HRP921367A2 - Plasticized polymer compositions - Google Patents
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- HRP921367A2 HRP921367A2 HR921367A HRP921367A HRP921367A2 HR P921367 A2 HRP921367 A2 HR P921367A2 HR 921367 A HR921367 A HR 921367A HR P921367 A HRP921367 A HR P921367A HR P921367 A2 HRP921367 A2 HR P921367A2
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- 229920000642 polymer Polymers 0.000 title claims description 36
- 239000000203 mixture Substances 0.000 title claims description 29
- 239000004014 plasticizer Substances 0.000 claims description 28
- 238000002360 preparation method Methods 0.000 claims description 13
- 150000002148 esters Chemical class 0.000 claims description 12
- 239000008280 blood Substances 0.000 claims description 9
- 210000004369 blood Anatomy 0.000 claims description 9
- 238000004519 manufacturing process Methods 0.000 claims description 8
- 125000004432 carbon atom Chemical group C* 0.000 claims description 4
- 125000001424 substituent group Chemical group 0.000 claims description 4
- 125000000217 alkyl group Chemical group 0.000 claims description 3
- 229920001169 thermoplastic Polymers 0.000 claims description 3
- 125000003342 alkenyl group Chemical group 0.000 claims description 2
- 125000003118 aryl group Chemical group 0.000 claims description 2
- 125000004122 cyclic group Chemical group 0.000 claims description 2
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 claims description 2
- 125000002347 octyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 claims description 2
- 210000000056 organ Anatomy 0.000 claims description 2
- 239000004416 thermosoftening plastic Substances 0.000 claims 1
- BJQHLKABXJIVAM-UHFFFAOYSA-N Diethylhexyl phthalate Natural products CCCCC(CC)COC(=O)C1=CC=CC=C1C(=O)OCC(CC)CCCC BJQHLKABXJIVAM-UHFFFAOYSA-N 0.000 description 13
- 239000004800 polyvinyl chloride Substances 0.000 description 13
- 229920000915 polyvinyl chloride Polymers 0.000 description 13
- CTJJGIVJOBVMEO-UHFFFAOYSA-N tetraoctyl benzene-1,2,4,5-tetracarboxylate Chemical compound CCCCCCCCOC(=O)C1=CC(C(=O)OCCCCCCCC)=C(C(=O)OCCCCCCCC)C=C1C(=O)OCCCCCCCC CTJJGIVJOBVMEO-UHFFFAOYSA-N 0.000 description 12
- 239000004808 2-ethylhexylester Substances 0.000 description 11
- MQIUGAXCHLFZKX-UHFFFAOYSA-N Di-n-octyl phthalate Natural products CCCCCCCCOC(=O)C1=CC=CC=C1C(=O)OCCCCCCCC MQIUGAXCHLFZKX-UHFFFAOYSA-N 0.000 description 11
- KRADHMIOFJQKEZ-UHFFFAOYSA-N Tri-2-ethylhexyl trimellitate Chemical compound CCCCC(CC)COC(=O)C1=CC=C(C(=O)OCC(CC)CCCC)C(C(=O)OCC(CC)CCCC)=C1 KRADHMIOFJQKEZ-UHFFFAOYSA-N 0.000 description 11
- 238000000605 extraction Methods 0.000 description 11
- 239000013060 biological fluid Substances 0.000 description 5
- 238000001125 extrusion Methods 0.000 description 5
- 238000000502 dialysis Methods 0.000 description 4
- 238000002156 mixing Methods 0.000 description 4
- 238000009826 distribution Methods 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 230000031018 biological processes and functions Effects 0.000 description 2
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 2
- 235000016236 parenteral nutrition Nutrition 0.000 description 2
- 239000004814 polyurethane Substances 0.000 description 2
- 229920002635 polyurethane Polymers 0.000 description 2
- 239000003381 stabilizer Substances 0.000 description 2
- 231100000419 toxicity Toxicity 0.000 description 2
- 230000001988 toxicity Effects 0.000 description 2
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 description 2
- BJQHLKABXJIVAM-BGYRXZFFSA-N 1-o-[(2r)-2-ethylhexyl] 2-o-[(2s)-2-ethylhexyl] benzene-1,2-dicarboxylate Chemical compound CCCC[C@H](CC)COC(=O)C1=CC=CC=C1C(=O)OC[C@H](CC)CCCC BJQHLKABXJIVAM-BGYRXZFFSA-N 0.000 description 1
- 239000004803 Di-2ethylhexylphthalate Substances 0.000 description 1
- 239000004605 External Lubricant Substances 0.000 description 1
- 239000004610 Internal Lubricant Substances 0.000 description 1
- 241000699670 Mus sp. Species 0.000 description 1
- 239000008037 PVC plasticizer Substances 0.000 description 1
- 230000007059 acute toxicity Effects 0.000 description 1
- 231100000403 acute toxicity Toxicity 0.000 description 1
- 125000002252 acyl group Chemical group 0.000 description 1
- -1 bags Chemical compound 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 239000008116 calcium stearate Substances 0.000 description 1
- 235000013539 calcium stearate Nutrition 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 238000001631 haemodialysis Methods 0.000 description 1
- 230000009931 harmful effect Effects 0.000 description 1
- 230000000322 hemodialysis Effects 0.000 description 1
- 239000007970 homogeneous dispersion Substances 0.000 description 1
- 238000000265 homogenisation Methods 0.000 description 1
- 231100001231 less toxic Toxicity 0.000 description 1
- 239000000944 linseed oil Substances 0.000 description 1
- 235000021388 linseed oil Nutrition 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 235000019198 oils Nutrition 0.000 description 1
- 239000004006 olive oil Substances 0.000 description 1
- 235000008390 olive oil Nutrition 0.000 description 1
- 125000001312 palmitoyl group Chemical group O=C([*])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 229920005573 silicon-containing polymer Polymers 0.000 description 1
- 239000003549 soybean oil Substances 0.000 description 1
- 235000012424 soybean oil Nutrition 0.000 description 1
- 125000003696 stearoyl group Chemical group O=C([*])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- CHJMFFKHPHCQIJ-UHFFFAOYSA-L zinc;octanoate Chemical compound [Zn+2].CCCCCCCC([O-])=O.CCCCCCCC([O-])=O CHJMFFKHPHCQIJ-UHFFFAOYSA-L 0.000 description 1
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- Compositions Of Macromolecular Compounds (AREA)
- External Artificial Organs (AREA)
Description
Sadašnji izum se odnosi na plastificirane polimerne pripravke, osobito na pripravke na temelju polivinil-klorida (ovdje kasnije "PVC"), koji obuhvaćaju posebne piromelitatne estere kao plastifikatore za proizvodnju artikala za biomedicinsku upotrebu i na artikle koji su iz njih načinjeni. The present invention relates to plasticized polymer compositions, in particular to compositions based on polyvinyl chloride (hereinafter "PVC"), which include special pyromellitic esters as plasticizers for the production of articles for biomedical use and to articles made from them.
Upotreba polimernih tvari nesumnjivo je doprinijela značajnom napretku u medicini i kirurgiji. Na primjer, polimerne tvari se upotrebljavaju u hemodijalizi, u napravama za enteralnu i parenteralnu prehranu, vrećicama za krv i slično. The use of polymeric substances has undoubtedly contributed to significant progress in medicine and surgery. For example, polymeric substances are used in hemodialysis, in devices for enteral and parenteral nutrition, blood bags and the like.
Među polimernim tvarima koje se obično upotrebljavaju su PVC, poliuretani, silikoni i slično. U slučaju PVC, dosada upotrebljavani plastifikator bio je gotovo isključivo dietilheksil-ftalat (također poznat kao dioktil-ftalat i ovdje kasnije "DOP"). U novije vrijeme, za neke primjene, preporučivan je trioktiltrimelitat (ovdje kasnije "TOTM") umjesto DOP. Among the polymer substances commonly used are PVC, polyurethanes, silicones and the like. In the case of PVC, the plasticizer used so far has been almost exclusively diethylhexyl phthalate (also known as dioctyl phthalate and hereafter "DOP"). More recently, for some applications, trioctyltrimelitate (hereinafter "TOTM") has been recommended instead of DOP.
Međutim, dosada je uglavnom upotreba polimera koji sadrže esterske plastifikatore za biomedicinsku primjenu bila nezadovoljavajuća radi podložnosti estera ekstrakciji iz polimera koji su na njima plastificirani kada su u dodiru s biološkim tekućinama. Čak i ako TOTM smanjuje takav rizik ekstrakcije iz polimera, svejedno postoji rizik prijelaza TOTM u krvotok kao rezultat ekstrakcije, osobito kada su artikli koji su načinjeni iz polimera plastificirani s TOTM, npr., vrećice, cijevi za puhanje, itd., u dodiru s krvi. However, until now, mainly the use of polymers containing ester plasticizers for biomedical applications has been unsatisfactory due to the susceptibility of esters to extraction from the polymers plasticized on them when in contact with biological fluids. Even if TOTM reduces such risk of extraction from the polymer, there is still a risk of TOTM passing into the bloodstream as a result of extraction, especially when articles made from polymers plasticized with TOTM, e.g., bags, blowpipes, etc., come into contact with blood.
Tako je shvaćeno da plastifikator treba biti pogodan za biomedicinsku primjenu, kod čega artikli koji ih sadrže trebaju biti biokompatibilni. To jest, trebaju posjedovati sposobnost potpune disperzije u polimeru koji je s njima plastificiran; trebaju biti zadovoljavajuće slobodni od rizika ekstrakcije s biološkim tekućinama s kojima su u dodiru; i trebaju biti sposobni za mikrokompartmentalizaciju. Thus, it is understood that the plasticizer should be suitable for biomedical applications, where the articles containing them should be biocompatible. That is, they should have the ability to completely disperse in the polymer plasticized with them; they should be satisfactorily free from the risk of extraction with biological fluids with which they are in contact; and should be capable of microcompartmentalization.
Sada je otkriveno da se odgovarajućim izborom posebnih estera, problemi koji prate estere iz ranijeg umijeća u biomedicinskoj primjeni mogu bitno ublažiti. It has now been discovered that with the appropriate choice of special esters, the problems accompanying prior art esters in biomedical applications can be significantly alleviated.
Prema tome, sadašnji izum je plastificirani polimerni pripravak koji je pogodan za proizvodnju artikala za biomedicinsku primjenu, koji je karakteriziran time što plastifikator u pripravku obuhvaća jedan ili više piromelitatnih estera formule : - Therefore, the present invention is a plasticized polymer composition that is suitable for the production of articles for biomedical use, which is characterized by the fact that the plasticizer in the composition comprises one or more pyromellitic esters of the formula: -
[image] [image]
u kojoj su R1, R2, R3 i R4 iste ili različite in which R1, R2, R3 and R4 are the same or different
(a) alkil ili alkenil skupine, koje mogu biti ravne ili razgranate, i koje sadrže 1-15 atoma ugljika, ili, (a) alkyl or alkenyl groups, which may be straight or branched, and containing 1-15 carbon atoms, or,
(b) cikličke skupine koje sadrže 5-6 atoma ugljika u prstenu, kod čega je spomenuti prsten cikloalifatski ili aromatski s ili bez dodatnih supstituenata u strukturi prstena. (b) cyclic groups containing 5-6 carbon atoms in the ring, wherein said ring is cycloaliphatic or aromatic with or without additional substituents in the ring structure.
Piromelitati formule (I) u kojima, npr., supstituenti R1-R.4 predstavljaju alkil supstituent upotrebljavani su ranije kao plastifikatori polimernih pripravaka samo u svezi električnih primjena, ali ne i u svezi biomedicinske upotrebe. Pyromellitates of formula (I) in which, for example, the substituents R1-R.4 represent an alkyl substituent were previously used as plasticizers of polymer preparations only in connection with electrical applications, but not in connection with biomedical use.
Piromelitatni esterski plastifikatori su poželjno oni u kojima se skupine R1-R4 C1-C15 ravne ili razgranate alkil skupine. Među njima, one u kojima je najmanje jedan od supstituenata R1-R4 etil ili oktil skupina su najpoželjnije. Pyromellite ester plasticizers are preferably those in which the R1-R4 C1-C15 groups are straight or branched alkyl groups. Among them, those in which at least one of the substituents R1-R4 is an ethyl or octyl group are most preferred.
Usporedba relativnih rizika ekstrakcije konvencionalnih plastifikatora s piromelitatnim esterima u pripravcima iz sadašnjeg izuma pokazuje da kada su artikli načinjeni iz PVC koji sadrži ove plastifikatore u dodiru s, npr., volovskom krvi, tetraoktilpiromelitat se od 95-98% manje ekstrahira nego DEHP ili dioktil-ftalat, i najmanje 85% manje nego TOTM. Tako je jasno da u biomedicinskoj primjeni artikli koji su načinjeni od polimernih pripravaka koji sadrže piromelitatne estere kao plastifikatore pokazuju slijedeće prednosti. Oni pokazuju : A comparison of the relative risks of extraction of conventional plasticizers with pyromellitate esters in the compositions of the present invention shows that when articles made of PVC containing these plasticizers are in contact with, e.g., ox blood, tetraoctylpyromellitate is 95-98% less extracted than DEHP or dioctyl- phthalate, and at least 85% less than TOTM. It is thus clear that in biomedical applications, articles made from polymer preparations containing pyromellitic esters as plasticizers show the following advantages. They show:
1. Nižu toksičnost od TOTM ili dioktil-ftalata, pa tako ne utječu štetno na biološke procese. 1. Lower toxicity than TOTM or dioctyl-phthalate, so they do not have a harmful effect on biological processes.
2. Bitno zanemariv rizik ekstrakcije kada su u dodiru s krvi ili s ostalim biološkim tekućinama, i 2. Essentially negligible risk of extraction when they are in contact with blood or other biological fluids, i
3. Poboljšanu djelotvornost plastificiranja i trajnost artikla načinjenog od polimera koji sadrže spomenute plastifikatore. 3. Improved effectiveness of plasticization and durability of the article made of polymers containing the mentioned plasticizers.
Plastifikatori se mogu upotrebljavati u polimernim pripravcima u količini od najmanje 30-100 dijela na sto smole (ovdje u kasnijem tekstu "phr"), poželjno 60-90 phr na temelju polimera u pripravku, ovisno o polimeru koji se treba plastificirati, tvrdoći ili fleksibilnosti željenog konačnog produkta, ili od poželjnih barijernih osobina za posebnu medicinsku/biomedicinsku primjenu. Plasticizers can be used in polymer compositions in an amount of at least 30-100 parts per hundred resin (hereafter "phr"), preferably 60-90 phr based on the polymer in the composition, depending on the polymer to be plasticized, hardness or flexibility of the desired final product, or of desirable barrier properties for a specific medical/biomedical application.
Polimeri u polimernim pripravcima su pogodno termoplastični polimeri, osobito PVC, premda se također mogu upotrebljavati pogodno u poliuretanskim ili silikonskim polimerima. The polymers in the polymer compositions are preferably thermoplastic polymers, particularly PVC, although polyurethane or silicone polymers may also be used conveniently.
Polimerni pripravak se može načiniti npr., miješanjem plastifikatora s polimerom. Miješanje se pogodno obavlja na povišenoj temperaturi od 60-150°C. Polimerni pripravci mogu sadržavati dodatna konvencionalna unutrašnja ili vanjska maziva, stabilizatore i slično. Primjeri stabilizatora uključuju cink-dioktanoat, cink-distearat, kalcij-distearat i njihove smjese, N,N'-diaciletilendiamine koji poželjno imaju palmitoil ili stearoil skupine u acil skupinama, epoksidirana ulja, npr., sojino ulje, laneno ulje. A polymer preparation can be made, for example, by mixing a plasticizer with a polymer. Mixing is conveniently done at an elevated temperature of 60-150°C. Polymer preparations may contain additional conventional internal or external lubricants, stabilizers and the like. Examples of stabilizers include zinc dioctanoate, zinc distearate, calcium distearate and mixtures thereof, N,N'-diacylethylenediamines preferably having palmitoyl or stearoyl groups in the acyl groups, epoxidized oils, eg, soybean oil, linseed oil.
Polimerni pripravci se mogu oblikovati u artikle za biomedicinsku primjenu pogodno istiskivanjem, npr., u filmove. Kada se takvi filmovi upotrebljavaju za proizvodnju vrećica za krv, filmovi moraju biti minimalno debeli oko 0,35 mm. Kada pripravci trebaju za proizvodnju epruveta, takve epruvete se također mogu proizvesti istiskivanjem i debljina stijenke epruvete se može podesiti prema potrebi. Tipično za primjenu u dijalizi epruveta ima unutrašnji promjer oko 4,5-5 mm i vanjski promjer oko 8-8 mm, tj., debljina stjenke epruvete je oko 0,5-1,8 mm. The polymer compositions can be formed into articles for biomedical applications by convenient extrusion, eg, into films. When such films are used for the production of blood bags, the films must have a minimum thickness of about 0.35 mm. When the preparations are needed for the production of test tubes, such test tubes can also be produced by extrusion and the wall thickness of the test tube can be adjusted as needed. Typically for use in dialysis, the tube has an inner diameter of about 4.5-5 mm and an outer diameter of about 8-8 mm, i.e., the wall thickness of the tube is about 0.5-1.8 mm.
Istiskivanje pripravka se pogodno obavlja na temperaturi 120-190°C. Extrusion of the preparation is conveniently performed at a temperature of 120-190°C.
Polimerni pripravci iz sadašnjeg izuma koji sadrže piromelitatne estere kao plastifikatore mogu se upotrebljavati za proizvodnju mnogih artikala za biomedicinsku primjenu kao što su epruvete, pokretljive epruvete, vrećice, kateteri, ploče, rotametri i ostale takve komponente koje su potrebite za direktnu upotrebu i/ili pribori za djelovanje bilo koje naprave za biomedicinsku primjenu uključujući dijalizu, enteralnu ili parenteralnu prehranu, vantjelesni krvotok, umjetne organe i slično. The polymer compositions of the present invention containing pyromellitic esters as plasticizers can be used to manufacture many articles for biomedical applications such as test tubes, movable tubes, bags, catheters, plates, rotameters and other such components that are required for direct use and/or accessories. for the operation of any device for biomedical application including dialysis, enteral or parenteral nutrition, extracorporeal blood flow, artificial organs and the like.
U drugoj primjeni, sadašnji izum se odnosi na bilo koji oblikovani artikl koji je proizveden iz polimernih pripravka koji su gore zaštićeni i opisani. In another application, the present invention relates to any molded article that is manufactured from the polymeric compositions as claimed and described above.
Sadašnji izum je dalje prikazan slijedećim Primjerima. The present invention is further illustrated by the following Examples.
Primjer : Example:
Proizvedena su dva tipa epruvete za dijalizu uz pomoć konvencionalnih tehnika istiskivanja upotrebom različitih pripravaka. Upotrijebljeni pripravci su prikazani niže: Two types of dialysis tubes were produced using conventional extrusion techniques using different formulations. The preparations used are shown below:
[image] [image]
Opaske: PVC - Polivinil-klorid Notes: PVC - Polyvinyl chloride
TOPM - Tetraoktilpiromelitat TOPM - Tetraoctylpyromellitate
* - Registrirano trgovačko ime * - Registered trade name
S.T. 88 - Načinjem homogenim miješanjem kalcij-stearata (66% w/w) i cink-stearata (34% w/w) u obliku prašaka. S.T. 88 - Made by homogenously mixing calcium stearate (66% w/w) and zinc stearate (34% w/w) in powder form.
Homogenizacija pripravaka se postiže kod miješanja, dok su granulacija i temperatura istiskivanja prikazani niže: Homogenization of preparations is achieved during mixing, while granulation and extrusion temperature are shown below:
[image] [image]
Dobivene epruvete su imale slijedeće osobine : The test tubes obtained had the following characteristics:
[image] [image]
Proizvedene su nadalje epruvete za dijalizu sličnih dimenzija upotrebom PVC pripravaka koji sadrže plastifikatore dioktil-ftalat (DOP) i trioktiltrielitat (TOTM) tako da se upoređuju njihive osobine s epruvetama koje sadrže tetraoktil-piromelitat (TOPM). Upotrebljeni su slični pripravci s onima za gornju Epruvetu 1, ali su u svakom slučaju količine PVC i plastifikatora bile : Furthermore, dialysis tubes of similar dimensions were produced using PVC preparations containing the plasticizers dioctyl-phthalate (DOP) and trioctyltriellite (TOTM), so that their properties were compared with tubes containing tetraoctyl-pyromellitate (TOPM). Similar preparations were used as those for the above Test Tube 1, but in each case the amounts of PVC and plasticizer were:
DOP -45 kg PVC - 75 kg DOP - 45 kg PVC - 75 kg
TOTM -54 kg PVC - 75 kg TOTM -54 kg PVC - 75 kg
TOPM -35,526 kg PVC - 50 kg TOPM -35,526 kg PVC - 50 kg
Dobivene epruvete su testirane na njihovo gubljenje plastifikatora ekstrakcijom kada su u dodiru s volovskom krvi koja kruži kroz svaku od ovih epruveta termostatiranih na 37°C tijekom 4 sata brzinom od 15 minuta po ciklusu. Rezultati su pokazali daje brzina ekstrakcije plastifikatora kako slijedi : The resulting tubes were tested for their loss of plasticizer by extraction when in contact with ox blood circulating through each of these tubes thermostated at 37°C for 4 hours at a rate of 15 minutes per cycle. The results showed that the rate of plasticizer extraction is as follows:
TOPM se ekstrahira u količini koja je od 90-98% manja od DOP, dok se TOPM ekstrahira u količini koja je od 70-80% manja od TOTM. TOPM is extracted in an amount that is 90-98% less than DOP, while TOPM is extracted in an amount that is 70-80% less than TOTM.
Radi testiranja mogućnosti ekstrakcije ili raspodjele plastifikatora uz pomoć bioloških tekućina, osobito krvi, može se pretpostaviti da je krv bitno sastavljena od dvije komponente : hidrofilne komponente i lipofilne komponente u omjeru 90 : 10. Testovi se zato obavljaju upotrebom čistih plastifikatora za određivanje sposobnosti ekstrakcije ili raspodjele mućkanjem plastifikatora s 50/50 w/w smjese homogena hidrofilna (voda)/lipofilna (maslinovo ulje) disperzija. U ovim pokusima, koji su rađeni prema najgorem scenariju (radi njihovog relativno visokog lipofilnog sadržaja), rezultati su pokazali da je ekstrakcija/raspodjela odgovarajućih plastifikatora uz pomoć homogene disperzije bila kako slijedi : In order to test the possibility of extracting or distributing plasticizers with the help of biological fluids, especially blood, it can be assumed that blood is essentially composed of two components: hydrophilic components and lipophilic components in a ratio of 90:10. The tests are therefore performed using pure plasticizers to determine the ability to extract or distribution by shaking the plasticizer with a 50/50 w/w mixture of homogeneous hydrophilic (water)/lipophilic (olive oil) dispersion. In these experiments, which were performed according to the worst case scenario (due to their relatively high lipophilic content), the results showed that the extraction/distribution of the respective plasticizers with the help of homogeneous dispersion was as follows:
TOPM se ekstrahira/raspodjeljuje u lipofilnoj fazi u količini koja je 75-85% niža od DOP, dok se TOPM ekstrahira u istoj fazi u količini koja je 55-65% niža od TOTM. TOPM is extracted/distributed in the lipophilic phase in an amount that is 75-85% lower than DOP, while TOPM is extracted in the same phase in an amount that is 55-65% lower than TOTM.
Ekstrakcija/raspodjela plastifikatora u- hidrofilnoj fazi je relativno zanemariva. The extraction/distribution of the plasticizer in the hydrophilic phase is relatively negligible.
Poznato je da je akutna toksičnost ovih plastifikatora za miševe reda DOP>TOTM>TOPM. Tako, pored toga što su manje toksični za biološke procese nego ostala dva dobro poznata PVC plastifikatora, ovi rezultati pokazuju da se TOPM također ekstrahira u značajno manjoj količini uz pomoć bioloških tekućina. Nastaje sinergizam ekstrakcija toksičnost i zato su rezultati čak povoljniji kada se upotrebljava TOPM. The acute toxicity of these plasticizers to mice is known to be in the order DOP>TOTM>TOPM. Thus, in addition to being less toxic to biological processes than the other two well-known PVC plasticizers, these results show that TOPM is also extracted in a significantly smaller amount with the help of biological fluids. The synergism of toxicity extraction is created and that is why the results are even more favorable when TOPM is used.
Claims (10)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT8920105A IT1230071B (en) | 1989-04-11 | 1989-04-11 | Polymer compsn. contg. pyromellitate ester as plasticiser |
| IT1976090A IT1240337B (en) | 1990-03-22 | 1990-03-22 | Polymer compsn. contg. pyromellitate ester as plasticiser - has biomedical application due to minimal plasticiser migration when article is in contact with biological material |
| YU71490A YU47181B (en) | 1989-04-11 | 1990-04-11 | PLASTIC POLYMER PREPARATION FOR THE PRODUCTION OF FORMED ITEMS FOR BIOMEDICAL APPLICATION |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP921367A2 true HRP921367A2 (en) | 1995-12-31 |
Family
ID=27273000
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HR921367A HRP921367A2 (en) | 1989-04-11 | 1992-11-26 | Plasticized polymer compositions |
Country Status (2)
| Country | Link |
|---|---|
| HR (1) | HRP921367A2 (en) |
| SI (1) | SI9010714A (en) |
-
1990
- 1990-04-11 SI SI9010714A patent/SI9010714A/en unknown
-
1992
- 1992-11-26 HR HR921367A patent/HRP921367A2/en not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| SI9010714A (en) | 1997-08-31 |
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