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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nifdc.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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地塞米松脂肪乳滴眼液载药性能的评价

Drug-loading performance evaluation of dexamethasone eye drops with lipid emulsion as carrier

作者(英文):
分类号:R917
出版年·卷·期(页码):2017,37 (4):732-736
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:建立测定以脂肪乳为载体地塞米松滴眼液中药物在各相中的分布和包封率方法,并分析其作为载药性能评价指标的可行性。方法:根据脂质乳中相密度差异,在8℃、30 000 r·min-1离心力下分离在油、水及油水界面相中的药物;依据凝胶分子筛原理对脂质乳滴表面的游离药物和包封于乳滴中的药物进行柱分离;色谱条件:采用Sun Fire C18色谱柱(250 mm×4.6 mm,5 μm),以乙腈-水(28∶72)为流动相,流速1.0 mL·min-1,检测波长240 nm,柱温30℃,进样量20μL。结果:水相、油相、油水界面磷脂层中地塞米松的占比为42.43%、31.12%、24.45%,体系中地塞米松的包封率为50.11%。结论:相分布和包封率指标合用能准确评价脂肪乳的载药性能,所建立的方法可作为以脂肪乳为载体滴眼液的质量控制的手段之一。

-----英文摘要:---------------------------------------------------------------------------------------

Objective:To establish methods for distribution and encapsulation efficiency of dexamethasone in eye drops with lipid emulsion as carrier in different phases,and to analyze the feasibility of this method used in drug performance evaluation. Methods:Based on the differences of density in each phase of lipid emulsion,centrifuge with 8℃,30 000 r·min-1 was used to separate the drug in oil,in water and in oil/water interface phase. The free drug on the surface and drugs coated in the emulsion droplet were separated and determined by micro column centrifugation using gel molecular sieve method. A Sun Fire C18 column (250 mm×4. 6 mm, 5 μm) was adopted, the mobile phase was acetonitrile-water(28:72) at the flow rate of 1. 0 mL·min-1, the detection wavelength was 240 nm, the column temperature was 30℃,and the sample volume was 20 μL. Results:The distribution of dexamethasone in water phase, oil phase and lecithin layer at oil/water interface were 42.43%, 31. 12% and 24.45%, respectively. The encapsulation efficiency of dexamethasone in emulsion droplet was 50. 11%. Conclusion:The phase distribution and entrapment efficiency can accurately evaluate the performance of drugloading in eye drops with lipid emulsion as carrier,and the established method can be used for quality control.

-----参考文献:---------------------------------------------------------------------------------------

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