CN109385710B - Absorbable suture and preparation method thereof - Google Patents

Absorbable suture and preparation method thereof Download PDF

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CN109385710B
CN109385710B CN201811061284.XA CN201811061284A CN109385710B CN 109385710 B CN109385710 B CN 109385710B CN 201811061284 A CN201811061284 A CN 201811061284A CN 109385710 B CN109385710 B CN 109385710B
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suture
absorbable
silk
drying
degumming
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CN109385710A (en
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汪燕艳
赵洪石
陈隆坤
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Zhejiang Xingyue Biotechnology Co ltd
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    • DTEXTILES; PAPER
    • D02YARNS; MECHANICAL FINISHING OF YARNS OR ROPES; WARPING OR BEAMING
    • D02GCRIMPING OR CURLING FIBRES, FILAMENTS, THREADS, OR YARNS; YARNS OR THREADS
    • D02G3/00Yarns or threads, e.g. fancy yarns; Processes or apparatus for the production thereof, not otherwise provided for
    • D02G3/02Yarns or threads characterised by the material or by the materials from which they are made
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L17/00Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/06At least partially resorbable materials
    • A61L17/08At least partially resorbable materials of animal origin, e.g. catgut, collagen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L17/00Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/14Post-treatment to improve physical properties
    • A61L17/145Coating
    • DTEXTILES; PAPER
    • D02YARNS; MECHANICAL FINISHING OF YARNS OR ROPES; WARPING OR BEAMING
    • D02GCRIMPING OR CURLING FIBRES, FILAMENTS, THREADS, OR YARNS; YARNS OR THREADS
    • D02G3/00Yarns or threads, e.g. fancy yarns; Processes or apparatus for the production thereof, not otherwise provided for
    • D02G3/44Yarns or threads characterised by the purpose for which they are designed
    • D02G3/448Yarns or threads for use in medical applications
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M15/00Treating fibres, threads, yarns, fabrics, or fibrous goods made from such materials, with macromolecular compounds; Such treatment combined with mechanical treatment
    • D06M15/01Treating fibres, threads, yarns, fabrics, or fibrous goods made from such materials, with macromolecular compounds; Such treatment combined with mechanical treatment with natural macromolecular compounds or derivatives thereof
    • D06M15/15Proteins or derivatives thereof
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M2101/00Chemical constitution of the fibres, threads, yarns, fabrics or fibrous goods made from such materials, to be treated
    • D06M2101/02Natural fibres, other than mineral fibres
    • D06M2101/10Animal fibres
    • D06M2101/12Keratin fibres or silk
    • DTEXTILES; PAPER
    • D10INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10BINDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2211/00Protein-based fibres, e.g. animal fibres
    • D10B2211/01Natural animal fibres, e.g. keratin fibres
    • D10B2211/04Silk

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  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Textile Engineering (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Materials Engineering (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
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  • Animal Behavior & Ethology (AREA)
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  • Public Health (AREA)
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  • Materials For Medical Uses (AREA)
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Abstract

The invention discloses an absorbable suture, which is prepared by a suture main body obtained by mutually winding and weaving a plurality of silk threads and then processing the suture main body, wherein the number of the silk threads is 8-140, and the silk threads are natural mulberry silk. The invention also provides a preparation method of the absorbable suture. According to the absorbable silk suture disclosed by the invention, natural silk is selected as a raw material, so that the absorbable silk suture with high purity and high strength is obtained, and the absorbable silk suture can be used for surgical suture of common soft tissues, and can also be used for surgical suture of tissues with slower repair and higher mechanical requirements, such as meniscus, rotator cuff tissue, tendon and ligament tissue, and the like, so that the clinical requirements are met.

Description

Absorbable suture and preparation method thereof
Technical Field
The invention relates to the field of preparation of biological materials, in particular to an absorbable suture and a preparation method thereof.
Background
At present, all the suture threads used for the force bearing tissues such as meniscus, tendon, ligament and the like on the market are non-absorbable suture threads. The tissue can be temporarily replaced in the early stage of tissue healing and provides a mechanical connection or support function, the tissue still exists in a body in the form of foreign matters after the tissue is healed, a secondary operation is generally needed to remove the thread, otherwise, the problem of influencing the continuous healing of the tissue can exist, and the influence on teenagers with body tissues or organs in a growing period is particularly obvious. Absorbable sutures can compensate for this deficiency.
According to investigation, the consumption of the absorbable suture is only about 15 percent of the total consumption of the suture, the components of the absorbable suture mainly comprise three types of animal casings, collagen and polymer synthetic materials PGA, and the absorbable suture can be absorbed by hydrolysis or enzymolysis after being implanted into a body for 15 days generally, most of the absorbable suture is absorbed after 30 days, and the absorbable suture is completely absorbed after 60-90 days. However, these three types of absorbable sutures still have some drawbacks in use that require improvement. For example, catgut material is low in tension and not suitable for bearing tissues; the polymer synthetic thread (such as PGA polyglycolic acid) is implanted into a body and is hydrolyzed rapidly, the tension is reduced by 15 percent in 5 to 7 days, the tension is reduced by 50 percent in 14 days, and the tension strength is zero in 28 to 32 days; the pure collagen suture line has the characteristics of tendon, but can be completely enzymolyzed after being implanted into a body for 8-50 days.
Therefore, for meniscus, tendon and ligament tissues with high mechanical requirements, a novel absorbable suture line is needed, which can maintain mechanical strength for a long time and can be degraded after the tissues are healed, and is a great clinical demand at present.
Disclosure of Invention
In order to overcome the defects of the prior art, one of the purposes of the invention is to provide an absorbable suture, wherein natural silk is selected as a raw material to obtain the absorbable silk suture with high purity and high strength, and the absorbable silk suture can be used for surgical suture of common soft tissues and surgical suture of tissues with slower repair and higher mechanical requirements, such as meniscus tissues, rotator cuff tissues, tendon and ligament tissues, and the like, so that the absorbable suture meets the clinical requirements.
The invention also aims to provide a preparation method of the absorbable suture, which comprises a weaving step, a sericin removing step, a coating step and a forming step, the obtained suture can be directly absorbed by the body after the tissue is healed, a secondary operation removing mode is omitted, and the mechanical strength can be maintained for a long time.
One of the purposes of the invention is realized by adopting the following technical scheme:
an absorbable suture is prepared by interweaving multiple silk threads to obtain a suture main body, and processing the suture main body, wherein the number of the silk threads is 8-140, and the silk threads are natural mulberry silk.
Furthermore, the suture also comprises a core, and the core is 3-12 silk threads.
Furthermore, the type of the suture is 7-0#, 4-0#, 2#, 3# or 5#, and the diameter of the suture is 0.05-0.7 mm.
The second purpose of the invention is realized by adopting the following technical scheme:
a method for preparing an absorbable suture, comprising,
weaving: interweaving, winding and weaving a plurality of silk threads to obtain a suture main body;
a step of degumming: heating the degumming agent solution, soaking the suture body in the degumming agent, maintaining the water temperature, taking out the suture body, washing the suture body with water for 1-10 times, repeating the steps of soaking the degumming agent and washing with water for 2-6 times, and drying to obtain an absorbable uncoated suture;
coating: soaking absorbable uncoated suture in silk fibroin solution, taking out, drying, and repeating for 1-5 times to obtain coated suture;
a forming step: and (4) crosslinking the coating suture to obtain the absorbable suture after crosslinking.
Further, in the step of degumming, the degumming agent is 0.01-0.03mol/L sodium carbonate solution, 0.04-0.08mol/L sodium bicarbonate solution or 3-5mol/L calcium chloride solution.
Further, in the step of degumming, the solution of degumming agent is heated to 85-100 ℃, and the mass-volume ratio of the suture body to the degumming agent is 1 g: (50-200) mL, and keeping the water temperature for 5-60 minutes.
Further, in the step of degumming, the mass-volume ratio of the suture body to water is 1 g: (50-200) mL.
Further, in the step of degumming, the drying temperature is 25-80 ℃, and the drying time is 4-96 hours.
Further, in the coating step, the concentration of the silk fibroin solution is 0.1-10% w/v; the drying temperature is 30-90 deg.C, and the drying time is 0.5-8 hr.
Further, in the molding step, the conditions for suture crosslinking are as follows: the temperature is 30-90 ℃, the humidity is 70-100%, and the mixture is placed for 0.5-4 hours.
Compared with the prior art, the invention has the beneficial effects that:
(1) according to the absorbable suture disclosed by the invention, natural silk is selected as a raw material to obtain the high-purity and high-strength absorbable silk suture, so that the absorbable silk suture can be used for surgical suture of tissues which are slow in repair and high in mechanical requirement, such as meniscus, rotator cuff tissue and tendon ligament tissue, and the like, and the clinical requirement is met;
(2) the preparation method of the absorbable suture comprises a weaving step, a sericin removing step, a coating step and a forming step, the obtained suture can be directly absorbed by the body after the healing of tissues, a secondary operation removing mode is omitted, and the mechanical strength can be maintained for a long time.
Drawings
FIG. 1 is a cross-sectional schematic view of a suture of the present invention in a non-core-spun weave;
FIG. 2 is a cross-sectional view of a suture in a core-spun weave of the present invention;
FIG. 3 is a different gauge suture obtained by weaving;
FIG. 4 is a scanning electron micrograph of a braided suture;
FIG. 5 is a schematic representation of the use of the suture of example 3 for suturing a porcine meniscus;
FIG. 6 is a schematic view of the suture of example 4 used to suture the Achilles tendon;
FIG. 7 is a schematic view of the suture of example 5 used to suture a ligament;
FIG. 8 is a schematic view of the suture of example 6 used to suture a rotator cuff;
in the figure: alpha, 1 natural silk; beta, 1 strand of silk; gamma, inner core or outer suture surface.
Detailed Description
The present invention will be further described with reference to the accompanying drawings and the detailed description, and it should be noted that any combination of the embodiments or technical features described below can be used to form a new embodiment without conflict.
An absorbable suture is prepared by interweaving multiple silk threads to obtain a suture main body, and processing the suture main body, wherein the number of the silk threads is 8-140, and the silk threads are natural mulberry silk.
The weaving mode is a core-spun mode and a non-core-spun mode, the non-core-spun mode refers to fig. 1, and the core-spun mode refers to fig. 2.
As a further embodiment, the suture further comprises a core, the core being 3-12 filaments.
As a further embodiment, the suture is 7-0#, 4-0#, 2#, 3# or 5# in size, and the suture is 0.05-0.7mm in diameter.
The preparation method of the absorbable suture comprises the following steps,
weaving: interweaving, winding and weaving a plurality of silk threads to obtain a suture main body;
a step of degumming: heating the degumming agent solution, soaking the suture body in the degumming agent, maintaining the water temperature, taking out the suture body, washing the suture body with water for 1-10 times, repeating the steps of soaking the degumming agent and washing with water for 2-6 times, and drying to obtain an absorbable uncoated suture;
coating: soaking absorbable uncoated suture in silk fibroin solution, taking out, drying, and repeating for 1-5 times to obtain coated suture;
a forming step: and (4) crosslinking the coating suture to obtain the absorbable suture after crosslinking.
In a further embodiment, in the degumming step, the degumming agent is 0.01-0.03mol/L of sodium carbonate, 0.04-0.08mol/L of sodium bicarbonate or 3-5mol/L of calcium chloride.
In the step of degumming, the solution of degumming agent is heated to 85-100 ℃, and the mass-volume ratio of the suture body to the degumming agent is 1 g: (50-200) mL, and keeping the water temperature for 5-60 minutes.
As a further embodiment, in the step of degelatinizing, the mass-to-volume ratio of suture body and water is 1 g: (50-200) mL.
In a further embodiment, the drying temperature in the degummed step is 25 to 80 ℃ and the drying time is 4 to 96 hours.
As a further embodiment, in the coating step, the concentration of the silk fibroin solution is 0.1-10% w/v; the drying temperature is 30-90 deg.C, and the drying time is 0.5-8 hr.
As a further embodiment, in the molding step, the conditions for suture crosslinking are: the temperature is 30-90 ℃, the humidity is 70-100%, and the mixture is placed for 0.5-4 hours.
The following are specific examples of the present invention, and raw materials, equipments and the like used in the following examples can be obtained by purchasing them unless otherwise specified.
Example 1:
an absorbable suture, the suture prepared by the method comprising:
weaving: interweaving 140 mulberry silk threads, winding and weaving in a core-spun mode, wherein the inner core is 12 silks, and obtaining a suture main body;
a step of degumming: heating the degumming agent solution to 100 ℃, and soaking the suture body in the degumming agent, wherein the mass volume ratio of the suture body to the degumming agent is 1 g: 200mL, maintaining the water temperature for 30 minutes, taking out the suture body after the degumming agent is 0.03mol/L sodium carbonate solution, washing the suture body for 1 time by using water, wherein the mass-volume ratio of the suture body to the water is 1 g: 100mL, repeating the steps of soaking and washing the degumming agent for 3 times, and drying at the temperature of 80 ℃ for 6 hours to obtain an absorbable uncoated suture;
coating: soaking the absorbable uncoated suture in silk fibroin solution, taking out the silk fibroin solution with the concentration of 3% w/v, drying at 80 ℃ for 4 hours, and repeating for 2 times to obtain the coated suture;
a forming step: and (3) placing the coating suture for crosslinking under the conditions of 60 ℃ of temperature and 80% of humidity for 0.5-4 hours, and crosslinking to obtain the absorbable suture.
Example 2:
an absorbable suture, the suture prepared by the method comprising:
weaving: interweaving, winding and weaving 80 strands of silk threads, wherein each strand of silk thread contains 5 mulberry silks to obtain a suture main body;
a step of degumming: heating the degumming agent solution to 90 ℃, and then soaking the suture body in the degumming agent, wherein the mass volume ratio of the suture body to the degumming agent is 1 g: 100mL, maintaining the water temperature for 60 minutes, taking out the suture body after the degumming agent is 0.08mol/L sodium bicarbonate solution, and washing the suture body for 3 times by using water, wherein the mass-volume ratio of the suture body to the water is 1 g: 100mL, repeating the steps of soaking and washing with degumming agent for 3 times, and drying at 60 ℃ for 12 hours to obtain an absorbable uncoated suture;
coating: soaking the absorbable uncoated suture in a silk fibroin solution, taking out the silk fibroin solution with the concentration of 1% w/v, drying at 90 ℃ for 0.5 hour, and repeating for 5 times to obtain the coated suture;
a forming step: and (3) placing the coating suture for crosslinking under the conditions of 60 ℃ of temperature and 75% of humidity for 0.5 hour, and crosslinking to obtain the absorbable suture.
Example 3:
an absorbable suture, the suture prepared by the method comprising:
weaving: interweaving and winding 19 silks to weave in a core-spun mode, wherein an inner core contains 3 silks, the rest silks are divided into 8 strands on average, and each strand contains 2 natural mulberry silks to obtain a suture main body;
a step of degumming: heating the degumming agent solution to 95 ℃, and soaking the suture body in the degumming agent, wherein the mass volume ratio of the suture body to the degumming agent is 1 g: 100mL, maintaining the water temperature for 40 minutes, taking out the suture body from the degumming agent which is 0.04mol/L sodium bicarbonate solution, washing the suture body with water for 1 time, wherein the mass-volume ratio of the suture body to the water is 1 g: 150mL, repeating the steps of soaking and washing with the degumming agent for 3 times, and drying at the temperature of 60 ℃ for 12 hours to obtain an absorbable uncoated suture;
coating: soaking the absorbable uncoated suture in silk fibroin solution, taking out the silk fibroin solution with the concentration of 5% w/v, drying at the drying temperature of 60 ℃ for 0.5 hour, and repeating for 1 time to obtain the coated suture;
a forming step: and (3) placing the coating suture for crosslinking under the conditions of temperature 60 ℃ and humidity 85% for 4 hours to obtain an absorbable suture after crosslinking, and soaking the absorbable suture in water for injection for storage.
Example 4:
an absorbable suture, the suture prepared by the method comprising:
weaving: interweaving, winding and weaving 56 silks, wherein 8 silks are interwoven and wound to be woven in a mode of not covering a core to serve as an inner core, the rest silks are averagely divided into 16 strands to be woven, and each strand contains 3 mulberry silks to obtain a suture main body;
a step of degumming: heating the degumming agent solution to 95 ℃, and soaking the suture body in the degumming agent, wherein the mass volume ratio of the suture body to the degumming agent is 1 g: 200mL, maintaining the water temperature for 60 minutes, taking out the suture body after the degumming agent is a calcium chloride solution of 4mol/L, and washing the suture body for 1 time by using water, wherein the mass-volume ratio of the suture body to the water is 1 g: 50mL, repeating the steps of soaking and washing by the degumming agent for 6 times, and drying at the temperature of 80 ℃ for 6 hours to obtain an absorbable uncoated suture;
coating: soaking the absorbable uncoated suture in silk fibroin solution, taking out the silk fibroin solution with the concentration of 3% w/v, drying at 90 ℃ for 0.5 hour, and repeating for 5 times to obtain the coated suture;
a forming step: and (3) placing the coating suture for crosslinking under the conditions of temperature 60 ℃ and humidity 85% for 4 hours to obtain an absorbable suture after crosslinking, and soaking the absorbable suture in water for injection for storage.
Effect evaluation and Performance detection
The breaking strength of the sutures of examples 1-4 was tested and the results were as follows:
TABLE 1 test results
Suture type number Breaking strength (N)
Example 1 5# 120
Example 2 2# 65
Example 3 4-0# 12
Example 4 0# 50
As can be seen from table 1, the suture of example 1 has a breaking strength of 120N, see fig. 5, and can be used for suturing of menisci; the breaking strength of the suture of the example 2 is 65N, and the suture can be used for suturing tendons and ligaments, see figure 7; the breaking strength of the suture of the example 3 is 12N, and the suture can be used for suturing tendons and ligaments, see figure 6; the suture of example 4 has a breaking strength of 50N, see fig. 8, and can be used for rotator cuff suturing.
Figure 3 shows different gauge sutures being woven. Fig. 4 is a scanning electron micrograph of a braided suture, scale: 500 μm.
As can be seen from the fig. 5-8, the suture of the invention not only can meet the surgical suture of common soft tissues, but also can completely meet the surgical suture of tissues with slower repair and higher mechanical requirements, such as meniscus, rotator cuff tissue, tendon ligament tissue and the like, and can meet the clinical requirements.
The above embodiments are only preferred embodiments of the present invention, and the protection scope of the present invention is not limited thereby, and any insubstantial changes and substitutions made by those skilled in the art based on the present invention are within the protection scope of the present invention.

Claims (6)

1. The preparation method of the absorbable suture is characterized in that the absorbable suture is prepared by a suture main body which is obtained by mutually winding and weaving a plurality of silk threads, and then processing the suture main body, wherein the number of the silk threads is 8-140, and the silk threads are natural mulberry silk; the suture also comprises a core, wherein the core is 3-12 silk threads;
the preparation method of the absorbable suture comprises the following steps,
weaving: interweaving, winding and weaving a plurality of silk threads to obtain a suture main body;
a step of degumming: heating the degumming agent solution, soaking the suture body in the degumming agent, maintaining the water temperature, taking out the suture body, washing the suture body with water for 1-10 times, repeating the steps of soaking the degumming agent and washing with water for 2-6 times, and drying to obtain an absorbable uncoated suture; the degumming agent is 0.01-0.03mol/L sodium carbonate solution, 0.04-0.08mol/L sodium bicarbonate solution or 3-5mol/L calcium chloride solution; heating the degumming agent solution to 85-100 ℃, wherein the mass volume ratio of the suture body to the degumming agent is 1 g: (50-200) mL, and keeping the water temperature for 5-60 minutes;
coating: soaking absorbable uncoated suture in silk fibroin solution, taking out, drying, and repeating for 1-5 times to obtain coated suture;
a forming step: and (4) crosslinking the coating suture to obtain the absorbable suture after crosslinking.
2. The method of making an absorbable suture of claim 1, wherein the suture is 7-0#, 4-0#, 2#, 3# or 5# and the suture has a diameter of 0.05-0.7 mm.
3. The method of making an absorbable suture of claim 1, wherein in the degumming step, the mass to volume ratio of suture body to water is 1 g: (50-200) mL.
4. The method of making an absorbable suture of claim 1, wherein the temperature of drying is 25-80 ℃ and the time of drying is 4-96 hours in the step of degelatinizing.
5. The method of making an absorbable suture of claim 1, wherein in the step of coating, the silk fibroin solution concentration is 0.1-10% w/v; the drying temperature is 30-90 deg.C, and the drying time is 0.5-8 hr.
6. The method of making an absorbable suture of claim 1, wherein in the forming step, the suture is cross-linked under the conditions of: the temperature is 30-90 ℃, the humidity is 70-100%, and the mixture is placed for 0.5-4 hours.
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CN113730644B (en) * 2021-09-13 2022-07-19 苏州大学 Suture line with gel coating and preparation method thereof

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CN108442039A (en) * 2018-03-06 2018-08-24 苏州先蚕丝绸有限公司 A kind of preparation method of silk fibroin nano-fiber film

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