| The most widely used PVC plasticizers are dibutylphthalate ester, which is applied to plasticized PVC in medical infusion devices. However, the dibutylphthalate ester plasticizer has been identified as a possible carcinogen by International Agency for Research on Cancer. During the usage of plasticized PVC products, the plasticizer may occur migration, extraction or volatile, so the dibutylphthalate ester plasticized PVC products are prohibited to be used in medical field. Therefore, it is vital to develop a novel environmentally friendly non-toxic plasticizer.In this paper, a novel plasticizer, cyclohexane-1,2-dicarboxylate iso-octyl (DEHCH), was successfully prepared through reversible esterification reaction of cyclohexane dicarboxylic anhydride and isooctanol with sulfuric acid as a catalyst, and the optimum formula are used to the practical production of medical products. According to the medical intubation product standards, the optimum formula of DEHCH and epoxidized soybean oil (ESO) plasticizing system for preparing pellets medical intubation are explored and tested. Two kinds of polyester polyurethane (Bayer 80A and Coating TB-82AD) are further used to modify the PVC material plasticized by the aforementioned formula, and the transparency, mechanical properties, low temperature resistance, microstructure and toxicological properties of the blends are fully investigated.Here are the conclusions:(1) The optimum reaction conditions for the synthesis of DEHCH:molar ratio of hexahydrophthalic anhydride and isooctyl alcohol was 1:2.4, the amount of concentrated sulfuric acid was 0.5wt% of hexahydrophthalic anhydride, the reaction temperature and reaction time were 170℃ and 1.5 h. The esterification rate of this optimum reaction conditions was 98.99%.(2) The structure of esterified product was identified by infrared spectroscopy, organic elemental analysis and nuclear magnetic resonance, which was determined to be 1,2-dicarboxylate dioctyl. The purity of DEHCH in the product was nearly 100%, which was analyzed by gas chromatography and mass spectrometry. Moreover, the product has heterogeneous structures, and the ratio of cis and trans is controlled to be over 100:1.(3)Toxicological properties of synthetic plasticizers submission, obtain a long-term toxicity studies in rats, Y7 high-dose group and the control group of liver periportal inflammatory cell infiltration, focal inflammatory cell infiltration in the heart, lung focal inflammatory cell infiltration animals spontaneous lesions are not caused by adverse drug reactions. These results indicate that high doses of Y7 has no organ toxicity in rats by check, TI value lower than rats 50L · kg-1 · d-1.(4) Plasticized comparative tests show, DEHCH have similar plasticizing properties with other common non-toxic PVC plasticizers. It can replace traditional phthalate ester plasticizers to use in the application of PVC medical materials. Modified polyester urethane systems, with the increase of addition amount of Bayer 80A and Coating TB-82AD, the tensile strength of the blend remains substantially unchanged, the elongation at break gradually increased, the two kinds of polyester polyurethane has improve the low-temperature impact strength of the material, reducing its brittleness temperature, which brittleness temperature PVC/TPU (Bayer 80A) system, the largest decline was 7.5℃.(5) For widely used medical apparatus tracheal intubation. Using DEHCH to explore the formula, and reference to the standard of national product performance, that obtain the optimal formula. Test the product of the dissolution amount detection and toxicological, in simulated conditions of use clinical limit, by simulated body fluid as extraction medium, plasticizer of DEHCH dissolution for the total set of 1.40μg. |
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