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	紫杉醇自微乳释药体系的处方工艺及稳定性研究
	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 自微乳释药体系 制备 稳定性 Paclitaxel Self-microemulsifying drug delivery system Preparation Stability R943
其他题名	Formulation and Stability Studies on Paclitaxel Self-microemulsifying Drug Delivery System
中文摘要	目的优选紫杉醇自微乳的处方工艺,并研究其稳定性。方法以性状、粒径、含量、有关物质、细菌内毒素等为测定指标,考查不同pH和不同活性炭用量对工艺的影响,筛选出优化处方,并对其进行稳定性研究。结果制备的紫杉醇自微乳为淡黄色澄明液体,平均粒径19.6 nm,呈Gauss分布。紫杉醇自微乳释药体系(PTX-SMEDDS)经高速离心后稳定,影响因素实验结果表明,PTX-SMEDDS对高温和光不稳定。6个月的加速实验表明,各项指标均无明显变化。确定紫杉醇自微乳应密封、低温避光保存。结论紫杉醇自微乳制备工艺简便,制剂稳定,载药量高,适宜开发为注射自微乳释药体系。; Objective To study the preparation and stability of paclitaxel self-microemulsifying drug delivery system( PTX-SMEDDS). Methods The formulation of the PTX-SMEDDS was optimized by monitoring the appearance,particle size,concentration,relative substance,and bacterial endotoxin. Influence of different pH and different dosage of activated carbon on PTX-SMEDDS was investigated. Subsequently it was subjected to stability studies. Results The PTX-SMEDDS was a translucent diluted-yellow solution with a mean diameter of 19. 6 nm. High speed centrifugal test indicated PTX-SMEDDS was stable. The result of the influential factor tests showed PTX-SMEDDS was unstable to high temperature and light. In the accelerated tests for 6 months,the quality of PTX-SMEDDS was stable. The samples should be sealed and stored at low temperature and shady place. Conclusion Easily prepared and stable formulation of PTX-SMEDDS is achieved,and further investigation is warranted to develop self-microemulsifying drug delivery system for injection.
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=123456789/148457]
专题	清华大学
推荐引用方式 GB/T 7714	周丽娟,陈曦,刘清飞,等. 紫杉醇自微乳释药体系的处方工艺及稳定性研究[J],2016, 2016.
APA	周丽娟.,陈曦.,刘清飞.,王义明.,罗国安.,...&LUO Guo-an.(2016).紫杉醇自微乳释药体系的处方工艺及稳定性研究..
MLA	周丽娟,et al."紫杉醇自微乳释药体系的处方工艺及稳定性研究".(2016).

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