Particulate and microbial contamination in in-use admixed parenteral nutrition solutions

Particulate and microbial contamination in in-use admixed parenteral nutrition solutions
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DOI:
10.1248/bpb.28.2268
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发表时间:
2005-12-01
影响因子:
2
通讯作者:
Kamiya, A
Kamiya, A
中科院分区:
医学4区
文献类型:
--
作者:
Oie, S;Kamiya, A

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我们评估了10家医院共192份输液袋中剩余的混合和未混合肠外营养液的颗粒和微生物污染。192种混合溶液中使用的药物玻璃安瓿、塑料安瓿和小瓶的平均数量(范围)分别为3.38(1-13)、0.79(0-7)和1.2(0-8)。平均粒子数(范围)中包含192个样本根据粒子大小(直径)为960.9(30 - 9539)/毫升粒子> = 1.3μm, 42.8(0 - 587) /毫升5μm, 6.4(0 - 146) /毫升的> = 10μm和0.09(0 - 1)/毫升的> = 50μm。粒子数> = 1.3μm在192样品直径明显高于7样品(控制)的解决方案不与任何安瓿或小瓶混合(p < 0.0001)。4 ~ 13个玻璃安瓿溶液样品中直径>= 1.3 μ m的颗粒数显著高于1 ~ 3个玻璃安瓿溶液样品(p < 0.01)。另一方面,199个样品中没有细菌或真菌/5毫升残留溶液。有必要采取措施防止混合肠外营养液的微粒污染。
We evaluated particulate and microbial contamination in a total of 192 samples of in-use admixed and un-admixed parenteral nutrition solutions remaining in infusion bags in 10 hospitals. The mean numbers (range) of drug glass ampoules, plastic ampoules, and vials used in a total of 192 admixed solutions were 3.38 (1-13), 0.79 (0-7), and 1.2 (0-8), respectively. The mean number of particles (range) contained in the 192 samples according to the particle size (diameter) was 960.9 (30-9539)/ml for particles >= 1.3 mu m, 42.8 (0-587)/ml for those 5 mu m, 6.4 (0-146)/ml for those >= 10 mu m, and 0.09 (0-1)/ml for those >= 50 mu m. The number of particles >= 1.3 mu m in diameter was significantly higher in the 192 samples than in 7 samples (controls) of solutions not mixed with any ampoule or vial (p < 0.0001). In addition, the number of particles >= 1.3 mu m in diameter was significantly higher in samples of solutions mixed with 4-13 glass ampoules than in those of solutions mixed with 1-3 glass ampoules (p < 0.01). On the other hand, none of the 199 samples showed bacteria or fungi/5 ml residual solution. Measures against particulate contamination of admixed parenteral nutrition solutions are necessary.