含有尼龙6涂层的药品包装材料中己内酰胺单体浸出量的测定  

Determination of Caprolactam Monomer Leaching Amount in Pharmaceutical Packaging Materials Containing Nylon 6 Coating

作　　者：李颖 尹光 赵霞[1] LI Ying;YIN Guang;ZHAO Xia(Institute of Medical Excipients and Packaging Materials Testing,National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院药用辅料和包装材料检定所,北京100050

出　　处：《药品评价》2024年第11期1311-1315,共5页Drug Evaluation

基　　金：2024年度国家药品标准制修订研究课题(2024Y32-14)。

摘　　要：目的 建立高效液相色谱法测定多种含有尼龙6涂层药品包装材料中己内酰胺浸出量。方法 设定不同浸提条件,对收集到的两类含有尼龙6涂层的药品包装材料分别进行浸提,采用Waters XBridge C18色谱柱(4.6 mm×150 mm, 5μm);流动相:乙腈-水(20∶80);检测器:紫外检测器;检测波长:210 nm;流速:1.0 mL/min;柱温:30℃;进样量:10μL,对浸提液中己内酰胺单体含量进行测定。结果 己内酰胺在5.331~213.246μg/m L的浓度范围内线性良好(r=0.999 9),检出限为0.032μg/m L,精密度、稳定性RSD均小于1.0%,样品加标回收率为98.64%~102.48%。两类含有尼龙6涂层的药品包装材料中均未检出己内酰胺。结论 经方法学验证,本法可用于含有尼龙6涂层的药品包装材料中己内酰胺单体浸出量的测定。Objective To establish a method suitable for determining the leaching amount of caprolactam in various pharmaceutical packaging materials containing nylon 6 coatings.Methods Two types of pharmaceutical packaging materials containing nylon 6 coating were extracted in different extraction conditions separately.Waters XBridge C18 column(4.6 mm×150 mm,5μm)was used;mobile phase:acetonitrile water(20∶80);detector:UV detector;detection wavelength:210 nm;flow rate:1.0 mL/min;column temperature:30°C;injection volume:10μL,the content of caprolactam monomer in the extraction solution was determined.Results The linearity was good within the concentration range of 5.331-213.246μg/mL(r=0.9999),and the detection limit reaches 0.032μg/mL,precision and stability RSD were both less than 1.0%,and the recovery rate of sample spiking was between 98.64%and 102.48%.No caprolactam was detected in two types of pharmaceutical packaging materials containing nylon 6 coating.Conclusion Through legal verification,this method can be used to determine the leaching amount of caprolactam monomer in pharmaceutical packaging materials containing nylon 6 coating.

关 键 词：尼龙6涂层 己内酰胺单体浸出量 高效液相色谱法 药品包装材料 

分 类 号：TQ3[化学工程]