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聚氯乙烯医疗器械新型增塑剂的体外评价

An in vitro evaluation of a new plasticizer for polyvinylchloride medical devices.

作者信息

Jacobson M S, Kevy S V, Parkman R, Wesolowski J S

出版信息

Transfusion. 1980 Jul-Aug;20(4):443-7. doi: 10.1046/j.1537-2995.1980.20480260277.x.

DOI:10.1046/j.1537-2995.1980.20480260277.x
PMID:7404643
Abstract

The rate of Hatcol-200 (H-200) leaching from polyvinylchloride (PVC) by serum is one-hundredth that of di-2-ethylhexyl phthalate (DEHP) as determined by radioassay. There is a proportional decrease in leachability of DEHP but not of H-200 as the plasma proteins are diluted. Saline extracts of DEHP demonstrated a low but progressive rate of leaching with an accumulation of 11 microgram/ml after seven weeks whereas H-200 showed only a constant residue of 0.35 microgram/ml. Normal human serum incubated for three weeks at 37 C with PVC strips plasticized with DEHP produced significant growth-inhibition of human diploid fibroblasts. Human serum incubated in an identical manner with PVC plasticized with H-200 for up to four weeks demonstrated no effect on tissue culture. These studies indicate that H-200 deserves further evaluation as a replacement for DEHP in PVC biomedical devices.

摘要

通过放射性测定法确定,血清从聚氯乙烯(PVC)中浸出Hatcol-200(H-200)的速率是邻苯二甲酸二(2-乙基己基)酯(DEHP)的百分之一。随着血浆蛋白被稀释,DEHP的浸出率成比例下降,但H-200的浸出率没有下降。DEHP的盐水提取物显示出较低但持续的浸出速率,七周后积累量为11微克/毫升,而H-200仅显示出0.35微克/毫升的恒定残留量。在37℃下,用DEHP增塑的PVC条与正常人血清孵育三周,对人二倍体成纤维细胞产生了显著的生长抑制作用。以相同方式用H-200增塑的PVC与人血清孵育长达四周,对组织培养没有影响。这些研究表明,H-200作为PVC生物医学装置中DEHP的替代品值得进一步评估。

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