摘要
该文比较了聚山梨酯80、聚氧乙烯蓖麻油衍生物、泊洛沙姆、卵磷脂、聚乙二醇15-羟基硬脂酸酯、环糊精类等6种(类)注射用表面活性剂的中国、欧洲和美国药典标准,并分别对其化学组成、基本性质、配伍禁忌及安全性进行了论述。因中国药典(2005版)尚未收载注射用级别的表面活性剂,建议引进国外品种并参考国外标准制定相应的质量标准。
This article is an attempt to compare six surfactants for injection, such as polysorbate 80, polyoxyethylene castor oil derivatives, poloxamer188, lecithin, Solutol HS 15, cyclodextrins, from various countries' standards of pharmacopoeias and respectively gives an overview of their chemical compositions, physical appearance, incompatibility of medicines and safety, which provides reference data for new drug research and clinical study of injections. As for the surfactants for injection that are not recorded in the chinese pharmacopoeia (2005), we suggest that we introduce those foreign surfactants and make corresponding quality standards by referring to foreign standards.
出处
《中国实验方剂学杂志》
CAS
北大核心
2010年第1期115-119,共5页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家十一五支撑计划(2006BAI14B05)
"重大新药创制"科技重大专项(2009ZX09301-005-05)
中国中医科学院自主选题(ZZ2006108)
关键词
注射剂
表面活性剂
质量标准
安全性
injections
surfactants
quality specificationl safety