CN100999601A - Medical polyvinyl chloride plastic and preparation process thereof - Google Patents
Medical polyvinyl chloride plastic and preparation process thereof Download PDFInfo
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- CN100999601A CN100999601A CN 200610148001 CN200610148001A CN100999601A CN 100999601 A CN100999601 A CN 100999601A CN 200610148001 CN200610148001 CN 200610148001 CN 200610148001 A CN200610148001 A CN 200610148001A CN 100999601 A CN100999601 A CN 100999601A
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- polyvinyl chloride
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Abstract
The present invention discloses one kind of soft polyvinyl chloride plastic for medical use and its preparation process, and features that polyvinyl chloride resin in 100 weight portions is compounded with plasticizer in 20-80 weight portions. The plasticizer is one or several selected from trioctyl trimellitate, tri-n-butyl citrate, tri-n-octyl citrate, cyclohexane-1, 2-diisononyl dicarboxyllate, dioctyl adipate and tri-n-hexyl butyrul citrate. The soft polyvinyl chloride plastic for medical use has low cost, high biocompatibility and environment friendship, and is suitable for making disposable medicinal product to avoid cross infection.
Description
Technical field
The present invention relates to a kind of medical flexible polyvinyl chloride plastic that can be used for disposable medical article.Use softening agent and the other kinds auxiliary agent that does not contain phthalate specifically, polyvinyl chloride (PVC) RESINS is carried out modification.
Background technology
Polyvinyl chloride is easy to processing as a kind of, and mechanical property, erosion resistance are outstanding, and the abundant material of raw material sources, are widely used in industry-by-industries such as light industry, machinery, electronics, building, medical treatment.Dioctyl phthalate (DOP) always is considered to a kind of softening agent nontoxic, that wholesomeness good and cost performance is the highest and is used widely.Since follow-up story in 1980 phthalic ester plasticizers such as relevant DOP might carcinogenic problem, FDA, DOP has been carried out comprehensive and deep research, arguement to DOP is not calmed down so far yet, therefore, research and development do not contain the medical flexible polyvinyl chloride plastic of phthalate, as the starting material of Dispoable medical goods,, be the very problem of concern of people institute to guarantee security of products.
Summary of the invention
The technical issues that need to address of the present invention are to disclose a kind of medical flexible polyvinyl chloride plastic and preparation thereof, to overcome the above-mentioned defective that prior art exists, satisfy the needs in relevant field.
In the medical flexible polyvinyl chloride plastic component of the present invention, polyvinyl chloride (PVC) RESINS in 100 weight parts, the softening agent that contains 20～80 weight parts, said softening agent is selected from one or more in trioctyl trimellitate, ATBC, acetyl tributyl citrate three n-octyls, hexanaphthene 1,2 dicarboxylic acid dinonyl, Octyl adipate or the butyryl citric acid tri-n-hexyl ester;
Preferred medical flexible polyvinyl chloride plastic, composition that contains and parts by weight are:
Polyvinyl chloride (PVC) RESINS: 100 parts
Softening agent: 20～80 parts
Stablizer: 1～10 part
Auxiliary stabilizer: 1～10 part
Lubricant: 0.1～2 part
Oxidation inhibitor: 0.1～2 part
Preferred composition and parts by weight are:
Polyvinyl chloride (PVC) RESINS: 100 parts
Softening agent: 33～55 parts
Stablizer: 1～2 part
Auxiliary stabilizer: 8～5 parts
Lubricant: 0.8～0.5 part
Oxidation inhibitor: 0.3～1 part
Said polyvinyl chloride (PVC) RESINS is the polyvinyl chloride (PVC) RESINS that suspension method makes, the vinylchlorid residual quantity of resin≤1 μ g/g; The viscosity number of resin is 70mL/g ~ 160mL/g;
Said stablizer is powdery, pasty state or liquid calcium zinc stabilizer, composite calcium zinc stabilizing agent, Zinic stearas, Aluminium Tristearate Micronized sterile, stearoyl benzoyl methane C
26H
42O
2In one or more;
Said auxiliary stabilizer is epoxy soybean oil, epoxy linseed oil or the two mixture, and wherein epoxy soybean oil is flash-point 〉=300 ℃, goes back oxygen value 〉=6.1, goes back oxygen value 〉=6.0 after the heating, iodine number≤5.0; Epoxy linseed oil flash-point 〉=320 ℃, iodine number≤5.0, oxirane value 〉=8.0.
Said lubricant is one or more in ethylene bis stearic acid amide, oxidized polyethlene wax, stearic acid polyol ester such as single, double stearic acid glyceryl alcohol ester mixture etc., high carbon acid polyprotonic acid/pure complex ester, stearic acid or the hexanodioic acid pentaerythritol ester.
Said oxidation inhibitor is tricresyl phosphite (nonyl phenyl ester) or diphosphorous acid dihydroxyphenyl propane four C
12 ∽ 15Ester;
Said medical flexible polyvinyl chloride plastic manufacture method comprises the steps:
Proportionally, polyvinyl chloride (PVC) RESINS, softening agent, stablizer, auxiliary stabilizer, lubricant and oxidation inhibitor are mediated premix and swelling in kneader, mediating temperature is 100 ℃～140 ℃, the kneading time is 0.1～20 minute, be cooled to 50～100 ℃, enter in the two steps type forcing machine, plasticizing, extruding pelletization under 90 ℃～200 ℃ obtain product.
Said kneader and two steps type forcing machine are the general equipment in this area.Product as BUSS company;
The invention solves owing to phthalic acid two (2-ethylhexyl) ester is the detrimentally affect that the stripping of DEHP brings, particularly aspect the infusion of drug of special populations such as intestinal feeding class purposes, baby, pregnant woman, not only kept the PVC material source abundant, processing modified easily, product has excellent biological compatibility after the modification; Cheaply be applicable to disposable use avoiding characteristics such as cross infection, and reduced influence that belong to environmentally friendly product, product performance satisfy the existing standard requirement to environment.
Embodiment
Embodiment 1～2
Prescription:
| The composition of medical soft polychloroethylene | Weight fraction | |
| Example 1 | Example 2 | |
| Polyvinyl chloride (PVC) RESINS | 100 | 100 |
| Softening agent | 33 | 55 |
| Extender plasticizer | 8 | 5 |
| Stablizer | 2 | 1 |
| Oxidation inhibitor | 0.3 | 0.3 |
| Lubricant | 0.8 | 0.5 |
Softening agent: hexanaphthene 1,2 dicarboxylic acid dinonyl; Extender plasticizer: epoxy soybean oil; Stablizer: liquid calcium zinc stabilizer; Oxidation inhibitor: tricresyl phosphite (nonyl phenyl ester); Lubricant: higher fatty acid pentaerythritol ester.
The preparation method:
Proportionally, polyvinyl chloride (PVC) RESINS, softening agent, stablizer, auxiliary stabilizer, lubricant and oxidation inhibitor are mediated premix and swelling in kneader, mediating temperature is 120 ℃, the kneading time is 10 minutes, be cooled to 70 ℃, enter in the two steps type forcing machine, plasticizing, extruding pelletization under 150 ℃ obtain product.
It is as follows to obtain the result:
| Sequence number | Test event | Unit | Example 1 | Example 2 | Testing method |
| 1 | Tensile strength | MPa | 22.4 | 19.6 | GB1040-1992 |
| 2 | Elongation at break | ％ | 320 | 380 | GB1040-1992 |
| 3 | Reducing substance (indirect method) | ml | 0.03 | 0.05 | GB14232.1-2004 |
| 4 | Heavy metal | μg/ml | 0.3 | 0.3 | GB14232.1-2004 |
| 5 | Potential of hydrogen | ＜0.1 | ＜0.1 | GB14232.1-2004 | |
| 6 | The ultraviolet absorption degree | 0.07 | 0.05 | GB14232.1-2004 | |
| 7 | Water-intake rate | ％ | 0.18 | 0.24 | Chinese Pharmacopoeia 1977 |
| 8 | Non-volatile matter | mg/100ml | 0.3 | 0.3 | GB14232.1-2004 |
| 9 | Ash content | mg/g | 0.1 | 0.3 | GB14232.1-2004 |
| 10 | The alcohol leachable | μg/g | 18 | 39 | GB14232.1-2004 |
Claims (9)
1. medical flexible polyvinyl chloride plastic, it is characterized in that, polyvinyl chloride (PVC) RESINS in 100 weight parts, the softening agent that contains 20～80 weight parts, said softening agent is selected from one or more in trioctyl trimellitate, ATBC, acetyl tributyl citrate three n-octyls, hexanaphthene 1,2 dicarboxylic acid dinonyl, Octyl adipate or the butyryl citric acid tri-n-hexyl ester.
2. medical flexible polyvinyl chloride plastic according to claim 1 is characterized in that, composition and parts by weight are:
Polyvinyl chloride (PVC) RESINS: 100 parts
Softening agent: 20～80 parts
Stablizer: 1～10 part
Auxiliary stabilizer: 1～10 part
Lubricant: 0.1～2 part
Oxidation inhibitor: 0.1～2 part.
3. medical flexible polyvinyl chloride plastic according to claim 2 is characterized in that, preferred composition and parts by weight are:
Polyvinyl chloride (PVC) RESINS: 100 parts
Softening agent: 33～55 parts
Stablizer: 1～2 part
Auxiliary stabilizer: 8～5 parts
Lubricant: 0.8～0.5 part
Oxidation inhibitor: 0.3～1 part.
4. medical flexible polyvinyl chloride plastic according to claim 2 is characterized in that, said polyvinyl chloride (PVC) RESINS is the polyvinyl chloride (PVC) RESINS that suspension method makes, the vinylchlorid residual quantity of resin≤1 μ g/g; The viscosity number of resin is 70mL/g ~ 160mL/g.
5. medical flexible polyvinyl chloride plastic according to claim 2 is characterized in that, said stablizer is powdery, pasty state or liquid calcium zinc stabilizer, composite calcium zinc stabilizing agent, Zinic stearas, Aluminium Tristearate Micronized sterile, stearoyl benzoyl methane C
26H
42O
2In one or more.
6. medical flexible polyvinyl chloride plastic according to claim 2 is characterized in that, said auxiliary stabilizer is epoxy soybean oil, epoxy linseed oil or the two mixture, wherein epoxy soybean oil is flash-point 〉=300 ℃, also oxygen value 〉=6.0 are gone back in oxygen value 〉=6.1 after the heating, iodine number≤5.0; Epoxy linseed oil flash-point 〉=320 ℃, iodine number≤5.0, oxirane value 〉=8.0.
7. medical flexible polyvinyl chloride plastic according to claim 2, it is characterized in that said lubricant is one or more in ethylene bis stearic acid amide, oxidized polyethlene wax, stearic acid polyol ester such as single, double stearic acid glyceryl alcohol ester mixture etc., high carbon acid polyprotonic acid/pure complex ester, stearic acid or the hexanodioic acid pentaerythritol ester.
8. medical flexible polyvinyl chloride plastic according to claim 2 is characterized in that, said oxidation inhibitor is tricresyl phosphite (nonyl phenyl ester) or diphosphorous acid dihydroxyphenyl propane four C
12-15Ester.
9. the preparation method of medical flexible polyvinyl chloride plastic according to claim 2, it is characterized in that, comprise the steps: proportionally, polyvinyl chloride (PVC) RESINS, softening agent, stablizer, auxiliary stabilizer, lubricant and oxidation inhibitor are mediated premix and swelling in kneader, mediating temperature is 100 ℃～140 ℃, and the kneading time is 0.1～20 minute, be cooled to 50～100 ℃, enter in the two steps type forcing machine, plasticizing, extruding pelletization under 90 ℃～200 ℃ obtain product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610148001 CN100999601A (en) | 2006-12-26 | 2006-12-26 | Medical polyvinyl chloride plastic and preparation process thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610148001 CN100999601A (en) | 2006-12-26 | 2006-12-26 | Medical polyvinyl chloride plastic and preparation process thereof |
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| Publication Number | Publication Date |
|---|---|
| CN100999601A true CN100999601A (en) | 2007-07-18 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200610148001 Pending CN100999601A (en) | 2006-12-26 | 2006-12-26 | Medical polyvinyl chloride plastic and preparation process thereof |
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| CN101962461A (en) * | 2010-10-25 | 2011-02-02 | 欧阳伟 | Phthalate-free medical grade PVC plastic |
| CN101962460A (en) * | 2010-10-25 | 2011-02-02 | 欧阳伟 | Radiation resistant phthalate-free medical grade PVC plastic |
| CN101979434A (en) * | 2010-11-24 | 2011-02-23 | 成都市新津事丰医疗器械有限公司 | Low-temperature resistant medicinal PVC modified material |
| CN102020815A (en) * | 2011-01-12 | 2011-04-20 | 成都市新津事丰医疗器械有限公司 | Delustring medical soft PVC modified material with low temperature resistance and low DOP precipitation |
| CN102174233A (en) * | 2011-01-24 | 2011-09-07 | 张卫华 | Phthalate-free polyvinyl chloride granule formula and preparation method thereof |
| CN101343381B (en) * | 2008-08-27 | 2011-12-21 | 南亚塑胶工业股份有限公司 | Hexa-hydrogen phthalate compound and preparation thereof |
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| CN102643373A (en) * | 2012-05-08 | 2012-08-22 | 江苏苏云医疗器材有限公司 | Synthesis of polyvinyl chloride and production process of medical odorless polyvinyl chloride material |
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