CN101962461B - Phthalate-free medical polrvinyl chloride (PVC) plastic - Google Patents

Phthalate-free medical polrvinyl chloride (PVC) plastic Download PDF

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Publication number
CN101962461B
CN101962461B CN201010520379.0A CN201010520379A CN101962461B CN 101962461 B CN101962461 B CN 101962461B CN 201010520379 A CN201010520379 A CN 201010520379A CN 101962461 B CN101962461 B CN 101962461B
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medical
parts
containing
pvc
phthalic ester
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CN201010520379.0A
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Chinese (zh)
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CN101962461A (en
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欧阳伟
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欧阳伟
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Abstract

The invention discloses phthalate-free medical polrvinyl chloride (PVC) plastic. The plastic is prepared by blending the following components in part by weight: 100 parts of PVC resin, 25 to 95 parts of eco-friendly plasticizer, 0.1-8 parts of polyolefin and chloroethylene function modifier, 4.5-9 parts of heat stabilizer and 0.3-1.5 parts of lubricant, wherein the eco-friendly plasticizer is cyclohexane1,2-diisononyl phthalate, GRINDSTED TM, SOFT-N-SAFE, EPN or acetyl tributyl citrate; the polyolefin and chloroethylene function modifier are more than two of styrene, maleic anhydride, diethyl maleate and chloroethylene; the heat stabilizer is more than one of powdery, pasty and liquid calcium and zinc heat stabilizer; and the lubricant is butyl stearate or oxidized polyethlene wax. The phthalate-free medical PVC plastic is used for producing disposable medical supplies and is safe because the plastic is phthalate-free.

Description

Not containing the medical polyvinyl plastics of phthalic ester

Technical field

The present invention relates to a kind of medical polyvinyl plastics field for the production of disposable medical article, particularly relate to a kind of not containing the medical polyvinyl plastics of phthalic ester.

Background technology

The Medical transfusion pipe of prior art, tubing, infusion bag, conduit, the product such as intubate and oxygen mask are mainly all made up of medical polyvinyl plastics.Medical polyvinyl plastics has a wide range of applications in medical device, mainly because medical polyvinyl plastics itself has good physical properties.These physical propertiess comprise: the accessibility that medical polyvinyl plastics manufactures and this kind of material and vein (intravenous, IV) good between injection liquid and blood compatibility, so in medical, this plastics excellent property, easy to use, very popular with users.But pure pvc material, its hardness and flexibility all cannot meet medical demand, need to add softening agent and carry out plasticising to it.The effect of softening agent is: the accessibility increasing the flexibility of polymkeric substance, elongation or processing and manufacturing.The plasticized polyvinyl chloride class material feature that also tool is more transparent, and there is better chemical stability and economy.

At present, the softening agent that polyvinyl chloride is the most frequently used is dimixo-octyl phthalate (DOP).In recent years, the wholesomeness dispute about DOP was more, and the igelite of biomedical bound pair phthalic ester plasticising is queried human safety, thought that it can produce on animal a series of impacts comprising the carcinogenic effect of active organism.European Union determined to prohibit the use the o-benzoic acid ester plasticizers such as DINP in July, 2005; The U.S. and Japan also by adding one with in the toy of soft PVC manufacture in food sanitation amendment, prohibit the regulation containing phthalic acid composition.Based on this situation, selecting the new plasticizer that its toxicity ratio DOP is low, migration precipitation is less than DOP, for preparation not containing the medical polyvinyl plastics of phthalic ester, is very urgent problem.In order to ensure the safety of human body in medical procedure, people urgently wish a kind ofly not come out containing the medical polyvinyl plastics of phthalic ester.

Summary of the invention

Technical problem to be solved by this invention is, the defect that the medical polyvinyl plastics overcoming prior art contains phthalic ester, can have an impact in medical procedure to human body, there is provided a kind of not containing the medical polyvinyl plastics of phthalic ester, this medical polyvinyl plastics is not containing phthalic ester, the medical apparatus produced with this medical polyvinyl plastics, not containing phthalic ester, uses this Medical treatment device prodigiosin not containing phthalic ester to guarantee the safety of human body in medical procedure.

The technical solution adopted for the present invention to solve the technical problems is: not containing the medical polyvinyl plastics of phthalic ester, be prepared from by the component of following parts by weight is blended:

Polyvinyl chloride (PVC) RESINS 100 parts;

Environment-friendly plasticizer 25 ~ 95 parts;

Polyolefine and vinylchlorid functional modifier 0.1 ~ 8 part;

High Efficiency Thermal stablizer 4.5 ~ 9 parts;

Lubricant 0.3 ~ 1.5 part;

Described environment-friendly plasticizer is hexanaphthene, 2-dioctyl phthalate diisononyl esters, any one in SOFT-N-SAFE, EBN or tributyl acetylcitrate.

In technique scheme, the medical polyvinyl plastics not containing phthalic ester is prepared from by the component of following preferred weight number is blended:

Polyvinyl chloride (PVC) RESINS 100 parts;

Environment-friendly plasticizer 40 ~ 70 parts;

Polyolefine and vinylchlorid functional modifier 0.5 ~ 6 part;

High Efficiency Thermal stablizer 5 ~ 8 parts;

Lubricant 0.5 ~ 1.2 part;

Described environment-friendly plasticizer be hexanaphthene 1,2-dioctyl phthalate diisononyl esters, any one in SOFT-N-SAFE, EBN or tributyl acetylcitrate.

Described polyolefine and vinylchlorid functional modifier are two or more in vinylbenzene, maleic anhydride, diethyl maleate, vinylchlorid.

Described High Efficiency Thermal stablizer is more than one in powder, paste or liquid calcium zinc heat stabilizer.

Described lubricant is n-butyl stearate and/or oxidized polyethlene wax.

The invention has the beneficial effects as follows:

1, table 1 is that medical polyvinyl plastics of the present invention is not containing the report of phthalic acid series ester class testing, this part of test report illustrates by the blended medical polyvinyl plastics be prepared from of the component of above-mentioned parts by weight not containing phthalic ester (serial ester class), in table 1.The medical apparatus (as blood transfusion tube, tubing, infusion bag, conduit, intubate and oxygen mask etc.) produced with this medical polyvinyl plastics also just not containing phthalic ester, uses this medical device not containing phthalic ester can guarantee the safety of human body in medical procedure certainly.

Table 1 is not containing the examining report of the medical polyvinyl plastics of phthalic ester

2, table 2 is of the present invention not containing the survey report of the medical polyvinyl plastics of phthalic ester.Table 2 illustrates: have good character with the medical apparatus that this medical polyvinyl plastics manufactures.This medical apparatus (as blood transfusion tube, tubing, infusion bag, conduit, intubate and oxygen mask etc.) not containing phthalic ester is carrying out for human body, in medical process, in Acute systemic toxicity project, reacting without Acute systemic toxicity; In cytotoxicity project, cell-cytotoxic reaction: 1 grade; In sensitization of skin project, react without sensitization of skin; Stimulate in project at intracutaneous, stimulate without intracutaneous.In table 2.

Table 2 is not containing the survey report of the medical polyvinyl plastics of phthalic ester

3, table 3 is physico-chemical property assays not containing the medical polyvinyl plastics of phthalic ester that three embodiments of the present invention produce.Table 3 illustrates: this do not have good physical properties containing the medical polyvinyl plastics of phthalic ester, it is flexible, and elongation is high, convenient to its process (processing), there is more transparent feature, and there is better chemical stability and economy.In table 3.

The physico-chemical property assay of the individual medical polyvinyl plastics containing phthalic ester that table 3 three embodiments produce:

Sequence number Test event Unit Embodiment 1 Embodiment 2 Embodiment 3 Test force method 1 Tensile strength MPa 19 25 18.6 GB1040-1992 2 Elongation at break 350 290 385 GB1040-1992 3 Reducing substance (indirect method) ml 0.4 0.4 0.3 GB14232.1-2004 4 Heavy metal μg/ml 0.0 0.0 0.0 GB14232.1 2004 5 Potential of hydrogen <0.1 <0.1 <0.1 GB14232.1-2004 6 Uv absorption rate 0.01 0.01 0.01 GB14232.1-2004 7 Water-intake rate 0.18 0.15 0.17 Chinese Pharmacopoeia 1977 8 Non-volatile matter mg/100ml 0.2 0.15 0.16 GB14232.1-2004 9 Ash content mg/g 0.1 0.12 0.18 GB14232.1 2004 10 Alcohol leachable μg/g 0 0 0 GB14232.1-2004

Embodiment

Embodiment 1, a kind of medical polyvinyl plastics not containing phthalic ester described in the present embodiment, is prepared from by the component of following parts by weight is blended:

Polyvinyl chloride (PVC) RESINS 100 parts;

Environment-friendly plasticizer 60 parts;

Polyolefine and vinylchlorid functional modifier 2.5 parts;

High Efficiency Thermal stablizer 7 parts;

Lubricant 1 part;

Described polyvinyl chloride (PVC) RESINS is polyvinyl chloride (PVC) RESINS prepared by suspension method, and its polymerization degree is 1000 ~ 1300.Described environment-friendly plasticizer is hexanaphthene 1,2-dioctyl phthalate diisononyl esters.Described polyolefine and vinylchlorid functional modifier are vinylbenzene and maleic anhydride.Described High Efficiency Thermal stablizer is liquid calcium zinc heat stabilizer.Described lubricant is n-butyl stearate.

The preparation method of the present embodiment is; The component of above-mentioned parts by weight is dropped in high speed reactor and carries out polyreaction, temperature of reaction is 90 ~ 120 DEG C, twin screw extruder is entered by automatic transport pipeline, extrusion temperature is 100 ~ 180 DEG C, again through automatic pelletizing, cooling, detection and finished product packing operation, obtain a kind of medical polyvinyl plastics not containing phthalic ester described in the present embodiment.

Embodiment 2, a kind of medical polyvinyl plastics not containing phthalic ester described in the present embodiment, is prepared from by the component of following parts by weight is blended:

Polyvinyl chloride (PVC) RESINS 100 parts;

Environment-friendly plasticizer 25 parts;

Polyolefine and vinylchlorid functional modifier 0.1 part;

High Efficiency Thermal stablizer 9 parts;

Lubricant 1.5 parts;

Described polyvinyl chloride (PVC) RESINS is polyvinyl chloride (PVC) RESINS prepared by suspension method, and its polymerization degree is 1000 ~ 1300.Described environment-friendly plasticizer is sOFT-N-SAFE, sOFT-N-SAFE is by the novel acetylated monoglyceride of the one be derived in hydrogenated castor oil, and this product is produced by Danisco (China) company limited.Described polyolefine and vinylchlorid functional modifier are diethyl maleate and vinylchlorid.Described High Efficiency Thermal stablizer is paste calcium zinc heat stabilizer.Described lubricant is n-butyl stearate.

The preparation method of the present embodiment is: the component of above-mentioned parts by weight dropped in high speed reactor and carry out polyreaction, temperature of reaction is 90 ~ 20 DEG C, twin screw extruder is entered by automatic transport pipeline, extrusion temperature is 100 ~ 180 DEG C, again through automatic pelletizing, cooling, detection and finished product packing operation, obtain a kind of medical polyvinyl plastics not containing phthalic ester described in the present embodiment.

Embodiment 3, a kind of medical polyvinyl plastics not containing phthalic ester described in the present embodiment, is prepared from by the component of following parts by weight is blended:

Polyvinyl chloride (PVC) RESINS 100 parts;

Environment-friendly plasticizer 95 parts;

Polyolefine and vinylchlorid functional modifier 8 parts;

High Efficiency Thermal stablizer 4.5 parts;

Lubricant 0.3 part;

Described polyvinyl chloride (PVC) RESINS is polyvinyl chloride (PVC) RESINS prepared by suspension method, and its polymerization degree is 1000 ~ 1300.Described environment-friendly plasticizer is tributyl acetylcitrate (also can be produced by LG Corp of South Korea for EBN, EBN).Described polyolefine and vinylchlorid functional modifier are maleic anhydride and diethyl maleate.Described High Efficiency Thermal stablizer is powder calcium zinc heat stabilizer.Described lubricant is n-butyl stearate and oxidized polyethlene wax.

The preparation method of the present embodiment is: the component of above-mentioned parts by weight dropped in high speed reactor and carry out polyreaction, temperature of reaction is 90 ~ 120 DEG C, twin screw extruder is entered by automatic transport pipeline, extrusion temperature is 100 ~ 180 DEG C, again through automatic pelletizing, cooling, detection and finished product packing operation, obtain a kind of medical polyvinyl plastics not containing phthalic ester described in the present embodiment.

The above is only three preferred embodiments of the present invention, is not used for limiting the present invention, its similar embodiments all, such as: not containing the medical polyvinyl plastics of phthalic ester, be prepared from by the component of following parts by weight is blended:

Polyvinyl chloride (PVC) RESINS 100 parts;

Environment-friendly plasticizer 25 ~ 95 parts;

Polyolefine and vinylchlorid functional modifier 0.1 ~ 8 part;

High Efficiency Thermal stablizer 4.5 ~ 9 parts;

Lubricant 0.3 ~ 1.5 part;

Described environment-friendly plasticizer be hexanaphthene 1,2-dioctyl phthalate diisononyl esters, any one etc. in SOFT-N-SAFE, EBN or tributyl acetylcitrate, these features all should be covered by the protection domain of patent of the present invention.

Claims (4)

1., not containing the medical polyvinyl plastics of phthalic ester, it is characterized in that: be prepared from by the component of following parts by weight is blended:
Described environment-friendly plasticizer is any one in SOFT-N-SAFE or EBN;
Described polyvinyl chloride (PVC) RESINS is polyvinyl chloride (PVC) RESINS prepared by suspension method, and its polymerization degree is 1000 ~ 1300;
Described polyolefine and vinylchlorid functional modifier are two or more in vinylbenzene, maleic anhydride, diethyl maleate, vinylchlorid;
Preparation method is: the component of above-mentioned parts by weight dropped in high speed reactor and carry out polyreaction, temperature of reaction is 90 ~ 120 DEG C, twin screw extruder is entered by automatic transport pipeline, extrusion temperature is 100 ~ 180 DEG C, again through automatic pelletizing, cooling, detection and finished product packing operation, a kind of medical polyvinyl plastics not containing phthalic ester described in acquisition.
2. according to claim 1 not containing the medical polyvinyl plastics of phthalic ester, it is characterized in that: be prepared from by the component of following preferred weight number is blended:
3. according to claim 1 and 2 not containing the medical polyvinyl plastics of phthalic ester, it is characterized in that: described thermo-stabilizer is more than one in powder, paste or liquid calcium zinc heat stabilizer.
4. according to claim 1 and 2 not containing the medical polyvinyl plastics of phthalic ester, it is characterized in that: described lubricant is n-butyl stearate and/or oxidized polyethlene wax.
CN201010520379.0A 2010-10-25 2010-10-25 Phthalate-free medical polrvinyl chloride (PVC) plastic CN101962461B (en)

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CN102617951B (en) * 2012-04-01 2013-04-24 山东万图高分子材料有限公司 Preparation method of polyvinyl chloride (PVC)-based material granule plasticized by non-benzene plasticizer for preparing hard or semi-hard products
CN103172953A (en) * 2013-04-15 2013-06-26 江西3L医用制品集团股份有限公司 Method for preparing detaining needle long catheter
JP6148564B2 (en) * 2013-07-31 2017-06-14 リケンテクノス株式会社 Medical radiation sterilized vinyl chloride resin composition and medical device comprising the same
JP6148563B2 (en) * 2013-07-31 2017-06-14 リケンテクノス株式会社 Medical radiation sterilized vinyl chloride resin composition and medical device comprising the same
CN106905494B (en) * 2017-02-09 2018-12-04 黑龙江林海华安新材料股份有限公司 The method that resin promotees its manufacture wood-plastic decorating material of plasticiser and its preparation and application

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