乙二胺四乙酸二钠对异丙酚脂肪乳注射液污染微生物的影响

The Antimicrobial Effects of EDTA in Propofol Fat Emulsion Injection: An In Vitro Study

目的研究比较含和不含乙二胺四乙酸二钠(EDTA)的异丙酚脂肪乳注射液对微生物的影响。方法参照《中国药典》2015年版四部1121'抑菌效力检查法',以大肠埃希菌、铜绿假单胞菌、金黄色葡萄球菌、黑曲霉和白色念珠菌为试验菌,对含和不含EDTA的异丙酚脂肪乳注射液各3批样品进行试验菌接种后12 h的存活菌数测定。结果供试品接种12 h后,与0 h比较,含EDTA的样品存活菌数均未增加,其中铜绿假单胞菌、大肠杆菌和白色念珠菌降低了约0. 5 lg值;不含EDTA的样品除存活菌数除黑曲霉未增加外,金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌和白色念珠菌分别增加了0. 5、0. 4、0. 6、1. 6 lg值。结论与不含EDTA的异丙酚脂肪乳注射液相比,含EDTA的样品可降低意外污染引起的感染。但是,不能降低所有致病性威胁。

OBJECTIVE To research and compare the antimicrobial effects of propofol fat emulsion injection(PFEI)which contains disodium edetate(EDTA)or not.METHODS According to the requirements of Antimicrobial Effectiveness in 2015 edition of Chinese Pharmacopoeia(Ch.P volume 4,1121),Escherichia coli,Pseudomonas aeruginosa,Staphylococcus aureus,Aspergillus niger and Candida albicans were used as the test microorganisms,the number of viable microorganisms in 3 batches of PFEI with and without EDTA was determined at 12 h after inoculation.RESULTS Compared with zero hour,the number of viable microorganisms in PFEI which contains EDTA didn’t increase at 12 h,therein the number of Pseudomonas aeruginosa,Escherichia coli and Candida albicans increased by about 0.5 lg;however,the number of Staphylococcus aureus,Pseudomonas aeruginosa,Escherichia coli and Candida albicans in the samples without EDTA increased by 0.5,0.4,0.6 and 1.6 lg respectively,except for Aspergillus niger which did not increase.CONCLUSION Compared with PFEI without EDTA,the samples containing EDTA may reduce the risk of infection caused by accidental contamination.However,it cannot reduce all pathogenic threats for propofol preparations.