CN112625373B - High heat-resistant electron beam sterilization-resistant medical hard PVC material and preparation method thereof - Google Patents
High heat-resistant electron beam sterilization-resistant medical hard PVC material and preparation method thereof Download PDFInfo
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L27/00—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers
- C08L27/02—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers not modified by chemical after-treatment
- C08L27/04—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers not modified by chemical after-treatment containing chlorine atoms
- C08L27/06—Homopolymers or copolymers of vinyl chloride
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2201/00—Properties
- C08L2201/08—Stabilised against heat, light or radiation or oxydation
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2205/00—Polymer mixtures characterised by other features
- C08L2205/02—Polymer mixtures characterised by other features containing two or more polymers of the same C08L -group
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2205/00—Polymer mixtures characterised by other features
- C08L2205/03—Polymer mixtures characterised by other features containing three or more polymers in a blend
- C08L2205/035—Polymer mixtures characterised by other features containing three or more polymers in a blend containing four or more polymers in a blend
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Abstract
The invention relates to a high heat-resistant electron beam irradiation sterilization medical hard PVC material and a preparation method thereof. The invention comprises the following components in parts by weight: 100.0 parts of medical PVC resin powder; 2.0-3.0 parts of organic tin stabilizer; 15.0-30.0 parts of heat-resistant modified resin, 5.0-10.0 parts of impact modifier and 1.0-2.0 parts of processing aid; 2.0-5.0 parts of auxiliary heat stabilizer; an antioxidant: 0.5-1.0 parts; 1.0-2.0 parts of composite free radical quencher; 0.5-1.0 parts of lubricant. The invention mainly solves the problems of serious yellowing and rapid decline of mechanical properties of the existing medical hard PVC material after the sterilization by electron beam irradiation, and simultaneously improves the service temperature of the material.
Description
Technical Field
The invention relates to a high heat-resistant and radiation-resistant medical hard PVC material and a preparation method thereof.
Background
At present, three modes of high-temperature steam sterilization, ethylene oxide sterilization, irradiation sterilization and the like are generally adopted for disposable polyvinyl chloride medical consumables worldwide, along with the increasing strictness of environmental protection, the traditional ethylene oxide sterilization is eliminated in recent years in international developed areas and countries, the steam sterilization has very high requirements on materials and is difficult to popularize, and the adoption of an electron beam irradiation sterilization mode for sterilizing medical instruments has a series of advantages of high penetrating power, high sterilization speed, high efficiency, normal temperature sterilization and the like. However, as no plasticizer is added into the medical hard PVC material, when the medical hard PVC material is sterilized by electron beam irradiation, the electron beam directly damages the PVC material, the PVC is rapidly degraded and subjected to intermolecular dehydrochlorination reaction to rapidly form a chromogenic group, so that the hard PVC material is severely yellow (dark brown) and the mechanical property is rapidly reduced. Meanwhile, although various processing aids are added into the hard PVC material, the service temperature of the material is not improved, and when the hard PVC material is used at a higher temperature, the hard PVC material tends to deform.
Therefore, the problem that the cracking risk of the hard joint prepared by the hard PVC material in the use process is caused by the rapid reduction of the mechanical property due to the severe yellowing (dark brown) of the existing medical hard PVC material after the electron beam sterilization is urgently needed to be found. Meanwhile, the current medical instruments are transported at a long-time and high temperature in a trans-regional way, the thermal deformation temperature of the existing medical hard PVC material is not high, and the problem that medical devices are invalid due to the fact that the existing medical hard PVC material is easy to deform due to heating in the transportation process is solved, so that the improvement of the thermal deformation temperature of the hard PVC material is also an urgent problem to be solved.
Disclosure of Invention
The invention aims to provide a high heat-resistant electron beam sterilization-resistant medical hard PVC material and a preparation method thereof, and mainly solves the two problems that the existing medical hard PVC material is seriously yellow (dark brown) after being sterilized by rays, the mechanical property is rapidly reduced and the thermal deformation temperature of the existing medical hard PVC material is improved.
In order to solve the technical problems, the invention adopts the following technical scheme:
the medical hard PVC material with high heat resistance and radiation resistance is characterized by comprising the following raw materials in parts by weight:
medical PVC resin powder: 100.0 parts;
organotin stabilizers: 2.0-3.0 parts;
heat-resistant modified resin: 15.0-30.0 parts
Impact modifiers: 5.0-10.0 parts;
processing aid: 1.0-2.0 parts;
auxiliary heat stabilizer: 2.0-5.0 parts;
an antioxidant: 0.5-1.0 parts;
complex radical quenchers: 1.0-2.0 parts;
and (3) a lubricant: 0.5-1.0 parts.
As a limitation of the present invention: the invention is that
The medical PVC resin powder is suspension PVC resin, the polymerization degree is 500-800, and the dosage is 100 parts by weight.
The organic tin stabilizer is methyl tin mercaptide stabilizer, and the dosage of the organic tin stabilizer is 2.0-3.0 parts by weight.
The heat-resistant modified resin is a mixture composed of 30-50% of alpha-methyl styrene polymer, 30-40% of styrene-maleic anhydride copolymer and 10-30% of styrene acrylonitrile, and the dosage of the heat-resistant modified resin is 15.0-30.0 parts by weight.
The impact modifier is a styrene impact modifier and is used in an amount of 5.0 to 10.0 parts by weight.
The processing aid is methacrylate processing aid, and the dosage of the processing aid is 1.0-2.0 parts by weight.
The auxiliary heat stabilizer is epoxy linseed oil, and the dosage of the auxiliary heat stabilizer is 2.0-5.0 parts by weight.
The antioxidant consists of 30-40% of beta- (3, 5-di-tert-butyl-4-hydroxyphenyl) propionic acid n-stearyl alcohol ester (antioxidant 1076), 30-40% of thiodipropionic acid dioctadecyl ester (antioxidant DSTP) and 20-30% of tricridecyl phosphite (TTDP), and the dosage of the antioxidant is 0.5-1.0 part by weight.
The compound free radical quencher is 50-70% of stearic acid rare earth metal organic complex and 30-50% of 2-mercaptobenzimidazole, and the dosage is 1.0-2.0 parts by weight.
The lubricant consists of 40-60% of stearic acid and 40-60% of polyethylene wax, and the dosage of the lubricant is 0.5-1.0 part by weight.
As a further limitation of the invention, the preparation method of the medical hard PVC material with low yellowing after electron beam sterilization comprises the following specific preparation steps:
1) Adding PVC resin into a high-speed mixer, regulating the rotating speed to 400rpm, adding a certain amount of organotin stabilizer, heat-resistant modified resin, impact modifier, processing aid, auxiliary stabilizer, antioxidant, compound free radical quencher and lubricant, increasing the rotating speed to 1000-1200rpm, putting the materials into a cooling mixer after the temperature of the materials with the high-speed mixing value reaches 110-120 ℃, controlling the rotating speed to 15rpm, and discharging until the temperature of the materials reaches 40-50 ℃;
2) Adding the cooled materials into a double-screw extrusion granulator, wherein the temperature of four areas of a machine barrel is respectively as follows: zone I90-100deg.C, zone II 100-110deg.C, zone III 100-110deg.C, zone IV 110-120deg.C, die temperature 120-130deg.C, screw rotation speed 60-100rpm;
3) Extruding, plasticizing and granulating the materials, cooling to 35-45 ℃, and then obtaining the medical hard PVC material, and packaging for later use.
In the technical scheme, the composite free radical quencher used in the invention has the advantages of high-efficiency inhibition and combination of free radicals generated after irradiation sterilization of the PVC electron beam, wherein the composite free radical quencher is a rare earth stearate organic complex and 2-mercaptobenzimidazole. The organic complex of rare earth stearate is prepared by reacting rare earth nitrate with stearic acid dissolved in ethanol under alkaline condition. The rare earth metal elements include lanthanum (La), cerium (Ce), neodymium (Nd) and the like, and rare earth metal ions in the rare earth organic complex and organic ligands mainly form ion coordination bonds through electrostatic attraction and easily form stable complex with chlorine. Therefore, the existence of rare earth cations can effectively inhibit the removal reaction of active chlorine on the PVC chain, thereby effectively inhibiting the generation of free radicals on the PVC molecular chain. After the 2-mercaptobenzimidazole compound is irradiated by high-energy rays, free radicals can be rapidly formed, and the free radicals react with PVC degradation free radicals to rapidly terminate the degradation process.
The antioxidant 1076 and DSTP used in the invention can further inhibit the decomposition of PVC molecular chains after electron beam irradiation sterilization, and meanwhile, the phosphite ester is added to have high-efficiency chelation and hydrogen chloride absorption effects on PVC; the auxiliary stabilizer epoxy linseed oil can absorb hydrogen chloride to prevent the self-catalysis of PVC.
The heat-resistant modified resin used in the invention is a mixture composed of 30-50% of alpha-methyl styrene polymer, 30-40% of styrene-maleic anhydride copolymer and 10-30% of styrene acrylonitrile. The resin contains a large number of benzene rings on a molecular chain, has high rigidity, and has good heat resistance; meanwhile, the benzene ring structure can absorb a large amount of radiation energy and is homogenized in molecules, so that molecular chains are not easy to break and degrade during irradiation sterilization, and the yellowing resistance of the PVC material is further enhanced.
The invention can obviously inhibit serious yellowing and mechanical property reduction of medical hard PVC material after radiation sterilization by combining the above materials, thereby achieving the purpose of radiation-resistant sterility.
Drawings
FIG. 1 is a complex of rare earth metal ions in a rare earth organic complex with chlorine in an organic ligand, where RE is a rare earth metal.
Detailed Description
The present invention will now be described in detail with reference to specific examples.
Example 1
The material provided by the invention is prepared from the following raw materials in parts by weight:
medical PVC resin powder: 100.0 parts;
organotin stabilizers: 2.0 parts;
heat-resistant modified resin: 15.0 parts;
impact modifiers: 5.0 parts;
processing aid: 2.0 parts;
auxiliary heat stabilizer: 5.0 parts;
an antioxidant: 0.5 parts;
complex radical quenchers: 2.0 parts;
and (3) a lubricant: 0.6 part.
The medical PVC resin powder is suspension PVC resin with polymerization degree of 500-800; the organic tin stabilizer is methyl tin mercaptide stabilizer; the heat-resistant modified resin is a mixture composed of 30-50% of alpha methyl styrene polymer, 30-40% of styrene maleic anhydride copolymer and 10-30% of styrene acrylonitrile; the impact modifier is a styrene impact modifier; the processing aid is a methacrylate processing aid; the auxiliary stabilizer is epoxy linseed oil; the antioxidant is a compound consisting of 30-40% of beta- (3, 5-di-tert-butyl-4-hydroxyphenyl) propionic acid n-stearyl alcohol ester (antioxidant 1076), 30-40% of thiodipropionic acid dioctadecyl ester (antioxidant DSTP) and 20-30% of tricridecyl phosphite (TTDP); the compound free radical quencher is a compound composed of 50% -70% of stearic acid rare earth metal organic complex and 30% -50% of 2-mercaptobenzimidazole; the lubricant is a compound consisting of 40-60% stearic acid and 40-60% polyethylene wax.
The specific manufacturing steps are as follows:
1) Adding PVC resin into a high-speed mixer, regulating the rotating speed to 400rpm, then adding an organotin stabilizer, an impact modifier, a processing aid, an auxiliary stabilizer, an antioxidant, a compound free radical quencher and a lubricant according to a proportion, increasing the rotating speed to 1000-1200rpm, putting the mixture into a cooling mixer after the temperature of the high-speed mixture reaches 110-120 ℃, controlling the rotating speed to 15rpm, and discharging until the temperature of the mixture reaches 40-50 ℃;
2) Adding the cooled materials into a double-screw extrusion granulator, wherein the temperature of four areas of a machine barrel is respectively as follows: zone I90-100deg.C, zone II 100-110deg.C, zone III 100-110deg.C, zone IV 110-120deg.C, die temperature 120-130deg.C, screw rotation speed 60-100rpm;
3) Extruding, plasticizing and granulating the materials, cooling to 35-45 ℃ to obtain the medical hard PVC material, and packaging for later use.
Example 2
The material provided by the invention is prepared from the following raw materials in parts by weight:
medical PVC resin powder: 100.0 parts;
organotin stabilizers: 3.0 parts;
heat-resistant modified resin: 20.0 parts
Impact modifiers: 8.0 parts;
processing aid: 1.5 parts;
auxiliary heat stabilizer: 3.0 parts;
an antioxidant: 1.0 parts;
complex radical quenchers: 1.0 parts;
and (3) a lubricant: 0.8 parts.
The medical PVC resin powder is suspension PVC resin with polymerization degree of 500-800; the organic tin stabilizer is methyl tin mercaptide stabilizer; the heat-resistant modified resin is a mixture composed of 30-50% of alpha methyl styrene polymer, 30-40% of styrene maleic anhydride copolymer and 10-30% of styrene acrylonitrile; the impact modifier is a styrene impact modifier; the processing aid is a methacrylate processing aid; the auxiliary stabilizer is epoxy linseed oil; the antioxidant is a compound consisting of 30-40% of beta- (3, 5-di-tert-butyl-4-hydroxyphenyl) propionic acid n-stearyl alcohol ester (antioxidant 1076), 30-40% of thiodipropionic acid dioctadecyl ester (antioxidant DSTP) and 20-30% of tricridecyl phosphite (TTDP); the compound free radical quencher is a compound composed of 50% -70% of stearic acid rare earth metal organic complex and 30% -50% of 2-mercaptobenzimidazole; the lubricant is a compound consisting of 40-60% stearic acid and 40-60% polyethylene wax.
The preparation method is the same as in example 1.
Example 3
The material provided by the invention is prepared from the following raw materials in parts by weight:
medical PVC resin powder: 100 parts;
organotin stabilizers: 3.0 parts;
heat-resistant modified resin: 20.0 parts;
impact modifiers: 7.0 parts;
processing aid: 1.0 parts;
auxiliary heat stabilizer: 2.0 parts;
an antioxidant: 0.5 parts;
complex radical quenchers: 1.5 parts;
and (3) a lubricant: 1.0 parts.
The medical PVC resin powder is suspension PVC resin with polymerization degree of 500-800; the organic tin stabilizer is methyl tin mercaptide stabilizer; the heat-resistant modified resin is a mixture composed of 30-50% of alpha methyl styrene polymer, 30-40% of styrene maleic anhydride copolymer and 10-30% of styrene acrylonitrile; the impact modifier is a styrene impact modifier; the processing aid is a methacrylate processing aid; the auxiliary stabilizer is epoxy linseed oil; the antioxidant is a compound consisting of 30-40% of beta- (3, 5-di-tert-butyl-4-hydroxyphenyl) propionic acid n-stearyl alcohol ester (antioxidant 1076), 30-40% of thiodipropionic acid dioctadecyl ester (antioxidant DSTP) and 20-30% of tricridecyl phosphite (TTDP); the compound free radical quencher is a compound composed of 50% -70% of stearic acid rare earth metal organic complex and 30% -50% of 2-mercaptobenzimidazole; the lubricant is a compound consisting of 40-60% stearic acid and 40-60% polyethylene wax.
The preparation method is the same as in example 1.
Example 4
The material provided by the invention is prepared from the following raw materials in parts by weight:
medical PVC resin powder: 100 parts;
organotin stabilizers: 2.5 parts;
heat-resistant modified resin: 30 parts;
impact modifiers: 10.0 parts;
processing aid: 1.0 parts;
auxiliary heat stabilizer: 2.0 parts;
an antioxidant: 0.5 parts;
complex radical quenchers: 1.2 parts;
and (3) a lubricant: 1.0 parts.
The medical PVC resin powder is suspension PVC resin with polymerization degree of 500-800; the organic tin stabilizer is methyl tin mercaptide stabilizer; the heat-resistant modified resin is a mixture composed of 30-50% of alpha methyl styrene polymer, 30-40% of styrene maleic anhydride copolymer and 10-30% of styrene acrylonitrile; the impact modifier is a styrene impact modifier; the processing aid is a methacrylate processing aid; the auxiliary stabilizer is epoxy linseed oil; the antioxidant is a compound consisting of 30-40% of beta- (3, 5-di-tert-butyl-4-hydroxyphenyl) propionic acid n-stearyl alcohol ester (antioxidant 1076), 30-40% of thiodipropionic acid dioctadecyl ester (antioxidant DSTP) and 20-30% of tricridecyl phosphite (TTDP); the compound free radical quencher is a compound composed of 50% -70% of stearic acid rare earth metal organic complex and 30% -50% of 2-mercaptobenzimidazole; the lubricant is a compound consisting of 40-60% stearic acid and 40-60% polyethylene wax.
The preparation method is the same as in example 1.
4 examples were chosen for the basic formulation of the invention to perform the verification and test the properties, see table 1, table 2.
Table 1: three example performance comparison tables
Table 2: performance detection according to GB 16886-2011 medical instruments biological evaluation
Test conditions: the material prepared under the conditions of the invention is sterilized by 40KGY of radiation.
According to various performance tests of 3 embodiments, the medical hard PVC material prepared by the method greatly improves the heat distortion temperature, meanwhile, the mechanical property of the material after 40KGY electron beam irradiation sterilization meets the requirements, the biological property meets the standard requirements of GB 16886-2011 biological evaluation of medical instruments, and the method is suitable for the medical hard PVC material with high heat resistance and electron beam irradiation sterilization resistance.
The foregoing description is merely illustrative of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. It is intended that all equivalent variations and modifications made in accordance with the teachings of the present invention shall fall within the technical scope of the present invention.
Claims (9)
1. The medical hard PVC material is characterized by comprising the following raw materials in parts by weight:
medical PVC resin powder: 100.0 parts;
organotin stabilizers: 2.0-3.0 parts;
heat-resistant modified resin: 15.0-30.0 parts;
impact modifiers: 5.0-10.0 parts;
processing aid: 1.0-2.0 parts;
auxiliary heat stabilizer: 2.0-5.0 parts;
an antioxidant: 0.5-1.0 parts;
complex radical quenchers: 1.0-2.0 parts;
and (3) a lubricant: 0.5-1.0 parts;
wherein the heat-resistant modified resin is a mixture composed of 30-50% of alpha methyl styrene polymer, 30-40% of styrene maleic anhydride copolymer and 10-30% of styrene acrylonitrile; the compound free radical quencher is composed of 50% -70% of stearic acid rare earth metal organic complex and 30% -50% of 2-mercaptobenzimidazole; the medical hard PVC material is suitable for the field of medical instrument consumables.
2. The material of claim 1, wherein the medical PVC resin powder is a suspension PVC resin having a degree of polymerization of 500-800.
3. The material according to claim 1, characterized in that the organotin stabilizer is a methyl tin mercaptide stabilizer.
4. The material of claim 1 wherein said impact modifier is a styrenic impact modifier.
5. The material of claim 1 wherein said processing aid is a methacrylate processing aid.
6. The material of claim 1 wherein said auxiliary heat stabilizer is epoxy linseed oil.
7. The material according to claim 1, characterized in that the antioxidant consists of 30-40% of n-stearyl β - (3, 5-di-tert-butyl-4-hydroxyphenyl) propionate (antioxidant 1076), 30-40% of dioctadecyl thiodipropionate (antioxidant DSTP) and 20-30% of tris (tridecyl) phosphite (TTDP).
8. The material of claim 1 wherein said lubricant is a composite of 40-60% stearic acid and 40-60% polyethylene wax.
9. The preparation method of the high heat-resistant and electron beam irradiation-resistant sterilization medical hard PVC material according to claim 1, which is characterized by comprising the following specific preparation steps:
1) Adding PVC resin into a high-speed mixer, regulating the rotating speed to 400rpm, adding a certain amount of organotin stabilizer, heat-resistant modified resin, impact modifier, processing aid, auxiliary stabilizer, antioxidant, compound free radical quencher and lubricant, increasing the rotating speed to 1000-1200rpm, putting the materials into a cooling mixer after the temperature of the materials with the high-speed mixing value reaches 110-120 ℃, controlling the rotating speed to 15rpm, and discharging until the temperature of the materials reaches 40-50 ℃;
2) Adding the cooled materials into a double-screw extrusion granulator, wherein the temperature of four areas of a machine barrel is respectively as follows: zone I90-100deg.C, zone II 100-110deg.C, zone III 100-110deg.C, zone IV 110-120deg.C, die temperature 120-130deg.C, screw rotation speed 60-100rpm;
3) And (3) extruding, plasticizing and granulating the materials, cooling to 35-45 ℃ to obtain the hard PVC material, and packaging for later use.
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