CN112316198A - Absorbable and degradable suture line - Google Patents

Absorbable and degradable suture line Download PDF

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Publication number
CN112316198A
CN112316198A CN202011266439.0A CN202011266439A CN112316198A CN 112316198 A CN112316198 A CN 112316198A CN 202011266439 A CN202011266439 A CN 202011266439A CN 112316198 A CN112316198 A CN 112316198A
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parts
absorbable
polylactic acid
suture
degradable
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沈坤
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Zhejiang Tongxuan Medical Technology Co Ltd
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Zhejiang Tongxuan Medical Technology Co Ltd
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    • 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
    • A61L17/10At least partially resorbable materials containing macromolecular materials
    • A61L17/12Homopolymers or copolymers of glycolic acid or lactic acid
    • 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
    • A61L17/10At least partially resorbable materials containing macromolecular materials
    • 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
    • A61L17/10At least partially resorbable materials containing macromolecular materials
    • A61L17/105Polyesters not covered by A61L17/12

Abstract

The invention discloses an absorbable and degradable suture line which comprises the following components in parts by weight: 60-80 parts of degradable base material, 5-15 parts of polyglycolic acid, 5-15 parts of poly (glycolide-lactide), 10-20 parts of chitosan, 1-5 parts of polyethylene glycol, 2-3 parts of lubricant and 1-3 parts of antibacterial agent. The composite material has excellent tensile strength and toughness, good absorbability and degradability, and excellent antibacterial and bacteriostatic properties and hydrophilicity.

Description

Absorbable and degradable suture line
Technical Field
The invention relates to the technical field of medical instruments, in particular to an absorbable and degradable suture.
Background
The surgical suture line is a special line for ligation hemostasis, suture hemostasis and tissue suture in the surgical operation or the trauma treatment, and can be generally divided into two categories of absorbable lines and non-absorbable lines, wherein the absorbable suture line is divided into two categories according to the difference of material and absorption degree: catgut, chemically synthesized suture, and pure natural collagen suture.
Polylactic acid is a novel green environment-friendly biodegradable material, is a high-molecular polyester material synthesized by starch substances extracted from renewable plants (such as cassava and corn), has rich and renewable raw material sources, the prepared suture has silk-like hand feeling, and the product generated by degradation can be rapidly absorbed by human tissues, but the polylactic acid suture has poor hydrophilicity and weak cell adhesion. In addition, polylactic acid has poor crystallization ability, reducing the strength and toughness of the polylactic acid suture. The degradation speed of the polylactic acid suture line in vivo is unstable.
Disclosure of Invention
The present invention is directed to an absorbable and degradable suture to solve the above problems of the background art.
In order to solve the above problems, the first aspect of the present invention provides an absorbable and degradable suture thread, which is prepared from the following raw materials in parts by weight: 60-80 parts of degradable base material, 5-15 parts of polyglycolic acid, 5-15 parts of poly (glycolide-lactide), 10-20 parts of chitosan, 1-5 parts of polyethylene glycol, 2-3 parts of lubricant and 1-3 parts of antibacterial agent.
As a preferred technical scheme, the degradable base material is modified polylactic acid, and the preparation method of the modified polylactic acid comprises the following steps:
adding polylactic acid, polycaprolactone and a dichloromethane solvent into a conical flask, and stirring to fully dissolve the polylactic acid and the polycaprolactone into the dichloromethane solvent to obtain a dissolved solution; and transferring the obtained dissolved solution into a culture dish, putting the culture dish into a constant-temperature drying oven to slowly volatilize the solvent, and obtaining the modified polylactic acid after the solvent is completely volatilized.
In a preferable technical scheme, the polylactic acid is L-polylactic acid, and the intrinsic viscosity of the L-polylactic acid is 1.00-2.50 dL/g.
As a preferable technical scheme, the viscosity-average molecular weight of the polycaprolactone is 40000-60000.
As a preferable technical scheme, the weight ratio of the polylactic acid to the polycaprolactone is (12-16): 1.
In a preferable embodiment, the polyglycolic acid has an intrinsic viscosity of 0.50 to 1.50 dL/g.
As a preferable technical scheme, the poly (glycolide) is a mixture of poly (glycolide) with a viscosity average molecular weight of 10-25 ten thousand and poly (glycolide) with a viscosity average molecular weight of 1-8 ten thousand, and the weight ratio is (4-6): 1.
as a preferable technical scheme, the hydroxyl value of the polyethylene glycol is 150-300 mgKOH/g.
As a preferable technical scheme, the antibacterial agent comprises one or a mixture of any more of mannitol, cinnamaldehyde and eugenol.
The second aspect of the invention provides a preparation method of an absorbable and degradable suture line, which comprises the following steps:
s1, preparing suture fibers: uniformly mixing the degradable base material, polyglycolic acid, poly (lactide-co-glycolide), chitosan, polyethylene glycol, a lubricant and an antibacterial agent, extruding by using a double-screw extruder, cooling by water, air-drying, and granulating to obtain master batches; melting and defoaming the master batch, and obtaining primary fiber through a spinneret plate; stretching the primary fiber in a water bath to obtain suture fiber;
s2, drying and sterilizing: and (3) further drying and sterilizing the suture fiber by using ethylene oxide to obtain the absorbable and degradable suture.
Compared with the prior art, the invention has the beneficial effects that:
1. through blending modification, the polycaprolactone serving as a nucleating agent can improve the crystallization capacity and the crystallization speed of polylactic acid, so that intermolecular acting force is improved, the suture has higher heat resistance and mechanical property, and the degradability of the suture is not influenced.
2. When the viscosity average molecular weight of polycaprolactone is 40000-60000, the suture has higher flexibility.
3. In the blending modification, the weight ratio of the polylactic acid to the polycaprolactone is (12-16): 1, which is beneficial to eliminating the adverse effect on the crystallization process caused by poor compatibility of the polylactic acid and the polycaprolactone.
4. The inherent viscosity of the polyglycolic acid is 0.50-1.50 dL/g, water molecules are promoted to permeate into an amorphous region of the polyglycolic acid to swell the polyglycolic acid, the hydrolysis reaction is facilitated, the stability of the suture structure is further damaged, and the degradation of other components such as polylactic acid with low degradation speed in the suture is facilitated.
5. The weight ratio of the poly (glycolide-lactide) with the viscosity average molecular weight of 10-25 ten thousand to the poly (glycolide-lactide) with the viscosity average molecular weight of 1-8 ten thousand is (4-6): 1; chain entanglement of the differently oriented microfibers of the reinforced suture inhibits relative slippage of the microfibers, thereby increasing the tensile strength of the suture.
Detailed Description
The invention will be further understood by reference to the following detailed description of preferred embodiments of the invention and the examples included therein. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. To the extent that a definition of a particular term disclosed in the prior art is inconsistent with any definition provided in the present disclosure, the definition of the term provided in the present disclosure controls.
As used herein, a feature that does not define a singular or plural form is also intended to include a plural form of the feature unless the context clearly indicates otherwise. It will be further understood that the term "prepared from …," as used herein, is synonymous with "comprising," including, "comprising," "having," "including," and/or "containing," when used in this specification means that the recited composition, step, method, article, or device is present, but does not preclude the presence or addition of one or more other compositions, steps, methods, articles, or devices. Furthermore, the use of "preferred," "preferably," "more preferred," etc., when describing embodiments of the present invention, is meant to refer to embodiments of the invention that may provide certain benefits, under certain circumstances. However, other embodiments may be preferred, under the same or other circumstances. In addition, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, nor is it intended to exclude other embodiments from the scope of the invention.
In order to solve the above problems, the invention provides an absorbable and degradable suture line, which comprises the following raw materials in parts by weight: 60-80 parts of degradable base material, 5-15 parts of polyglycolic acid, 5-15 parts of poly (glycolide-lactide), 10-20 parts of chitosan, 1-5 parts of polyethylene glycol, 2-3 parts of lubricant and 1-3 parts of antibacterial agent.
In order to improve the mechanical strength of the suture, in some preferred embodiments, the degradable base material is modified polylactic acid, and the polycaprolactone is used as a nucleating agent to improve the crystallization capacity and the crystallization speed of the polylactic acid through blending modification, so that the intermolecular acting force is improved, the suture has higher heat resistance and mechanical property, and the degradability of the suture is not influenced. The blending modification method comprises the following steps:
adding 10-20 parts by weight of polylactic acid, 0.8-1.2 parts by weight of polycaprolactone and 500 parts by weight of dichloromethane solvent into a conical flask, stirring for 3-4 hours to fully dissolve the polylactic acid and the polycaprolactone into the dichloromethane solvent to obtain a dissolved solution, transferring the dissolved solution into a culture dish, putting the culture dish into a constant-temperature drying oven to slowly volatilize the solvent, setting the temperature of the drying oven to be 25-30 ℃, and completely volatilizing the solvent to obtain the modified polylactic acid.
In order to improve the biocompatibility of the polylactic acid, in some preferred embodiments, the polylactic acid in the blending modification is levorotatory polylactic acid. In some more preferred embodiments, the inherent viscosity of the poly-L-lactic acid is 1.00-2.50 dL/g, and if the inherent viscosity is too high, the poly-L-lactic acid is not beneficial to uniformly dispersing polycaprolactone, and the stirring efficiency is also reduced; if the intrinsic viscosity is too high, the polycaprolactone is not favorable for inducing the crystallization of the polylactic acid.
In order to improve the flexibility of the suture, in some preferred embodiments, the inventors have surprisingly found that the suture has a higher flexibility when the polycaprolactone has a viscosity average molecular weight of 40000 to 60000. This is probably because the molecular weight of polycaprolactone affects the cohesive force and adhesion of the contacting surface of polylactic acid and polycaprolactone, and further affects the intermolecular force of polylactic acid, thereby affecting the flexibility of the suture.
In order to improve the nucleation crystallization capability and the nucleation uniformity of the modified polylactic acid, in some preferred embodiments, the weight ratio of the polylactic acid to the polycaprolactone in the blending modification is (12-16): 1, which is beneficial to eliminating the adverse effect on the crystallization process caused by poor compatibility of the polylactic acid and the polycaprolactone. If the content of polycaprolactone is too low and the nucleation quantity is insufficient, the crystallization capability of polylactic acid is reduced; if the content of the polycaprolactone is too high, the polycaprolactone chain segments with strong motion capability are firstly gathered together, which is not beneficial to the uniform dispersion of nucleation and the induction of polylactic acid crystallization.
In order to improve the degradability of the suture in vivo, in some preferred embodiments, the polyglycolic acid has an intrinsic viscosity of 0.50-1.50 dL/g, which is beneficial to the flow of the polyglycolic acid in the suture in the human body environment, promotes water molecules to permeate into an amorphous region of the polyglycolic acid to swell the polyglycolic acid, is beneficial to the progress of hydrolysis reaction, further destroys the stability of the suture structure, and is beneficial to the degradation of other components such as polylactic acid with a slow degradation speed in the suture.
In order to improve the tensile strength of the suture, in some preferred embodiments, the poly (glycolide) is a mixture of poly (glycolide) having a viscosity average molecular weight of 10 to 25 ten thousand and poly (glycolide) having a viscosity average molecular weight of 1 to 8 ten thousand. In some more preferred embodiments, the weight ratio of the poly (glycolide) having a viscosity average molecular weight of 10 to 25 ten thousand to the poly (glycolide) having a viscosity average molecular weight of 1 to 8 ten thousand is (4 to 6): 1; is favorable for improving the mutual entanglement of the poly (glycolide-co-glycolide), the polylactic acid and the polyglycolic acid, thereby enhancing the chain entanglement of the microfibers with different orientations of the suture thread, inhibiting the relative sliding of the microfibers and improving the tensile strength of the suture thread.
In order to improve the hydrophilicity of the suture, in some preferred embodiments, the hydroxyl value of the polyethylene glycol is 150 to 300mg KOH/g. If the hydroxyl value is too low, the hydrophilicity of the polylactic acid is not improved, and the improvement of the hydrophilicity of the suture is influenced; if the hydroxyl value is too high, the micromolecule polyethylene glycol can damage the structural stability of macromolecules in the suture, so that the flexibility of the suture is reduced.
In some preferred embodiments, the lubricant comprises one or a mixture of sulfonated castor oil and cassia oil.
In order to promote wound healing, antiulcer, etc., in some preferred embodiments, the antimicrobial agent includes one or any mixture of mannitol, cinnamaldehyde, eugenol.
The second aspect of the invention provides a preparation method of an absorbable and degradable suture line, which comprises the following steps:
s1, preparing suture fibers: putting the degradable base material, polyglycolic acid, poly (lactide-co-glycolide), chitosan, polyethylene glycol, a lubricant and an antibacterial agent into a reaction kettle, uniformly mixing, heating to 100-120 ℃, and stirring at the speed of 500-800 r/min for 3-4 h to obtain a mixture; then putting the mixture into a double-screw extruder for extrusion, wherein the extrusion temperature is 200-240 ℃, the screw rotating speed is 900-1200 r/min, and water cooling, air drying and grain cutting are carried out to obtain master batches; heating the obtained master batch to 140-180 ℃ to melt and defoam the master batch, and obtaining primary fiber through a spinneret plate; stretching the primary fiber in a water bath at 50-80 ℃ to obtain suture fiber;
s2, drying and sterilizing: and (3) further drying and sterilizing the suture fiber by using ethylene oxide to obtain the absorbable and degradable suture.
The present invention will be specifically described below by way of examples. It should be noted that the following examples are only for illustrating the present invention and should not be construed as limiting the scope of the present invention, and that the insubstantial modifications and adaptations of the present invention by those skilled in the art based on the above disclosure are still within the scope of the present invention.
In addition, the starting materials used are all commercially available, unless otherwise specified.
Examples
The technical solution of the present invention is described in detail by the following examples, but the scope of the present invention is not limited to the examples.
Example 1
Embodiment 1 provides an absorbable and degradable suture thread, which is prepared from the following raw materials in parts by weight: 70 parts of modified polylactic acid, 10 parts of polyglycolic acid, 10 parts of poly (glycolide-lactide), 15 parts of chitosan, 3 parts of polyethylene glycol, 3 parts of cassia oil and 2 parts of cinnamaldehyde;
the preparation method of the modified polylactic acid comprises the following steps:
adding 14 parts by weight of L-polylactic acid (with intrinsic viscosity of 1.50-2.00dL/g, obtained from Wuhan Haishan science and technology Limited company, the model of PLLA-20) and 1 part of polycaprolactone (with viscosity average molecular weight of 50000, obtained from Shenzhen Guanghua Webster, the model of Esung 500C) into an erlenmeyer flask, stirring for 3.5h to fully dissolve the L-polylactic acid and the polycaprolactone in a dichloromethane solvent to obtain a dissolved solution, transferring the dissolved solution into a culture dish, putting the culture dish into a constant-temperature drying box to slowly volatilize the solvent, setting the temperature of the drying box to 28 ℃, and completely volatilizing the solvent to obtain the modified polylactic acid.
The polyglycolic acid has the intrinsic viscosity of 0.70-1.00 dL/g, is purchased from Bollier biomaterial Co., Ltd, Shenzhen, and has the model of PGA-08.
The poly (glycolide-co-lactide) is a mixture of poly (glycolide-co-lactide) (from the type No. PLGA75-25) with the viscosity average molecular weight of 15-20 ten thousand and poly (glycolide-co-lactide) (from the type No. PLGA75-10) with the viscosity average molecular weight of 3-5 ten thousand, and the weight ratio is 5: 1.
The chitosan was purchased from bio-engineering limited, spacious, west.
The hydroxyl value of the polyethylene glycol is 268-294 mg KOH/g, and the polyethylene glycol is purchased from the chenchen Taixin Lanxing technology Co., Ltd, and the model is FEG-400.
Example 1 also provides a method of making an absorbable, degradable suture comprising the steps of:
s1, preparing suture fibers: putting modified polylactic acid, polyglycolic acid, poly (glycolide-lactide), chitosan, polyethylene glycol, cassia oil and cinnamaldehyde into a reaction kettle according to the weight ratio, uniformly mixing, heating to 110 ℃, and stirring at the speed of 600r/min for 4 hours to obtain a mixture; then putting the mixture into a double-screw extruder for extrusion, wherein the extrusion temperature is 220 ℃, the screw rotating speed is 1000r/min, and the master batch is obtained through water cooling, air drying and grain cutting; heating the obtained master batch to 170 ℃ to melt and defoam the master batch, and obtaining primary fiber through a spinneret plate; stretching the primary fiber in a water bath at 70 ℃ to obtain suture fiber;
s2, drying and sterilizing: and (3) further drying and sterilizing the suture fiber by using ethylene oxide to obtain the absorbable and degradable suture.
Example 2
An absorbable, degradable suture and method of making the same are provided similar to example 1, but the raw materials for making include, in parts by weight: 60 parts of modified polylactic acid, 10 parts of polyglycolic acid, 10 parts of poly (glycolide-lactide), 15 parts of chitosan, 3 parts of polyethylene glycol, 3 parts of cassia oil and 2 parts of cinnamaldehyde.
Example 3
An absorbable, degradable suture and method of making the same are provided similar to example 1, but the raw materials for making include, in parts by weight: 80 parts of modified polylactic acid, 10 parts of polyglycolic acid, 10 parts of poly (glycolide-lactide), 15 parts of chitosan, 3 parts of polyethylene glycol, 3 parts of cassia oil and 2 parts of cinnamaldehyde.
Example 4
An absorbable, degradable suture and method of making the same are provided similar to example 1, but the raw materials for making include, in parts by weight: 80 parts of modified polylactic acid, 10 parts of polyglycolic acid, 10 parts of poly (glycolide-lactide), 15 parts of chitosan, 3 parts of polyethylene glycol, 3 parts of sulfonated castor oil and 2 parts of mannitol.
Example 5
An absorbable, degradable suture and method of making the same are provided similar to example 1, but the raw materials for making include, in parts by weight: 70 parts of modified polylactic acid, 5 parts of polyglycolic acid, 10 parts of poly (glycolide-lactide), 15 parts of chitosan, 3 parts of polyethylene glycol, 3 parts of cassia oil and 2 parts of cinnamaldehyde.
Example 6
An absorbable, degradable suture and method of making the same are provided similar to example 1, but the raw materials for making include, in parts by weight: 70 parts of modified polylactic acid, 15 parts of polyglycolic acid, 10 parts of poly (glycolide-lactide), 15 parts of chitosan, 3 parts of polyethylene glycol, 3 parts of cassia oil and 2 parts of cinnamaldehyde.
Comparative example 1
An absorbable, degradable suture and method of making the same are provided similar to example 1, but the raw materials for making include, in parts by weight: 50 parts of modified polylactic acid, 10 parts of polyglycolic acid, 10 parts of poly (glycolide-lactide), 15 parts of chitosan, 3 parts of polyethylene glycol, 3 parts of cassia oil and 2 parts of cinnamaldehyde.
Comparative example 2
An absorbable and degradable suture and a preparation method thereof are provided similarly to example 1, but the viscosity average molecular weight of the polycaprolactone is 80000, which is purchased from Shenzhen Guanghua Webster Limited and has the model number of Esun 800C.
Comparative example 3
An absorbable, degradable suture and method of making is provided similar to example 1, but with the weight ratio of the levorotatory polylactic acid to polycaprolactone in the blending modification being 18: 1.
Comparative example 4
An absorbable, degradable suture and method of making the same are provided similar to example 1, but the polyglycolic acid has an intrinsic viscosity greater than 1.80dL/g, and is available from brier biomaterial, inc.
Comparative example 5
An absorbable, degradable suture and a method for preparing the same are provided similarly to example 1, but the weight ratio of the poly (glycolide) having a viscosity average molecular weight of 10 to 25 ten thousand to the poly (glycolide) having a viscosity average molecular weight of 1 to 8 ten thousand is 3: 1.
comparative example 6
An absorbable, degradable suture and a method for preparing the same are provided similarly to example 1, but the weight ratio of the poly (glycolide) having a viscosity average molecular weight of 10 to 25 ten thousand to the poly (glycolide) having a viscosity average molecular weight of 1 to 8 ten thousand is 7: 1.
comparative example 7
An absorbable, degradable suture and method of making the same are provided similar to example 1, but the raw materials for making include, in parts by weight: 70 parts of modified polylactic acid, 0 part of polyglycolic acid, 10 parts of poly (glycolide-lactide), 15 parts of chitosan, 3 parts of polyethylene glycol, 3 parts of cassia oil and 2 parts of cinnamaldehyde.
Comparative example 8
An absorbable, degradable suture and method of making the same are provided similar to example 1, but the raw materials for making include, in parts by weight: 70 parts of modified polylactic acid, 10 parts of polyglycolic acid, 0 part of poly (glycolide-lactide), 15 parts of chitosan, 3 parts of polyethylene glycol, 3 parts of cassia oil and 0 part of cinnamaldehyde.
Comparative example 9
An absorbable, degradable suture and method of making the same are provided similar to example 1, but the raw materials for making include, in parts by weight: 70 parts of modified polylactic acid, 10 parts of polyglycolic acid, 10 parts of poly (glycolide-lactide), 15 parts of chitosan, 3 parts of polyethylene glycol, 3 parts of cassia oil and 0 part of cinnamaldehyde.
And (3) performance testing:
1. mechanical Property test
The absorbable and degradable suture lines prepared in the examples 1 to 6 and the comparative examples 1 to 9 are subjected to mechanical property test, a single-yarn electronic strength machine is adopted, the tensile rate is set to be 20mm/min, the breaking strength and the breaking elongation of the sample are respectively tested, if the breaking strength is more than 5cN/dtex, the breaking strength is marked as qualified, otherwise, the breaking strength is marked as unqualified; if the elongation at break is more than 35 percent, marking as qualified, otherwise, marking as unqualified; the test results are reported in table 1.
2. Degradability test
The absorbable and degradable sutures prepared in examples 1 to 6 and comparative examples 1 to 9 were tested for degradation performance, the suture samples were placed in simulated human body fluid and subjected to in vitro degradation tests, and the suture samples were dried and weighed to test the loss rate of the absorbable suture on the 21 st day of degradation, with the loss rate being greater than 90% and recorded as pass, otherwise recorded as fail, and the test results are recorded in table 1.
3. Antibacterial property test
The absorbable and degradable sutures prepared in examples 1 to 6 and comparative examples 1 to 9 are subjected to antibacterial property test, the suture samples are subjected to antibacterial test by adopting an oscillation method, the staphylococcus aureus concentrations of the solutions containing the suture samples before and after oscillation for 18 hours are respectively measured, and the antibacterial rate is calculated according to the staphylococcus aureus concentrations, if the antibacterial rate is higher than 95%, the antibacterial rate is recorded as excellent, and if not, the antibacterial rate is recorded as poor; the test results are reported in table 1.
TABLE 1
Figure BDA0002776211590000101
Figure BDA0002776211590000111
As can be seen from examples 1-6 and comparative examples 1-9, the present invention provides an absorbable and degradable suture thread having excellent tensile strength and toughness, good absorbability and degradability, and excellent antibacterial activity.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims (10)

1. An absorbable, degradable suture, characterized in that: the preparation raw materials comprise the following components in parts by weight: 60-80 parts of degradable base material, 5-15 parts of polyglycolic acid, 5-15 parts of poly (glycolide-lactide), 10-20 parts of chitosan, 1-5 parts of polyethylene glycol, 2-3 parts of lubricant and 1-3 parts of antibacterial agent.
2. An absorbable, degradable suture according to claim 1, characterized by: the degradable base material is modified polylactic acid, and the preparation method of the modified polylactic acid comprises the following steps:
adding polylactic acid, polycaprolactone and a dichloromethane solvent into a conical flask, and stirring to fully dissolve the polylactic acid and the polycaprolactone into the dichloromethane solvent to obtain a dissolved solution; and transferring the obtained dissolved solution into a culture dish, putting the culture dish into a constant-temperature drying oven to slowly volatilize the solvent, and obtaining the modified polylactic acid after the solvent is completely volatilized.
3. An absorbable, degradable suture according to claim 2, characterized by: the polylactic acid is L-polylactic acid, and the intrinsic viscosity of the L-polylactic acid is 1.00-2.50 dL/g.
4. An absorbable, degradable suture according to claim 2, characterized by: the viscosity average molecular weight of the polycaprolactone is 40000-60000.
5. An absorbable, degradable suture according to any of claims 2-4, characterized by: the weight ratio of the polylactic acid to the polycaprolactone is (12-16) to 1.
6. An absorbable, degradable suture according to claim 1, characterized by: the polyglycolic acid has an intrinsic viscosity of 0.50 to 1.50 dL/g.
7. An absorbable, degradable suture according to claim 1, characterized by: the poly (glycolide) is a mixture of poly (glycolide) with viscosity average molecular weight of 10-25 ten thousand and poly (glycolide) with viscosity average molecular weight of 1-8 ten thousand, and the weight ratio is (4-6): 1.
8. an absorbable, degradable suture according to claim 1, characterized by: the hydroxyl value of the polyethylene glycol is 150-300 mgKOH/g.
9. An absorbable, degradable suture according to claim 1, characterized by: the antibacterial agent comprises one or a mixture of any more of mannitol, cinnamaldehyde and eugenol.
10. A method for preparing an absorbable and degradable suture line according to any one of claims 1 to 9, comprising the steps of:
s1, preparing suture fibers: uniformly mixing the degradable base material, polyglycolic acid, poly (lactide-co-glycolide), chitosan, polyethylene glycol, a lubricant and an antibacterial agent, extruding by using a double-screw extruder, cooling by water, air-drying, and granulating to obtain master batches; melting and defoaming the master batch, and obtaining primary fiber through a spinneret plate; stretching the primary fiber in a water bath to obtain suture fiber;
s2, drying and sterilizing: and (3) further drying and sterilizing the suture fiber by using ethylene oxide to obtain the absorbable and degradable suture.
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CN112587714A (en) * 2020-12-18 2021-04-02 朱炜 Absorbable wire capable of promoting skin collagen synthesis and using method thereof
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CN115869455A (en) * 2022-12-02 2023-03-31 上海玮启医疗器械有限公司 Modified polylactic acid, preparation method thereof and degradable left atrial appendage occluder suture

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CN112587714A (en) * 2020-12-18 2021-04-02 朱炜 Absorbable wire capable of promoting skin collagen synthesis and using method thereof
CN113171488A (en) * 2021-04-23 2021-07-27 宁波市第一医院 Absorbable suture line and preparation method thereof
CN115869455A (en) * 2022-12-02 2023-03-31 上海玮启医疗器械有限公司 Modified polylactic acid, preparation method thereof and degradable left atrial appendage occluder suture

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