铝佐剂疫苗《中国药典》铝含量测定不确定度评定  

Evaluation of the uncertainty of aluminum content determination for aluminum adjuvant vaccine in Chinese Pharmacopoeia

作　　者：李玉立 邵天舒 刘齐 李想 马一星 李文东 LI Yu-li;SHAO Tian-shu;LIU Qi;LI Xiang;MA Yi-xing;LI Wen-dong(Beijing Institute for Drug Control(Beijing Center for Vaccine Control),NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验研究院(北京市疫苗检验中心)国家药品监督管理局仿制药研究与评价重点实验室中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《药物分析杂志》2022年第8期1457-1464,共8页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立2020年版《中国药典》通则3106《氢氧化铝(或磷酸铝)测定法》的不确定度评定模型,并以含铝佐剂疫苗品种进行示例计算。方法:根据JJP1059.1-2012《测量不确定度的评定与表示》等规范对影响测量结果的各个不确定度来源进行分析和评估,建立了不确定度评定模型,并示例计算合成不确定度。结果:通过测定方法的分量分析建立了不确定度评定模型,在结果判断中基于扩展不确定度可设置严格接受标准与宽松接受标准。示例计算结果表明,锌滴定液的标定浓度及消耗滴定液体积引入的不确定度是该示例品种不确定度的主要来源。结论:通过建立不确定度评定模型,可对采用该方法进行铝含量测定的所有铝佐剂疫苗及其他含铝制剂的不确定度进行评定。根据评定结果,可以更合理地进行结果判断并从多个维度有效降低不确定度,更针对性地指导检验工作,同时该模型对于容量分析法的不确定度评定具有很好的借鉴作用。Objective:To establish the uncertainty evaluation model of determination of aluminum hydroxide(or aluminum phosphate) from General Chapter 3106 in Chinese Pharmacopoeia 2020,and calculate the model using the aluminum adjuvant vaccine as an example.Methods:The sources of uncertainty affecting the measurement results were analyzed and evaluated,according to the specifications such as JJP1059.1-2012 Evaluation and expression of measurement uncertainty.And the combined uncertainty was calculated based on the established uncertainty evaluation model as an example.Results:The model wasestablished throughanalysis of uncertainty components from the measurement method,whilestringent acceptan ce stan dard and relaxed acceptan ce stan dard wereintroduced in the expanded uncertainty result judgment.The uncertainty introduced by the calibrated concentration of zinc titrant and the volume of consumed titrant were the main sources,according to calculation results of the example.Conclusion:All aluminum adjuvant vaccines and other aluminum-containing preparations,using the same method for aluminum content determination,are able toevaluate the measurement uncertainty on the basisof this model.The result judgment can be more reasonable and the uncertainty reduction can be more effectively,consequentlyto guidethe testing workin a more targeted way and offer useful references to evaluate the measurement uncertainty of capacity analysis.

关 键 词：铝佐剂疫苗 铝含量测定 药典 不确定度评定 络合滴定法 严格接受标准 宽松接受标准 

分 类 号：R917[医药卫生—药物分析学]