摘要
目的:设计并优化青蒿素自乳化制剂工艺,并对其进行体外质量评价。方法:通过测定青蒿素在不同油、表面活性剂、助表面活性剂中的溶解度,选择辅料。在三元相图的基础上,利用星点设计法优化青蒿素自乳化处方。以外观、溶解度、乳化时间、乳化后粒径和多分散系数为评价指标对青蒿素自乳化制剂进行质量评价。结果:青蒿素自乳化制剂最佳处方为中链甘油三酸酯-聚山梨醇酯-80-无水乙醇质量比31∶37∶20,外观透明均一,粒径234.7 nm,多分散系数0.235,溶解度2.775 g·L-1,乳化时间25 s。结论:青蒿素自乳化制剂工艺简单、性质稳定的,各项理化性质良好。
Objective：To design and optimize technology of artemisinin self-emulsifying preparation,and evaluate its in vitro quality evaluation.Method：Excipients was selected by determining solubility of artemidinin in different oils,surfactants and co-surfactants.Based on ternary phase diagram,artemisinin self-emulsifying prescription was optimized by central composite design method.With appearance,solubility,emulsification time,particle size after emulsified and polydispersity coefficient as indexes to do quality evaluation of artemisinin emulsifying preparation.Result：Optimum prescription of this preparation was：MCT-tween-80-ethanol 31∶ 37∶ 20,it had uniform and transparent appearance,particle size was 234.7 nm,polydispersity coefficient 0.235,self-emulsifying time was 25 s,solubility was 2.775 g·L-1.Conclusion：Technology of arteannuin self-emulsifying preparation was simple and stable,it had good physical and chemical properties.
出处
《中国实验方剂学杂志》
CAS
北大核心
2012年第9期59-63,共5页
Chinese Journal of Experimental Traditional Medical Formulae
关键词
青蒿素
自乳化
质量评价
三元相图
星点设计
artemisinin
self-emulsifying
quality evaluation
ternary phase diagram
central composite design-response surface method
