CN220938291U - Medical silk non-woven fabric application - Google Patents
Medical silk non-woven fabric application Download PDFInfo
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- CN220938291U CN220938291U CN202222368875.XU CN202222368875U CN220938291U CN 220938291 U CN220938291 U CN 220938291U CN 202222368875 U CN202222368875 U CN 202222368875U CN 220938291 U CN220938291 U CN 220938291U
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Landscapes
- Materials For Medical Uses (AREA)
Abstract
The utility model discloses a silk non-woven fabric medical application which comprises a release layer, a core layer and an adhesive tape layer which are laminated and compounded from top to bottom, wherein the core layer is silk non-woven fabric, and the release layer is adhesive tape and is used for covering and protecting the core layer. The multifunctional medical silk non-woven fabric application is caused by various advantages of silk, and is actually simple in structure and is formed by compounding a release layer, a core layer, an adhesive layer and an adhesive tape layer. The dressing core layer is not required to be formed by composite needling of hemostatic materials, moisturizing materials, wound healing promoting materials, antioxidant components and antibacterial components, and ventilation holes are not required to be designed, so that the preparation process is simple and the cost is low.
Description
Technical Field
The utility model relates to the field of medical application, in particular to a silk non-woven fabric medical application.
Background
The body is injured with bleeding in a considerable number of cases. In general, bleeding from small wounds can be resolved by the body's own clotting functions and by some simple care measures. When the wound and the bleeding are slight, the blood coagulation function is normal, and the hemostatic patch can be used for solving the problem by applying simple first aid. In daily life work, small wounds often occur, and hemostatic bandaging is needed to prevent excessive blood loss, affected wound healing and infection. The common bundi benzalkonium chloride plaster has similar basic effects, and the furacilin band-aid has the main components of disinfection dressing and sterilization components, limited hemostatic effect of the dressing, poor air permeability and poor wound healing promotion.
Hemostatic care is also often required for clinical minimally invasive surgical wounds and venous puncture sites. The wound hemostasis nursing requirements of minimally invasive surgery meet the effects of stopping bleeding, diminishing inflammation, keeping the wound environment moist, healing and the like, and the requirements cannot be met well when absorbent gauze containing liquid medicine is applied or embedded into the wound. The puncture point should be stopped immediately after clinical venipuncture, and when the hemostatic effect is poor, infection or subcutaneous hemorrhage/hematoma occurs. At present, the traditional method of sticking the infusion patch on the vein puncture point is still adopted, the structure of the infusion patch is that a thin cotton sheet is arranged in the middle of a pure adhesive tape, and the infusion patch needs to be pressed when stopping bleeding, but the accurate pressing time is not easy to grasp, and the hemostatic effect cannot be ensured. In particular, an arteriovenous internal fistula is a vascular access commonly used by a maintenance hemodialysis patient, maintenance of the internal fistula is extremely important for frequent dialysis of the patient, correct compression hemostasis is an important link for protecting the internal fistula, a hemostasis method adopts clustered sterile gauze to press a bleeding point, then bandages or adhesive tapes are used for fixing and bandaging, subcutaneous hematoma, external hemorrhage or damage to blood vessels are caused by improper pressing, even the internal fistula is blocked, and proper pressure standards are that hemostasis is achieved, blood vessel tremors can be felt, and the middle is loose, so that the operation is inconvenient.
Silk is the finest and lightest natural fiber, has comfortable feeling of clinging to skin, mainly consists of sericin and silk fibroin, and has the advantages of moisture absorption, ventilation, softness, very strong antibacterial property, flame resistance, ultraviolet resistance, oxidation resistance, good extensibility and the like. The mulberry silk has the most special functions that the wound and skin inflammation can be directly wrapped by the mulberry silk, and the wound healing can be quickened. The hygroscopicity of silk fiber is derived from specific composition and structure, and the components of many hydrophilic polar groups and the internal porosity of the void fraction up to about 30% make silk fiber have the ability to absorb moisture in air, whereas moist silk fiber is wetted in dry air. Because the polar side chain of the sericin occupies 74.61 percent of amino acid, the moisture absorption and release performances of the sericin are better than those of the sericin.
Wettability refers to the ability of a liquid to wet a solid surface, measured by the static contact angle θ, if the static contact angle of a liquid drop on the surface of a solid material is between 90 ° and 180 °, we refer to the surface of the material as a hydrophobic surface; when the static contact angle of the liquid drop on the surface of the solid material is larger than 150 degrees, the surface of the material is called as a super-hydrophobic surface. There are 4 models regarding the hydrophobic aspect: young's equation is applicable to an ideal smooth and even surface with uniform composition. The Wenzel model considers the case where only the grooves of the roughened surface are filled with liquid, in which case the liquid is in contact with only one medium. In practice, however, the liquid is not merely in contact with a medium. Therefore, cassie and Baxter supplement the Wenzel theory in a related way, and a Cassie-Baxter model is proposed, wherein liquid is in composite contact with a solid surface and an air interface; there is also a Wenzel and Cassie coexistence model. Researchers found the cause of superhydrophobic surface generation: the presence of both low surface energy materials and coarse structures on the surface, such as the "lotus effect" is a composite structure that combines very low surface energy waxes with micro-and nanostructures. The preparation of the super-hydrophobic surface on the material mainly can be realized by forming a coarse structure on the surface of the material and then modifying the surface with a low-surface-energy substance or directly constructing the coarse structure on the surface of the material with lower surface energy. The functional requirements of people on the fabric have the functions of water resistance, antibacterial function, self-cleaning function, ultraviolet resistance and the like. The super-hydrophobic fabric can be widely applied to the fields of waterproof cloth, medical fabrics and the like by virtue of excellent waterproof, anti-bonding, self-cleaning and other performances. After the fabric is subjected to steam ironing at 200 ℃, hydrophobic grafted chain segments migrate from the inside of the fiber to the surface of the fiber due to the high temperature effect, so that the superhydrophobicity of the cotton fabric is enhanced. The preparation method of the super-hydrophobic fabric has complex process, harsh industrial conditions and high preparation cost; some of the materials have certain harm to the environment, some of the materials are not enough in mechanical stability, easy to age and lose efficacy, and the materials are not strong in practicability and cannot be produced in a large-scale industrialized mode.
The flame is prevented from spreading on the fabric due to natural flame resistance, and the ultraviolet-proof function of the mulberry silk avoids skin hazard. The non-woven fabric medical product has the advantages of strong water absorption, no bacteria, no irritation, no mildew and rot, no fluorescent agent and multiple advantages. The human body contact is safe and reliable, has no toxic or side effect, no irritation, no sensitization, environmental protection and the like. The preparation method of the non-woven fabric comprises needling, water needling, melt blowing, spunbonding and other methods. However, medical non-woven fabrics in the market have various defects including single function, poor ventilation effect, incapability of absorbing seepage, insufficient uniformity, poor portability, promotion of wound infection and the like.
In summary, it is necessary to develop a non-woven fabric application which has the functions of stopping bleeding and moisturizing, promoting wound healing, inhibiting bacteria and the like, and also has the advantages of good air permeability and self-application. The silk has various advantages, and is hopeful to prepare medical non-woven fabric application for realizing various functions.
Disclosure of Invention
Aiming at the technical problems in the prior art, the application provides a medical application of silk non-woven fabric.
The utility model provides a silk non-woven fabrics medical application, includes from last to lower range upon range of compound release layer, applies sandwich layer and adhesive tape layer, it is silk non-woven fabrics to apply the sandwich layer, release layer is the adhesive tape for cover protection applies the sandwich layer.
Preferably, an adhesive layer is further arranged between the core layer and the adhesive tape layer.
Preferably, the adhesive layer is medical pressure-sensitive adhesive, zinc oxide-coated hot melt adhesive or acrylic adhesive.
Preferably, the release layer is adhered to the adhesive layer through a pressure-sensitive adhesive and is used for covering the core layer.
Preferably, an opening for tearing is arranged at the edge or the middle of the release layer so as to tear and expose the core layer.
Preferably, the adhesive cloth layer is medical nonwoven flat cloth or medical nonwoven elastic cloth.
Preferably, the release layer and the adhesive layer are rectangular, square or round with the same size.
Preferably, the length and width dimensions or circular diameter of the release layer and the adhesive tape layer are both greater than the dimension or diameter of the core layer.
The present application is described in further detail below:
The application aims to solve the defects of the existing products and provides the silk non-woven fabric medical application which has the advantages of multiple functions, ventilation, comfort, simple structure, convenience in use and easiness in storage.
According to the application, the content of hydrophobic silk fibroin is increased by reducing the content of hydrophilic sericin, and the hydrophobic component is migrated to the surface of the fiber by high-temperature treatment, so that the rough porous gap on the surface of the non-woven fabric improves the degree of a hydrophobic structure.
The technical scheme adopted by the application is as follows: the utility model provides a multi-functional silk non-woven fabrics medical application, from the top down is including lamination complex release layer, apply sandwich layer, adhesive layer and adhesive tape layer, applies the sandwich layer and is silk non-woven fabrics web layer, and silk is made by acupuncture or water thorn after high temperature treatment.
The application discloses a multifunctional silk non-woven fabric medical application which comprises a laminated composite release layer, a core layer, an adhesive layer and an adhesive tape layer from top to bottom, wherein the core layer is a silk non-woven fabric fiber net layer, and silk is prepared by needling or water needling after being subjected to high-temperature physical treatment. Because of the excellent characteristics of moisture absorption, wound healing promotion, oxidation resistance, antibacterial property, air permeability and the like of silk, the dressing core layer is not required to be formed by composite needling of hemostatic materials, moisturizing materials, wound healing promotion materials, antioxidant components and antibacterial components, no ventilation holes are required to be designed, the manufacturing process is simple, and the cost is low. Also because silk is heat-resistant, flame-resistant and ultraviolet-resistant, the medical application has the advantages of high stability, easy storage and carrying, etc. The medical dressing has the functions of stopping bleeding, preserving moisture, promoting wound healing, inhibiting bacteria and the like; the wound dressing change device also has the advantages of good air permeability, difficult edge curling and the like, and a patient can change the wound by himself, so that the wound dressing change device is more convenient.
The utility model provides a multi-functional silk non-woven fabrics medical application, the non-woven fabrics is including laminating compound release layer, apply sandwich layer, adhesive layer and adhesive tape layer, applies the sandwich layer and is silk non-woven fabrics web layer, and silk obtains silk non-woven fabrics blank after high temperature treatment, is made by acupuncture or water thorn again.
As a further improvement scheme, the dressing core layer is a silk non-woven fabric net layer, silk is subjected to high-temperature physical treatment to obtain silk non-woven fabric blanks, and then the silk non-woven fabric blanks are manufactured by a needling method.
The preparation method of the needling comprises the following steps:
(1) Blank: silk cocoons are subjected to cocoon cooking, silk reeling, refining and silk making processes, glutaraldehyde is selected to crosslink and fix sericin to reduce sericin loss in the refining process, after silk cotton quilts are made, the silk cocoons are sheared into short cloths with certain length and width, and physical treatments for improving hydrophobicity, such as high-temperature baking (0.5 to 2 hours) at 200 ℃ to 230 ℃ are carried out, so that silk non-woven fabric blanks are obtained;
(2) Opening: firstly, tearing and loosening the non-woven fabric blank manually, then putting the non-woven fabric blank into a loosening machine for loosening pretreatment, and removing fiber impurities while loosening;
(3) Carding: delivering the opened fibers into a single cylinder double doffer carding machine to be carded into a fiber web, adopting double doffer configuration to form two layers of fiber webs, and finally superposing the two layers of fiber webs to form a slightly thick fiber web in order to reduce the fiber web unevenness and improve the quality;
(4) Lapping: the cross lapping is adopted, the thin fiber web output by the carding machine reaches the top transverse curtain through the inclined curtain and then enters the clamping curtain to swing back and forth to form a fiber web with a certain thickness, and the thickness of the cloth can be accurately regulated and controlled by controlling the lapping layer number;
(5) Needling: the fluffy fiber web is repeatedly needled by using a needle with triangular cross section (or other shapes) and hooked edges in a needling machine, and is reinforced into a whole to form the needled non-woven fabric.
As a further improvement scheme, the dressing core layer is a silk non-woven fabric web layer, and silk is prepared by a water-jet method after being subjected to physical treatment and high-temperature treatment for improving hydrophobicity.
The preparation method of the water thorn comprises the following steps:
(1) Blank: silk cocoons are subjected to cocoon cooking, silk reeling, refining and silk making processes, glutaraldehyde is selected to crosslink and fix sericin to reduce sericin loss in the refining process, after silk cotton quilts are made, short cloths with certain length and width are cut, and silk non-woven fabric blanks are obtained through physical treatment for improving hydrophobicity, namely, high-temperature treatment for 0.5 hour to 2 hours at 200 ℃ to 230 ℃;
(2) Modification (selection): because the physical treatment such as heat denaturation of sericin in silk at high temperature is reduced in hydrophilicity, the silk non-woven fabric blank can be subjected to hydrophilic modification treatment, and the hydrophilicity can be partially recovered to achieve better initial wound adhesiveness, and the hydrophilic treatment method comprises plasma, ultrasonic waves, microwaves, lauryl alcohol, hydrogen peroxide, baking soda, edible alkali, edible salt and the like;
(3) Opening: firstly, tearing and loosening the non-woven fabric blank manually, then putting the non-woven fabric blank into a loosening machine for loosening pretreatment, and removing fiber impurities while loosening;
(4) The hydrophilic modified or non-modified silk non-woven fabric blank is subjected to opening carding, cross lapping, water needling interlacing, oven drying and coiling storage to obtain the non-woven fabric.
As a further improvement, the release layer is a protective layer for protecting the core layer.
As a further improvement, the release layer is adhered to the adhesive layer through the pressure-sensitive adhesive and covers the core layer.
As a further improvement, an opening for tearing is arranged at the edge or the middle of the release layer and is used for tearing the dressing core layer exposing the covered wound.
As a further development, the core layer adjacent to the adhesive side is coated with a medical pressure-sensitive adhesive/zinc oxide-coated hot melt adhesive/acrylic adhesive for bonding to the adhesive. Or the silk non-woven fabric and the adhesive tape can be bonded by adopting a hot pressing roller.
As a further improvement scheme, the adhesive layer on the adhesive tape is medical pressure-sensitive adhesive/zinc oxide coated hot melt adhesive/acrylic adhesive.
As a further improvement scheme, the adhesive cloth layer is medical non-woven flat cloth or medical non-woven elastic cloth.
As a further improvement scheme, the release layer and the adhesive cloth layer are rectangular, square or round with the same size.
As a further improvement, the length and width dimensions or the circular diameter of the release layer and the adhesive tape layer are both larger than the dimension or the diameter of the dressing layer.
As a further improvement scheme, the medical application can be used for hemostasis of small amount of bleeding in daily life work, hemostasis of minimally invasive operation wounds, hemostasis of puncture points after venipuncture, prevention of bleeding at arteriovenous fistula parts of hemodialysis patients with renal failure, health care and nursing pad and the like.
The specific scheme is further described below.
The core layer is a silk non-woven fabric net layer, and the silk is prepared by needling, water needling or other non-woven fabric preparation methods after high temperature treatment. The preparation method of the needling comprises the following steps:
(1) Blank: silk cocoons are subjected to cocoon cooking, silk reeling, refining and silk making processes, glutaraldehyde is selected to crosslink and fix sericin to reduce sericin loss in the refining process, after silk cotton quilts are made, short cloths with certain length and width are cut, and physical treatment for improving hydrophobicity, such as high temperature treatment of 200 ℃ to 230 ℃ for 0.5 to 2 hours, so as to obtain silk non-woven fabric blanks;
(2) Opening: firstly, tearing and loosening the non-woven fabric blank manually, then putting the non-woven fabric blank into a loosening machine for loosening pretreatment, and removing fiber impurities while loosening;
(3) Carding: delivering the opened fibers into a single cylinder double doffer carding machine to be carded into a fiber web, adopting double doffer configuration to form two layers of fiber webs, and finally superposing the two layers of fiber webs to form a slightly thick fiber web in order to reduce the fiber web unevenness and improve the quality;
(4) Lapping: the cross lapping is adopted, the thin fiber web output by the carding machine reaches the top transverse curtain through the inclined curtain and then enters the clamping curtain to swing back and forth to form a fiber web with a certain thickness, and the thickness of the cloth can be accurately regulated and controlled by controlling the lapping layer number;
(5) Needling: the fluffy fiber web is repeatedly needled by using a needle with triangular cross section (or other shapes) and hooked edges in a needling machine, and is reinforced into a whole to form the needled non-woven fabric.
The release layer is a protective layer for protecting the core layer, is adhered to the adhesive tape through the pressure sensitive adhesive and covers the core layer. An opening for tearing is arranged at the edge or the middle of the release layer and is used for tearing the dressing core layer exposed out of the covered wound. The release layer plays a role in isolating the viscose of the viscose layer before the product is used, so that the viscosity of the viscose layer is ensured.
The core layer near the adhesive tape side is coated with medical pressure-sensitive adhesive/zinc oxide-coated hot melt adhesive/acrylic adhesive for adhesion to the adhesive tape. Or the silk non-woven fabric cloth and the adhesive tape can be bonded by adopting a hot pressing roller in a hot pressing way, so that the method is efficient and environment-friendly.
The adhesive cloth layer is medical nonwoven flat cloth or medical nonwoven elastic cloth; the adhesive layer on the adhesive tape is medical pressure-sensitive adhesive/zinc oxide coated hot melt adhesive/acrylic acid adhesive.
The release layer and the adhesive layer are rectangular, square or round with the same size; the length and width dimensions or circular diameter of the release layer and the adhesive tape layer are both greater than the dimension or diameter of the dressing layer.
The application has the following advantages:
(1) The multifunctional medical silk non-woven fabric application is caused by various advantages of silk, and is actually simple in structure and is formed by compounding a release layer, a core layer, an adhesive layer and an adhesive tape layer. The dressing core layer is not required to be formed by composite needling of hemostatic materials, moisturizing materials, wound healing promoting materials, antioxidant components and antibacterial components, and ventilation holes are not required to be designed, so that the preparation process is simple and the cost is low.
(2) Also because silk is heat-resistant, flame-resistant and ultraviolet-resistant, the medical application has the advantages of high stability, easy storage and carrying, etc.
(3) The medical dressing has the functions of stopping bleeding, preserving moisture, promoting wound healing, inhibiting bacteria and the like; the wound dressing change device also has the advantages of good air permeability, difficult edge curling and the like, and a patient can change the wound by himself, so that the wound dressing change device is more convenient.
(4) The medical application of the application has wider application, and can be used for hemostasis of small amount of bleeding in daily life, hemostasis of minimally invasive operation wounds, hemostasis of puncture points after venipuncture, prevention of bleeding at arteriovenous fistula parts of hemodialysis patients with renal failure, health care and nursing pad and the like.
Drawings
In order to more clearly describe the technical solution of the present application, a brief description will be given below with reference to the accompanying drawings. It is apparent that these drawings are merely some of the specific embodiments of the present application. The present application includes, but is not limited to, these figures.
FIG. 1 is a schematic view of the medical application of example 1;
FIG. 2 is a graph showing the contact angle of silk nonwoven fabric with a core layer in example 2;
FIG. 3 is a scanning electron microscope image of the silk nonwoven fabric with a core layer in example 3;
FIG. 4 is a glowing residue of the silk nonwoven fabric of the core layer of example 4;
FIG. 5 is an in vitro cytotoxicity of the silk nonwoven fabric extract of the core layer of example 8;
Fig. 6 shows the hemostatic effect of the silk nonwoven fabric with core layer of example 11 on the femoral artery hemorrhage model of mice.
Detailed Description
For a further understanding of the present invention, exemplary aspects of the invention will be described below in conjunction with the following examples. These descriptions are merely illustrative of some of the features and advantages of the silk nonwoven medical application of the present invention and are not intended to limit the scope of the present invention.
The experimental methods used in the following examples are all conventional methods unless otherwise specified; the materials, reagents and the like used, unless otherwise specified, are all commercially available.
The medical silk non-woven fabric application of the application is described in detail below with reference to the accompanying drawings:
The utility model provides a silk non-woven fabrics medical application, includes from last to lower range upon range of compound release layer 1, applies sandwich layer 2 and adhesive tape layer 3, it is silk non-woven fabrics (i.e. silk non-woven fabrics web layer) to apply sandwich layer 2, release layer 1 is the adhesive tape for cover protection applies sandwich layer 2, and this adhesive tape adopts medical non-woven fabric plain cloth (or also can adopt medical non-woven fabric stretch cloth). An adhesive layer is further arranged between the core layer 2 and the adhesive tape layer 3, the adhesive layer is a medical pressure-sensitive adhesive (or zinc oxide hot melt adhesive or acrylic adhesive can be coated), the core layer 2 is fixed on the adhesive tape layer 3 through the adhesive layer, and the adhesive tape layer 3 is a medical non-woven flat cloth (or medical non-woven elastic cloth can be also used). The size of the release layer 1 and the adhesive tape layer 3 are the same and larger than the size of the core layer 2. The release layer 1 is adhered to the adhesive cloth layer 3 through pressure-sensitive adhesive and is used for covering the core layer 2. The edges of the release layer 1 (or possibly also centrally) are provided with an opening 11 for tearing open the exposed core layer 2.
Preferably, the release layer 1 and the adhesive tape layer 3 are rectangular, square or round with the same size.
Example 1
Silk non-woven fabric dressing core layer for preparing medical dressing
The silk non-woven fabric uses the puncture needle of the needle machine to intertwine the fibers in the silk fiber net, thereby forming the silk non-woven fabric core layer. The preparation process includes opening, carding and needling to strengthen short fiber. In needling, the number of needle strokes, the depth of needle strokes, the density of needle strokes, the type of needles and the arrangement of the needles are the main factors affecting the bulk and thickness of the finished product. Needling machine parameters example: the needling frequency is 800 needling per minute, the needling density is 2200 needles per meter, and the needling depth is 5mm. The invention is not limited to this parameter.
As a result, the fluffy and thinner silk non-woven fabric dressing core layer is successfully prepared, and is suitable for preparing medical application.
Example 2 measurement of the hydrophobicity value of Silk nonwoven Fabric with core layer
Contact angle measurement the contact angle measured with an optical contact angle measuring instrument (OCA 50AF,DataPhysics Instruments GmbH,Germany), the contact angle measured in fig. 2 (left panel) was approximately 150 °, and a contact angle greater than 90 ° was known to represent hydrophobic, indicating that the core-spun silk nonwoven fabric was hydrophobic; the cotton contact angle of fig. 2 (right panel) is 0 deg., indicating that the cotton is super hydrophilic.
Example 3 scanning electron microscope observation of core-coated Silk nonwoven fabrics
The microscopic view of the nonwoven fabric was photographed by a scanning electron microscope (see FIG. 3 for the results), and the fiber diameter of the scanning electron microscope photograph was measured with Image J, about 10. Mu.m.
Example 4 glowing residues of core-coated Silk nonwoven fabrics
The glowing residue measurement of the silk nonwoven fabrics of the core layer is measured according to the method of the "limit check" 0800, the method of the fourth general rule of pharmacopoeia, the glowing residue check of 0841. Taking 1.0-2.0g of a sample or the weight specified under each variety, placing the sample into a crucible which is burnt to constant weight, precisely weighing, slowly burning to complete carbonization, and cooling; burning at 700-800 deg.C to constant weight. As a result, as shown in FIG. 4, the residue of burning of the silk nonwoven fabric was greater than that of the silk raw material, both of which were less than 1%.
Example 5 loss on drying of core Silk nonwoven
The dry weight loss measurement of the silk non-woven fabric of the core coating layer is carried out according to the method of 0800 'limit check method' -0831 dry weight loss measurement of the fourth general rule of pharmacopoeia. Taking a test sample, uniformly mixing, taking about 1g or the weight specified under each variety item, placing the test sample into a flat weighing bottle which is dried to constant weight under the same condition as the test sample, precisely weighing, drying to constant weight at 105 ℃ unless specified otherwise, and calculating the drying weight loss of the test sample according to the weight loss and the sampling amount. Results: the non-woven fabric has a drying weight loss of 0.25%.
EXAMPLE 6 heavy metal content of core Silk nonwoven
The contents of heavy metal elements chromium (Cr), arsenic (As), cadmium (Cd), lead (Pb) and mercury (Hg) are measured according to a general rule of a GB/T37837-2019 quadrupole inductively coupled plasma mass spectrometry method. The main equipment used is PERKIN ELMER Nex ION 300X type ICP-MS and Shanghai Yao TOPEX microwave digestion instrument. The measuring method comprises the following steps: and mixing the sample solution with the mixed internal standard solution by adopting an online internal standard method, and then entering an ICP-MS instrument. During measurement, the isotope is 52Cr、63Cu、75 As and 74 Ge is used As an internal standard; 111 Cd takes 115 In as an internal standard; 202Hg、208 Pb has 209 Bi as an internal standard. And respectively analyzing the series of mixed standard solution, blank solution and sample solution, and quantifying by adopting a standard curve method.
As a result, the content of 5 heavy metals was less than 1mg/kg. Taking Cr of International element IHE standard "ICH Harmonised Guideline,16December 2014" as an example, parenteral exposure is 1.07mg/day, calculated as no more than 10g hemostatic material per use, 5 heavy metals do not exceed the standard.
Example 7 antibacterial test of core Silk nonwoven fabrics
Before the test, a 1X 1cm 1mm thick sample of silk nonwoven fabric was taken and placed into each well of a 24-well plate. After 1h of UV irradiation, the bacterial suspension (10. Mu.L, 10 8 CFUs/mL bacteria) was dropped onto the material surface. After incubation at 37℃for 2h, 1000. Mu.L of sterile PBS was added to each well to resuspend the surviving bacteria. Taking out 20 mu L of the re-suspended bacterial liquid, and diluting the re-suspended bacterial liquid by 100 times to obtain the final diluted bacterial liquid. mu.L of the diluted bacterial liquid was spread on the surface of LB agar plate and cultured at 37 ℃. After overnight incubation, CFUs formed on each LB agar plate were counted. The results show that the silk nonwoven fabric has obvious bactericidal effect on escherichia coli (ATCC 25922), but has no bactericidal effect on staphylococcus aureus (ATCC 29213).
Example 8 in vitro cytotoxicity test of Silk nonwoven fabrics
In vitro cytotoxicity was tested on L929 cells according to GBT 16886.5. The results of FIG. 6 show that the in vitro toxicity of the 1mm thick No. 2 needled non-woven fabric (X2) 24h 100% leaching solution to L929 cells for intervention 24h is grade I reaction, and the non-woven fabric raw materials are grade 1 reaction, and are all qualified; the relative proliferation rate (relative growt h rate, RGR) of cells of the positive control (0.3% phenol) was a grade ii response, moderately severe cytotoxicity; the strong growth rate, namely, the 100% leaching solution of the yarn positive hemostatic material in 24h is added into a culture medium, the yellow turbidity is immediately presented, adherent cells cannot be seen under a microscope, RGR which intervenes in L929 for 24h is III-level reaction, and the RGR is moderately severe cytotoxicity. Comprehensive comparison, in vitro cytotoxicity test evaluation results of the powdery and needled non-woven fabrics JCJ show that the safety is safer than that of the commercial high-speed yarn.
Example 9
Skin irritation test of Silk nonwoven fabrics
Skin irritation tests were carried out according to GB/T16886.10.
Healthy skin, intact SD rats weighing 200-250g were selected as subjects (females), fed free drinking water, and after one week of feeding in SPF environment, the test was started.
The experimental part is the back of the rat, and is divided into an experimental group and a control group, wherein each group comprises 5 animals, the experimental group uses the prepared supernatant of the leaching liquor, and the control group is physiological saline. Two experiments were performed simultaneously on each subject animal, namely an experimental group and a control group, with two areas of test material and two areas of blank material, respectively.
The animal was haired out at about 8cm x 8cm areas on both sides of the back spine 24 hours prior to the test as a test and observation site. For ease of observation, repeated dehairing may be required.
The prepared leaching solution is dripped on 4 layers of medical gauze pieces with the size of 2.5cm multiplied by 2.5cm, the leaching solution is preferably used for soaking the gauze pieces, and generally 0.5mL of leaching solution is dripped on each gauze piece and is applied to the two sides of the back of a tested animal. Sterile saline was dropped onto a gauze of the same size and applied to the control contact site.
After covering with 1 layer of weighing paper, fixing with adhesive tape, fixing with bandage (semi-closed or closed) for 4 hr, removing the patch, marking the contact site with durable ink, and removing residual test material (such as cleaning with warm water or other suitable non-irritating solvent and carefully wiping).
Skin erythema and edema were observed in the 24h animal test area and recorded for each contact site, while skin erythema and edema were scored according to the table (skin response class scoring criteria).
TABLE 1 skin reaction score table
| Erythema and crusting reactions | Edema reaction | Scoring of |
| Without any means for | No edema | 0 |
| Very slight erythema | Very slight | 1 |
| Clear red spot | Clear (raised, not beyond the edge of the area) | 2 |
| Moderate erythema | Middle degree (bulge, about 1 mm) | 3 |
| Severe erythema to eschar formation | Severe (ridge greater than 1mm and beyond contact range) | 4 |
The results showed that the other parts were treated with cloth and physiological saline, except for the 10% SDS positive control part, which was scored as 1-4 according to Table 1, and the skin reaction score was 0, indicating that the coke cocoon material extract was highly biosafety.
Example 10
Guinea pig sensitization test of Silk nonwoven fabrics
Skin sensitization test was performed according to GB/T16886.10. The blocking application test (Buehler) of GBT 16886.10-2017 was used. The experimental group is silk non-woven fabric leaching liquor, the negative control group is physiological saline, and the positive control group is 2, 4-dinitrochlorobenzene solution with concentration of 0.5% prepared by ethanol. The experiment was divided into two phases: induction phase (7 days+14 days), excitation phase (6 hours). The preparation stage: a) Thoroughly shearing or removing all test part fur of the animal before starting the test; b) For topical application, three layers of absorbent gauze pieces (2.5 cm×2.5 cm) were impregnated with the test sample, applied to the dehairing sites of animals, and secured with a closed binder (6-soil 0.5) for h; c) For topical application, a suitable filter paper or gauze is applied to the pelt-removed skin and secured around the animal's torso with a closed bandage. Main test: (1) three weeks induction phase. Preparing hairs in a region of 3X 3cm on the left upper back of a guinea pig 24 hours before the experiment to serve as a test part; the test area was cleaned with 70% ethanol before the start of the experiment, and three layers of absorbent gauze pieces (2.5 cm. Times.2.5 cm) were placed to soak the test sample; this procedure was repeated for 3 consecutive days in 1 week, and the same procedure was followed for 3 weeks. (2) an excitation stage. After the last induction application (14+/-1) d, applying corresponding solution on unhairing untrusted parts of each animal, attaching an application patch, covering with 1 layer of weighing paper, and fixing with adhesive tape; (6 th 0.5 th) then removing the bandages and patches, marking the contact sites with permanent ink, and removing residual test material; the test animals were observed for erythema and edema at the site of the test excitation by scoring (skin response class scoring) according to the grading criteria given in table 1 for 24h and 48h of the excitation patch removal.
Scoring and grading were performed according to the criteria of tables 1 and 2, and the results of guinea pig sensitization evaluation are shown in Table 3. After 24h of excitation, the tested parts of the tested animals of the positive control group have different degrees of erythema and edema, the sensitization degree reaches 100%, and the sensitization reaction of the positive control group is V-grade according to Mafhusson sensitization reaction grading standards, which shows that 0.5% of 2, 4-dinitrochlorobenzene solution (DNCB) has extremely strong sensitization effect on guinea pigs under the experimental condition. No significant erythema or edema was observed in the skin in both the negative control and the extract groups, no significant differences were observed between the experimental and negative control groups, and the score was 0, with no sensitization.
TABLE 2 Mafhusson sensitization fractionation criteria
| Sensitization Rate (%) | Grading | Classification |
| 0-8 | Ⅰ | No difference from the negative control |
| 9-28 | Ⅱ | Slight reaction |
| 29-64 | Ⅲ | Moderate reaction |
| 65-80 | Ⅳ | Intense reaction |
| 81-100 | Ⅴ | Extremely strong reaction |
TABLE 3 results of evaluation of guinea pig sensitization
Example 11
Hemostatic test of silk nonwoven fabric in mouse femoral artery hemorrhage model
The hemostatic test results of the mouse femoral artery hemorrhage model show (fig. 6), the hemostatic time consumption of the silk non-woven fabric (X3) is equivalent to that of the strong growth rate (Q), namely yarn, and the hemostatic time consumption of the burnt silkworm cocoons (H) is slightly higher than that of the strong growth rate, namely yarn, but the hemostatic time consumption of the non-woven fabric is obviously shorter than that of the raw material (X0, about 60 s) without obvious difference.
The embodiments described in the foregoing description are only some of the embodiments of the present invention and various changes and modifications may be made therein without departing from the spirit and scope of the invention as defined in the appended claims.
Claims (7)
1. The utility model provides a silk non-woven fabrics medical application which characterized in that: the silk non-woven fabric comprises a release layer, a core coating layer and an adhesive tape layer which are laminated and compounded from top to bottom, wherein the core coating layer is silk non-woven fabric, the release layer is adhesive tape and is used for covering and protecting the core coating layer, and the silk non-woven fabric is prepared by sequentially carrying out opening, carding and needling on short fibers;
The edge of the release layer is provided with an opening for tearing so as to tear and expose the core layer.
2. A silk nonwoven medical application according to claim 1, characterized in that: an adhesive layer is arranged between the core layer and the adhesive tape layer.
3. A silk nonwoven medical application according to claim 2, characterized in that: the adhesive layer is medical pressure-sensitive adhesive, zinc oxide-coated hot melt adhesive or acrylic adhesive.
4. A silk nonwoven medical application according to claim 1, characterized in that: the release layer is adhered to the adhesive cloth layer through pressure-sensitive adhesive and is used for covering the core layer.
5. A silk nonwoven medical application according to claim 1, characterized in that: the adhesive cloth layer is medical nonwoven flat cloth or medical nonwoven elastic cloth.
6. A silk nonwoven medical dressing according to any one of claims 1-5, characterized in that: the release layer and the adhesive cloth layer are rectangular, square or round with the same size.
7. A silk nonwoven medical dressing according to any one of claims 1-5, characterized in that: the length and width dimensions or the circular diameter of the release layer and the adhesive tape layer are both larger than the dimension or the diameter of the core layer.
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