Hansen E W, Nielsen P L
Royal Danish School of Pharmacy, Department of Biology, Copenhagen, Denmark.
J Clin Pharm Ther. 1987 Oct;12(5):325-31. doi: 10.1111/j.1365-2710.1987.tb00544.x.
Microbial contamination of total parenteral nutrition including fat emulsions in 1-3 litres plastic infusion bags (the i.v. bag) was studied during production in the pharmacy and administration both at home and in the hospital. Production contamination was investigated by dispensing test bags containing growth medium mixed with dextrose-salt solution. In this highly sensitive system, contamination was detected in less than 4% of cases. In-use contamination was estimated at the end of the infusion. The average contamination rate (+/- growth) in the five patients studied was 6.7% accompanied by considerable variation. Identification of the contaminants revealed that 85% of the contaminated bags contained staphylococci, indicating skin contamination. An investigation on the effect of the procedure used for attaching the infusion set on the contamination rate, was carried out with bags that contained sterile growth medium. This showed no contamination in 14 cases indicating the catheter as the most plausible source of contamination. It is concluded that both production in the community pharmacy and administration in the home are not associated with a higher microbial contamination than in central hospitals. It is, however, recommended that the microbial quality of the production process and the administration procedure are regularly monitored.
对药房生产过程中以及家庭和医院给药过程中，1 - 3升塑料输液袋（静脉输液袋）中全胃肠外营养制剂（包括脂肪乳剂）的微生物污染情况进行了研究。通过分发装有与葡萄糖 - 盐溶液混合的生长培养基的测试袋来调查生产过程中的污染情况。在这个高度敏感的系统中，不到4%的案例检测到污染。在输液结束时估计使用过程中的污染情况。所研究的5名患者的平均污染率（±生长）为6.7%，且存在相当大的差异。对污染物的鉴定表明，85%的受污染袋子含有葡萄球菌，表明是皮肤污染。使用装有无菌生长培养基的袋子，对连接输液器的操作程序对污染率的影响进行了调查。结果显示14个案例中未出现污染，表明导管是最有可能的污染源。结论是，社区药房的生产和家庭给药与中心医院相比，微生物污染并不更高。然而，建议定期监测生产过程和给药程序的微生物质量。
