CN1552466A - Absorbable medical chitin suture lines and their production - Google Patents

Absorbable medical chitin suture lines and their production Download PDF

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Publication number
CN1552466A
CN1552466A CNA031299768A CN03129976A CN1552466A CN 1552466 A CN1552466 A CN 1552466A CN A031299768 A CNA031299768 A CN A031299768A CN 03129976 A CN03129976 A CN 03129976A CN 1552466 A CN1552466 A CN 1552466A
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China
Prior art keywords
chitosan
solution
naoh
stitching thread
absorbable medical
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CN100420488C (en
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勇 张
张勇
邓志强
邓云强
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JIUKANG BIOENGINEERING DEVELOPMENT Co Ltd TIANJIN
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JIUKANG BIOENGINEERING DEVELOPMENT Co Ltd TIANJIN
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Abstract

An absorbable medical chitosan suture is prepared from chitosan and glycerine or vegetable oil through preparing coarse chitosan suture, preparing saturated high-concentration chitosan solution, twisting and coating film. Its advantage is high tension strength.

Description

Chitosan absorbable medical suture and manufacture method thereof
One, technical field
The present invention relates to a kind of manufacture method of suture, especially with the pure natural macromolecule polysaccharide---chitosan is made the manufacture method of absorbable medical suture.
Two, technical background
Medical operation suture thread mainly contains two classes, and a class is non-absorbent stitching thread, and the sutural disadvantage of this class is to need to take out stitches after the operation, and online stitch place often leaves tangible cicatrix.Another kind of is the absorbability suture, and this type of stitching thread postoperative need not to take out stitches, and line stitch place cicatrix is slight or do not have a cicatrix.So many domestic and international research institutions all are being devoted to the research in this field.
At present, domestic had some patents of invention for absorbable medical suture, is called polyester absorbable medical suture and method for production thereof as patent publication No. for the CN1195559A name; The CN85108766A name is called suture of amniotic membrane and preparation method thereof; The CN1051510A name is called collagen---and polyvinyl alcoholic operation sutures and preparation method thereof and CN1125622A name are called medical absorbable biological material, the flexible suture line.These patent institute materials useds are the composite of synthetic material or natural material or synthetic material and natural material.Though these materials have certain degradable, can be organized the function that cell absorbs, but still there is certain weak point, lower as sutural fracture strength, the absorption phase is long, certain zest is arranged, biocompatibility is relatively poor, complex manufacturing, or material source has the defective of aspects such as certain limitation.
Three, summary of the invention
Purpose of the present invention is that raw material is made the absorbability suture with the chitosan exactly, overcomes the existing shortcoming of above-mentioned absorbability stitching thread, and another object of the present invention is the manufacture method that provides the chitosan absorbable medical suture.
Chitosan is a kind of pure natural macromolecule polysaccharide, its avirulence, nonirritant, without any side effects, and can well have been studies confirm that by the many scientific research institutions in the world by the characteristic of the lysozyme degraded and absorbed of inside of human body and raw material sources extensive, chitosan is the material that the absorbability suture is made in a kind of splendid being used to thus.
Technological process of the present invention is simple, and is easy to operate, is easy to suitability for industrialized production, and do not use any deleterious reagent and deleterious organic solvent in whole process of production, thereby makes security of products more reliable.
The purpose of invention solves by following scheme:
Chitosan absorbable medical suture main component is a chitosan, also is added with an amount of glycerol or vegetable oil in addition to improve sutural pliability.
The manufacture method of chitosan absorbable medical suture:
1, makes chitosan stitching thread thick line
Choose fine chitosan,, be configured to certain density chitosan solution with acetic acid or dissolve with hydrochloric acid solution.Can add a certain amount of softener in the solution, softener can be glycerol or some vegetable oil.Solution is fully stirred the back under vacuum condition, remove bubble, solution is poured in the plate glass groove, then the glass guide channel horizontal positioned.Dry at a certain temperature, make it film forming, film is cut into strip on special mould, then groove being put into certain density NaOH solution or NaOH and alcoholic acid mixed solution heats, (between 40 ℃-98 ℃ of the temperature), after 5-30 minute, the strip film is rolled to the centre by both sides nature, be the bar wire and from glass planar, come off automatically, be chitosan stitching thread thick line.Thick line taken out in pure water clean repeatedly for several times, NaOH or NaOH and alcohol flushing is clean, dry standby.
2, make the chitosan saturated solution of high concentration
Prepare certain density acetic acid or hydrochloric acid solution, add excessive chitosan, fully stir, be made into the saturated solution of chitosan, solution is filtered, get clear liquid, and then concentrate, obtain the chitosan saturated solution of high concentration.
3, twisted filament
Above-mentioned prepared chitosan stitching thread thick line is put into taken out after soaking certain hour in the saturated solution of chitosan, on twisting frame, twist with the fingers into filament, and filament is suitably stretched, after to be dried, take off, put into NaOH (2%) solution and soak taking-up in 5-30 minute, washing totally is the finished product stitching thread.
4, plated film
As requested, stitching thread is put into again soaked certain hour in the saturated solution of chitosan and take out, after the drying, put into NaOH (2%) solution and soak taking-ups in 5-30 minute once more, washing totally.This operation can repeat repeatedly, to reach repeatedly " plated film ", improves the smoothness on stitching thread surface and the diameter of increase line, and improves the purpose of the tensile strength of line.
Advantage of the present invention is:
1, no matter the stitching thread that makes of the present invention is under dry state or hygrometric state condition, the tensile strength of this line and corresponding knot strength, its works very well.
2, the stitching thread that makes of the present invention, its absorption phase is 7-15 days, it can satisfy clinical instructions for use its suitable absorption.Deposit under suitable condition, the degradation rate of this line is very little, and every index of this line all is not less than the regulation of American Pharmacopeia the 22 edition.
3, add the pliability that an amount of glycerol or vegetable oil have improved this line in the stitching thread of the present invention, more convenient when using clinically.
4, the obtained stitching thread of the present invention proves through zoopery and clinic trial, this line do not have any tissue reaction, non-stimulated, have no side effect, absorb fully, and the mending stitch place does not have cicatrix behind the wound healing.
Four, specific embodiment:
(1) selects suitable chitosan, the deacetylation of chitosan, viscosity, molecular weight, pH value, the ash index of grading is: deacetylation: 65%-95%, and moisture :≤10%, ash :≤1%, viscosity: 80mPa.s-200mPa.s, total arsenic :≤1.0mg/kg is (with AS 2O 2Meter), lead :≤1.5mg/kg (in pb), hydrargyrum :≤0.3mg/Kg (in Hg); The selection of chitosan should absorb the length of phase according to stitching thread to be determined, general deacetylation height, and its absorption phase is then long more, and the viscosity of chitosan or molecular weight are high more, and then the tensile strength of line is big more.With acetic acid or the dissolving with hydrochloric acid of 0.1%-2%, the concentration that makes chitosan can add a small amount of glycerol or vegetable oil to improve the pliability of stitching thread finished product then as required at 0.01%-2%.Stir the vacuum removal bubble.
(2) saturated solution of preparation chitosan, acetic acid or dissolving with hydrochloric acid chitosan with 0.05%-0.5% make chitosan excessive,, filter more than 6 hours in 40 ℃-60 ℃ stirrings, get clear liquid.Heating concentrates under vacuum condition then, and (temperature is at 40 ℃-60 ℃) make chitosan concentration between 2%-15%.
(3) system thick line: pour in the plate glass groove with 1 chitosan solution that makes, the amount of pouring into should decide according to sutural thickness model.Then the plate glass groove is heated oven dry under level conditions, temperature is advisable between 30 ℃-60 ℃.After the oven dry, chitosan is film forming on the plate glass groove, with the film tool plate glass groove is entangled, and then film is cut into strip, and the width of bar is generally 0.5-3cm.The plate glass groove is being put into solution by NaOH (0.5%-2%) or NaOH (0.5%-2%) and ethanol (0.1%-1%) in 40 ℃ of-98 ℃ of heating then, be curled into wire and come off until the strip chitosan film from glass plate, line is taken out, clean up with distilled water, be thick line after drying.
(4) 3 thick lines that make are put into the 2 chitosan saturated solutions that make and soaked after 2-20 minute, take out, twisted filament and stretching on twisting frame.Dry the back and in 2%NaOH solution, soaked 20 minutes, take out, be finished product after in distilled water, cleaning up.Also can as required this line be put into the chitosan saturated solution that has made and soak, taking-up is dried, put into 2%NaOH solution again and soak once more, so repeated multiple times can make line repeatedly " plated film " to improve its smoothness and tensile strength.

Claims (3)

1, a kind of chitosan absorbable medical suture, primary raw material is a chitosan, it is characterized in that: it also comprises glycerol or vegetable oil.
2, a kind of manufacture method of chitosan absorbable medical suture is characterized in that: its manufacturing process flow is:
(1) makes chitosan stitching thread thick line
Choose fine chitosan,, be configured to certain density chitosan solution with acetic acid or dissolve with hydrochloric acid solution.Can add a certain amount of softener in the solution, softener can be glycerol or some vegetable oil.Solution is fully stirred the back under vacuum condition, remove bubble, solution is poured in the plate glass groove, then the glass guide channel horizontal positioned.Dry at a certain temperature, make it film forming, film is cut into strip on special mould, then groove is put into NaOH solution or NaOH and alcoholic acid mixed solution heats, temperature is between 40 ℃-98 ℃, and after 5-30 minute, the strip film is rolled to the centre by both sides nature, be the bar wire and from glass planar, come off automatically, be chitosan stitching thread thick line.Thick line taken out in pure water clean repeatedly for several times, NaOH or NaOH and alcohol flushing is clean, dry standby.
(2) the chitosan saturated solution of making high concentration
Prepare certain density acetic acid or hydrochloric acid solution, add excessive chitosan, fully stir, be made into the saturated solution of chitosan, solution is filtered, get clear liquid, and then concentrate, obtain the chitosan saturated solution of high concentration.
(3) twisted filament
Above-mentioned prepared chitosan stitching thread thick line is put into taken out after soaking certain hour in the saturated solution of chitosan, on twisting frame, twist with the fingers into filament, and filament is suitably stretched, after to be dried, take off, put into 2% NaOH solution and soak and took out in 5-30 minute, washing totally is the finished product stitching thread.
(4) plated film
Stitching thread is put into again soaked certain hour in the saturated solution of chitosan and take out, after the drying, put into NaOH (2%) solution and soak taking-ups in 5-30 minute once more, washing totally.This operation can repeat repeatedly.
3, the manufacture method of chitosan absorbable medical suture according to claim 2 is characterized in that: the described NaOH solution concentration of step (1) is 0.1%-2%, and concentration of alcohol is 1%-5%.
CNB031299768A 2003-06-03 2003-06-03 Absorbable medical chitin suture lines and their production Expired - Lifetime CN100420488C (en)

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Application Number Priority Date Filing Date Title
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CN100420488C CN100420488C (en) 2008-09-24

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102406961A (en) * 2011-11-29 2012-04-11 司忠 Absorbable operating suture line and preparation method thereof
CN101703794B (en) * 2009-11-18 2013-06-12 中国人民解放军第二炮兵总医院 Controlled degradable surgical suture thread and fabricating method thereof
CN103301510A (en) * 2013-06-20 2013-09-18 孙文善 Acupuncture implantation material
CN107811752A (en) * 2017-09-21 2018-03-20 温州医科大学 A kind of biocompatibility Aqueous Humor of Glaucomas drainage tube and preparation method thereof
CN108348660A (en) * 2015-09-03 2018-07-31 株式会社真友生物 It is coated with the manufacturing method and its high performance sewing yarn of the high performance sewing yarn of hyaluronate
CN115300662A (en) * 2022-01-28 2022-11-08 温州医科大学 Chitosan surgical suture and preparation method thereof

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN85108766B (en) * 1985-11-22 1988-02-17 吕强 Suture of amniotic membrane and its mfg process
CN1034351C (en) * 1994-10-12 1997-03-26 中国纺织大学 Method for preparing chitin fiber
CN1065773C (en) * 1994-12-28 2001-05-16 天津纺织工学院膜天膜技术工程公司 Flexible suture of absobable biological material for medical use
JP3104212B2 (en) * 1995-11-24 2000-10-30 大日精化工業株式会社 Method for treating chitin and / or chitosan particles
CN1062773C (en) * 1998-04-16 2001-03-07 中国纺织大学 Polyester absorbable medical suture and its manufacturing method
CN1301758C (en) * 2002-11-14 2007-02-28 王浦林 Medical supplementary material producing process

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101703794B (en) * 2009-11-18 2013-06-12 中国人民解放军第二炮兵总医院 Controlled degradable surgical suture thread and fabricating method thereof
CN102406961A (en) * 2011-11-29 2012-04-11 司忠 Absorbable operating suture line and preparation method thereof
CN102406961B (en) * 2011-11-29 2013-12-18 司忠 Absorbable operating suture line and preparation method thereof
CN103301510A (en) * 2013-06-20 2013-09-18 孙文善 Acupuncture implantation material
CN103301510B (en) * 2013-06-20 2014-12-24 孙文善 Acupuncture implantation material
CN108348660A (en) * 2015-09-03 2018-07-31 株式会社真友生物 It is coated with the manufacturing method and its high performance sewing yarn of the high performance sewing yarn of hyaluronate
CN108348660B (en) * 2015-09-03 2021-04-06 株式会社真友生物 Method for manufacturing high-performance suture coated with hyaluronate and high-performance suture thereof
CN107811752A (en) * 2017-09-21 2018-03-20 温州医科大学 A kind of biocompatibility Aqueous Humor of Glaucomas drainage tube and preparation method thereof
CN115300662A (en) * 2022-01-28 2022-11-08 温州医科大学 Chitosan surgical suture and preparation method thereof

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