项目名称: 粉状药物品质鉴定的表面解吸化学电离质谱研究
项目编号: No.21305011
项目类型: 青年科学基金项目
立项/批准年度: 2014
项目学科: 数理科学和化学
项目作者: 张兴磊
作者单位: 东华理工大学
项目金额: 25万元
中文摘要: 针对粉末状药物种类多、来源广、成分复杂、品质良莠不齐、缺乏快速品质鉴定技术之现状,本项目以表面解吸常压化学电离质谱(DAPCI-MS)技术为基础,以内酰胺类抗生素粉末药物为主要研究对象,在不需要样品预处理的条件下,开发无污染、非破坏快速检测抗生素产品的质谱学分析新方法,对样品中的不同含量组分如有效成分、痕量成分等进行多级质谱研究和结构鉴定,确定其种类和含量;结合化学计量学,考察不同厂家样品的特征质谱指纹谱图与药品品质、生产工艺、原料之间的联系,建立粉末状药物品质快速质谱检测方法和溯源评价模型,并验证该技术体系的科学性和模型的适配性。本项研究为粉末状药物的生产过程控制、品质评价与溯源等提供科学基础,对抗生素产品质量的监管和市场的规范具有积极意义。
中文关键词: 抗生素;直接质谱;快速检测;;
英文摘要: Powdered inferior pharmaceutical products could affect the health of people and may lead to death in many cases. Pharmaceutical analysis, as a key step to prevent people from taking counterfeit pharmaceutical products, is thus of paramount importance. In this study, powdered pharmaceutical products, such as lactam antibiotics, will be analyzed using surface desorption atmospheric pressure chemical ionization mass spectrometry (DAPCI-MS). The type and content of active components, degradation products and trace impurities in various commercial pharmaceutical preparations will be researched by tandem mass spectrometry and structure identification without sample pretreatment. Combined with chemometrics, the relation of quality, production technology, material and fingerprints of products made by different manufacturers will be studied, a new detection method, based on DAPCI-MS, and tracing origins model about quality analysis of powdered pharmaceuticals will be established and proved. Our research will prove that DAPCI-MS is a valuable tool for the entire pharmaceutical supply chain to prevent counterfeit intrusions and for rapidly differentiating the quality of commercial pharmaceutical products.
英文关键词: antibiotics;ambient mass spectrometry;rapid analysis;;