高效液相色谱法测定冠脉药物释放球囊扩张导管中紫杉醇含量的不确定度评定  

Evaluation of Uncertainty for Determination of Paclitaxel in Coronary Drug Release Balloon Dilated Catheter by High Performance Liquid Chromatography

作　　者：彭俊 王书晗 马森菊 高小凤 周汨 刘尧 PENG Jun;WANG Shuhan;MA Senju;GAO Xiaofeng;ZHOU Mi;LIU Yao(Shenzhen Institute for Drug Control(Shenzhen Testing Center of Medical Device),Guangdong Shenzhen 518057,China)

机构地区：[1]深圳市药品检验研究院(深圳市医疗器械检测中心),广东深圳518057

出　　处：《广州化工》2024年第19期97-100,共4页GuangZhou Chemical Industry

基　　金：广东省药品监督管理局2021年科技创新团队项目:高风险医疗器械可沥滤物研究及标准化科技创新团队(No:2021TDB29);广东省药品监督管理局2022年科技创新团队项目:手术机器人临床前动物实验评价科技创新团队(No:2022TDB51);广东省药品监督管理局2022年科技创新团队项目:血液接触类医疗器械/材料涂层牢固度评价方法研究科技创新团队(No:2022TDB52);深圳市药品检验研究院2023年度十大科研课题:从可沥滤物研究角度建立ECMO产品质量评价体系(编号YNK20230202)。

摘　　要：采用高效液相色谱法测定冠脉药物释放球囊扩张导管中紫杉醇的含量,通过分析试验流程,建立对应的数学模型,对试验中测量结果的不确定度来源分别进行分析和评估,并计算合成不确定度。分析结果表明,通过高效液相色谱法测定冠脉药物释放球囊扩张导管中紫杉醇含量,其测量不确定度主要来源于三个方面:按照影响的大小依次是标准曲线拟合、测量结果的重复性、样品前处理。本次评定球囊扩张导管中紫杉醇含量的测量结果为(1201.06±34.83)μg,其中第二项为扩展不确定度,k=2。The content of paclitaxel in coronary drug release balloon dilation catheter was determined by high performance liquid chromatography(HPLC).The measurement process was analyzed and a mathematical model was built.The sources of uncertainty of measurement results was analyzed and evaluated.And the synthetic uncertainty was also calculated.The results showed that the uncertainty of paclitaxel content in balloon dilated catheter by HPLC was mainly derived from standard curve fitting,measurement repeatability and sample pretreatment.The uncertainty introduced by curve fitting had a greater influence.The measurement result of paclitaxel content in balloon dilated catheter was(1200.775±36.744)μg.The second item was the value of expansion uncertainty,k=2.

关 键 词：紫杉醇 不确定度 高效液相色谱法 球囊扩张导管 

分 类 号：O657.7[理学—分析化学]