药学研究2016，Vol.35Issue(7)：399-400,411,3.DOI:10.13506/j.cnki.jpr.2016.07.009
PEG - rhIFN -β-1a 注射液中聚山梨酯20检测方法研究
Study on determination of polysorbate 20 in PEG - rhIFN - β -1a Injection
孙颖 1赵文才 1张贵民1
作者信息
- 1. 鲁南制药集团股份有限公司，国家手性制药工程技术研究中心，山东 临沂 276006
- 折叠
摘要
Abstract
Objective To establish an improved method for the determination of polysorbate 20 in Polyglycolated Re-combinant Human Interferon β - 1a(PEG - rhIFN - β - a)Injections. Methods The tested samples were reactead with chloroform and sulfur cyanogens cobalt ammonium,after standing at room temperature,the content of polysorbate 20 was de-termined by spectrophotometer at 620 nm wavelength. Results The results showed that the measured value of polysorbate 20 was consistent with the added value in the tested samples,the recovery was 98% ~ 102% and the RSD was less than 2. 0% . Conclusion The method was convenient,accurate,can be used to quantitative detect polysorbate 20 content in PEG- rhIFN - β - 1a Injection and other formulations.关键词
干扰素 β - 1a/聚山梨酯 20/检测/分光光度法Key words
RhIFN - β - 1a/Polysorbate 20/Determination/Spectrophotometry分类
药学引用本文复制引用
孙颖,赵文才,张贵民..PEG - rhIFN -β-1a 注射液中聚山梨酯20检测方法研究[J].药学研究,2016,35(7):399-400,411,3.
