首页|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

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

扫码查看
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.
Rapid screening of illegally added glucocorticoid drugs in medical devices for application by liquid chromatography
Objective To observe the effectiveness of liquid chromatography in screening for illegally add-ed glucocorticoid drugs in medical devices for application.Methods Liquid chromatography was used to rap-idly 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.

application medical devices productsglucocorticoidsliquid chromatography

黄忠亮、李树康、陆珊珊、方珍文

展开 >

广西壮族自治区医疗器械检测中心,广西 南宁 530031

贴敷类医疗器械产品 糖皮质激素 液相色谱法

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

2024

右江民族医学院学报
右江民族医学院

右江民族医学院学报

影响因子:0.708
ISSN:1001-5817
年,卷(期):2024.46(4)