注射用聚氧乙烯山梨糖醇酐单油酸酯质量标准草案商榷

Analysis on Quality Standard of Tween-80 for Injection

近年,注射剂出现了严重的安全问题,人们把更多的目光投向药用辅料的质量和安全性。增溶性辅料聚氧乙烯山梨糖醇酐单油酸酯(吐温-80)因其在注射剂中的广泛应用,其生产工艺、产品质量和体外安全性成为研究焦点。作者调研了国内外吐温-80质量标准现状,在此基础上对注射用吐温-80质量标准进行较深入的探讨。在2010年版《中国药典》药用级吐温-80质量标准的基础上,建立注射用吐温-80质量标准草案,以期为注射用吐温-80质量标准的建立、注射剂安全性问题研究提供参考。

In recent years,injection has a serious security problem,people put more attention on the quality of pharmaceutical excipients and its safety.Because of its wide application in its production processes,product quality and safety research in vitro of polysorbate 80（tween-80） in the injection become the focus.This paper examined polysorbate 80 quality standard,on the basis of the standard home and abroad,injectable polysorbate 80 quality standards is thoroughly discussed.In order to establish injectable polysorbate 80 quality standards,provide the reference to injection safety problems.