CN102921043B - The preparation method of the absorbable double layer fibre film hernia paster of part - Google Patents

The preparation method of the absorbable double layer fibre film hernia paster of part Download PDF

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CN102921043B
CN102921043B CN201210444924.1A CN201210444924A CN102921043B CN 102921043 B CN102921043 B CN 102921043B CN 201210444924 A CN201210444924 A CN 201210444924A CN 102921043 B CN102921043 B CN 102921043B
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preparation
solution
basic unit
spinning
double layer
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CN102921043A (en
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韩志超
许杉杉
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TransEasy Medical Tech. Co.,Ltd.
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Wuxi Zhongke Guangyuan Biomaterials Co Ltd
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Abstract

The present invention relates to a kind of part and can absorb the preparation method of double layer fibre film hernia paster, use PVDF as material of main part, make to support basic unit and there is the mechanical strength of excellence, good compliance, there is within the implantation phase good biocompatibility and histocompatibility, and can well assist tissue remodeling;Use PLGA and add macromolecule softener so that functional layer has good cellular affinity and histocompatibility, adding small-molecule drug and make functional layer have hemostasis, the antibacterial and effect of anti;Preparation means easily operates, low cost, can scale, end properties is excellent, can extensively be used as internal hernia paster material.

Description

The preparation method of the absorbable double layer fibre film hernia paster of part
Technical field:
The present invention relates to degradable high polymer material and field of compound material, be specifically related to a kind of be entered by incompatible material The part that row is combined can absorb the preparation method of double layer fibre film hernia paster.
Background technology:
Hernia paster is a kind of conventional medical embedded timbering material in treating hernia.The support of one-component often due to Its performance limits and is difficult to meet actual demand, and being developed into of the most compound material designs a big hands of multi-functional material Section.Such as, in hernia paster material, polypropylene mesh structure adds poly (glycolide-lactide), embedded material can be improved and plant Enter the histocompatibility at position, reduce the formation of healing early stage cicatrix, thus the safety in utilization of material can be improved with effective Property.
In recent ten years, electrospinning biocompatible fibres film is widely studied due to the superiority of its structure and performance.Example As, the most studied confirmation of electricity spinning fibre has the surface compatability of excellence due to the surface texture of its class cytoskeleton;Take To the bootable cells in situ of electricity spinning fibre film grow in original topological structure and arrange;The knot that fibrous membrane is three-dimensional porous Structure is conducive to keeping the environment of implant site circulation;The soft characteristic of fibrous membrane light weight can increase embedded material operability and Comfortableness, etc..According to the development of nearest Electrospinning, composite electrospun cortina makes the performance of electrospun membrane more diversified And performance-based.Such as, solution blending spining technology and co spun technology can be prepared containing two kinds or many by regulation and control spinning condition Plant the composite fiber membrane material of different macromolecular materials so that prepared material property variation, more can be according to the actual requirements;Enter Row regulation and control;Milk thread can realize the embedding in fibrous membrane of Medicine small molecule and gene, RNA, DNA isoreactivity macromole and Do not destroy structure and the character of embedded object so that the fibrous membrane character function prepared.
But using electrostatic spinning to be combined by the macromolecule that two kinds incompatible, to obtain the method for stabilizing material the rarest, especially It is not yet to be seen in report in hernia paster field.
Summary of the invention:
It is an object of the invention to provide and a kind of the part that incompatible material carries out being combined is can absorb double layer fibre film The preparation method of hernia paster.
To achieve these goals, the present invention propose following technical scheme realize:
The absorbable double layer fibre film hernia paster of part, it is characterised in that: double layer fibre film hernia paster by support basic unit, Functional layer forms;Described support basic unit is with non-degradable macromolecular material as material of main part;Described functional layer is with biodegradable Macromolecular material is material of main part, adds macromolecule softener;Supporting basic unit, functional layer all uses electrostatic spinning technique to make.
Described double layer fibre film hernia paster thickness is 60 μm~500 μm.
Described non-degradable macromolecular material is PVDF, number-average molecular weight 100,000~400,000.
In described functional layer, biodegradable polymer accounts for the 80%~100% of oeverall quality, and macromolecule is submissive Agent accounts for the 1%~20% of oeverall quality.
Described functional layer also includes small-molecule drug.
Described small-molecule drug accounts for the 0.05%~10% of biodegradable polymer quality.
Described biodegradable polymer is PLGA, number-average molecular weight 30,000~500,000, and segment mol ratio L: G=90: 10~40: 60.
Described macromolecule softener is one or more in polycaprolactone, Merlon and PLA-b-PEG, and number is divided equally Son amount 5,000~100,000.
Described small-molecule drug be Aminomethylbenzoic Acid, tranamic acid, 6-aminocaprolc acid, reptilase, thrombin, metronidazole, One or more in tinidazole, ornidazole.
The preparation method of the preparation method of the absorbable double layer fibre film hernia paster of part, comprises the steps:
(1) preparation macromolecular solution: being dissolved in corresponding cosolvent by non-degradable macromolecular material, being configured to concentration is 10 ~the solution of 60wt%;Biodegradable polymer is dissolved in corresponding cosolvent to macromolecule softener and small-molecule drug In, it is configured to the solution of concentration 5~50wt%, wherein biodegradable polymer accounts for the 80%~100% of gross mass, high Molecule softener accounts for the 1%~20% of gross mass, small-molecule drug account for biodegradable polymer quality 0.05%~ 10%;
(2) support basic unit is spun: controlling spinning environment temperature is 25~50 DEG C, and the non-degradable macromolecule (1) obtained is molten Liquid is placed in the feed injector of electrospinning device, and the distance between regulation spinning head and roller is 7~15cm, in environment Air velocity controls 0.5~0.8m3/ hr, opens high voltage power supply and feed injector pump, regulation voltage to 10~35KV, The delivery rate of solution is 10~30 μ l/min, obtains the support basic unit spun on rotating drum;
(3) functional layer is spun: controlling spinning environment temperature is 25~50 DEG C, the biodegradable high score then (1) obtained Sub-material, macromolecule softener, small-molecule drug mixed solution are placed in the feed injector of electrospinning device, obtain in (2) To support basic unit on carry out spinning, the distance between regulation spinning head and roller is 7~15cm, the air velocity control in environment System is 0.5~0.8m3/ hr, opens high voltage power supply and feed injector pump, regulation voltage to 10~35KV, the feed of solution Speed is 10~30 μ l/min, obtains electrospun fibers composite membrane on a rotating drum.
Described cosolvent is DMF, acetone, trifluoroethanol, hexafluoroisopropanol, THF, dimethyl acetylamide, dichloromethane In one or more.
Described electrospinning device is many spinning heads electrostatic spinning machine.
Beneficial effects of the present invention: use PVDF as material of main part so that support basic unit have excellence mechanical strength, Well compliance, has good biocompatibility and histocompatibility within the implantation phase, and can well assist tissue weight Mould;Use PLGA and add macromolecule softener so that functional layer has good cellular affinity and histocompatibility, adding Small-molecule drug makes functional layer have hemostasis, the antibacterial and effect of anti;Preparation means easily operates, low cost, can scale Changing, end properties is excellent, can extensively be used as internal hernia paster material.
Detailed description of the invention:
Hereinafter describe the preferred embodiment of the present invention, but be not limited to the present invention.
Embodiment 1:
It is prepared as follows and partly can absorb double layer fibre film hernia paster:
(1) preparation of solution: PVDF (molecular weight 250000) is dissolved in DMF molten with the mixing of acetone (volume ratio is 7: 3) In agent, it is configured to the electrospun solution that PVDF concentration is 15wt%;By PLGA (molecular weight 50000), polycaprolactone (molecular weight 50000) and metronidazole is dissolved in DMF, it is configured to the electrospun solution that concentration is 45wt%, wherein PLGA: PCL=85: 15, PLGA : metronidazole=100: 5;
(2) support basic unit is spun: the PVDF solution (1) obtained is placed in the feed injector of many spinning heads electrostatic spinning machine In, controlling spinning environment temperature is 50 DEG C, and the distance between regulation spinning head and roller is 7~15cm, the air stream in environment Speed controls 0.5~0.8m3/hr;Open high voltage power supply and feed injector pump, regulation voltage to 10~35KV, solution Delivery rate is 10~30 μ l/min, obtains the support basic unit spun on rotating drum;
(3) functional layer is spun: the PLGA that (1) obtained, polycaprolactone, metronidazole mixed solution are placed in many spinning heads Static Spinning In the feed injector of silk machine, controlling spinning environment temperature is 25 DEG C, carries out spinning in the support basic unit that (2) obtain, regulation Distance between spinning head and roller is 7~15cm, and the air velocity in environment controls 0.5~0.8m3/hr;Open high pressure Power supply and feed injector pump, regulation voltage is to 10~35KV, and the delivery rate of solution is 10~30 μ l/min, is rotating rolling Electrospun fibers composite membrane is obtained on Tong.
Embodiment 2:
It is prepared as follows and partly can absorb double layer fibre film hernia paster:
(1) preparation of solution: PVDF (molecular weight 200000) is dissolved in DMF molten with the mixing of acetone (volume ratio is 5: 5) In agent, it is configured to the electrospun solution that PVDF concentration is 20wt%;By PLGA (molecular weight 80000), polycaprolactone (molecular weight 80000), metronidazole, 6-aminocaprolc acid be dissolved in DMF, be configured to the electrospun solution that concentration is 40wt%, wherein PLGA: PCL= 90: 10, PLGA: metronidazole: 6-aminocaprolc acid=100: 2: 2;
(2) support basic unit is spun: the PVDF solution (1) obtained is placed in the feed injector of many spinning heads electrostatic spinning machine In, controlling spinning environment temperature is 50 DEG C, and the distance between regulation spinning head and roller is 7~15cm, the air stream in environment Speed controls 0.5~0.8m3/hr;Open high voltage power supply and feed injector pump, regulation voltage to 10~35KV, solution Delivery rate is 10~30 μ l/min, obtains the support basic unit spun on rotating drum;
(3) functional layer is spun: the PLGA that (1) obtained, polycaprolactone, metronidazole, 6-aminocaprolc acid mixed solution are placed in many In the feed injector of spinning head electrostatic spinning machine, controlling spinning environment temperature is 50 DEG C, and the support basic unit obtained in (2) is enterprising Row spinning, the distance between regulation spinning head and roller is 7~15cm, and the air velocity in environment controls 0.5~0.8m3/ hr;Opening high voltage power supply and feed injector pump, regulation voltage is to 10~35KV, and the delivery rate of solution is 10~30 μ l/ Min, obtains electrospun fibers composite membrane on a rotating drum.

Claims (4)

1. part can absorb the preparation method of double layer fibre film hernia paster, it is characterised in that:
Described part can absorb double layer fibre film hernia paster by supporting basic unit, functional layer forms;Described support basic unit is with can not Degraded macromolecular material is material of main part;Described functional layer, with biodegradable polymer as material of main part, adds high score Sub-softener, wherein biodegradable polymer accounts for the 80%~100% of gross mass, and macromolecule softener accounts for oeverall quality 1%~20%;Also including small-molecule drug in described functional layer, described small-molecule drug accounts for biodegradable polymer The 0.05%~10% of quality;
(1) preparation macromolecular solution: non-degradable macromolecular material is dissolved in corresponding cosolvent, be configured to concentration be 10~ The solution of 60wt%;Biodegradable polymer is dissolved in corresponding cosolvent to macromolecule softener and small-molecule drug In, it is configured to the solution that concentration is 5~50wt%;
(2) support basic unit is spun: controlling spinning environment temperature is 25~50 DEG C, and the non-degradable macromolecular solution (1) obtained is put In the feed injector of electrospinning device, the distance between regulation spinning head and roller is 7~15cm, the air in environment Flow speed control is 0.5~0.8m3/ hr, opens high voltage power supply and feed injector pump, regulation voltage to 10~35KV, solution Delivery rate be 10~30 μ l/min, rotating drum obtains the support basic unit spun;
(3) functional layer is spun: controlling spinning environment temperature is 25~50 DEG C, the Biodegradable high-molecular material then (1) obtained Material, macromolecule softener, small-molecule drug mixed solution are placed in the feed injector of electrospinning device, obtain in (2) Supporting and carry out spinning in basic unit, the distance between regulation spinning head and roller is 7~15cm, and the air velocity in environment controls 0.5~0.8m3/ hr, opens high voltage power supply and feed injector pump, regulation voltage to 10~35KV, the delivery rate of solution It is 10~30 μ l/min, obtains electrospun fibers composite membrane on a rotating drum;Described non-degradable macromolecular material is PVDF, number-average molecular weight 100,000~400,000;Described biodegradable polymer is PLGA, number-average molecular weight 30,000~500,000, segment mol ratio L: G=90: 10~40: 60;Described macromolecule softener is polycaprolactone, poly-carbon One or more in acid esters and PLA-b-PEG, number-average molecular weight 5,000~100,000.
Part the most according to claim 1 can absorb the preparation method of double layer fibre film hernia paster, it is characterised in that: institute The small-molecule drug stated is Aminomethylbenzoic Acid, tranamic acid, 6-aminocaprolc acid, reptilase, thrombin, metronidazole, tinidazole, nitre difficult to understand One or more in azoles.
Part the most according to claim 1 can absorb the preparation method of double layer fibre film hernia paster, it is characterised in that: step (1) is used for dissolving non-degradable macromolecular material or biodegradable polymer and macromolecule softener and little point suddenly The cosolvent of sub-medicine is in DMF, acetone, trifluoroethanol, hexafluoroisopropanol, THF, dimethyl acetylamide, dichloromethane Plant or multiple.
Part the most according to claim 1 can absorb the preparation method of double layer fibre film hernia paster, it is characterised in that: use Spin in step (2) and support that to spin the electrospinning device of functional layer in basic unit or step (3) be many spinning heads electrostatic spinning machine.
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CN104096272A (en) * 2013-04-03 2014-10-15 中国科学院化学研究所 Postoperation anti-infectious composite electrostatic-spinning nanometer fiber-film sheet for repairing hernia and preparation method thereof
CN103656741B (en) * 2013-11-21 2016-02-10 无锡中科光远生物材料有限公司 A kind of bacteriostatic film
CN103705978B (en) * 2013-11-21 2016-02-10 无锡中科光远生物材料有限公司 A kind of preparation method of bacteriostatic film
CN104963092A (en) * 2015-07-31 2015-10-07 武汉蓝普医品有限公司 Preparation device and method for non-woven high polymer material optilene mesh
CN107537067A (en) * 2017-09-15 2018-01-05 深圳大学 A kind of composite artificial endocranium and preparation method thereof
CN107510520B (en) * 2017-09-21 2020-08-11 上海松力生物技术有限公司 Cruciate ligament regenerative implant and preparation method and application thereof
CN111803713A (en) * 2020-05-29 2020-10-23 广州新诚生物科技有限公司 Woven film, woven bag and weaving method

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US7927620B2 (en) * 2007-05-15 2011-04-19 Boston Scientific Scimed, Inc. Medical devices having antifouling character
CN101530353B (en) * 2008-04-11 2010-08-25 北京天助畅运医疗技术股份有限公司 Anti-adhesion hernia repair patch
CN102085122B (en) * 2011-03-01 2013-04-17 东华大学 Polypropylene/polyvinylidene fluoride composite hernia patch and preparation method thereof

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Address after: 100027 Beijing City, Dongcheng District No. 40 East Street, Yuanjia Residence Internazionale B block 3 layer

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Patentee before: Wuxi Zhongke Guangyuan Biomaterial Co., Ltd.