PIVAS使用非PVC双阀软袋包装输液后的无菌检查研究
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篇名: PIVAS使用非PVC双阀软袋包装输液后的无菌检查研究
TITLE:
摘要: 目的:研究静脉药物集中调配中心(PIVAS)使用非PVC双阀软袋包装输液后的无菌检查情况。方法:按照输液的包装类型和配制环境将试验分为3组,每组320份。第1组采用非PVC双阀软袋葡萄糖液,于PIVAS配制;第2组采用非PVC双阀软袋葡萄糖液,于病区配制;第3组采用塑瓶葡萄糖液,于病区配制。穿刺1、3、6、9次后将输液成品(n=80)分别放置在病区环境中0、2、4、6 h(n=20),按照2010版《中国药典》(二部)无菌检查法项下薄膜过滤法进行无菌检查,并分析3组输液穿刺9次时的污染情况。结果:第1组无菌生长,第2、3组阳性检出率分别为2.5%和3.8%(n=320);穿刺1、3、6、9次后各组总的阳性检出率分别为0、0.4%、0.4%、7.5%(n=240),第1组阳性检出率均为0(n=80),第2组分别为0、1.25%、0、8.75%(n=80),第3组分别为0、0、1.25%、13.75%(n=80);穿刺9次时分别放置0、2、4、6 h后第1组的阳性检出率均为0(n=20),第2组分别为25%、5%、0、5%(n=20),第3组分别为5%、15%、5%、30%(n=20)。结论:在PIVAS使用非PVC双阀软袋输液可有效预防微生物污染。
ABSTRACT: OBJECTIVE: To study sterility test after using Non-PVC bivalve soft-bag injection in PIVAS. METHODS: The test was divided into 3 groups according to the type of transfusion solution packaging and dispensing environment. Group 1 received Glucose solution using bivalve soft-bag, dispensed in PIVAS; group 2 received Glucose solution using bivalve soft-bag, dispensed in wards area; group 3 received Glucose solution using plastic bottle, dispensed in wards area. After puncturing 1, 3, 6, 9 times (n=80), finished products placed in ward for 0, 2, 4, 6 h (n=20), and then sterility test was conducted with membrane filtration method stated in second part of Chinese Pharmacopoeia (2010 edition). Infusion contamination of 3 groups was analyzed at 9th puncture. RESULTS: The growth of bacteria was not found in group 1; the positive detection rate of group 2 and 3 were 2.5% and 3.8% (n=320). The total positive detection rates after puncturing 1, 3, 6, 9 times were 0, 0.4%, 0.4%, 7.5% (n=240); the positive detection rates of group 1 were all 0, those of group 2 were 0,1.25%,0,8.75% and those of group 3 were 0,0,1.25%,13.75% (n=80). After 9 times of puncture, the positive detection rates of group 1 after placing 0, 2, 4, 6 h were all 0, those of group 2 were 25%,5%,0,5%; those of group 3 were 5%,15%,5%,30% (n=20). CONCLUSIONS: The use of the Non-PVC bivalve soft-bag injection in PIVAS can effectively prevent microbial contamination.
期刊: 2016年第27卷第1期
作者: 朱慧娟,黄蔚茹,张胜安,李荣,张爱玲,高巍,李艳玲
AUTHORS: ZHU Huijuan,HUANG Weiru,ZHANG Shengan,LI Rong,ZHANG Ailing,GAO Wei,LI Yanling
关键字: 静脉药物集中调配中心;非PVC双阀软袋包装输液;无菌检查
KEYWORDS: PIVAS; Non-PVC bivalve soft-bag injection; Sterility test
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