CN104689367A - Absorbable skin suturing nail and preparation method thereof - Google Patents
Absorbable skin suturing nail and preparation method thereof Download PDFInfo
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- CN104689367A CN104689367A CN201510117194.8A CN201510117194A CN104689367A CN 104689367 A CN104689367 A CN 104689367A CN 201510117194 A CN201510117194 A CN 201510117194A CN 104689367 A CN104689367 A CN 104689367A
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Abstract
The invention provides an absorbable skin suturing nail and a preparation method thereof. The absorbable skin suturing nail comprises an inner body and an outer coating which are both manufactured from degradable materials, wherein the degrading speed of the material of the outer coating is less than that of the material of the inner body. According to the absorbable skin suturing nail comprising the inner body and the outer coating, the inner layer is mainly used for achieving mechanical property, and the outer coating is mainly used for insulating; the degrading speed of the outer coating is less than that of the inner body, so that the degrading time of the whole absorbable skin suturing nail can be prolonged, and as a result, the degrading rate of the whole absorbable skin suturing nail is reduced, the mechanical property can be maintained well for some time.
Description
Technical field
The present invention relates to medical instruments field, particularly relate to a kind of Absorbable rod skin closure nail and preparation method thereof.
Background technology
Skin closure is the type of surgery on basis in surgical operation, Skin sewing needle is medical apparatus and instruments conventional in surgical operation, operation principle is substantially identical with the principle of stapler, in the propelling movement of operation process by stiching instrument, suturing nail in nail bin is out pushed, and thrust skin incision both sides epidermis or internal layer, realize skin closure.The mode of skin closure has epidermis to sew up, and also has subcuticular suture.Skin closure nail also has two types, and nonabsorable skin closure nail is followed closely with Absorbable rod skin closure, and nonabsorable skin closure nail is metal, can only be used for epidermis at present and sew up; Absorbable rod skin closure nail both can be used for subcuticular suture and also can be used for epidermis stitching.
The Absorbable rod skin closure nail used clinically is at present mainly used in subcuticular suture, this nail body shape as English alphabet " U ", at two ends with inside barb, in case suturing nail comes off in skin, the size of nail is moderate, to meet the characteristic of skin closure.In sewing process, this staple is sewn device and is pushed to below skin according to certain rule, and fixing wound; In wound healing process, this Absorbable rod skin closure nail is progressively degraded, but good mechanical strength can be kept to fix wound; After wound heals substantially, the mechanical strength of this Absorbable rod skin closure nail just drops to enough little, and nail generation disintegrate itself, and gradually absorb by human body.
Fig. 1 is the overall dimensions of clinical conventional Absorbable rod skin closure nail.The thickness of conventional Absorbable rod skin closure nail is generally 0.7 ~ 1.0mm, and length is about 4 ~ 6mm, and width is about 3 ~ 4mm.
According to the approval data of U.S. FDA, the initial tensile strength of Absorbable rod skin closure nail is not less than 6.7 Ns and pauses; 37 DEG C, containing salt buffer in after one day, tensile strength is not less than 3.4 Ns and pauses; And 37 DEG C, containing salt buffer in 7 days, residual tensile strength is not less than 1.7 newton.
Usually, the healing of post-operative wound needs two time-of-weeks, and three time-of-weeks should heal completely, and in initial healing stage 0-7 days, wound also keeps comparatively hightension, and now the tensile strength of Absorbable rod skin closure nail should be higher; Along with the progressively healing of wound, the tension force of wound self can progressively reduce, and now the tensile strength of Absorbable rod skin closure nail can appropriateness decline; Generally to after two weeks, wound heals substantially, and suturing nail can not be needed to play fixing suturing, and after three weeks, wound heals completely, and now follow closely should timely disintegrate in several days for Absorbable rod skin closure, and absorb by human body.
Summary of the invention
The technical problem that the present invention mainly solves is to provide a kind of new Absorbable rod skin closure nail and prepares preparation method, mechanical characteristic and the degradation characteristic of this Absorbable rod skin closure nail can meet wound healing rule preferably, and its initial tensile strength is not less than 6.7 newton; Wound suture second day, the tensile strength of Absorbable rod skin closure nail is not less than 4.7 Ns and pauses; At the 7th day, the tensile strength of Absorbable rod skin closure nail was not less than 3.4 Ns and pauses; At the 14th day, residual tensile strength was not less than 1.7 Ns and pauses; And 21-30 days after it has been gathered, the disintegrate of Absorbable rod skin closure nail; Afterwards, Absorbable rod skin closure nail material gradually absorb by human body decomposition.
For solving the problems of the technologies described above, the present invention adopts the Absorbable rod skin closure of band coating to follow closely;
An Absorbable rod skin closure nail, comprises interior layer main body and outer coating;
The material of described interior layer main body and the material of described outer coating are degradation material;
The degradation speed of the material of wherein said outer coating is less than the degradation speed of the material of described interior layer main body;
The material of wherein said interior layer main body is the blend of PLGA and PDLGA, and in described blend, the ratio of quality and the number of copies of PLGA and PDLGA is 99 ~ 80:1 ~ 20;
In wherein said PLGA, the mol ratio of L-lactide and Acetic acid, hydroxy-, bimol. cyclic ester is 55 ~ 70:45:30, mol ratio 55 ~ 70:45 ~ 30 of DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester in wherein said PDLGA.
The material of described outer coating is PLLA or the blend for PLLA and PDLA; In the blend of described PLLA and PDLA, the ratio of quality and the number of copies of PLLA and PDLA is 70 ~ 99:30 ~ 1.
Wherein in an embodiment, the viscosity of the PLGA of described internal layer material of main part is 1.8 ~ 3.0dl/g, and the dispersion of molecular weight is 1.4 ~ 1.7;
The viscosity of described PDLGA is 2.0 ~ 2.5dl/g, and the dispersion of molecular weight is 1.4 ~ 1.7;
Monomer residue molar content in described PLGA and described PDLGA is all not more than 1%;
Water content in described PLGA and described PDLGA is all less than 500ppm.
Wherein in an embodiment, the intrinsic viscosity of described outer coating material PLLA or PDLA is 2.0-4.0dl/g, molecular weight dispersity 1.4-1.7;
Water content in described PLLA and described PDLA is all less than 500ppm.
Wherein in an embodiment, the thickness of described outer coating is 10 microns to 100 microns.
Wherein in an embodiment, described outer coating is evenly coated in the surface of described interior layer main body.
The preparation method of above-mentioned Absorbable rod skin closure nail, comprises the steps:
S100: layer main body in preparation;
S200: adopt the method for dipping or spraying to prepare outer coating on described interior layer main body;
S300: dried is carried out to described outer coating.
Wherein in an embodiment, step S200 and step S300 repeats for many times.
Wherein in an embodiment, the thickness of the outer coating of each dipping or coating is less than 10 microns.
Wherein in an embodiment, described dried is carried out in vacuum or nitrogen or noble gas.
Wherein in an embodiment, also comprise in described step S200 and outer coating material dissolves is obtained coating solution, then adopt described coating solution to carry out the step flooded or spray, the mass percent of wherein said coating solution ectomesoderm coating material is not more than 5%.
The invention has the beneficial effects as follows: Absorbable rod skin closure nail of the present invention comprises interior layer main body and outer coating, and wherein internal layer mainly realizes mechanical characteristic, and outer coating mainly plays insulating effect; Degradation speed due to outer coating is significantly less than the degradation speed of interior layer main body, therefore, it is possible to extend the degradation time of whole Absorbable rod skin closure nail, thus the degradation rate making whole Absorbable rod skin closure follow closely is relatively slack-off, mechanical property is retainable relatively good; Outer layer degrades to a certain extent time; because moisture starts to infiltrate internal layer; internal layer can start degraded; but due to outer field protective effect; the degradation speed that Absorbable rod skin closure is followed closely can be slow than the nail speed that simple body is made; especially at the wound healing initial stage, the good mechanical strength of suturing nail can be retained better.Protective finish can not be blocked up, the overall dimensions of blocked up meeting appreciable impact Absorbable rod skin closure nail.
Accompanying drawing explanation
Fig. 1 is the overall schematic of the Absorbable rod skin closure nail used at present;
Fig. 2 is the schematic cross-section of an embodiment of Absorbable rod skin closure of the present invention nail;
Fig. 3 is the schematic cross-section of the other direction of an embodiment of Absorbable rod skin closure of the present invention nail;
Fig. 4 a-Fig. 4 d is the degradation experiment figure of the Absorbable rod skin closure nail of embodiment one;
Fig. 5 a-Fig. 5 d is the degradation experiment figure of the Absorbable rod skin closure nail of comparative example;
Fig. 6 is the tensile strength curve of the Absorbable rod skin closure nail of embodiment one and comparative example.
Detailed description of the invention
Object, technical scheme and the advantage of to follow closely to make Absorbable rod skin closure of the present invention and preparation method thereof are clearly understood, below in conjunction with concrete drawings and the specific embodiments, are further elaborated to the present invention.
It should be noted that, when not conflicting, the embodiment in the application and the feature in embodiment can combine mutually.
Follow closely to make skin closure and can meet degradation characteristic requirement as much as possible, see Fig. 2 and Fig. 3, the invention provides a kind of Absorbable rod skin closure nail, comprise interior layer main body 100 and outer coating 200; The material of described interior layer main body 100 and the material of described outer coating 200 are degradation material; The degradation speed of the material of wherein said outer coating 200 is less than the degradation speed of the material of described interior layer main body 100.Preferably, at 37 DEG C, in the phosphate buffer of pH=7.3-7.5, the degradation speed of outer coating 200 is 3-7 days, and the time being degraded to initial tensile strength 50% of interior layer main body 100 is 5-10 days.
The material of wherein said interior layer main body is the blend of PLGA (random copolymer of L-lactide and Acetic acid, hydroxy-, bimol. cyclic ester) and PDLGA (random copolymer of DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester), and the ratio of quality and the number of copies of PLGA and PDLGA is 99 ~ 80:1 ~ 20.The internal layer body of Absorbable rod skin closure of the present invention nail adopt the blend of PLGA and PDLGA; PLGA is L-PLGA, in PLGA used in the present invention, the mol ratio of L-lactide and Acetic acid, hydroxy-, bimol. cyclic ester is 55 ~ 70:45 ~ 30, namely the molar content of L-lactide is 55% ~ 70%, the molar content 45% ~ 30% of Acetic acid, hydroxy-, bimol. cyclic ester; PDLGA of the present invention is the random copolymer of DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester, wherein mol ratio 55 ~ 70:45 ~ 30 of DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester in PDLGA, namely the molar content of DL-lactide is 55% ~ 70%, and the molar content of Acetic acid, hydroxy-, bimol. cyclic ester is 45% ~ 30%.
PLGA (random copolymer of L-lactide and Acetic acid, hydroxy-, bimol. cyclic ester) and PDLGA (random copolymer of DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester) has good biodegradability and biocompatibility, vitrification point is greater than 40 DEG C, therefore often by as medical material, extensive use is obtained clinically; Merely, select PLGA or PDLGA for the material followed closely as Absorbable rod skin closure, the mechanical property of its goods and degradation characteristic often can not meet the demands simultaneously.The Absorbable rod skin closure nail that the intermingling material of PLGA or PLGA and PDLGA makes, by regulating the blended proportioning of properties of materials viscosity or material, can meet initial tensile strength requirement, but degradation time is often than comparatively fast; And if adopt the PLGA (wherein the molar content of L lactide is 100% ~ 80%) of the slow high L-lactide proportioning of degradation time, degradation time can extend greatly, but material is more crisp, extensibility is poor, and mechanical property cannot be up to standard.
Meanwhile, the intrinsic viscosity of the PLGA used is 1.8 ~ 3.0dl/g, and the dispersion of molecular weight is 1.4 ~ 1.7, and the intrinsic viscosity of more excellent PLGA is 2.1 ~ 2.3dl/g.The intrinsic viscosity of the PDLGA used is 2.0 ~ 2.5dl/g, and the dispersion of molecular weight is 1.4 ~ 1.7, and the intrinsic viscosity of more excellent PDLGA is 2.1-2.3dl/g.
More excellent, the intrinsic viscosity of PLGA and PDLGA in interior layer main body should be equal.
It should be noted that the monomer residue molar content in the PLGA in the present invention should be not more than 1%, and the monomer residue molar content in PDLGA is also not more than 1%; Percent water in PLGA and PDLGA all should be less than 500ppm.
The skin coating outer coating of the internal layer body of Absorbable rod skin closure nail, the outer coating in the present embodiment is another kind of degradation material, and the degradation speed of outer coating material is significantly slower than the degradation speed of internal layer bulk material.The material of the present embodiment ectomesoderm coating is the blend of PLLA (PLLA) or PLLA and PDLA (DL-polylactic acid).PLLA with PDLA is the same with the material of interior layer main body, has good biocompatibility, and can absorb by human body decomposition.When outer coating is the blend of PLLA and PDLA, in blend, the ratio of quality and the number of copies of PLLA and PDLA is 99 ~ 80:1 ~ 20.
Wherein the intrinsic viscosity of PLLA and PDLA is 2.0 ~ 4.0dl/g (preferably, the intrinsic viscosity of PLLA and PDLA is 2.0 ~ 3.0dl/g), molecular weight dispersity 1.4 ~ 1.7.When outer coating is the blend of PLLA and PDLA, the intrinsic viscosity of PLLA and PDLA should be preferably equal or close, more easily controls like this to the mechanical characteristic of material.
Meanwhile, material PLLA and the PDLA water content separately of described outer coating is all less than 500ppm.
Preferably, as a kind of embodiment, the thickness of described outer coating 200 is 10 microns to 100 microns.
Preferably, as a kind of embodiment, described outer coating 200 is evenly coated in the surface of described interior layer main body 100.
The preparation method that the present invention provides a kind of Absorbable rod skin closure to follow closely simultaneously, comprises the following steps:
S100: layer main body in preparation; The preparation method of interior layer main body comprises with the intermingling material of PLGA and PDLGA for raw material, is obtained by the technique of injection moulding.Its preparation process is first mixed according to a certain percentage by PLGA and PDLGA raw material, and be heated to certain temperature and melt and become molten condition, then injection moulding under pressure, adopts the way of mold injection to form interior layer main body.In injection moulding process, keep intermingling material melting and injection temperature to be 150-180 DEG C, injection moulding keeps pressure to be 50-80bar.In injection moulding process, raw material should be dry further at exsiccator, and prevent moisture in air from invading; And all have nitrogen protection in injection machine charging and raw-material melting process; When mould is cooled directly with water below 40 DEG C, the interior layer main body that can obtain Absorbable rod skin closure nail is taken off in the demoulding, and sizing in 24 hours in the dry state.
S200: adopt the method for dipping or spraying to prepare outer coating on described interior layer main body.After prepared by interior layer main body, apply at the skin of interior layer main body.Concrete operation step is the blended as coating material of the material choosing PLLA material or PLLA (PLLA) and PDLA (DL-polylactic acid); Choose chloroform or other easily molten organic solvents, coating material is dissolved in a solvent.Coating mainly contains dip-coating method or spraying process, and dip-coating method is exactly nail body is placed in solution then lift, and spraying process to be exactly solution mist change into fine particle is evenly sprayed at nail body surface.Dip-coating method can choose any solution of thickness a little, and in coating solution, the mass percent of solute is 3 ~ 5%; And the mass percent of solute should be less than or equal to 1% in the coating that spraying process uses.For infusion process coating, each Best-Effort request out afterwards should be dry rapidly; For spraying process, also can adopt spraying once, dry way once.The repeatedly thickness of dipping or spray painting control coating.The thickness of outer coating is 10 ~ 100 microns.
S300: dried is carried out to described outer coating.
Preferably, step S200 and step S300 repeats for many times.Thicker for coating thickness requirement, the way of Best-Effort request or spraying be taked repeatedly.Usually, for thicker coating, can repeatedly apply, coating evenly should be unlikely to too thick first, and dry rapidly, in order to avoid dissolution with solvents body and cause body distortion.
Wherein, the thickness of the outer coating of single impregnation or spraying is less than 10 microns, then dry rapidly, avoids solvent to the dissolving of internal layer material.Best-Effort request painting method, single coating layer thickness can not be too thick, is generally and is less than 10 microns, can take repeatedly dry, the method for repeatedly flooding; And spraying process to ensure spray solution thickness suitable, spraying all with, speed is moderate.Especially first the thickness of the outer coating of dipping or spraying definitely should be less than 10 microns.
Way mainly boulton process or seasoning of bleeding dry described in above-mentioned steps, if will heat, must control in the scope of safety below vitrification point.After coating terminates, vacuum drying should be utilized in time to remove residual solvent and moisture.
Wherein, also comprise in described step S200 and outer coating material dissolves is obtained outer coating solution, then adopt outer coating solution to carry out the step flooded or spray.Wherein the preparation of the coating of outer coating adopts organic solvent by outer coating material dissolves, and organic solvent is chloroform, and in time adopting infusion process, in coating solution, the mass percent of solute (i.e. outer coating material) should be less than 5%; Should make adjustment according to equipment comparative example when spraying process, but in coating solution, the mass percent of solute is generally no more than 1%.
It should be noted that, the raw material adopted in following examples and equipment are commercially available.
Embodiment one
The interior layer main body of the Absorbable rod skin closure nail in the present embodiment is the blend of PLGA and PDLGA, and wherein the ratio of quality and the number of copies of PLGA and PDLGA is 80:20.In the PLGA adopted in the present embodiment, the molar content of L-lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than being 70:30, and in the PDLGA of employing, the molar content of DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than being 70:30.Wherein the intrinsic viscosity of PLGA is 1.8dl/g, and the dispersion of molecular weight is 1.4; The intrinsic viscosity of PDLGA is 2.0dl/g, and the dispersion of molecular weight is 1.4.
The material of the outer coating in the present embodiment is PLLA and PDLA blend, and wherein the ratio of quality and the number of copies of PLLA and PDLA is 80:20.The thickness of outer coating is 20 microns.Wherein the intrinsic viscosity of PLLA is 2.0dl/g, and the dispersion of molecular weight is 1.4; The intrinsic viscosity of PDLA is 4.0dl/g, and the dispersion of molecular weight is 1.4.
In the present embodiment, the thickness of Absorbable rod skin closure nail is 0.8mm.
Comparative example
Absorbable rod skin closure nail in comparative example only comprises interior layer main body, and its internal layer material of main part is the blend of PLGA (70:30) and PDLGA (70:30), and the ratio of quality and the number of copies of PLGA and PDLGA is 80:20.The thickness of the Absorbable rod skin closure nail in comparative example is 0.8mm.
By the Absorbable rod skin closure nail of the Absorbable rod skin closure of embodiment one nail and comparative example all employing dosage be that the radiated by gamma-ray of 25KGY carries out sterilization treatment.Then the Absorbable rod skin closure nail of Absorbable rod skin closure nail of the present invention and comparative example is placed on all separately 37 DEG C, in the phosphate buffer of pH=7.3 ~ 7.5, does degradation experiment.
Wherein Fig. 4 a-Fig. 4 d is the degraded picture of the Absorbable rod skin closure nail of embodiment one, wherein Fig. 4 a is the Absorbable rod skin closure nail degraded photo of 1 day of embodiment one, Fig. 4 b is the Absorbable rod skin closure nail degraded photo of 7 days of embodiment one, Fig. 4 c is the Absorbable rod skin closure nail degraded photo of 14 days of embodiment one, and Fig. 4 d is the Absorbable rod skin closure nail degraded photo of 21 days of embodiment one.
Fig. 5 a-Fig. 5 d is the degraded picture of the Absorbable rod skin closure nail of comparative example, wherein Fig. 5 a is the Absorbable rod skin closure nail degraded photo of 1 day of comparative example, Fig. 5 b is the Absorbable rod skin closure nail degraded photo of 7 days of comparative example, Fig. 5 c is the Absorbable rod skin closure nail degraded photo of 14 days of comparative example, and Fig. 5 d is the Absorbable rod skin closure nail degraded photo of 21 days of comparative example.
The muddy degree of Absorbable rod skin closure nail itself can show the degree that moisture infiltrates this suturing nail.Can be found by the contrast of the picture of Fig. 4 a-Fig. 4 d and Fig. 5 a-Fig. 5 d, whether the ratio of band coating or not the more difficult of invaded by moisture.
Test for tensile strength data and curve are see Fig. 6.See Fig. 6, the experimental result of the Absorbable rod skin closure nail of embodiments of the invention one is as follows: initial tensile strength 7.8 Ns is paused; Degrade after 1 day, tensile strength 6.3 Ns is paused; After 7 days, tensile strength 4 Ns is paused; After 14 days, tensile strength 1.8 Ns is paused; After 21 days, tensile strength 0.5 newton, 25 days there is disintegrate in suturing nail, meet the demands.
See Fig. 6, the tensile strength experimental result of the Absorbable rod skin closure nail of comparative example is as follows: initial tensile strength 7.6 Ns is paused; Degrade after one day, tensile strength 5.5 newton, degrade after 7 days, tensile strength 2.7 Ns is paused; After 14 days, tensile strength 1.2 newton, after 21 days, disintegrate.Therefore can obviously see, the tensile strength of tensile strength in each stage of testing apparently higher than comparative example of the Absorbable rod skin closure nail of embodiment one, namely the Absorbable rod skin closure of Absorbable rod skin closure nail all higher than the band coating of embodiment one on degradation speed and tensile strength loss speed of the not band coating of comparative example is followed closely.
Embodiment two
The interior layer main body of the Absorbable rod skin closure nail in the present embodiment is the blend of PLGA and PDLGA, and wherein the ratio of quality and the number of copies of PLGA and PDLGA is 99:1.In the PLGA adopted in the present embodiment, the molar content of L-lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than being 70:30, and in the PDLGA of employing, the molar content of DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than being 70:30.Wherein the intrinsic viscosity of PLGA is 2.1dl/g, and the dispersion of molecular weight is 1.5; The intrinsic viscosity of PDLGA is 2.1dl/g, and the dispersion of molecular weight is 1.6.
The material of the outer coating in the present embodiment is PLLA and PDLA blend, and wherein the ratio of quality and the number of copies of PLLA and PDLA is 99:1.The thickness of the present embodiment ectomesoderm coating is 10 microns.The intrinsic viscosity of PLLA is 2.5dl/g, and the dispersion of molecular weight is 1.5; The intrinsic viscosity of PDLA is 2.5dl/g, and the dispersion of molecular weight is 1.6.
Embodiment three
The interior layer main body of the Absorbable rod skin closure nail in the present embodiment is the blend of PLGA and PDLGA, and wherein the ratio of quality and the number of copies of PLGA and PDLGA is 90:10.In the PLGA adopted in the present embodiment, the molar content of L-lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than being 70:30, and in the PDLGA of employing, the molar content of DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than being 70:30.Wherein the intrinsic viscosity of PLGA is 2.3dl/g, and the dispersion of molecular weight is 1.6; The intrinsic viscosity of PDLGA is 2.3dl/g, and the dispersion of molecular weight is 1.6.
The material of the outer coating in the present embodiment is PLLA and PDLA blend, and wherein the ratio of quality and the number of copies of PLLA and PDLA is 80:20.The thickness of outer coating is 30 microns.The intrinsic viscosity of PLLA is 3.0dl/g, and the dispersion of molecular weight is 1.6; The intrinsic viscosity of PDLA is 3.5dl/g, and the dispersion of molecular weight is 1.7.
Embodiment four
The interior layer main body of the Absorbable rod skin closure nail in the present embodiment is the blend of PLGA and PDLGA, and wherein the ratio of quality and the number of copies of PLGA and PDLGA is 85:15.In the PLGA adopted in the present embodiment, the molar content of L-lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than being 55:45, and in the PDLGA of employing, the molar content of DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than being 70:30.Wherein the intrinsic viscosity of PLGA is 2.6dl/g, and the dispersion of molecular weight is 1.7; The intrinsic viscosity of PDLGA is 2.5dl/g, and the dispersion of molecular weight is 1.7.The material of the outer coating in the present embodiment is PLLA and PDLA blend, and wherein the ratio of quality and the number of copies of PLLA and PDLA is 90:10.The thickness of outer coating is 60 microns.The intrinsic viscosity of PLLA is 4.0dl/g, and the dispersion of molecular weight is 1.7; The intrinsic viscosity of PDLA is 4.0dl/g, and the dispersion of molecular weight is 1.7.
Embodiment five
The interior layer main body of the Absorbable rod skin closure nail in the present embodiment is the blend of PLGA and PDLGA, and wherein the ratio of quality and the number of copies of PLGA and PDLGA is 95:5.In the PLGA adopted in the present embodiment, the molar content of L-lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than being 60:40, and in the PDLGA of employing, the molar content of DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than being 70:30.Wherein the intrinsic viscosity of PLGA is 3.0dl/g, and the dispersion of molecular weight is 1.7; The intrinsic viscosity of PDLGA is 2.5dl/g, and the dispersion of molecular weight is 1.7.
The material of the outer coating in the present embodiment is PLLA.The thickness of outer coating is 80 microns.The intrinsic viscosity of PLLA is 4.0dl/g, and the dispersion of molecular weight is 1.7; The intrinsic viscosity of PDLA is 4.0dl/g, and the dispersion of molecular weight is 1.7.
Embodiment six
The interior layer main body of the Absorbable rod skin closure nail in the present embodiment is the blend of PLGA and PDLGA, and wherein the ratio of quality and the number of copies of PLGA and PDLGA is 90:10.In the PLGA adopted in the present embodiment, the molar content of L-lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than being 70:30, and in the PDLGA of employing, the molar content of DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than being 55:45.Wherein the intrinsic viscosity of PLGA is 3.0dl/g, and the dispersion of molecular weight is 1.7; The intrinsic viscosity of PDLGA is 2.5dl/g, and the dispersion of molecular weight is 1.7.
The material of the outer coating in the present embodiment is PLLA.The thickness of outer coating is 90 microns.The intrinsic viscosity of PLLA is 4.0dl/g, and the dispersion of molecular weight is 1.7; The intrinsic viscosity of PDLA is 4.0dl/g, and the dispersion of molecular weight is 1.7.
Embodiment seven
The interior layer main body of the Absorbable rod skin closure nail in the present embodiment is the blend of PLGA and PDLGA, and wherein the ratio of quality and the number of copies of PLGA and PDLGA is 90:10.In the PLGA adopted in the present embodiment, the molar content of L-lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than being 70:30, and in the PDLGA of employing, the molar content of DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than being 60:40.Wherein the intrinsic viscosity of PLGA is 3.0dl/g, and the dispersion of molecular weight is 1.7; The intrinsic viscosity of PDLGA is 2.5dl/g, and the dispersion of molecular weight is 1.7.
The material of the outer coating in the present embodiment is PLLA and PDLA blend, and wherein the ratio of quality and the number of copies of PLLA and PDLA is 70:30.The thickness of outer coating is 100 microns.The intrinsic viscosity of PLLA is 4.0dl/g, and the dispersion of molecular weight is 1.7; The intrinsic viscosity of PDLA is 4.0dl/g, and the dispersion of molecular weight is 1.7.
The above embodiment only have expressed several embodiment of the present invention, and it describes comparatively concrete and detailed, but therefore can not be interpreted as the restriction to the scope of the claims of the present invention.It should be pointed out that for the person of ordinary skill of the art, without departing from the inventive concept of the premise, can also make some distortion and improvement, these all belong to protection scope of the present invention.Therefore, the protection domain of patent of the present invention should be as the criterion with claim.
Claims (10)
1. an Absorbable rod skin closure nail, is characterized in that, comprise interior layer main body and outer coating;
The material of described interior layer main body and the material of described outer coating are degradation material;
The degradation speed of the material of wherein said outer coating is less than the degradation speed of the material of described interior layer main body;
The material of wherein said interior layer main body is the blend of PLGA and PDLGA, and in described blend, the ratio of quality and the number of copies of PLGA and PDLGA is 99 ~ 80:1 ~ 20; In wherein said PLGA, the mol ratio of L-lactide and Acetic acid, hydroxy-, bimol. cyclic ester is 55 ~ 70:45 ~ 30, mol ratio 55 ~ 70:45 ~ 30 of DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester in wherein said PDLGA;
The material of described outer coating is PLLA or the blend for PLLA and PDLA; In the blend of described PLLA and PDLA, the ratio of quality and the number of copies of PLLA and PDLA is 70 ~ 99:30 ~ 1.
2. Absorbable rod skin closure nail according to claim 1, it is characterized in that, in the material of described interior layer main body, the intrinsic viscosity of described PLGA is 1.8 ~ 3.0dl/g, and the dispersion of molecular weight is 1.4-1.7;
The intrinsic viscosity of described PDLGA is 2.0 ~ 2.5dl/g, and the dispersion of molecular weight is 1.4-1.7;
The molar content of the monomer residue in described PLGA and described PDLGA is all not more than 1%;
Water content in described PLGA and described PDLGA is all less than 500ppm.
3. Absorbable rod skin closure nail according to claim 1, it is characterized in that, in the material of described outer coating, the intrinsic viscosity of described PLLA or described PDLA is 2.0-4.0dl/g, and molecular weight dispersity is 1.4-1.7;
Water content in described PLLA and described PDLA is all less than 500ppm.
4. Absorbable rod skin closure nail according to claim 1, it is characterized in that, the thickness of described outer coating is 10 microns to 100 microns.
5. Absorbable rod skin closure nail according to claim 1, it is characterized in that, described outer coating is evenly coated in the surface of described interior layer main body.
6. the preparation method of the Absorbable rod skin closure nail described in claim 1 to 5 any one, is characterized in that, comprise the steps:
S100: layer main body in preparation;
S200: adopt the method for dipping or spraying to prepare outer coating on described interior layer main body;
S300: dried is carried out to described outer coating.
7. preparation method according to claim 6, is characterized in that, step S200 and step S300 repeats for many times.
8. preparation method according to claim 7, is characterized in that, the thickness of the outer coating of each dipping or coating is less than 10 microns.
9. preparation method according to claim 6, is characterized in that, described dried is carried out in vacuum or nitrogen or noble gas.
10. preparation method according to claim 6, it is characterized in that, also comprise in described step S200 and the material dissolves of outer coating is obtained coating solution, then adopt described coating solution to carry out the step flooded or spray, the mass percent of the material of wherein said coating solution ectomesoderm coating is not more than 5%.
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| CN201510117194.8A CN104689367B (en) | 2015-03-17 | 2015-03-17 | Absorbable skin suturing nail and preparation method thereof |
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| CN104689367B (en) | 2017-01-11 |
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