天然维生素E微乳给药系统的研制  

Vitamin E Microemulsion

作　　者：龚银华 葛亮[1] 刘建平[1] 朱家壁[1] 

机构地区：[1]中国药科大学药物制剂研究所,南京210009

出　　处：《药学与临床研究》2013年第6期625-629,共5页Pharmaceutical and Clinical Research

基　　金：江苏省自然科学基金SBK201241121;中国药科大学中央高校基本科研业务费专项资金资助JKPZ2013007

摘　　要：研究天然维生素E微乳的制备并对其质量进行评价。考察天然维生素E在不同油相中的溶解情况,再采用逐滴加水法绘制伪三元相图,研究不同乳化剂、助乳化剂和Km值形成微乳的区域和能力,用origin 8.0软件绘制不同处方组成的相图,在此工作基础上制备天然维生素E水包油微乳。以Labrafac Lipophile WL 1349(MCT)/Cremophor EL-35/甘油/水形成了均匀稳定的微乳系统;用不同的介质稀释后,天然维生素E微乳粒径无明显变化;初步稳定性实验表明,室温储存3个月,药物含量和粒径均没有显著变化,稳定性良好。天然维生素E微乳易于制备,质量稳定,为开发新型天然维生素E制剂提供了依据。This article is to study the preparation of natural vitamin E-loaded microemulsion and evaluate its quality. Natural vitamin E microemulsion was prepared by using the the titration methods to prepare the pseudo-ternary diagram. Various factors which affect the formation of microemulsion were investigated. We used Origin 8.0 to make the pseudo-ternary diagram of different formulations. The contents of natural vitamin E in microemulsion were determined by an HPLC method and the droplet size of natural vitamin E microemulsion was determined by a laser particle analyzer. The preliminary stability of natural vitamin E was determined. The natural vitamin E microemulsion which consisted of LABRAFAC LIPOPHILE WL 1349誖（MCT）/Cremophor EL-35/glycerol/water was stable. The particle size and drug content of microemulsion was stable after the microemulsion was diluted by different solutions. The natural vitamin E microemulsion is easy to prepare by using LABRAFAC LIPOPHILE WL 1349（MCT）/Cremophor EL-35/glycerol/water. An excellent drug delivery system for natural vitamin E was developed.

关 键 词：天然维生素E 微乳 伪三元相图 质量评价 

分 类 号：R944.9[医药卫生—药剂学]