Particulate and Microbial Contamination in In-Use Admixed Intravenous Infusions(Biopharmacy)
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概要
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We compared particulate and microbial contamination in residual solutions of peripheral intravenous admixtures after the termination of drip infusion between intravenous fluids admixed with glass ampoule drugs and those admixed with pre-filled syringe drugs. The mean number of particles ≥1.3μm in diameter per 1ml of residual solution was 758.4 for fluids (n=60) admixed with potassium chloride in a glass ampoule (20ml volume), 158.6 for fluids (n=63) admixed with potassium chloride in a pre-filled syringe (20ml volume), 736.5 for fluids (n=66) admixed with sodium chloride in a glass ampoule (20ml volume), 179.2 for fluids (n=15) admixed with sodium chloride in a pre-filled syringe (20ml volume), 1884.5 in fluids (n=30) admixed with dobutamine hydrochloride in 3 glass ampoules (5ml volume), and 178.9 (n=10) in diluted dobutamine hydrochloride in pre-filled syringes (50ml volume: For these samples alone, particulate and microbial contamination were evaluated in sealed products.) Thus, for potassium chloride or sodium chloride for injection, the number of particles ≥1.3μm in diameter in the residual intravenous solution was significantly higher for fluids admixed with glass ampoule drugs than for those admixed with pre-filled syringe drugs (p<0.0001). For dobutamine hydrochloride for injection, the number of particles ≥1.3μm in diameter in the residual intravenous solution was estimated to be higher for fluids admixed with its glass ampoule drug than for those admixed with its pre-filled syringe drug. Observation of the residual solutions of fluids admixed with potassium chloride, sodium chloride, or dobutamine hydrochloride in glass ampoules using an electron microscope with an X-ray analyzer showed glass fragments in each residual solution. Therefore, for the prevention of glass particle contamination in peripheral intravenous admixtures, the use of pre-filled syringe drugs may a useful method. No microbial contamination was observed in any of the residual solutions of 5 types of admixture.
- 公益社団法人日本薬学会の論文
- 2006-11-01
著者
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OIE Shigeharu
Department of Pharmacy, Yamaguchi University Hospital
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KAMIYA Akira
Department of Pharmacy, Yamaguchi University Hospital
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Kamiya Akira
山口大学医学部附属病院 薬剤部
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Oie Shigeharu
Yamaguchi Univ. Hospital Ube Jpn
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Oie Shigeharu
Department Of Pharmacy Yamaguchi University Hospital
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Kamiya Akira
Department Of Biomedical Engineering University Of Tokyo
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IMAMURA Akihisa
Department of Pharmacy, Yamaguchi University School of Medicine
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Imamura Akihisa
Department Of Pharmacy Saiseikai Yamaguchi General Hospital
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YORIOKA Katsuhiro
Department of Pharmacy, Saiseikai Yamaguchi General Hospital
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OOMAKI Masafumi
Department of Pharmacy, Saiseikai Yamaguchi General Hospital
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Oomaki Masafumi
Department Of Pharmacy Saiseikai Yamaguchi General Hospital
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