化学药品标准物质定量分析方法研究进展  

Research progress in quantitative analysis methods for chemical reference substances

作　　者：谭丽媛 蔡彤[1] 王岩[1] TAN Liyuan;CAI Tong;WANG Yan(National Institutes for Food and Drug Control‚NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院化学药品所,化学药品质量研究与评价重点实验室,北京102629

出　　处：《中国药物警戒》2023年第11期1209-1216,共8页Chinese Journal of Pharmacovigilance

基　　金：国家重点研发计划(2019YFC1200704)。

摘　　要：目的 综述目前化学药品标准物质的定量分析方法,为药品质量监管、药物安全性评价、药品检验及研发机构的标准物质研制提供借鉴。方法 对化学药品标准物质定量分析方法的基本原理、适用范围、影响因素等进行介绍,并对不同定量方法的利弊进行分析。结果和结论 药品标准物质是药品研发、质量检测、安全监测等过程中检验检测的物质基础,是保证药品质量和保障药品标准实施的关键,而化学药品标准物质是其中占比最大的一类,其量值的准确性至关重要。在对化学药品标准物质进行定量分析时,要充分考虑各方法的适用性,选择最合适的方法。Objective To study the quantitative analysis methods for chemical reference substances,so as to offer evidence and suggestions for drug quality regulation,drug safety evaluation and drug testing and research institutes that performing the establishment of reference substances.Methods The basic principles,scope,and influencing factors of the cutting-edge quantitative analysis methods of chemical drug standard substances were introduced.The pros and cons between different methods were compared and stated.Results and Conclusion Pharmaceutical Reference substances are the material basis for drug development,quality control testing,safety monitoring and etc.,which are crucial to the insurance of the drug quality and the implementation of pharmaceutical specifications.The largest category among Pharmaceutical Reference standards are chemical drug reference substances,which makes the accuracy of their value are of vital importance.The applicability of each method should be fully considered in order to choose the most appropriate method in quantitative analysis of the chemical reference substances.

关 键 词：化学药品 标准物质 定量分析方法 药品检验 基准方法 安全性评价 质量控制 

分 类 号：R917[医药卫生—药物分析学]