Screening study on hemolysis suppression effect of an alternative plasticizer for the development of a novel blood container made of polyvinyl chloride

• Published in: Journal of biomedical materials research. Part B, Applied biomaterials Applied biomaterials, 2014-05, Vol.102 (4), p.721-728
• Main Authors: Haishima, Yuji, Kawakami, Tsuyoshi, Hasegawa, Chie, Tanoue, Akito, Yuba, Toshiyasu, Isama, Kazuo, Matsuoka, Atsuko, Niimi, Shingo
• Format: Article
• Language: English
• Subjects: Adenine; alternative plasticizer; Benzoates - pharmacology; Biological and medical sciences; Biomedical materials; blood container; Blood Preservation - instrumentation; Citrates; Cyclohexanecarboxylic Acids - pharmacology; DEHP; Depression, Chemical; Dicarboxylic Acids - pharmacology; Diethylhexyl Phthalate - pharmacology; Diethylhexyl Phthalate - toxicity; Gas Chromatography-Mass Spectrometry; Glucose; hemolysis; Hemolysis - drug effects; Heparin; Humans; Inosine Nucleotides - pharmacology; Mannitol; Materials research; Materials science; Medical sciences; Oxazoles - pharmacology; Plasticizers - chemistry; Plasticizers - pharmacology; Polyvinyl Chloride; PVC medical device; Pyrimidinones - pharmacology; Structure-Activity Relationship; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Technology. Biomaterials. Equipments
• ISSN: 1552-4973; 1552-4981
• DOI: 10.1002/jbm.b.33052

The aim of this study is to identify a plasticizer that is effective in the suppression of the autohemolysis of the stored blood and can be used to replace di(2-ethylhexyl) phthalate (DEHP) in blood containers. The results of hemolysis test using mannitol-adenine-phosphate/red cell concentrates (MAP/RCC) spiked with plasticizers included phthalate, phthalate-like, trimeliate, citrate, and adipate derivatives revealed that di-isononyl-cyclohexane-1,2-dicarboxylate (Hexamoll(®) DINCH), di(2-ethylhexyl)-1,2,3,6-tetrahydro-phthalate (DOTP), and diisodecyl phthalate (DIDP) exhibited a hemolysis suppression effect almost equal to that of DEHP, but not other plasticizers. This finding suggested that the presence of 2 carboxy-ester groups at the ortho position on a 6-membered ring of carbon atoms may be required to exhibit such an effect. The hemolytic ratios of MAP/RCC-soaked polyvinyl chloride (PVC) sheets containing DEHP or different amounts of DINCH or DOTP were reduced to 10.9%, 9.2-12.4%, and 5.2-7.8%, respectively (MAP/RCC alone, 28.2%) after 10 weeks of incubation. The amount of plasticizer eluted from the PVC sheet was 53.1, 26.1-36.5, and 78.4-150 µg/mL for DEHP, DINCH, and DOTP, respectively. PVC sheets spiked with DIDP did not suppress the hemolysis induced by MAP/RCC because of low leachability (4.8-6.0 µg/mL). These results suggested that a specific structure of the plasticizer and the concentrations of least more than ∼10 µg/mL were required to suppress hemolysis due to MAP/RCC.