聚山梨酸酯增溶作用在中药液体制剂中的适应性  

Study on Solubilization of Tween 80 in Liquid Preparation of Traditional Chinese Medicine

作　　者：张海燕[1,2] 马鸿雁[3] 丛英[3] 张明令[1] 韦迎春[1] 邬伟魁[1] 邹文铨[4] 杨明[1,3] 

机构地区：[1]江西中医学院现代中药制剂教育部重点实验室,南昌330004 [2]西南交通大学材料先进技术教育部重点实验室,成都610003 [3]成都中医药大学,成都611137 [4]四川大学,成都610064

出　　处：《中国实验方剂学杂志》2012年第19期322-324,共3页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：中医药行业科研专项项目(200708006);重大新药创制重大专项(2009ZX09103-393;2009ZX09310-005)

摘　　要：对常用增溶性药用辅料吐温80在中药液体制剂中的适应性研究进行文献整理和分析。结果显示近年中药注射剂出现了较严重的安全问题,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。从吐温80对中药液体制剂增溶作用的局限性,吐温80当建立严格的质量标准,提高国产吐温80的质量,提高药典吐温80的质量标准,中药注射剂出现不良反应不是吐温80惹的祸等方面进行探讨。吐温80在一定的限量范围内运用于中药液体制剂是安全有效的。吐温80作为增溶剂或稳定剂用于中药注射剂时必须建立注射级质量标准,严格控制产品质量,在充分的实验数据支持下确定其使用量。This article mainly expounds the common solubilization polysorbate 80 ﹙Tween 80﹚in the adaptability in Chinese medicine liquid formulation.Polysorbate 80＇s increase soluble object,quality and standard etc were discussed.Polysorbate 80 is widely used as a solubilizer,emulsifier and stabilizer in the liquid formulations of traditional Chinese medicine for decades.In recent years,people put more attention on the quality of pharmaceutical excipients and their safety because injection has a serious security problem.Because of its wide application in its production processes,product quality and safety research in vitro of tween 80 in the injection become the focus.More studies are needed on Chinese medicine liquid formulation and the safety problems of tween 80 in production and application.

关 键 词：聚山梨酸酯80 增溶作用 中药液体制剂 

分 类 号：R283[医药卫生—中药学]