聚山梨酯80质量分析与致敏原探究

吐温80在药物制剂特别是注射剂中应用广泛,但是近年来临床上含吐温80的中药注射剂多有不良反应发生,许多研究指出吐温80是引起不良反应的主要原因之一,通过研究发现国内市售的吐温80质量层次不齐,有的样品二甘醇含量大于34ppm。有在产品中添加双氧水进行脱色的问题。同时发现吐温80的质量同其过敏反应密切相关,吐温80中双氧水含量同Beagle犬的过敏反应存在正相关,此外吐温80的过敏反应还与其分子量分布有关,吐温80的过敏反应存在种属差异,犬对吐温80比较敏感,而猴并不敏感。

Tween 80 was widely used in medicines,especially in the injection.However,a lot of reports was about the adverse reaction after using of Chinese medicine injection contained the Tween 80 recently.Tween 80 was thought as the allergen.In this study,the quality of Tween 80 produced in domestic were analysed.The diethylene glycol content in all pieces was over 34ppm.Many producers use the hydrogenperoxide as the discolouring agent.The hydrogenperoxide had positive correlation of the adverse reaction.Species differences of the adverse reaction existed in dog and monkey.The anaphylactic reaction of Tween 80 was closely related to the molecular weight distribution.