摘要
目的建立吐温80化学组分的分离和鉴定方法,为研究吐温80的致敏原奠定基础。方法收集国内外不同企业生产的吐温80样品,先通过HPLC-ELSD确定了高效液相色谱分离吐温80组分的实验条件,然后通过HPLC-MS的方法鉴定各个色谱峰的化学组分归属。结果不同结构类型的化学组分得到有效的分离,各色谱峰均得到准确的归属,不同厂家及批次吐温80的组分及其相对含量均有所不同,并有非法添加勾兑的问题存在。结论建立的分离分析方法快速、简便、可用于对吐温80的生产质量控制,也可为下一步通过分离或合成的手段研究吐温80中不同组分的物理化学性质,发现致敏原奠定基础。
OBJECTIVE To establish a method for the separation and identification of the components in polysorbate 80 and to lay the foundation for identifing the sensitinogen of polysorbate 80. METHODS Polysorbate 80 samples from both domestic and foreign manufacturers were collected. The separation condition was first established using HPLC-ELSD, and then the chemical composition of each chromatographic peak was identified by HPLC-MS. RESULTS The chemical components with different types of structures were ef- ficiently separated, and each chromatographic peak was properly assigned. Polysorbate 80 samples of different batches and manufacturers showed different chemical compositions and relative contents. There was illegal blending during the production of polysorbate 80. CONCLUSlON The proposed method is rapid and simple, which is not only suitable for the process control of polysorbate 80 but also lays foundation for further investigation of the physical and chemical properties of the components thus to find the sensitinogen.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2012年第2期149-154,共6页
Chinese Pharmaceutical Journal
基金
国家自然科学基金资助项目(81160523)
关键词
吐温80
化学组分
蒸发光散射
质谱
polysorbate 80
chemical composition
evaporative light-scattering detector
MS detector
