摘要
目的制备罗红霉素自乳化制剂,并初步探讨其体外质量评价。方法通过测定药物在不同油相中的溶解度,确定油相与各种乳化剂(助乳化剂)的配伍对自乳化效率的影响;通过绘制伪三相图,筛选罗红霉素自乳化制剂的最佳处方;考察该制剂水稀释液的微乳外观、粒径和乳化时间。结果自乳化制剂处方为罗红霉素:肉豆蔻酸异丙酯:Tween80(甘油)为3∶3∶4,该制剂稀释50倍后仍为澄清透明液体,粒径约75nm,呈正态分布,乳化时间约10min。结论罗红霉素自乳化制剂制备简单,质量稳定,能显著提高药物的溶解度。
Objective To prepare the roxithromycin self-emulsifying fornlulation and evaluate its quality.Methods The roxithromycin self-emulsifying fomlulation was optimized based on the roxithromycin solubility in different oils,and the self-emulsifying efficiency of various emulsifiers.We got the best formulation with establish of the pseudo-ternary phase diagram and evaluated the size and emulsifying time.Results The best formulation was roxithromycin：IPM：Tween80（glycerol） with the weight ratio of 3∶3 ∶4.After being diluted with water,the appearance of self-emulsifying drug was clear liquid.The average particle size was 75nm,the emulsifying time was about 10 minutes.Conclution The solubility of roxithromycin was significantly increased in self-emulsifying system and the formulation was stable and easy to prepare.
出处
《中国医药指南》
2011年第20期205-206,共2页
Guide of China Medicine
关键词
罗红霉素
自乳化
质量评价
Roxithromycin
Self-emulsify
Quality evaluation
