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	紫杉醇自微乳释药系统的制备及评价
	周丽娟 ; 陈曦 ; 刘清飞 ; 王义明 ; 罗国安 ; ZHOU Li-juan ; CHEN Xi ; LIU Qing-fei ; WANG Yi-ming ; LUO Guo-an
	2016-03-30 ; 2016-03-30
关键词	紫杉醇 自微乳释药系统 伪三元相图 制备 质量评价 paclitaxel self-microemulsifying drug delivery system pseudo-temary phase diagram preparation quality evaluation R944
其他题名	Preparation and Quality Evaluation of Paclitaxel Self-Microemulsifying Drug Delivery System
中文摘要	目的研制紫杉醇自微乳并进行质量评价。方法考察紫杉醇在不同油相、乳化剂和助乳化剂中的溶解度,再通过滴制法绘制伪三元相图,确定最优的Km值和处方,制备紫杉醇自微乳;并考察自微乳的外观、形态、粒径、载药量和稳定性。结果以聚氧乙烯蓖麻油EL35-卵磷脂/无水乙醇/中碳链甘油酯/水形成了均匀稳定的系统;紫杉醇自微乳为淡黄色澄明液体,稳定,平均粒径19.4 nm,呈Gauss分布,透射电镜下成圆球形,分布均匀。自微乳经0.9%的氯化钠注射液和5%的葡萄糖注射液稀释10及50倍后,外观、pH值、载药量、粒径均无明显变化。结论紫杉醇自微乳易于制备、质量稳定,为紫杉醇新型制剂的研发提供了科学依据。; OBJECTIVE To prepare paclitaxel self-microemulsifying drug delivery system( PTX-SMEDDS) and evaluate its quality. METHODS The equilibrium solubility of paclitaxel in different compositions of oil,emulsifiers and assistant emulsifiers was investigated. The optimal Kmwas determined and PTX-SMEDDS was prepared by using the method of titration to establish the pseudo-ternary phase diagram. The appearance,morphology,size distribution,concentration and stability of PTX-SMEDDS were determined. RESULTS PTX-SMEDDS prepared with EL-35,lecithin and anhydrous ethanol at the ratio of 4 ∶ 1 ∶ 6,containing 6% DOC-Na and 7. 5% of MCT,was a uniform and stable colloidal system displaying as a translucent diluted-yellow solution. PTX-SMEDDS under electron microscopy consisted of small spherical drops with a mean diameter of 19. 4 nm. The appearance,pH,concentration and particle size of SMEDDS were stable after it was diluted with sodium chloride injection and glucose injection by 10-fold or 50-fold,respectively. CONCLUSION The PTX-SMEDDS is easy to prepare and its quality is stable,which provieds some information for the development of new paclitaxel formulations.
语种	中文 ; 中文
内容类型	期刊论文
源URL	[http://ir.lib.tsinghua.edu.cn/ir/item.do?handle=123456789/148418]
专题	清华大学
推荐引用方式 GB/T 7714	周丽娟,陈曦,刘清飞,等. 紫杉醇自微乳释药系统的制备及评价[J],2016, 2016.
APA	周丽娟.,陈曦.,刘清飞.,王义明.,罗国安.,...&LUO Guo-an.(2016).紫杉醇自微乳释药系统的制备及评价..
MLA	周丽娟,et al."紫杉醇自微乳释药系统的制备及评价".(2016).

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