高效液相色谱法测定药物涂层球囊中紫杉醇含量的不确定度评定  

Evaluation of uncertainty for determination of paclitaxel content in drug-eluting balloons by high performance liquid chromatography

作　　者：孙钰朋 杜福映 郭利娟 张丽莹 孟晓依 SUN Yupeng;DU Fuying;GUO Lijuan;ZHANG Liying;MENG Xiaoyi(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,NMPA Key Laboratory of Safety Evaluation for Biomaterials and Medical Devices,Shandong Key Laboratory of Biological Evaluation for Medical Devices,Jinan 250101,China)

机构地区：[1]山东省医疗器械和药品包装检验研究院,国家药品监督管理局生物材料器械安全性评价重点实验室,山东省医疗器械生物学评价重点实验室,济南250101

出　　处：《化学分析计量》2022年第8期72-76,共5页Chemical Analysis And Meterage

摘　　要：采用高效液相色谱法测定药物涂层球囊中紫杉醇的含量,并评定测量不确定度。建立了测量不确定度评定模型,测量过程中的不确定度来源主要有标准溶液配制、样品处理、标准曲线拟合、测量重复性。比较结果表明,高效液相色谱法测定药物涂层球囊中紫杉醇含量的测量不确定度主要来自测量重复性和标准工作溶液的配制两个方面。药物涂层球囊中紫杉醇含量的合成标准不确定度为0.104 mg,扩展不确定度为0.21 mg,测量结果可表示为(11.54±0.21)mg(k=2)。The content of paclitaxel in drug-eluting balloons(DEB)was determined by high performance liquid chromatography(HPLC).The model of uncertainty evaluation for this process was established and the sources of uncertainty were assessed as standard solution preparation,sample treatment,standard curve and measurement repeatability.The uncertainty of paclitaxel content in drug-eluting balloons mainly resulted from the repeatability of determination and the preparation of standard solutions with the comparison among the components of uncertainty.The synthetic standard uncertainty of paclitaxel content in drug-eluting balloons was 0.104 mg,and the expanded uncertainty was 0.21 mg.The result of measurement was(11.54±0.21)mg(k=2).

关 键 词：测量不确定度 药物涂层球囊 紫杉醇 高效液相色谱法 

分 类 号：O657.7[理学—分析化学]