CN110448723B - Synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material and preparation method thereof - Google Patents
Synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material and a preparation method thereof. The artificial joint material is prepared by compounding antioxidant vitamin E and synergistic antioxidant sugar alcohol and medical-grade ultrahigh molecular weight polyethylene through compression molding and irradiation crosslinking, and comprises the following steps: (1) compounding vitamin E and sugar alcohol; (2) doping a compound antioxidant; (3) compression molding; (4) and (4) performing irradiation crosslinking. According to the invention, vitamin E and sugar alcohol are compounded and cooperated to resist oxygen for the first time, so that the oxidation stability of the ultra-high molecular weight polyethylene material is improved, meanwhile, the irradiation crosslinking efficiency of the material is greatly increased, and the mechanical property of the material is not affected. The prepared synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material has excellent comprehensive performance and is expected to prolong the service life in vivo.
Description
Technical Field
The invention belongs to the field of high performance of biomedical high polymer materials, and particularly relates to a synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material and a preparation method thereof.
Background
Ultra-high molecular weight polyethylene (UHMWPE) is the material of choice for artificial joint liners for knee menisci and hip acetabular cartilage, by virtue of its good mechanical properties, impact resistance, wear resistance, fatigue resistance and biocompatibility (US 6146426A, US6464926B 1). In the long-term in-vivo service process, after abrasion dust generated by friction of UHMWPE joint material and accessory material is phagocytized by macrophages, the abrasion dust cannot be degraded and absorbed, so that the macrophages die and induce inflammatory reaction, and even peripheral tissue necrosis and osteolysis are caused, and secondary or even multiple revision surgeries are required to be performed (Muratoglu OK, et al biomaterials 1999,20(16), 1463-. The irradiation crosslinking can significantly improve the wear resistance of the ultra-high molecular weight polyethylene material, but the residual free radicals induced by irradiation can generate chain oxidation reaction with dissolved oxygen, so that the mechanical property and the wear resistance of the material are greatly reduced, and finally the failure in the forms of oxidation fracture, wear delamination and the like of the prosthesis is shown (Lewis G. biomaterials 2001,22(4), 371-.
To solve the above problems, a biocompatible antioxidant is used to scavenge free radicals. Currently, vitamin e (vitamin e) has been successfully used in the clinic to improve the oxidative stability of irradiation crosslinked ultra-high molecular weight polyethylene artificial joint materials (US 6448315B1, european patent EP0995450B 1). The proton hydrogen on the phenolic hydroxyl group of vitamin E (. alpha. -tocopherol) can bind to free radicals, blocking their chain reaction (Oral E, et al. biomaterials 2006,27(32), 5580-. However, vitamin E also inactivates the free radicals generated by irradiation, significantly reducing the efficiency of irradiation cross-linking. In particular, at high vitamin E addition levels, even increasing the irradiation dose does not increase the crosslink density of the material, but rather results in a large decrease in oxidative stability (Oral E, et al biomaterials 2008,29(26), 3557-.
In conclusion, the wear resistance and the oxidation stability of the vitamin E-doped ultra-high molecular weight polyethylene material are difficult to be unified and considered, and the fundamental reason is that the vitamin E hinders irradiation crosslinking, which also limits the research and development of the ultra-high molecular weight polyethylene artificial joint implant with good comprehensive performance.
Disclosure of Invention
Aiming at the defects of the prior art, the invention aims to provide a preparation method of a synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material. The vitamin E and the sugar alcohol are compounded for the first time to cooperate with antioxidation, so that the oxidation stability of the ultra-high molecular weight polyethylene material is improved. Meanwhile, the proportion of the vitamin E in a compound antioxidant system is reduced, and the crosslinking density of the ultra-high molecular weight polyethylene material after irradiation is improved, so that good wear resistance is obtained. The mechanical property of the prepared material is not influenced by sugar alcohol, has excellent comprehensive performance, and is beneficial to improving the long-term service performance of the ultrahigh molecular weight polyethylene artificial joint implant.
The invention provides a synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material and a preparation method thereof. The synergistic antioxidant is sugar alcohol, including one or more of sorbitol, mannitol, maltitol, isomaltitol, and galactitol. The oxidation stability of the material is improved through the synergistic effect after the vitamin E is compounded, and the improvement effect of the material on the oxidation stability of the ultra-high molecular weight polyethylene is better than the sum of the improvement effects of the vitamin E or the sugar alcohol which is added independently. Compared with a material singly doped with vitamin E, the cross-linking density of the material can be greatly improved after the vitamin E and the sugar alcohol are compounded and doped, and meanwhile, the mechanical property is not changed. The obtained artificial joint material has excellent comprehensive performance.
According to an embodiment of the preparation method of the synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material, the preparation method specifically comprises the following steps:
A. compounding vitamin E and sugar alcohol: rapidly dissolving sugar alcohol in deionized water through ultrasonic-assisted dispersion, simultaneously adding vitamin E according to a certain mass ratio, and continuously performing ultrasonic treatment to obtain a uniform solution;
B. and (3) doping a compound antioxidant: adding ultrahigh molecular weight polyethylene and the compound solution in the step (A) into isopropanol, stirring at a high speed, and drying the obtained mixture in vacuum to obtain mixed powder;
C. compression molding: placing the mixed powder in the step (B) into a die for compression molding, then slowly cooling to room temperature, and demolding to obtain a molded blank;
D. irradiation crosslinking: and (C) radiating and crosslinking the mould pressing blank packed in vacuum (step C) by high-energy rays to obtain the synergistic antioxidant high-crosslinking ultrahigh molecular weight polyethylene artificial joint material.
According to one embodiment of the preparation method of the synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material, the ultrahigh molecular weight polyethylene is biomedical grade, and the relative molecular mass is 5 multiplied by 106～6×106g/mol, density of 0.93-0.98 g/cm3The particle diameter is 120 to 160 μm.
According to one embodiment of the preparation method of the synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material, the synergistic antioxidant is sorbitol.
According to one embodiment of the preparation method of the synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material, the total mass of the compound antioxidant accounts for 0.1-1.0% of the total mass of the ultrahigh molecular weight polyethylene and the compound antioxidant.
According to an embodiment of the preparation method of the synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material, in the step A, the mass ratio of the vitamin E to the sugar alcohol is 9: 1-1: 9.
According to one embodiment of the preparation method of the synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material, in the step C, the compression molding temperature is 180-220 ℃, the compression molding pressure is 5-50 MPa, and the compression molding time is 2-6 h.
According to an embodiment of the preparation method of the synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material, in the step D, the high-energy rays are electron beams or gamma rays, and the irradiation dose is 50-200 kGy.
Compared with the prior art, the invention has the following remarkable advantages:
(1) the invention uses sugar alcohol as the synergistic antioxidant of vitamin E for the first time, and improves the oxidation stability of the ultra-high molecular weight polyethylene by utilizing the synergistic effect of the polyhydroxy of the sugar alcohol and the vitamin E;
(2) under the condition of a certain total amount of the additive, the sugar alcohol is added, so that the ratio of the vitamin E is reduced, and the material has higher crosslinking density after irradiation crosslinking;
(3) the ultrahigh molecular weight polyethylene artificial joint material prepared by the invention has excellent comprehensive performance and can greatly prolong the service life in vivo of the joint.
Drawings
Figure 1 shows the synergistic antioxidant effect of sugar alcohols with vitamin E.
FIG. 2 shows the overall performance of the samples at a radiation dose of 100 kGy.
Detailed Description
All of the features disclosed in this specification, or all of the steps in any method or process so disclosed, may be combined in any combination, except combinations of features and/or steps that are mutually exclusive.
Any feature disclosed in this specification may be replaced by alternative features serving equivalent or similar purposes, unless expressly stated otherwise. That is, unless expressly stated otherwise, each feature is only an example of a generic series of equivalent or similar features.
The synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material and the preparation method thereof of the present invention will be described in detail below.
According to an exemplary embodiment of the invention, the preparation method of the synergistic antioxidant type high cross-linked polyethylene artificial joint material comprises the steps of compounding vitamin E and sugar alcohol by using a mixed solvent of water and isopropanol, uniformly doping ultra-high molecular weight polyethylene, and carrying out compression molding and irradiation cross-linking on the obtained mixed powder to obtain the synergistic antioxidant type high cross-linked ultra-high molecular weight polyethylene artificial joint material.
That is, according to the invention, a small amount of sugar alcohol is added to the medical ultra-high molecular weight polyethylene to cooperate with the antioxidant, so that the antioxidant performance which is more excellent than the total effect of independently adding the sugar alcohol and the vitamin E is obtained, the cross-linking density of the material is greatly improved, and the mechanical property is not influenced by the sugar alcohol. The method improves the comprehensive use performance of the ultrahigh molecular weight polyethylene joint material, and is beneficial to prolonging the service time of the ultrahigh molecular weight polyethylene joint material implanted into a body.
The compound antioxidant accounts for 0.1-1.0% of the total mass of the ultrahigh molecular weight polyethylene and the compound antioxidant, preferably, the mass ratio of the sugar alcohol to the vitamin E is 5:5, and the proportion can furthest ensure the embodiment of the beneficial effects.
Specifically, the production method of the present invention may include the following steps.
Step A: compounding of vitamin E and sugar alcohol
Quickly dissolving sugar alcohol in deionized water through ultrasonic-assisted dispersion, simultaneously adding vitamin E according to a certain mass ratio, and continuously performing ultrasonic treatment to obtain a uniform solution. Wherein the mass ratio of the vitamin E to the sugar alcohol is 9: 1-1: 9.
And B: doping of complex antioxidants
Adding ultrahigh molecular weight polyethylene and the compound solution into isopropanol, stirring at high speed, and vacuum drying the obtained mixture to obtain mixed powder; wherein the compound antioxidant accounts for 0.1-1.0% of the total mass of the ultrahigh molecular weight polyethylene and the compound antioxidant.
According to the invention, the selected ultra-high molecular weight polyethylene is biomedical grade, and the relative molecular mass is 5 multiplied by 106～6×106g/mol, density of 0.93-0.98 g/cm3The particle diameter is 120 to 160 μm.
According to the present invention, the sugar alcohol synergistic antioxidant for compounding selected is Sorbitol (Sorbitol, abbreviated as S in the diagram).
And C: compression molding
And D, placing the mixed powder prepared in the step B into a die for compression molding, slowly cooling to room temperature, and demolding to obtain a molded blank.
In the step, the mould pressing temperature is controlled to be 180-220 ℃, the mould pressing pressure is controlled to be 5-50 MPa, and the mould pressing time is 2-6 h, so that a better pressing effect is ensured.
Step D: crosslinking by irradiation
And (3) carrying out radiation crosslinking on the mould pressing blank packaged in vacuum by using high-energy rays to obtain the high-oxidation-resistance high-crosslinking ultrahigh molecular weight polyethylene artificial joint material.
In the step, the high-energy rays are electron beams or gamma rays, and the irradiation dose is 50-150 kGy.
The synergistic antioxidant type high cross-linked ultrahigh molecular weight polyethylene artificial joint material and the preparation method thereof according to the present invention will be further described with reference to specific examples and comparative examples.
Examples 1 to 10:
(1) compounding VE and sorbitol: dissolving sorbitol in deionized water through ultrasonic-assisted dispersion, adding VE with equal mass, and continuously performing ultrasonic treatment to obtain a uniform solution.
(2) Compound antioxidant doped UHMWPE: UHMWPE and the above-mentioned compounded solution (the ratio of VE and sorbitol to the total mass of UHMWPE, VE and sorbitol is shown in Table 1) were added to isopropanol and stirred at high speed, and the resulting mixture was vacuum-dried to obtain a mixed powder.
(3) Compression molding: and (3) placing the obtained (VE + S)/UHMWPE mixed powder into a mould, carrying out compression molding on the obtained (VE + S)/UHMWPE mixed powder at the temperature of 200 ℃ and under the pressure of 10MPa, then slowly cooling to room temperature, and demoulding to obtain a blank.
(4) Irradiation crosslinking: the vacuum packed (VE + S)/UHMWPE moulded blanks were irradiated with a 10MeV electron beam at room temperature with the irradiation dose shown in Table 1.
Comparative examples 1 to 10:
(1) VE-doped UHMWPE: UHMWPE and VE (the proportion of VE to the total mass of UHMWPE and VE is shown in Table 1) were added to isopropanol and stirred at high speed, and the resulting mixture was vacuum dried to give a mixed powder.
(2) Compression molding: and (2) placing the mixed VE/UHMWPE powder into a die, and carrying out compression molding on the VE-doped UHMWPE powder at the temperature of 200 ℃ and the pressure of 10 MPa. Then slowly cooling to room temperature, and demoulding to obtain the blank.
(4) Irradiation crosslinking: the vacuum packed (VE + S)/UHMWPE moulded blanks were irradiated with a 10MeV electron beam at room temperature with the irradiation dose shown in Table 1.
Comparative example 11:
(1) dissolution of sorbitol: sorbitol was dissolved in deionized water by ultrasonic assisted dispersion to give a homogeneous solution.
(2) Sorbitol-doped UHMWPE: UHMWPE and sorbitol solutions were added to isopropanol such that sorbitol accounted for 1% of the total mass of UHMWPE and sorbitol. After high-speed stirring, the obtained mixture is dried in vacuum to obtain mixed powder.
(3) Compression molding: and placing the obtained S/UHMWPE mixed powder into a mould, carrying out compression molding on the S/UHMWPE mixed powder at the temperature of 200 ℃ and under the pressure of 10MPa, then slowly cooling to room temperature, and demoulding to obtain a blank.
(4) Irradiation crosslinking: the vacuum packed S/UHMWPE moulded blank was irradiated with a 10MeV electron beam at room temperature at a dose of 150 kGy.
TABLE 1 formulations and irradiation conditions for examples 1-10 and comparative examples 1-10
TABLE 2 crosslink density, antioxidant and mechanical Properties of examples 1-10 and comparative examples 1-11
The oxidation induction times of the examples and comparative examples were tested by differential scanning calorimetry according to ISO11357-6: 2002. From the results of the single sorbitol addition in table 1 (comparative example 11), sorbitol by itself had no ability to improve the oxidation resistance of UHMWPE. But after the vitamin E is compounded, the oxidation resistance of the doped material is equivalent to that of the vitamin E when the doped material is independently used. As can be seen from the set of comparison results in fig. 1, the vitamin E has a higher sum of oxidation induction times than the sorbitol alone or the vitamin E alone added to the sorbitol formulated sample (as in example 10 versus comparative examples 10 and 11), demonstrating that there is a synergistic effect of sorbitol and vitamin E on the antioxidant properties of UHMWPE, which improves the material oxidation stability.
The material was tested for crosslink density according to ASTM F2214 and the results are shown in table 1. Under the condition of the same total addition amount, the cross-linking density of a sorbitol and vitamin E compound sample is higher than that of a sample added with vitamin E alone under the same irradiation dose, and the difference is more obvious after the total mass percentage is more than 0.4%, and even can reach more than twice of the cross-linking density of the sample added with vitamin E alone. From the result of the simple addition of sorbitol (comparative example 11), it was found that the sugar alcohol does not inhibit the irradiation crosslinking in cooperation with the antioxidant. The compound antioxidant greatly improves the crosslinking density of the material by reducing the vitamin E proportion, thereby being beneficial to improving the wear resistance of the joint material.
In order to evaluate the mechanical properties of the prepared synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material, the tensile property test is carried out according to ASTM-D638, and the impact property test is carried out according to ASTM-F648. As shown in Table 1, the tensile properties and impact properties of the sorbitol and vitamin E samples are equivalent under each irradiation dose, no obvious difference occurs, and the addition of the sugar alcohol is proved not to influence the mechanical properties of the material.
FIG. 2 summarizes the oxidation induction time, crosslink density and impact strength of materials after 100kGy irradiation (example 4 and comparative example 4). Compared with the comprehensive properties of the group, the combination of sorbitol and vitamin E greatly improves the oxidation stability and the crosslinking density of the material, and does not influence the mechanical properties of the material. Compared with the single use of vitamin E, the combination of sorbitol and vitamin E endows the material with more excellent comprehensive performance.
In conclusion, the invention provides a preparation method of a synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material. The oxidation stability of the material is improved through the synergistic effect of the sorbitol and the vitamin E after compounding, the proportion of the vitamin E in the system is reduced, the crosslinking density is improved, and the mechanical property of the material is not influenced by the sorbitol. The prepared artificial joint material has more excellent comprehensive performance compared with singly doped vitamin E, and is expected to improve the service life in vivo.
Although the present invention has been described in connection with the exemplary embodiments, it will be apparent to those skilled in the art that various modifications and variations can be made to the above-described embodiments without departing from the spirit and scope of the claims.
Claims (9)
1. The preparation method of the synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material is characterized in that a mixed solvent of water and isopropanol is utilized to uniformly dope antioxidant vitamin E and synergistic antioxidant sugar alcohol in ultrahigh molecular weight polyethylene, and the synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material is prepared by compression molding and irradiation crosslinking.
2. The preparation method of the synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material as claimed in claim 1, wherein the preparation method specifically comprises the following steps:
A. compounding vitamin E and sugar alcohol: rapidly dissolving sugar alcohol in deionized water through ultrasonic-assisted dispersion, simultaneously adding vitamin E according to a certain mass ratio, and continuously performing ultrasonic treatment to obtain a uniform solution;
B. and (3) doping a compound antioxidant: adding ultrahigh molecular weight polyethylene and the compound solution into isopropanol, stirring at high speed, and vacuum drying the obtained mixture to obtain mixed powder;
C. compression molding: placing the mixed powder in a die for compression molding, then slowly cooling to room temperature, and demolding to obtain a molded blank;
D. irradiation crosslinking: and (3) carrying out radiation crosslinking on the mould pressing blank packaged in vacuum by using high-energy rays to obtain the synergistic antioxidant high-crosslinking ultrahigh molecular weight polyethylene artificial joint material.
3. The preparation method of the synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material as claimed in claim 1 or 2, wherein the ultrahigh molecular weight polyethylene is biomedical grade, and the relative molecular mass is 5 x 106～6×106g/mol, density of 0.93-0.98 g/cm3The particle diameter is 120 to 160 μm.
4. The method for preparing the synergistic antioxidant type high-crosslinked ultrahigh molecular weight polyethylene artificial joint material according to claim 1 or 2, wherein the synergistic antioxidant is one or more of sorbitol, mannitol, maltitol, isomalt and galactitol.
5. The method for preparing the synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material as claimed in claim 4, wherein the synergistic antioxidant is sorbitol.
6. The preparation method of the synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material as claimed in claim 2, wherein the total mass of the compound antioxidant accounts for 0.1-1.0% of the total mass of the ultrahigh molecular weight polyethylene and the compound antioxidant.
7. The preparation method of the synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material as claimed in claim 2, wherein in the step A, the mass ratio of vitamin E to sugar alcohol is 9: 1-1: 9.
8. The preparation method of the synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material as claimed in claim 2, wherein in the step C, the compression molding temperature is 180-220 ℃, the compression molding pressure is 5-50 MPa, and the compression molding time is 2-6 h.
9. The preparation method of the synergistic antioxidant type high-crosslinking ultrahigh molecular weight polyethylene artificial joint material as claimed in claim 2, wherein in the step D, the high-energy rays are electron beams or gamma rays, and the irradiation dose is 50-200 kGy.
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