摘要
参照欧洲药典(EP5.4)中的质量标准,对国内外4种不同来源吐温80的质量控制指标进行检查,将结果进行拟合得到综合质量指数。通过豚鼠过敏试验比较了4种吐温80的最低致敏剂量和过敏反应的严重程度。结果显示4种吐温80的综合质量指数与其最低致敏剂量呈正相关,与过敏反应的严重程度呈负相关。说明吐温80的致敏性与产品质量密切相关。
This investigation carried out quality inspection items of four kinds of polysorbate 80 of different sources according to the European Pharmacopoeia（EP 5.4）and fitted the results in order to obtain the overall quality index.The sensitivity tests using guinea-pig allowed the comparison of the minimum sensitizing dose and the extent of anaphylactoid reaction of the polysorbate 80.The results showed that the overall quality index and the minimum sensitizing dose was positively correlated,while the overall quality index and the extent of anaphylactoid reaction was negatively correlated,indicating that the quality and sensitization of polysorbate 80 is closely related.
出处
《中国药科大学学报》
CAS
CSCD
北大核心
2010年第3期244-247,共4页
Journal of China Pharmaceutical University
基金
国家科技支撑计划资助项目(No.2008BAI55B03)
国家"重大新药创制"科技重大专项资助项目(No.2009ZX09310-004)~~
关键词
吐温80
质量控制
过敏反应
polysorbate 80
quality control
hypersensitivity
