CN104667340A - A biodegradable suture with bioactivity - Google Patents

A biodegradable suture with bioactivity Download PDF

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Publication number
CN104667340A
CN104667340A CN201310603436.5A CN201310603436A CN104667340A CN 104667340 A CN104667340 A CN 104667340A CN 201310603436 A CN201310603436 A CN 201310603436A CN 104667340 A CN104667340 A CN 104667340A
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China
Prior art keywords
spinning
stitching thread
chitosan
monofilament
spinning solution
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CN201310603436.5A
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Chinese (zh)
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沈攀攀
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Individual
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Individual
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Priority to CN201310603436.5A priority Critical patent/CN104667340A/en
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Abstract

The invention provides a suture having a controlled degradation speed and drug release effects. The suture is manufactured from a monofilament or a multifilament formed by spinning a spinning solution, wherein the spinning solution comprises one or more than two components selected from chitin, chitosan and derivatives thereof, and clastic enzymes thereof. The suture is characterized in that the clastic enzymes are mixed with and exist on surfaces of or inside the monofilament or the multifilament; a composite ultrafine fiber at least one ultrafine fiber of which is of a core-shell structure is prepared from a plurality of ultrafine spinning fibers by a coaxial cospinning technique and by after-treatment; the core material comprises a bioactive component; and the shell is a biodegradable material.

Description

Biodegradable and bioactive stitching thread
Technical field
The present invention relates to therapeutic medical stitching thread and preparation method thereof, relate more specifically to a kind of biodegradation rate controlled, degraded after release load bioactive ingredients, there is the stitching thread of flexibility, intensity, Release Performance.
Background technology
Surgical suture can be divided into the absorbable sutures and the nonabsorbable stitching thread absorbed that is not decomposed in vivo that are decomposed in vivo and absorb.This absorbable sutures and nonabsorbable stitching thread separately use according to operative site or during sewing up etc.Nonabsorbable stitching thread to have in operation required stable tensile strength, but there is such shortcoming: need re-treatm ent after Removal, remain in stitching thread in organism as foreign body.On the other hand, absorbable sutures is absorbed in vivo due to Post operation, does not therefore need re-treatm ent.But according to operative site, the external force acting on this position due to Post operation is different, therefore, needs to control sutural tensile strength over time according to object: decomposition rate.That is, in order to until operative site cures this position of ligation always, need the tensile strength with regulation, but preferably decomposition rate obtains the stitching thread of control thus makes it be decomposed while operative site is cured.Desirable stitching thread, except will possessing regulatable absorbability, insignificant toxicity, mechanical strength that can be lasting, good pliability, resistant to the sterilising, easily sterilizing, also should have antibacterial and treatment function.The stitching thread that antibiosis anti-inflammatory drug, analgesic or other medicines with therapeutic effect are had regulation tensile strength as anticarcinogen or bioactive substance (as somatomedin) are incorporated into is inner or surperficial, to eliminate wound infection, to promote that wound healing, reduction of patient are painful, it is an important development direction of suture.Conventional method is that medicine is directly coated in stitching thread surface, though have certain effect to control postoperative infection, is difficult to the controlled release realizing medicine.
Summary of the invention
The object of the present invention is to provide a kind of bioabsorbable and bioactive stitching thread, it contains chitin, chitosan or their derivant as raw material, and easily can control decomposition rate according to the difference of object and purposes; The bioactive ingredients that after degraded, release loads, has the controllability of the performances such as flexibility, intensity, release and degraded.
Solve the means of problem:
The invention provides the controlled stitching thread simultaneously with release effect of a kind of decomposition rate, the monofilament of spinning from spinning solution or multifilament manufacture, wherein said spinning solution contains the catabolic enzyme being selected from one kind or two or more composition in chitin, chitosan and their derivant and these compositions, it is characterized in that, described catabolic enzyme mixing is present in surface and the inside of described monofilament or multifilament; Being prepared from by Dispersion relation technology and post processing by many microspun fibers has at least a superfine fibre to be the composite ultrafine fiber of core-shell structure, and this core comprises bioactive ingredients, and shell is biological degradable material.
Sandwich layer is used as with the bioactive ingredients such as medicine or somatomedin, the controlled spinning of decomposition rate is as shell, object bioactive ingredients being coated to composite ultrafine fiber sandwich layer can be realized by Dispersion relation, different according to Fiber Materials, contained drug can be released soon, often release, slow release or controlled release, because pharmaceutical pack is rolled in the sandwich layer of superfine fibre, sheath polymers plays barrier action, form a kind of depot, primarily of the degraded of Shell Materials to realize the system of drug release, be conducive to the controlled release of medicine.
Principle of the present invention is: the composite ultrafine fiber being loaded with bioactive ingredients obtained by Dispersion relation, is gathered into along or trends towards the fibre bundle of same direction arrangement by directional collecting device, then by these tow groups synthesis stitching thread.When this stitching thread is placed in after in organism, along with the progressively degraded of single superfine fibre, bioactive ingredients contained in it just constantly discharges.Because individual fiber diameter is very tiny, reach submicron order or nanoscale, thus, single fiber can be easy to realize degraded in vivo, discharges even also can ensure bioactive ingredients at the initial stage that stitching thread is inserted; On the other hand, stitching thread is made up of thousands of this superfine fibres, a small amount of fiber degradation at initial stage can't constitute a threat to sutural intensity, just as the fracture of the tiny steel wire of some root in steel wire rope can't constitute a threat to the intensity of steel wire rope.
In core, the content of biological activity goods and materials and composition can adjust on request: can be pure bioactive substance, also can be the mixture of bioactive substance and biological degradable material, wherein, biological degradable material can be the biological degradable material identical with shell, also can be the other biological degradable materials being different from Shell Materials.
On the basis of such scheme, described bioactive ingredients is antibacterial-anti-inflammatory drug, cancer therapy drug, analgesic drug product, and other wound suture place is to the one in the medicine somatomedin of human body generation effect, anticoagulant, procoagulant activity material or its compositions.On the basis of such scheme, described biological degradable material is the one in polylactic acid, polycaprolactone, polyglycolic acid, PPDO, polyglycolic acid, lactic acid/co-glycolic acid.
On the basis of such scheme, described superfine fibre be submicron order to nanoscale, external diameter is 0.01-10um, and preferred external diameter is 0.1-2um.
Detailed description of the invention
In embodiments, catabolic enzyme is carried on that spinning fibre is performed such: from the spinning solution containing chitin class and catabolic enzyme thereof, long filament is carried out spinning.By by the long filament obtained like this, catabolic enzyme mixing can be obtained and be present in surface and inside.Above-mentioned long filament can be monofilament, also can be multifilament.
(1) spinning can be undertaken by general wet spinning.Wet spinning is by spinning solution being discharged in solidification liquid the method obtaining fiber.Chitin, chitosan or their derivant being dissolved in wherein each composition is in the known mixed solvent of suitable mixed proportion, and carries out filtering and deaeration process, using the transparent high viscosity solution of gained as spinning solution.Chitin class is preferably dissolved with the amount being 8-10 percentage by weight relative to solvent.Above-mentioned mixed solvent is not limited, as long as normally used solvent, such as, can use the mixed solution etc. of the mixed solution of the mixed solution of dimethyl acetylamide and lithium chloride, N-Methyl pyrrolidone and lithium chloride, trichloroacetic acid and halogenated hydrocarbons.
The preparation of starting material solution:
Shell: biological degradable material is chitin powder or Chitosan powder, solvent is acetate buffer solution (pH5.6), take chitin powder or the Chitosan powder of certain mass, be dissolved in solvent and be made into the shell spinning solution that concentration is 8-10 percentage by weight, 4-5h is shaken in ultrasound wave, obtain the shell spinning solution of clear homogeneous, in the spinning solution obtained like this, be pre-mixed chitinous catabolic enzyme, the catabolic enzyme of chitosan or the catabolic enzyme of their derivant.It is 0.0001-10U/g that preferred interpolation catabolic enzyme makes relative to its active unit of spinning solution, at this, is described the active unit of enzyme, and 1U is the enzymatic activity making the N-acetyl glucosamine of 1umol or glycosamine dissociate in 1 minute; Sandwich layer: bioactive ingredients is cefotaxime sodium, and solvent is deionized water, takes the cefotaxime sodium of different quality, is dissolved in solvent that to be made into concentration be 10 percentage by weights respectively, 20 percentage by weights, the core spinning solution of 30 percentage by weights; Coating: biological degradable material chitosan (deacetylation 80%, molecular weight about 100,000), solvent is 1% acetum, and chitosan is dissolved in solvent and is made into the chitosan-acetic acid solution that concentration is 1 percentage by weight.
By regulating the amount of catabolic enzyme mixed in spinning solution, concentration and activity, the amount of the catabolic enzyme that stitching thread can be regulated to support, concentration and activity.Therefore, according to above-mentioned carrying method, can easily control sutural decomposition rate.Generally speaking, the amount of the catabolic enzyme that stitching thread supports, concentration and activity are higher, and sutural decomposition rate is faster.
(2) preparation of medicine carrying superfine fibre line
Adopt Dispersion relation device, above-mentioned shell spinning solution and core spinning solution are placed in shell syringe pump and core syringe pump respectively, and the driving velocity of shell syringe pump is 3ml/h; The driving velocity of core syringe pump is 0.2m1/h, and controlling output voltage during Dispersion relation is 20-30KV, and voltage and sandwich layer solution are connected, and receiving range is 10-13cm, and time of reception is 3-4min, and the external diameter of obtained composite ultrafine fiber is 0.1-0.68um.
(3) preparation of fibre bundle
Preheating 30 seconds at obtained most stock fibre bundles are placed in 80 DEG C, and remain on this temperature and stretch, restrained stretching elongation 50 scholar 5%, carries out twisting to it subsequently and processes, and remains on twisting tension and 90 DEG C of temperature thermal finalization 2 hours.
(4) preparation of medicine carrying litzendraht wire
By the fibre bundle through preheating, stretching, twisting and thermal finalization post processing that above-mentioned implementation step obtains, adopt the miniature braider of 8 ingot to weave, obtain the litzendraht wire that the homogeneous medicine carrying superfine fibre of close structure, diameter is formed.
(5) sutural preparation and characterization
Medicine carrying superfine fibre litzendraht wire obtained for above-mentioned implementation step to be fully immersed in chitosan-acetic acid solution of preparation in (1) 30 minutes, neutrality is washed till again with the sodium hydroxide of 1Wt%, with deionized water rinsing 3 times, place in atmosphere and dry, make chitosan on medicament-carrying nano-fiber litzendraht wire, form the thin film cladding layer of one deck densification.This stitching thread meets Federal Food and drug inspection office substantially about sutural use standard.Especially it is worthy of note, medicine carrying stitching thread and the sutural tensile property of non-medicine carrying adopting same material and step to prepare are contrasted, a few zero difference of both tensile properties.
In order to check the sutural suitability of above-mentioned medicine carrying superfine fibre further, this stitching thread is applied to rat muscle of upper extremity and sews up by us, in sewing process, suture has certain tension force, there is not fracture, and stitching after 28 days, knotting situation are still good, show that this stitching thread can be applied to the stitching of biological tissue.

Claims (4)

1. the controlled stitching thread simultaneously with release effect of decomposition rate, the monofilament of spinning from spinning solution or multifilament manufacture, wherein said spinning solution contains the catabolic enzyme being selected from one kind or two or more composition in chitin, chitosan and their derivant and these compositions, it is characterized in that, described catabolic enzyme mixing is present in surface and the inside of described monofilament or multifilament; Being prepared from by Dispersion relation technology and post processing by many microspun fibers has at least a superfine fibre to be the composite ultrafine fiber of core-shell structure, and this core comprises bioactive ingredients, and shell is biological degradable material.
2. stitching thread according to claim 1, it is characterized in that described spinning fibre is adhering to described composition catabolic enzyme from the monofilament of spinning solution spinning containing the one kind or two or more composition be selected from chitosan, chitosan and their derivant or the surface of multifilament is formed, at least on described sutural surface, be attached with described catabolic enzyme.
3. stitching thread according to claim 1, it is characterized in that, described bioactive ingredients is antibacterial-anti-inflammatory drug, cancer therapy drug, analgesic drug product, and other wound suture place is to the one in the medicine somatomedin of human body generation effect, anticoagulant, procoagulant activity material or its compositions.
4. described stitching thread according to claim 1, it is characterized in that, described biological degradable material is the one in polylactic acid, polycaprolactone, polyglycolic acid, PPDO, polyglycolic acid, lactic acid/co-glycolic acid.
CN201310603436.5A 2013-11-26 2013-11-26 A biodegradable suture with bioactivity Pending CN104667340A (en)

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Application Number Priority Date Filing Date Title
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CN104667340A true CN104667340A (en) 2015-06-03

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105088465A (en) * 2015-08-11 2015-11-25 安徽省康宁医疗用品有限公司 Absorbable surgical suture line resistant to degradation and good in compatibility and preparing method of absorbable surgical suture line resistant to degradation and good in compatibility
CN105770978A (en) * 2016-03-21 2016-07-20 江苏广达医材集团有限公司 Biodegradable medical abdominal surgical suture material
CN107970487A (en) * 2017-12-26 2018-05-01 徐州仁和医疗科技有限公司 A kind of novel medical operation suture
CN109480932A (en) * 2018-11-09 2019-03-19 付亚坤 A kind of epidermis beauty treatment suturing device
CN110302417A (en) * 2019-06-18 2019-10-08 珠海稻田医疗科技有限公司 A kind of antibacterial, biodegradable suture
CN116135177A (en) * 2023-02-23 2023-05-19 赫美康健(北京)医疗器械有限公司 Degradable self-fixing preperitoneal patch

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105088465A (en) * 2015-08-11 2015-11-25 安徽省康宁医疗用品有限公司 Absorbable surgical suture line resistant to degradation and good in compatibility and preparing method of absorbable surgical suture line resistant to degradation and good in compatibility
CN105770978A (en) * 2016-03-21 2016-07-20 江苏广达医材集团有限公司 Biodegradable medical abdominal surgical suture material
CN107970487A (en) * 2017-12-26 2018-05-01 徐州仁和医疗科技有限公司 A kind of novel medical operation suture
CN109480932A (en) * 2018-11-09 2019-03-19 付亚坤 A kind of epidermis beauty treatment suturing device
CN110302417A (en) * 2019-06-18 2019-10-08 珠海稻田医疗科技有限公司 A kind of antibacterial, biodegradable suture
CN116135177A (en) * 2023-02-23 2023-05-19 赫美康健(北京)医疗器械有限公司 Degradable self-fixing preperitoneal patch

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Application publication date: 20150603