摘要
目的:建立高效液相色谱仪(HPLC)测定贴敷中解热镇痛类阿司匹林、氨基比林、布洛芬、双氯芬酸钠、吲哚美辛、对乙酰氨基酚、吡罗昔康、萘普生、保泰松、美洛昔康、尼美舒利、水杨酸甲酯12种化学药物含量的方法。方法:样品用加热冷凝回流法进行前处理,用高效液相色谱法(HPLC)对阿司匹林等12种化学药物进行检测。结果:12种化学药物在相应测定范围内线性关系良好,相关系数均大于0.9992;仪器定量限为0.006mg/贴~0.2mg/贴,精密度RSD为0.9%~4.8%,平均回收率为79.2%~118.6%,重复性RSD均在1.7%以下。结论:本方法灵敏度高,回收率、重复性较好,可准确、高效测定贴敷类医疗器械中非法添加化学药物情况。
A high-performance liquid chromatography(HPLC)method for determining the content of 12 chemical drugs,including antipyretic and analgesic aspirin,aminopyrine,ibuprofen,diclofenac sodium,indomethacin,acetaminophen,piroxicam,naproxen,prednisone,meloxicam,nimesulide,and methyl salicylate,in patches is established.The samples are pretreated using the heating condensation reflux method,and 12 chemical drugs,including aspirin,are detected using high-performance liquid chromatography(HPLC).The 12 chemical drugs show good linear relationships within the corresponding measurement range,with correlation coefficients greater than 0.9992.The quantitative limit of the instrument is 0.006mg/patch to 0.2mg/patch,the precision RSD is 0.9% to 4.8%,the average recovery rate is 79.2% to 118.6%,and the repeatability RSD is below 1.7%.This method has high sensitivity,good repeatability,accurate and efficient.
作者
张珏
罗洁
颜敏
刘磅
易必新
Zhang Jue;Luo Jie;Yan Min;Liu Bang;Yi Bixin(Hunan Institute for Drug Control,Hunan Provincial Drug Inspection Center,Changsha 410010,China)
出处
《分析仪器》
2025年第4期13-18,共6页
Analytical Instrumentation
基金
湖南省自然科学基金科药联合基金项目(项目名称:贴敷类医疗器械非法添加常见解热镇痛抗炎药、抗过敏药检测方法研究,项目编号:2022JJ80072)。
关键词
贴敷类医疗器械
解热镇痛
非法添加
高效液相色谱仪
Adhesive medical devices
Antipyretic and analgesic
Illegal addition
High performance liquid chromatography
