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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, there has been a serious safety problem with injectables, and people are paying more attention to the quality and safety of pharmaceutical excipients. Soluble excipients polyoxyethylene sorbitan monooleate (Tween -80) due to its widespread use in the injection, the production process, product quality and safety in vitro to become the focus of research. The author investigated the status quo of domestic and international Tween-80 quality standards, based on which the Tween-80 quality standards for injection for more in-depth discussion. On the basis of the pharmaceutical grade Tween-80 quality standard of “Chinese Pharmacopoeia” in the 2010 edition, a draft Tween-80 quality standard for injection was established with the aim of establishing a Tween-80 quality standard for injection and research on the safety of injection reference.