低温蒸汽甲醛灭菌后的甲醛残留分析  

Analysis of formaldehyde residue after low temperature steam formaldehyde sterilization

作　　者：鲍丽克 刘学玲 卢冰[3] 张红[4] BAO Li-ke;LIU Xue-ling;LU Bing(Central Sterile Supply Department,Zibo Maternal and Child Health Hospital,Zibo 255433,China;不详)

机构地区：[1]淄博市妇幼保健院消毒供应中心,山东淄博255433 [2]淄博市妇幼保健院护理部,山东淄博255433 [3]淄博市妇幼保健院医务科,山东淄博255433 [4]淄博市妇幼保健院妇产科,山东淄博255433

出　　处：《中国医学装备》2023年第8期159-165,共7页China Medical Equipment

摘　　要：目的:分析确定低温蒸汽甲醛灭菌载体表面甲醛残留量,为医院低温蒸汽甲醛灭菌的正确使用提供依据。方法:载体样品灭菌后用水浸泡提取,以2,4-二硝基苯肼乙腈溶液(含5%乙酸)进行衍生,采用ZORBAX C18(4.6 mm×250 mm,5μm)色谱柱分离,流动相为乙腈-水(65∶35,V∶V),进样量5μl,流速1.0 ml/min,柱温35℃,采用高效液相色谱法(HPLC)测定不同规格不锈钢管、聚四氟乙烯管、硅胶管、滤纸、纸塑包装袋和无纺布不同载体灭菌完成后表面的甲醛残留含量。结果:甲醛浓度在0~5.0μg/ml范围内与峰面积呈良好线性关系,R^(2)=0.9992,检测限为0.060μg/ml;加标量为10~50μg时,平均回收率在100.35%~110.83%之间。各材质对甲醛的脱附能力大小顺序为:不锈钢≈聚四氟乙烯>无纺布>硅胶>纸塑包装袋>滤纸,其中滤纸样品中甲醛残留量最高,为0.012900g/m^(2),未超出医药行业标准中滤纸的0.0520 g/m^(2)浓度限值。结论:个体样本之间的甲醛残留浓度存在差异,与灭菌物品摆放位置关联不明显,且均符合医药行业标准的浓度要求。经低温蒸汽甲醛灭菌后的物品表面甲醛残留量在安全限值以下,符合使用标准。Objective:To analyze and determine the formaldehyde residue on the surface of carriers after low temperature steam formaldehyde sterilization.Methods:The sample was soaked in water for extraction after sterilization,derivatized with 2,4-dinitrophenylhydrazine in acetonitrile(containing 5%acetic acid),and separated on a ZORBAX C18 column(4.6 mm×250 mm,5μm)with a mobile phase of acetonitrile-water(65:35,V:V),an injection volume of 5μl and a flow rate of 1.0 ml/min at 35℃.The formaldehyde residual content on the surface of stainless steel pipe(different specifications),polytetrafluoroethylene(PTFE)pipe,silica gel pipe,filter paper,paper plastic packaging bag and non-woven fabric was determined after sterilization by high performance liquid chromatography(HPLC).Results:A good linear relationship existed between the formaldehyde concentration in the range of 0~5.0μg/ml and peak area with a r2 of 0.9992,and the limit of detection was 0.060μg/ml.The average recovery was 100.35%to 110.83%when the scalar quantity was between 10μg and 50μg.The order of the desorption capacity of each material to formaldehyde was determined as follows,stainless steel≈PTFE>non-woven fabric>silica gel>paper-plastic packaging bag>filter paper.Among them,the formaldehyde residue in the filter paper sample was the highest at 0.012900 g/m2,which did not the pharmaceutical industry standard concentration limit for filter paper of 0.0520 g/m2.Conclusion:There was difference in the residual formaldehyde concentration among individual samples,with no obvious correlation with placement of the sterilized articles,and all were within the concentration range as required in pharmaceutical industry standards.The residual amount of formaldehyde on the surface of articles after low-temperature steam formaldehyde sterilization was below the safety limit,which met the use standard.

关 键 词：高效液相色谱法(HPLC) 甲醛残留 灭菌 检测限 

分 类 号：R187[医药卫生—流行病学]