基于液相色谱法快速筛查贴敷医疗器械产品中非法添加的糖皮质激素类药物  

Rapid screening of illegally added glucocorticoid drugs in medical devices for application by liquid chromatography

作　　者：黄忠亮 李树康 陆珊珊 方珍文 HUANG Zhongliang;LI Shukang;LU Shanshan;FANG Zhenwen(Guangxi Testing Center for Medical Devices,Nanning 530031,Guangxi,China)

机构地区：[1]广西壮族自治区医疗器械检测中心,广西南宁530031

出　　处：《右江民族医学院学报》2024年第4期601-605,共5页Journal of Youjiang Medical University for Nationalities

基　　金：广西壮族自治区药品监督管理局2023年直属单位药品安全科研项目(桂药监科直属〔2023〕003号)。

摘　　要：目的观察液相色谱法筛查贴敷医疗器械产品中非法添加糖皮质激素类药物的效果。方法采用液相色谱法快速测定贴敷类医疗器械产品中非法添加的氢化可的松、地塞米松、醋酸泼尼松、醋酸可的松、醋酸地塞米松等5种糖皮质激素类化学物质。结果5种化学药物的浓度在1~20 mg/L范围内,标准曲线线性良好(r>0.999),5种物质最低检出限在0.008~0.042 mg/kg范围内,加标回收率为89.28%~107.50%,RSD为0.02%~0.29%;精密度试验、稳定性试验结果良好。结论建立的测定方法具有预处理时间短,精密度、稳定性好的优势,可用于快速筛查贴敷类医疗器械产品中非法添加的5种化学药物。Objective To observe the effectiveness of liquid chromatography in screening for illegally added glucocorticoid drugs in medical devices for application.Methods Liquid chromatography was used to rapidly determine the presence of five illegally added glucocorticoid chemicals in medical devices for application:hydrocortisone,dexamethasone,prednisone acetate,cortisone acetate,and dexamethasone acetate.Results The concentrations of the five chemicals ranged from 1 to 20 mg/L,with good linearity in the standard curves(r>0.999).The minimum detection limits for the five substances ranged from 0.008 to 0.042 mg/kg,with recovery rates between 89.28%and 107.50%,and RSDs from 0.02%to 0.29%.The precision and stability test results were satisfactory.Conclusion The established method has the advantages of short pretreatment time,good precision and stability,and can be used for rapid screening of five illegal chemicals added in the medical devices for application.

关 键 词：贴敷类医疗器械产品 糖皮质激素 液相色谱法 

分 类 号：R446.1[医药卫生—诊断学]