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黄连素口服纳米乳的研制、质量及安全性评价 被引量:16

Preparation,Quality and Safety Evaluation of Berberine Nanoemulsion for Oral Application
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摘要 研究选择适宜的油相、表面活性剂和助表面活性剂,利用伪三元相图,以新型纳米乳为载体,对黄连素的传统剂型进行改进,研制出适合口服的纳米乳制剂;以离心(13000r·min-1,30min)稳定性和乳滴粒径作为主要的评价标准,对纳米乳的黏度、电导率、折光率、粒径和初步稳定性等方面进行质量评价;用小鼠灌胃的急性毒性实验对纳米乳的安全性进行评价。结果表明研制出的黄连素口服纳米乳为澄清透明的液体,透射电镜下观察为球状液滴,平均粒径为56.8nm;高速离心稳定、高温和强光条件下考察10d,其含量和粒径均未发生明显变化;小鼠灌胃结果,纳米乳无毒性。由此证明研制出的黄连素口服纳米乳是一种质量稳定、安全性高的良好药物传递系统。 Suitable for oral nanoemulsion of berberine was prepared by choosing appropriate of oil, surfactant (SF), and co-surfactant (CoSF). It was improved with new nanoemulsion carrier to the traditional preparations of berberine, by studying the pseudotemary phase diagrams. The nanoemulsion was assessed by key two evolutional normal: centrifuge stable (13 000 r·min^-1,30 min)and the diameter. In respect of the quality, the viscosity, electric conductivity, refraction and particle of the nanoeulsion were inspected. Its safety was evaluated to mice, through acute toxicity oral test. The results showed that the preparative nanoemulsion of bererine was a kind of clear solution and small spherical drops under election microscopy, with the average diameter of about 56.8 nm. The nanoemulsion for oral application of berberine was stable after high speed centrifuging. And also their content and diameters had no obvious change. The acute toxicity oral test suggested that the nanoemulison is no toxicity to mice. These results can proof that the preparative nanoemulsion of berberine is a good drag delivery system with stable quality and high safety.
出处 《上海交通大学学报(农业科学版)》 2007年第1期60-65,共6页 Journal of Shanghai Jiaotong University(Agricultural Science)
基金 西北农林科技大学校长基金项目资助(130709)
关键词 黄连素 纳米乳 稳定性 安全性评价 berberine nanoemulsion stable safety evaluated
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