the thickness of each dressing is consistent.
The ICR mice of the full-skin injury treated by the composite amniotic membrane dressings are a composite amniotic membrane dressing group, the ICR mice of the full-skin injury treated by the pure amniotic membrane dressings are an amniotic membrane group, and the ICR mice of the full-skin injury treated by the calcium alginate fiber dressings are a calcium alginate dressing group.
All ICR mice with full skin lesions were anesthetized and then shaved on the back, and the area 1X 1 cm square was marked with a marker pen, sterilized and then the skin was excised. Each dressing was covered and fixed on the excised skin area of each mouse, and the wound area of each mouse was measured after 14 days. See table 5 for statistical results. As can be seen from table 5, the average wound area of each experimental mouse of the composite amniotic membrane dressing groups of examples 2, 4 and 5 after being treated with the composite amniotic membrane dressing is significantly smaller than that of each experimental mouse of the amniotic membrane group and the alginate dressing group, and a good repairing effect is shown.
TABLE 5
Although the embodiments of the present invention have been described in detail hereinabove, it is apparent to those skilled in the art that various modifications and variations can be made to these embodiments. However, it is to be understood that such modifications and variations are within the scope and spirit of the present invention as set forth in the following claims. Moreover, the invention as described herein is capable of other embodiments and of being practiced or of being carried out in various ways.
Claims (10)
1. A composite amniotic dressing comprising:
the recombinant amniotic membrane layer consists of carboxyl-containing polysaccharide and amniotic membrane powder loaded on the carboxyl-containing polysaccharide;
the average diameter of the amniotic membrane powder is 5-500 micrometers, the amniotic membrane powder accounts for 5-83% of the mass of the recombinant amniotic membrane layer, the weight average molecular weight of the carboxyl-containing polysaccharide is 10-200 ten thousand, and the amniotic membrane powder accounts for 17-95% of the mass of the recombinant amniotic membrane layer;
the non-woven fabric layer is 0.02-0.2 g/cubic centimeter in density, and consists of calcium-containing hydrophilic fibers, the diameter of the calcium-containing hydrophilic fibers is 5-60 microns, and the content of calcium in the calcium-containing hydrophilic fibers is 4-9 wt%;
the recombined amniotic membrane layer and the non-woven fabric layer are both in a three-dimensional network structure, and the recombined amniotic membrane layer and part of the non-woven fabric layer are crosslinked to form an interpenetrating network layer.
2. The composite amniotic dressing according to claim 1, wherein the amniotic powder has a grammage of 1-20 grams per square meter and the carboxyl-containing polysaccharide has a grammage of 2-50 grams per square meter.
3. The composite amniotic dressing according to claim 1, wherein the height of the interpenetrating network layer is 0.1-1 mm.
4. The composite amniotic dressing according to claim 1, wherein the calcium-containing hydrophilic fiber is a swellable fiber to be in a gel state after imbibing liquid.
5. The composite amniotic dressing according to claim 4, wherein the swellable fiber is calcium alginate fiber.
6. The composite amniotic dressing according to claim 1, wherein the carboxyl-containing polysaccharide is at least one of sodium alginate, sodium carboxymethylcellulose, and sodium hyaluronate.
7. A method of preparing a composite amniotic dressing according to any one of claims 1 to 6, comprising the steps of:
s1: providing a mixed dispersion and a nonwoven material;
s2: coating the mixed dispersion liquid on the surface of the non-woven fabric material to finish coating treatment;
s3: performing freeze-drying treatment on the non-woven fabric material obtained by the coating treatment to obtain the composite amnion dressing;
in the step S1:
the mixed dispersion comprises 1-10% by mass of the carboxyl-containing polysaccharide and 0.5-5% by mass of the amniotic membrane powder, and the viscosity of the mixed dispersion is 0.4-18 Pa.s;
the non-woven fabric material is in a sheet shape, has the density of 0.02-0.2 g/cubic centimeter and consists of the calcium-containing hydrophilic fiber.
8. The method of claim 7, wherein the step of applying the mixed dispersion to the surface of the non-woven material in step S2 comprises:
the coating weight of the mixed dispersion liquid is controlled to be 100-800 g/square meter.
9. The method of claim 7, wherein the step of applying the mixed dispersion to the surface of the non-woven material in step S2 comprises:
control is performed to perform the step S3 within 60 minutes after the coating process is completed.
10. The method of claim 7, wherein the step of lyophilizing the coated non-woven material in step S3 comprises:
and controlling the temperature of the freeze-drying treatment to be-40-25 ℃, and controlling the vacuum degree to be not lower than 50 pascal.
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| CN114939190A (en) * | 2022-06-14 | 2022-08-26 | 健诺维(成都)生物科技有限公司 | Drainage tube material for treating glaucoma and preparation method thereof |
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