环氧乙烷在*及卫生用品的消毒方面应用广泛。在药品包装材料生产领域,部分药品包装材料厂生产的口服药用塑料瓶,在内包装后也进行环氧乙烷灭菌。环氧乙烷穿透性强,消毒后因被消毒材料对其吸附能力不同,其完全消散时间也不相同。残留的环氧乙烷对人体有一定毒性。
浩瀚色谱(山东)应用技术开发有限公司采用SE-30毛细管柱,测定口服药用塑料瓶中环氧乙烷残留量,结果在0.4173~12.519μg.mL-1内呈线性关系(r=0.9996);平均回收率为99.7%,RSD=0.3%。结论该方法准确、灵敏、简便,适用于对口服药用塑料瓶中环氧乙烷残留量的检测。
Ethylene oxide is widely used in the disinfection of medical devices and sanitary products. In the field of pharmaceutical packaging materials production, some pharmaceutical plastic bottles produced by pharmaceutical packaging materials factories are also sterilized with ethylene oxide after being packaged inside. Ethylene oxide has strong penetrability, and its complete dissipation time is different due to the different adsorption capacity of the sterilized material after disinfection. The residual ethylene oxide is toxic to human body.
Haohan Chromatographic (Shandong) Application Technology Development Co., Ltd. used SE-30 capillary column to determine the residual ethylene oxide in oral pharmaceutical plastic bottles. The results were 0.4173~12.519 μ There is a linear relationship in g.mL-1 (r=0.9996); The average recovery was 99.7%, RSD=0.3%. Conclusion The method is accurate, sensitive, simple and suitable for the determination of ethylene oxide residues in oral plastic bottles.