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ABSTRACT: The risk assessment of di(2-ethylhexyl)phthalate (DEHP) migrating from polyvinyl chloride (PVC) medical devices is an important issue. Many studies have been conducted to determine the level of DEHP migration. A recent report has indicated that DEHP in blood bags is hydrolyzed by esterase into mono(2-ethylhexyl)phthalate (MEHP). However, MEHP is thought to be even more toxic than the parent compound. Therefore, a method for the simultaneous determination of DEHP and MEHP was developed. The limits of quantification (LOQs) of DEHP and MEHP were 2.5 and 0.75 ng/ml, respectively. In this study, the effect of sterilization process on the levels of DEHP and MEHP migration was investigated. The level of migration of DEHP from gamma(gamma)-ray sterilized PVC sheet was low compared with that of the unsterilized control. By contrast, the level of MEHP migration from the gamma-ray sterilized PVC sheet was high compared with that of the unsterilized control. In addition, a high content of MEHP was found in the gamma-ray sterilized PVC sheet.
Journal of Pharmaceutical and Biomedical Analysis 06/2006; 41(2):455-60. · 2.97 Impact Factor
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Rie Ito, Fumie Seshimo,
Yuji Haishima,
Chie Hasegawa,
Kazuo Isama,
Takeshi Yagami,
Keisuke Nakahashi,
Haruko Yamazaki,
Koichi Inoue,
Yoshihiro Yoshimura,
Koichi Saito,
Toshie Tsuchiya,
Hiroyuki Nakazawa
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ABSTRACT: We attempted to determine the processing conditions for decreasing the migration of phthalate esters, particularly di-2-ethylhexyl phthalate (DEHP), from polyvinyl chloride (PVC) products using a drug solvent after dilution based on the package insert. PVC sheets and PVC tubing were subjected to optical irradiation (ultraviolet (UV), visible light irradiation) and heat treatment to determine whether they are deteriorated by these treatments. UV irradiation to one side of the PVC sheet decreased the levels of DEHP migration from the sheets by almost 50%, although the amount of DEHP content in PVC sheet was observed no significant change. On the other hand, the levels of DEHP migrating from the inner surface of PVC tubing UV-irradiated from the outer surface were not decreased compared with the control. Therefore, the surface structure was examined by conducting Fourier transform infrared spectroscopy (FT-IR), electron spectroscopy for chemical analysis (ESCA) and static angle of contact measurement. In FT-IR analysis, we found that the UV-irradiated PVC sheets were exhibited broadened absorption bands with time. In ESCA analysis, the chlorine content was decreased and the oxygen content was increased with time in UV-irradiated PVC sheets. Moreover, the other treated PVC sheets shows no significant change compared with the non-UV-irradiated PVC sheet. Therefore, the surface structure of the UV-irradiated PVC sheet was changed. As a result, the migration of DEHP from PVC products can be decreased with simple treatment, such as UV-irradiation. This could be a useful method to develop novel PVC products.
International Journal of Pharmaceutics 11/2005; 303(1-2):104-12. · 3.35 Impact Factor
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ABSTRACT: The risk assessment of di(2-ethylhexyl) phthalate (DEHP) that migrated from polyvinyl chloride (PVC) medical devices is an important issue for hospitalized patients. Many studies have been conducted to determine the level of DEHP migration. A recent report has indicated that DEHP in blood bags was hydrolyzed by esterase to mono(2-ethylhexyl) phthalate (MEHP). Therefore, a method for the simultaneous determination of DEHP and MEHP was developed. The migration of DEHP and MEHP from PVC tubing to drugs was examined. Although we detected MEHP in the drugs, we found no enzymatic activity involved in the migration process. Some reports have indicated that hydrolysis may have occurred during sterilization by autoclaving. However, we did not perform any heat treatment. It is speculated that the MEHP migrated directly from the PVC tubing. The simultaneous determination of DEHP and MEHP is required for risk assessment, as MEHP may be even more toxic than the parent compound.
Journal of Pharmaceutical and Biomedical Analysis 11/2005; 39(5):1036-41. · 2.97 Impact Factor
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Yuji Haishima, Fumie Seshimo,
Tae Higuchi,
Haruko Yamazaki,
Chie Hasegawa,
Shun-ichiro Izumi,
Tsunehisa Makino,
Keisuke Nakahashi,
Rie Ito,
Koichi Inoue,
Yoshihiro Yoshimura,
Koichi Saito,
Takeshi Yagami,
Toshie Tsuchiya,
Hiroyuki Nakazawa
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ABSTRACT: This study deals with the development of a simple method for predicting the elution levels of di-2-ethylhexyl phthalate (DEHP) from medical devices made of polyvinyl chloride (PVC) by using the physicochemical properties of pharmaceutical injections as a marker. GC-MS analysis showed that the release of DEHP from medical grade PVC product was concentration-dependently increased by extraction with two kinds of lipophilic injections (Sandimmun and Prograf) and three kinds of surfactants (HCO-60, Tween 80, and SDS). The solubility of lipophilic pigments such as Sudan III, methyl yellow, and 1,4-diamino-anthraquinone against these solutions were also increased in a concentration-dependent manner, in which methyl yellow showed the highest response regarding the increase of optical density (O.D.). Further, electrical conductivity and static contact angle to the PVC sheet of the solutions were also increased or decreased in the same manner. As a result of the comparative study, significant correlation was found between DEHP release levels and these three physicochemical properties, particularly methyl yellow solubility, of the solutions tested. To evaluate the relationship in detail, DEHP release levels from PVC tubing and methyl yellow solubility of 53 injections used in gynecologic and obstetric fields were determined. None of the hydrophilic medicines showed any significant release of DEHP, and all showed low solubility of methyl yellow. On the other hand, the lipophilic medicines releasing a large amount of DEHP showed high solubility of methyl yellow (greater than O.D. 0.8). These results indicate that a significant proportional relationship exists between DEHP release potency and methyl yellow solubility of pharmaceutical solutions, and the risk of DEHP exposure to the patients administered pharmaceuticals through transfusion set could be easily predicted by the solubility test without complicated elution tests of DEHP using GC-MS or LC-MS.
International Journal of Pharmaceutics 08/2005; 298(1):126-42. · 3.35 Impact Factor
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ABSTRACT: Apitherapy has become the focus of attention as a form of folk and preventive medicine for treating certain conditions and diseases as well as promoting overall health and well-being. In apitherapy, honey is the therapeutic agent used for dressing surgical wounds, burns or skin ulcers, as well as for dyspepsia, peptic ulcer, etc., because of its antioxidant activity. Therefore, it is important to determine the antioxidants in honey by analytical techniques. In the present study, the antioxidant activities of honeys from different floral sources were investigated by electron spin resonance (1,1-diphenyl-2-picrylhydrazyl (DPPH) and H2O2/NaOH/DMSO scavenging systems), liquid chromatography with coulometric array detection (LC-ED), and liquid chromatography with electrospray mass spectrometry (LC-MS). The antioxidant activities of some unifloral honeys (acacia, Chinese milk vetch, buckwheat and manuka) were evaluated using the radical scavenging systems. It was shown that DPPH radical scavenging activity was significantly different among the honeys, with buckwheat and manuka honeys having significantly higher scavenging activity than acacia honey. In addition, only manuka honey had specific scavenging activity for superoxide anion radicals. The compound responsible for this activity in manuka honey was identified by LC-ED and LC-MS. Careful examination of the LC-ED chromatographic patterns of manuka and other honey samples revealed a distinct peak in the chromatogram of manuka honey to be methyl syringate (MSYR). The radical scavenging activity of MSYR was specific for superoxide anion radicals, similar to the case of manuka honey. Copyright © 2005 Society of Chemical Industry
Journal of the Science of Food and Agriculture 04/2005; 85(5):872 - 878. · 1.44 Impact Factor
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Migaku Kawaguchi,
Shima Takahashi, Fumie Seshimo,
Norihiro Sakui,
Noriya Okanouchi,
Rie Ito,
Koichi Inoue,
Yoshihiro Yoshimura,
Shun-ichiro Izumi,
Tsunehisa Makino,
Hiroyuki Nakazawa
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ABSTRACT: A novel analytical method has been developed for the determination of 4-tert.-octylphenol (OP) and 4-nonylphenol (NP) in laboratory animal feed samples, which involves stir bar sorptive extraction (SBSE) followed by liquid desorption (LD) and column-switching liquid chromatography-mass spectrometry (CS-LC-MS) with solid-phase extraction (SPE). The method required correction by stable isotopically labeled surrogate standards, deuterium 4-tert.-octylphenol (OP-d) and [2H5] 4-(1-methyl)octylphenol (m-OP-d5). A feed sample was homogenized with methanol by ultrasonication. After centrifugation, the supernatant was subjected to extraction for 120 min at room temperature (25 degrees C) using a stir bar coated with polydimethylsiloxane. After the extraction, the analyte was desorbed from the stir bar by LD using acetonitrile. Then, the liquid sample was analyzed by CS-LC-MS with SPE. The average recoveries from laboratory feed samples spiked with OP and NP at 20 ng g(-1) were 99.5 and 103.8%, respectively, with correction using the added surrogate standards. The limits of quantification were 1 ng g(-1) for OP and 5 ng g(-1) for NP in feed sample. The measurement of OP and NP in commercial laboratory animal feed samples resulted in the detection of sub ng g(-1) NP
Journal of Chromatography 09/2004; 1046(1-2):83-8. · 4.53 Impact Factor
