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。
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 at9 th 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.
出处
《中国药房》
CAS
北大核心
2016年第1期137-139,共3页
China Pharmacy
