CN113197705B - Barbed silk suture line and preparation method thereof - Google Patents

Barbed silk suture line and preparation method thereof Download PDF

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Publication number
CN113197705B
CN113197705B CN202110359376.1A CN202110359376A CN113197705B CN 113197705 B CN113197705 B CN 113197705B CN 202110359376 A CN202110359376 A CN 202110359376A CN 113197705 B CN113197705 B CN 113197705B
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silk
suture
silk suture
solution
barb
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CN113197705A (en
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赵芳
陈镜宇
王金秀
付晏泽
郝家庆
徐磊
许愿
卢神州
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Paraxon Pharmaceutical Biotechnology Shanghai Co ltd
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Suzhou University
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Priority to CN202211056153.9A priority patent/CN115444612A/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0059—Cosmetic or alloplastic implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/0097—Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention discloses a preparation method of a barbed silk suture, which comprises the following steps: (1) degumming the silk suture line: immersing the silk suture in alkali liquor, treating for 30-60 minutes under a slightly boiling state, and cleaning with warm water; (2) activation of silk suture: immersing the degummed silk suture in a strong alkali solution, treating at 20-55 ℃, taking out, cleaning with an acetic acid solution, and then cleaning with deionized water; (3) preparing a ginsenoside finishing liquid: adding ginsenoside water solution into silk fibroin solution, aging at room temperature for 1-5 hr; (4) carrying out medicine loading on the silk suture: immersing the activated silk suture in the ginsenoside finishing liquid, carrying out padding treatment, and then baking and drying; (5) and (3) forming barbs: placing the silk suture line with the drug loaded into a mould, pouring a silk fibroin solution, removing air bubbles in vacuum and drying; (6) shaping: and taking the dried suture out of the mold, and carrying out wet heat treatment to obtain the barbed silk suture.

Description

Barbed silk suture line and preparation method thereof
Technical Field
The invention relates to the technical field of sutures, in particular to a novel knotting-free barb-like silk suture for promoting wound healing and a preparation method thereof.
Background
In the medical and American field, the barb suture line is often used for operations such as line carving, facial lifting, and the like, and the tension that the application barb produced promotes to restore to the throne behind the soft tissue anchoring that will age and receive the influence of gravity, sag, reach the purpose of youthfulization.
Most of the materials of the existing knotting-free suture line are composite materials, and researches show that the absorbable and degradable materials have swelling at implanted parts with different degrees after being implanted, and the phenomenon of aseptic effusion is generated. The material degradation fragments, monomers, catalyst release, dead cell content release and the like can all cause acute inflammatory reaction, and are not suitable for the field of cosmetology; also, in some places where the tension is high, the strength of the absorbable thread may be difficult to achieve and its use may be limited. Because the existing knotting-free suture is prepared by cutting and stabbing on line, the strength of the suture is uneven, and the risk of fracture of the suture exists in the operation process and after the operation.
As a natural protein material, the silk does not have adverse effect on human bodies. Clinical experiment results of silk sutures used in a large number of hospitals prove that the silk sutures after complete degumming can not cause any inflammatory reaction after being implanted into human tissues, and are not easy to cause biological rejection reaction, and the silk sutures as natural proteins with excellent performance have good promotion effect on wound healing and repair, can promote wound healing early, have smaller scar remaining probability compared with other composite material sutures, and have huge market potential.
On the other hand, the Chinese herbal medicine has wide resources and low cost, has the unique advantages of incomparable western medicines such as natural materials, stable effect, small toxic and side effect and the like, wherein the ginseng is a well-known famous and precious Chinese traditional Chinese medicinal material, has high medicinal value, and chemical components of the ginseng are gradually disclosed through analysis of modern biochemistry. Ginseng contains abundant proteins, polysaccharides and saponins. Ginsenoside is the main active substance in ginseng, contains various subtypes, has broad-spectrum pharmacological activities of diminishing inflammation, detoxifying, resisting tumors, resisting myocardial ischemia, resisting aging, improving memory and the like, and has the functions of eliminating free radicals, improving oxidation resistance, increasing the content of skin collagen fibers and collagen, regulating the immune function of an organism, improving microcirculation and the like.
If the ginsenoside and silk fibroin of silk can be combined together in the barb operation line, the ginsenoside can be durably acted on a wound, the drug effect is prolonged, the situation of wound inflammation is effectively improved, and the wound healing is promoted.
Disclosure of Invention
In view of the above, in order to overcome the drawbacks of the prior art and to achieve the above objects, the present invention provides a method for preparing a barbed silk suture thread by combining ginsenoside and silk fibroin into a barbed surgical thread.
In order to achieve the purpose, the invention adopts the following technical scheme:
a preparation method of a barbed silk suture comprises the following steps:
(1) degumming the silk suture line: immersing the silk suture in alkali liquor, treating for 30-60 minutes under a slightly boiling state, and cleaning with warm water;
(2) activation of silk suture: immersing the degummed silk suture in a strong base solution with the concentration of 5-50 g/L, treating for 1-10 minutes at 20-55 ℃, taking out, cleaning with an acetic acid solution, and then cleaning with deionized water;
(3) preparing a ginsenoside finishing liquid: the ginsenoside water solution is prepared by mixing the following ginsenoside: adding silk fibroin at a ratio of 1:10-100 into the silk fibroin solution, uniformly mixing, and aging at room temperature for 1-5 hours to obtain a ginsenoside finishing solution;
(4) carrying out medicine loading on the silk suture: immersing the silk suture activated in the step (2) into the ginsenoside finishing liquid prepared in the step (3), carrying out padding treatment, and then baking and drying;
(5) forming barbs: placing the silk suture line with the drug loaded into a mould, wherein a plurality of barb areas for forming a barb structure are arranged in the mould, then pouring silk fibroin solution into the mould, and drying after removing bubbles in vacuum;
(6) shaping: and taking the dried suture out of the mold, and carrying out damp-heat treatment at 120-130 ℃ to obtain the barbed silk suture.
To facilitate the formation of barbs. The concentration of the silk fibroin solution added in the step (5) is 3% -10%, too low solubility can cause severe shrinkage and barb deformation in the drying process of the solution; if the concentration is too high, silk fibroin is unstable and is easy to form gel.
According to some preferred embodiments of the invention, the alkali solution in step (1) is a sodium carbonate solution with a mass concentration of 0.02-0.08%.
According to some preferred aspects of the present invention, the strong alkaline solution in step (2) is an aqueous solution of sodium hydroxide and/or potassium hydroxide, and the concentration of the strong alkaline solution is 5g/L to 50 g/L. Activating with strong alkali to form more amino groups, wherein the amino groups react with hemiacetal structure on ginsenoside to form Schiff base, so as to improve the binding force between ginsenoside and silk fibroin. After the strong alkali solution is treated, weak acid is used to eliminate the influence of the strong alkali, so as to prevent the strength of the suture from being reduced.
According to some preferred implementation aspects of the invention, the padding treatment in the step (4) comprises the following steps:
padding for the first time: the padding pressure is 0.4kg/cm 2 ～2kg/cm 2 The rolling residual rate is 10-20%;
and (3) padding for the second time: the padding pressure is 0.2kg/cm 2 ～1kg/cm 2 The rolling residual rate is 20-40%;
and (3) padding for the third time: padding pressure of 0.1kg/cm 2 ～0.5kg/cm 2 The rolling residual rate is 40-60%.
According to some preferred embodiments of the present invention, the conditions of the baking and drying in the step (4) are: the baking temperature is 110-130 ℃, and the baking time is 1-30 minutes. The baking temperature is set above 100 ℃, but not too high to damage the silk fibres and not too long. Baking is to improve the fastness of the drug loading.
According to some preferred embodiments of the invention, the drying conditions in step (5) are: the temperature is 20-40 ℃, and the humidity is 50-70%.
In some embodiments of the invention, the preparation method of the knotting-free barbed silk suture for promoting wound healing, which is disclosed by the invention, comprises the following steps of:
(1) degumming the silk suture: the silk suture is prepared by mixing the following components in a bath ratio of 1:100 is immersed in 0.05 percent (w/v) sodium carbonate solution, treated for 30 to 60 minutes under the condition of slight boiling, and washed for 3 times by warm water at the temperature of 30 to 40 ℃;
(2) activation of silk suture: and (3) mixing the degummed silk suture thread in a bath ratio of 1: 500 is immersed in strong alkali solution with the concentration of 5g/L to 50g/L, treated for 1 to 10 minutes at the temperature of 20 to 55 ℃, taken out and washed by 0.5 to 3 percent (v/v) of acetic acid solution, and then washed by deionized water for 3 times;
(3) preparing a ginsenoside finishing liquid: preparing a 1% ginsenoside aqueous solution by mass ratio of ginsenoside: adding silk fibroin at a ratio of 1:10-100 into the silk fibroin solution, uniformly mixing, and aging at room temperature for 1-5 hours;
(4) carrying out medicine loading on the silk suture: immersing the activated silk suture in the ginsenoside finishing liquid, performing 3-immersion and 3-rolling treatment, and then quickly baking and drying at the baking temperature of 110-130 ℃ for 1-30 minutes;
(5) forming barbs: placing the silk suture line with the drug loaded into a mould, wherein a plurality of barb areas for forming a barb structure are arranged in the mould, then pouring silk fibroin solution into the mould, and drying after removing bubbles in vacuum;
(6) shaping: and taking the dried suture out of the mold, and carrying out damp-heat treatment at 120-130 ℃ for 10-100 minutes to obtain the knotting-free silk suture capable of promoting wound healing.
The invention also provides a barbed silk suture prepared by the preparation method, which comprises a wire body positioned inside, a silk fibroin surface body wrapped on the surface of the wire body, and a plurality of barbs protruding outwards from the silk fibroin surface body, wherein the barbs are uniformly distributed on the surface of the silk fibroin surface body in a spiral shape; the silk fibroin surface body and the barbs are formed by coagulating silk fibroin solution.
The silk fibroin surface body and the barbs of the silk fibroin are adopted, so that the biocompatibility of the suture is good, the stimulation and the immunoreaction of the wound can not be caused, the cell growth factors can be adsorbed, and the tissue healing is promoted. The spiral barb type silk fibroin suture line has the advantages that in the surgical suture process, barbs are self-fixed, the suture time is short, knotting is not needed after suture is completed, and wounds can be automatically closed; and the barbs are spirally distributed, so that the tension of the wound is more uniformly distributed after the suture is finished, the pain is not caused, and a larger scar is not generated after the wound is healed.
According to some preferred implementation aspects of the invention, the silk fibroin surface body is provided with two groups of barb units, each group of barb units comprises a plurality of barbs, and the plurality of barbs in each group of barb units are uniformly distributed on the surface of the silk fibroin surface body in a spiral shape. Through setting up two sets of or multiunit barb unitized construction for the atress is more dispersed and even, and the effect of sewing up is better.
According to some preferred aspect of the invention, the two sets of barb units are symmetrically distributed along the central axis of the wire body. The two or more groups of barb structures are symmetrically arranged, so that the suture line has the advantages of stable tissue anchoring effect, more excellent mechanical property and the like.
According to some preferred embodiments of the invention, the helical angle of the helix formed by the helical distribution of each group of the barb units is 45-60 °; the pitch of a spiral line formed by spirally distributing each group of the barb units is 0.1 cm-1 cm; the spiral distribution of barb is left-handed distribution or dextrorotation distribution.
According to some preferred embodiments of the invention, the fibroin watch body and the barbs are integrally formed. In some embodiments of the invention, a three-dimensional silica gel mold is manufactured by 3D printing, and spirally distributed barb holes are imprinted on the mold, and the silk fibroin solution is poured into the mold during preparation, and can be cast and molded at one time after being dried.
According to some preferred embodiments of the invention, the included angle between the length direction of the barb and the length extension direction of the wire body is 20 ° to 60 °. Different barb angles can be set according to different sewing occasions. The even arrangement of barb heliciform also makes the tissue tension after the wound is sewed up distribute more evenly, reduces the painful sense of postoperative.
According to some preferred embodiments of the invention, the barb is conical and has a length of 0.1mm to 5mm and a diameter of 0.01mm to 1mm at the base of the barb. The suture lines with barbs of different sizes can be arranged according to the size and depth of the wound for suturing, so that the scar of the wound is relieved.
According to some preferred implementation aspects of the invention, the thread body is silk thread, and the fibroin surface body wraps the surfaces of the silk threads and is filled between the adjacent silk threads. The silk suture has better mechanical property and is not easy to break, so that the suture of the application keeps the superior performance of the silk suture and also adds a rigid barb structure.
According to some preferred embodiment aspects of the invention, the wire body has a diameter of 0.05mm to 2 mm.
According to some preferred embodiments of the invention, the silk fibroin is silk fibroin composed of a fibroin II crystal structure. The barb of silk fibroin material can be in the same place with silk thread is fine to be combined, has the same biocompatibility simultaneously, and silk fibroin II crystal structure can make the barb obtain more rigid structure, sews up to the tissue has better anchoring effect.
Due to the adoption of the technical scheme, compared with the prior art, the invention has the following benefits: according to the preparation method of the barbed silk suture, the ginsenoside and the silk fibroin are applied to the preparation and formation of the barbed suture, so that the novel knotting-free barbed silk suture capable of promoting wound healing is prepared; polysaccharide chains in the ginsenoside can form stable hydrogen bonds with silk fibroin, so that the ginsenoside can be durably (slowly released for a long time) acted on wounds, the drug effect is prolonged, the situation of wound inflammation is effectively improved, the wound healing is promoted, and the mechanical property of a suture line can be improved.
Drawings
In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.
FIG. 1 is a schematic front view of a spiral-barbed fibroin suture in accordance with an embodiment of the present invention;
FIG. 2 is a schematic top view of a spiral-barbed silk fibroin suture in accordance with an embodiment of the present invention;
in the drawings: 1-barb; 2-fibroin surface body; 3-a wire body.
Detailed Description
In order to make those skilled in the art better understand the technical solution of the present invention, the technical solution in the embodiment of the present invention will be clearly and completely described below with reference to the drawings in the embodiment of the present invention, and it is obvious that the described embodiment is only a part of the embodiment of the present invention, and not a whole embodiment. All other embodiments, which can be obtained by a person skilled in the art without making any creative effort based on the embodiments in the present invention, shall fall within the protection scope of the present invention.
Example 1
As shown in fig. 1-2, the barbed silk suture (spiral barbed silk fibroin suture) in this embodiment comprises a silk body 3 inside, a fibroin surface 2 wrapping the surface of the silk body 3, and a plurality of barbs 1 protruding from the fibroin surface 2. Silk fibroin table 2 in this embodiment has two sets of barbs 1 unit, and every group barb 1 unit all includes a plurality of barbs 1, and a plurality of barbs 1 in every group barb 1 unit all are heliciform evenly distributed in silk fibroin table 2's surface, and two sets of barbs 1 unit along the central axis symmetric distribution of the line body 3. Two or more groups of barb 1 unit structures are symmetrically arranged, so that the suture line has the advantages of more stable tissue anchoring effect, more excellent mechanical property and the like, and the suture effect is better.
The helix angle of the helix that the heliciform of barb 1 distributes and forms in this embodiment is 60, and the pitch of the helix that the heliciform of barb 1 distributes and forms is 0.5cm, and the heliciform of barb 1 distributes for levogyration or dextrorotation so that different barb 1 units distribute with symmetrical arrangement. In other embodiments, the helical angle of the spiral distribution of the barbs 1 is 45-60 degrees, and the length (pitch) of one turn of the spiral of the barbs 1 is 0.1-1 cm. The barbs 1 are spirally and uniformly arranged, so that the tissue tension after the wound is sutured is more uniformly distributed, and the postoperative pain is reduced.
In this embodiment, the included angle between the length direction of the barb 1 and the length extending direction of the wire 3 is 45 °. In other embodiments, the included angle between the length direction of the barb 1 and the length extending direction of the line body 3 is 20-60 degrees, and different angles of the barb 1 can be set according to different sewing occasions.
In this embodiment, the barb 1 is conical and has a length of 0.5cm and a diameter of 0.1mm at the bottom of the barb 1. In other embodiments, the length of the barb 1 is 0.1 mm-5 mm, the diameter of the bottom of the barb 1 is 0.01 mm-1 mm, and the barb 1 can be sewed by a suture line with different sizes of barbs 1 according to the size and depth of a wound, so that the scar of the wound is reduced.
The diameter of the thread body 3 is 0.05mm to 2mm, preferably 1.2mm in the present embodiment, and the thread body 3 in the present embodiment is a braided type silk suture thread formed by braiding a plurality of silk threads. The fibroin surface body 2 is wrapped on the surface of the silk threads and is filled between the adjacent silk threads. The silk suture has good mechanical property and is not easy to break, so that the suture of the embodiment keeps the superior performance of the silk suture, and is added with a rigid barb 1 structure, has good biocompatibility and can be harmlessly degraded in vivo.
The fibroin surface body 2 and the barb 1 in the embodiment are formed by integrally molding the coagulated fibroin solution. The silk fibroin in the silk fibroin surface body 2 is the silk fibroin formed by a silk fibroin II crystal structure, and the barb 1 is formed by crystalline silk fibroin. The silk fibroin material's barb 1 can be in the same place with silk thread is fine, has the same biocompatibility simultaneously, and silk fibroin II crystal structure can make barb 1 can obtain more rigid structure, sews up to the tissue has better anchoring effect.
Example 2 preparation of fibroin solution
Weighing 80g of silkworm cocoon shells by using a balance, putting the silkworm cocoon shells into a container, adding 4000mL of sodium bicarbonate/sodium carbonate aqueous solution with the mass fraction of 0.01M and the pH value of 9.5, heating the mixture to a boiling state by using an induction cooker, adjusting the power of the induction cooker, keeping the aqueous solution to be boiled for 30min continuously, taking out cocoon silks, and cleaning the cocoon silks by using deionized water. This was repeated three times to ensure complete removal of sericin.
Then the cocoon silk is taken out and is dried in a drying oven at the temperature of 60 ℃ to obtain the pure silk fibroin fiber. Dissolving pure silk fibroin fiber in a lithium bromide solution with the concentration of 9.3mol/L according to the bath ratio of 20:150, and dissolving in a constant-temperature magnetic stirrer at the temperature of 60 +/-2 ℃ for about 1 h. Cooling, taking out, putting into a dialysis bag, sealing, dialyzing in deionized water for 3-4 days, filtering with absorbent cotton to obtain a pure silk fibroin solution, drying, weighing to obtain the mass fraction of the pure silk fibroin solution, and placing in a refrigerator at 4 ℃ for later use.
EXAMPLE 3 preparation of barbed Silk sutures
(1) Degumming of silk suture
The silk suture is prepared by mixing the following components in a bath ratio of 1:100 was immersed in 0.05% (w/v) sodium carbonate solution, treated in a slightly boiling state for 40 minutes, and washed 3 times with warm water at 35 ℃.
(2) Activation of silk sutures
And (3) mixing the degummed silk suture thread in a bath ratio of 1: 500 was immersed in 25g/L sodium hydroxide solution, treated at 40 ℃ for 5 minutes, taken out, washed with 0.8% (v/v) acetic acid solution and then with deionized water 3 times.
(3) Preparation of ginsenoside finishing liquid
Preparing a 1% ginsenoside aqueous solution by mass ratio of ginsenoside: adding silk fibroin at the ratio of 1:30 into the silk fibroin solution, uniformly mixing, and aging at room temperature for 3 hours.
(4) Drug loading of silk sutures
Immersing the activated silk suture in the ginsenoside finishing liquid, and performing 3-immersion and 3-rolling treatment, wherein the method comprises the following steps: the first pressure was 0.4kg/cm 2 The rolling residue rate is 10 percent; immersing in silk fibroin solution again, and rolling under 0.2kg/cm 2 The rolling residual rate is 20 percent; immersing in the solution for the third time, and then passing through a padder under the pressure of 0.1kg/cm 2 The rolling residual rate is 40%. Then rapidly baking and drying at 120 ℃ for 10 minutes.
(5) Formation of barbs
Put into the silica gel mould of barb bed die with the silk stylolite after the medicine carrying, the silica gel template is made by 3D printing technique, and is equipped with a plurality of barb districts that are used for forming the barb structure in the silica gel mould, and the length extending direction in barb district is 45 with the contained angle of silk stylolite length extending direction, and the length in barb district is 0.5cm, then pours into silk fibroin solution into the mould, puts into vacuum drying incasement vacuum deaeration 1min, later puts into constant temperature and humidity room (temperature 25 ℃, humidity is 60%) dry.
(6) Shaping
And taking the dried suture out of the mold, and carrying out damp-heat treatment at 126 ℃ for 20 minutes to obtain the knot-free silk suture capable of promoting wound healing.
(7) Cutting package
Drying the shaped suture, cutting into 30cm long, and packaging to obtain the final product.
The use of suture: when the clinical operation is sewed, barbed suture lines with different specifications can be selected according to the sewing situations such as wound size, sewing position, sewing tissue and the like, and redundant suture lines are subtracted after the sewing is finished without knotting.
EXAMPLE 4 preparation of barbed Silk sutures
(1) Degumming of silk suture
The silk suture is prepared by mixing the following components in a bath ratio of 1:100 was immersed in 0.05% (w/v) sodium carbonate solution, treated in a slightly boiling state for 30 minutes, and washed 3 times with warm water at 40 ℃.
(2) Activation of Silk sutures
And (3) mixing the degummed silk suture thread in a bath ratio of 1: 500 into 50g/L potassium hydroxide solution, at 20 ℃ for 2 minutes, and then taken out and washed with 3% (v/v) acetic acid solution, and then with deionized water 3 times.
(3) Preparation of ginsenoside finishing liquid
Preparing a 1% ginsenoside aqueous solution by mass ratio of ginsenoside: adding silk fibroin at the ratio of 1:100 into the silk fibroin solution, uniformly mixing, and aging at room temperature for 5 hours.
(4) Drug loading of silk sutures
Immersing the activated silk suture in the ginsenoside finishing liquid, and performing 3-immersion and 3-rolling treatment, wherein the method comprises the following steps: the first pressure was 2kg/cm 2 The rolling residual rate is 10 percent; immersing in silk fibroin solution again, and then passing through padder under pressure of 1kg/cm 2 The rolling residual rate is 20 percent; immersing in the solution for the third time, and then passing through a padder under the pressure of 0.5kg/cm 2 The rolling residual rate is 40%. Then rapidly baking and drying at 130 deg.C for a period of timeWas 3 minutes.
(5) Barb formation
Put into the silica gel mould of barb bed die with the silk stylolite after the medicine carrying, the silica gel template is made by 3D printing technique, and is equipped with a plurality of barb districts that are used for forming the barb structure in the silica gel mould, and the length extending direction in barb district and the contained angle of silk stylolite length extending direction are 45, and the length in barb district is 0.5cm, then pours into silk fibroin solution into the mould, puts into vacuum drying incasement vacuum deaeration 1min, later puts into constant temperature and humidity room (temperature 25 ℃, humidity is 70%) dry.
(6) Shaping
And taking the dried suture out of the mold, and carrying out damp-heat treatment at 130 ℃ for 10 minutes to obtain the knotting-free silk suture capable of promoting wound healing.
(7) Cutting package
Drying the shaped suture, cutting into 30cm long, and packaging to obtain the final product.
EXAMPLE 5 preparation of barbed Silk sutures
(1) Degumming of silk suture
The silk suture is prepared by mixing the following components in a bath ratio of 1:100 was immersed in 0.05% (w/v) sodium carbonate solution, treated in a slightly boiling state for 40 minutes, and washed 3 times with warm water at 35 ℃.
(2) Activation of Silk sutures
And (3) mixing the degummed silk suture thread in a bath ratio of 1: 500 are immersed in a 5g/L sodium hydroxide solution, treated at 20 ℃ for 9 minutes, taken out and washed with 0.5% (v/v) acetic acid solution and then with deionized water 3 times.
(3) Preparation of ginsenoside finishing liquid
Preparing a 1% ginsenoside aqueous solution by mass ratio of ginsenoside: adding silk fibroin at a ratio of 1:10 into the silk fibroin solution, uniformly mixing, and aging at room temperature for 1 hour.
(4) Drug loading of silk sutures
Immersing the activated silk suture in the ginsenoside finishing liquid, and performing 3-immersion and 3-rolling treatment, wherein the method comprises the following steps: the first pressure was 0.4kg/cm 2 The rolling residue rate is 20 percent; immersing in silk fibroin solution again, and rolling under 0.2kg/cm 2 The rolling residual rate is 40 percent; immersing in the solution for the third time, and then passing through a padder under the pressure of 0.1kg/cm 2 The rolling residual rate is 60%. Then rapidly baking and drying at 115 ℃ for 25 minutes.
(5) Formation of barbs
Put into the silica gel mould of barb bed die with the silk stylolite after the medicine carrying, the silica gel template is made by 3D printing technique, and is equipped with a plurality of barb districts that are used for forming the barb structure in the silica gel mould, and the length extending direction in barb district and the contained angle of silk stylolite length extending direction are 45, and the length in barb district is 0.5cm, then pours into silk fibroin solution into the mould, puts into vacuum drying incasement vacuum deaeration 1min, later puts into constant temperature and humidity room (temperature 40 ℃, humidity is 50%) dry.
(6) Shaping
And taking the dried suture out of the mold, and carrying out damp-heat treatment at 120 ℃ for 100 minutes to obtain the knotting-free silk suture capable of promoting wound healing.
(7) Cutting package
Drying the shaped suture, cutting into 30cm long, and packaging to obtain the final product.
EXAMPLE 6 preparation of barbed Silk sutures
(1) Degumming of silk suture
The silk suture is prepared by mixing the following components in a bath ratio of 1:100 was immersed in a 0.05% (w/v) sodium carbonate solution, treated in a slightly boiling state for 30 minutes, and washed with warm water at 30 ℃ for 3 times.
(2) Activation of silk sutures
And (3) mixing the degummed silk suture thread in a bath ratio of 1: 500 are immersed in a 7g/L sodium hydroxide solution, treated at 30 ℃ for 7 minutes, taken out and washed with 2% (v/v) acetic acid solution and then with deionized water 3 times.
(3) Preparation of ginsenoside finishing liquid
Preparing a 1% ginsenoside aqueous solution by mass ratio of ginsenoside: adding silk fibroin at a ratio of 1:10 into the silk fibroin solution, uniformly mixing, and aging at room temperature for 1 hour.
(4) Drug loading of silk sutures
Immersing the activated silk suture in the ginsenoside finishing liquid, and performing 3-immersion and 3-rolling treatment, wherein the method comprises the following steps: the first pressure was 2kg/cm 2 The rolling residual rate is 20 percent; immersing in silk fibroin solution again, and then passing through padder under pressure of 1kg/cm 2 The rolling residual rate is 40 percent; immersing in the solution for the third time, and then passing through a padder under the pressure of 0.5kg/cm 2 The rolling residue rate is 60%. Then rapidly baking and drying at 120 ℃ for 20 minutes.
(5) Formation of barbs
Put into the silica gel mould of barb bed die with the silk stylolite after the medicine carrying, the silica gel template is made by 3D printing technique, and is equipped with a plurality of barb districts that are used for forming the barb structure in the silica gel mould, and the length extending direction in barb district and the contained angle of silk stylolite length extending direction are 45, and the length in barb district is 0.5cm, then pours into silk fibroin solution into the mould, puts into vacuum drying incasement vacuum deaeration 1min, later puts into constant temperature and humidity room (temperature 40 ℃, humidity is 50%) dry.
(6) Shaping
And taking the dried suture out of the mold, and carrying out damp-heat treatment at 126 ℃ for 50 minutes to obtain the knotting-free silk suture capable of promoting wound healing.
(7) Cutting package
Drying the shaped suture, cutting into 30cm long, and packaging to obtain the final product.
The invention relates to a knotting-free silk suture line with a barb structure and capable of promoting wound healing and a preparation method thereof, 1. on the basis of the existing barbed silk suture line, silk fibroin solution is cast around a line body through a mould, a plurality of barbs are formed on the suture line, and the barbs are uniformly distributed on the surface of the line body in a spiral shape; 2. the ginsenoside is applied to the manufacturing and forming of the barbed suture, and the polysaccharide chain in the ginsenoside can form a stable hydrogen bond with silk fibroin, so that the long-term slow release can be achieved, the ginsenoside can act on a wound for a long time, the drug effect is prolonged, the wound inflammation condition is effectively improved, the wound healing is promoted, and the mechanical property of the suture can be improved. The silk suture line of this application has utilized the superiority of silk line self performance promptly, adopts the heliciform arrangement mode simultaneously, makes the atress more even among the sewing process, and the wound is sewed up effectually, is difficult for arousing the postoperative infection. The suture retains the good biocompatibility of the original suture, has the effects of promoting the healing of skin wounds, improving the immunity of organisms, resisting oxidation and the like, and has stable and lasting effect and quick response.
The above embodiments are merely illustrative of the technical concept and features of the present invention, and the purpose thereof is to enable those skilled in the art to understand the content of the present invention and implement the invention, and not to limit the scope of the invention, and all equivalent changes or modifications made according to the spirit of the present invention should be covered by the scope of the present invention.

Claims (8)

1. A preparation method of a barbed silk suture line is characterized by comprising the following steps:
(1) degumming the silk suture: immersing the silk suture in alkali liquor, treating for 30-60 minutes under a slightly boiling state, and cleaning with warm water;
(2) activation of silk suture: immersing the degummed silk suture in a strong alkali solution, treating at 20-55 ℃ for 1-10 minutes, taking out, cleaning with an acetic acid solution, and then cleaning with deionized water;
(3) preparing a ginsenoside finishing liquid: the ginsenoside water solution is prepared by mixing the ginsenoside water solution: adding silk fibroin =1:10-100 into silk fibroin solution, mixing uniformly, and aging at room temperature for 1-5 hours to obtain ginsenoside finishing liquid;
(4) carrying out medicine loading on the silk suture: immersing the silk suture activated in the step (2) into the ginsenoside finishing liquid prepared in the step (3), carrying out padding treatment, and then baking and drying;
(5) forming barbs: placing the silk suture line with the drug loaded into a mould, wherein a plurality of barb areas for forming a barb structure are arranged in the mould, then pouring silk fibroin solution into the mould, and drying after removing bubbles in vacuum;
(6) shaping: taking the dried suture out of the mold, and carrying out damp-heat treatment at 120-130 ℃ to obtain the barbed silk suture;
the strong alkali solution in the step (2) is an aqueous solution of sodium hydroxide and/or potassium hydroxide, and the concentration of the strong alkali solution is 5 g/L-50 g/L; the baking and drying conditions in the step (4) are as follows: the baking temperature is 110-130 ℃, and the baking time is 1-30 minutes.
2. The preparation method of the barbed silk suture according to claim 1, wherein the alkali solution in the step (1) is a sodium carbonate solution with a mass concentration of 0.02 to 0.08%.
3. The method for preparing a barbed silk suture according to claim 1, wherein the padding process in step (4) comprises the steps of:
padding for the first time: the padding pressure is 0.4kg/cm 2 ～2kg/cm 2 The rolling residual rate is 10-20%;
and (3) padding for the second time: the padding pressure is 0.2kg/cm 2 ～1kg/cm 2 The rolling residual rate is 20-40%;
and (3) padding for the third time: the padding pressure is 0.1kg/cm 2 ～0.5kg/cm 2 The rolling residual rate is 40-60%.
4. The method for preparing a barbed silk suture according to claim 1, wherein the drying conditions in step (5) are: the temperature is 20-40 ℃, and the humidity is 50-70%.
5. The method for preparing the barbed silk suture according to any one of claims 1 to 4, wherein the barbed silk suture comprises an internal thread, a silk fibroin surface body wrapped on the surface of the thread, and a plurality of barbs protruding outwards from the silk fibroin surface body, wherein the plurality of barbs are uniformly distributed on the surface of the silk fibroin surface body in a spiral shape; the silk fibroin surface body and the barbs are formed by coagulating silk fibroin solution.
6. The method of claim 5, wherein the plurality of barb units are provided on the silk fibroin surface, each barb unit comprises a plurality of barbs, and each barb unit comprises a plurality of barbs uniformly distributed on the surface of the silk fibroin surface.
7. The method of making a barbed silk suture according to claim 6, wherein the plurality of sets of barb elements are symmetrically distributed along the central axis of the wire body.
8. A barbed silk suture thread produced by the production method according to any one of claims 1 to 7.
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